Showing posts with label qualified person. Show all posts
Showing posts with label qualified person. Show all posts
Wednesday, 12 March 2014
The Viva - Pt 1
After finally completing my QP journey I thought I would write a couple of posts to describe the final few steps leading up to the viva. This first post will concentrate on completion & submission of your forms and the final preparation leading up to the big day. The subsequent post will review the big day itself.
I've previously posted about the application form and by now this should all be complete and checked by your sponsor to ensure all aspects of the study guide have been met. Your sponsor will also need to complete the sponsor form before you can submit. This is an extensive form that will require your sponsor to document your suitability for QP eligibility. Completion of this form is not a 5 minute job so don't leave this to the last minute! The form was updated last year and requires significant input from your sponsor on your progress with detailed examples of how you have met certain aspects of the guide.
Someone once said 'the waiting is the hardest thing' and once you have submitted all your forms there is not much more you can do but wait. The first contact from your professional body's QP officer will be confirmation of receipt of your application and fee. Assuming there is no administrative errors with your application form the next contact from the QP officer will likely be a month away whilst your application form is reviewed by 2 QP assessors. Occasionally the QP officer will contact you on behalf of the assessors for further information or clarification of specific areas of your application. Once the assessors are satisfied with your application the QP officer will contact you to arrange a date for your viva. This date maybe anywhere from a few weeks away to over 6 months away - it all depends on the numbers of trainees and cancellations. Following a verbal confirmation of the viva date you will be sent details by post which you will need to confirm in writing that you are going to attend.
My Experience
My application forms were submitted early December 2013. Within a week my QP officer emailed me to request clarification regarding my sponsor's details. The next correspondence was a call from my QP officer in mid January 2014. This was to invite me to an assessment interview. At this point I was informed of a cancellation and a vacant slot for the first week of March. The next available dates were not until May/June so I decided to accept the offer of the earlier viva. I received confirmation of the date, time & location in the post a few days later. It was somewhat of a relief to finally have a date to work towards.
Final preparation
During the weeks leading up to my viva I continued to study but the focus changed from knowledge gathering to polishing my strategy for dealing with scenarios and answers to questions that were likely to come up. I worked closely with my sponsor at this point to test run specific answers to questions such as supply chain, legal/routine duties, tech transfer, water systems, cleaning validation & method validation. I also revisited the processes for my products to ensure I knew all the relevant critical control points. This also enabled me to start predicting scenarios relating to my processes and how I would tackle them if they arose during the viva. With only a week or so remaining I started to reduce my studying time as I was worried about burning out from all the work I had been putting in over the previous few months. I was happy that my knowledge and scenario strategy was ingrained within me so I saw no real need to try and cram more and more revision in. This decision was somewhat made for me as I had to prepare and host an MHRA inspection the week before and attend my friend’s stag weekend in Wales the weekend before – probably not the best preparation but it was nice to be able to switch off for a few days.
And then my viva date was finally here……
Friday, 22 November 2013
Friday's Round Up
Overkill Overview
A good article from Pharmaceutical Technology covering the concept of overkill sterilisation cycles for steam sterilising cycles.
J&J fined for off-label marketing
Yet more woes for J&J and its subsidiaries after the company was fined $2.2 billion for promoting off-label use. A good reminder of the updated PV requirements of 2010/84/EU stipulating that all off-label & unlicensed use must be incorporated into the PV system.
USP update for particulate inspection
A new draft USP monograph has finally provided a definition for 'essentially free from particles'. The definition involves a 100% inspection meeting an AQL of 0.65% or tighter for visible particles. Subvisible particles remain unchanged.
EMA's Risk Aversion
A very interesting article giving an insight into the EMA's thoughts on risk versus benefit during drug assessments and the potential shift to accept more uncertainty in their assessment. It is an example of how competent authorities are incorporating ICH Q9 principles into their quality systems. Some of these concepts may be of use in your decision making process for recall scenarios.
Responses to GMP updates
The EC has published comments from industry following draft updates to the GMP guide, GDP and excipient GMP.
Online QP training
Inspired Pharma have recently launched online medicinal chemistry QP training module with more modules scheduled for release over the coming months.
Ian Hudson Interview
The Pharmaceutical Journal have published an interview with Ian Hudson, the newly appointed chief executive of the MHRA. The interview highlights the increase in more specialist medicines such as biologicals and the increase in conditional authorisations.
Compounding for death
US compounders are rarely out of the news and this article raises yet more questions.
Friday, 27 September 2013
Friday's Round Up
Counterfeit Viagra & Cialis seizure
A large seizure of these popular lifestyle drugs has been reported in the Czech Republic. It is not clear how the counterfeit products were identified. It makes you wonder if any have actually gone through the system and ended up in the legitimate supply chain.
FDA Flu Vaccines
A good brief overview of the process of influenza vaccine production by the FDA. Interestingly the article states that the FDA actually release the vaccines into the US market. This mirrors some of the UK animal vaccine products that are released to market by the VMD and not the QP (although each batch does require QP certification prior to VMD release).
UK Class 2 recall
A recall of buprenorphine tablets due to a potential printing error with the carton supplier. This is a good example of when carton suppliers print the batch number as opposed to printing on-line in the high speed packaging lines. It is also a good opportunity to review the on line packaging controls that may have prevented this error. I'm guess that a blob detector was used to detect the presence of ink within the space for the batch number. A more complex optical character verification system may have prevented this error.
Poland's human tissue legislation not good enough
The EC has taken Poland to court as their transposition of EU directives surrounding the quality & safety of human tissues. I wonder where this leaves the QP's responsibility? If for example a UK IMP QP was certifying ATMPs manufactured in Poland.....
ATMPs on the radar
Only the 3rd ATMP application to the CAT and the 1st to include non-clinical data and eludes to more ATMP applications on the horizon. It is worth mentioning that a new MIA has established as part of ATMP manufacturing in a hospital setting. The MIA is termed 'MeAT'
FDA recall (Budesonide)
More sterility assurance issues with compounders in the States. This time a bottle of budesonide has been contaminated with fungal spores.
Medical Device Safety
The EC has introduced more measures to improve the safety of medical devices. This appears to focus the attention on the oversight of the Notifying Bodies. Yet more work for the MHRA.......
Happy Reading!
A large seizure of these popular lifestyle drugs has been reported in the Czech Republic. It is not clear how the counterfeit products were identified. It makes you wonder if any have actually gone through the system and ended up in the legitimate supply chain.
FDA Flu Vaccines
A good brief overview of the process of influenza vaccine production by the FDA. Interestingly the article states that the FDA actually release the vaccines into the US market. This mirrors some of the UK animal vaccine products that are released to market by the VMD and not the QP (although each batch does require QP certification prior to VMD release).
UK Class 2 recall
A recall of buprenorphine tablets due to a potential printing error with the carton supplier. This is a good example of when carton suppliers print the batch number as opposed to printing on-line in the high speed packaging lines. It is also a good opportunity to review the on line packaging controls that may have prevented this error. I'm guess that a blob detector was used to detect the presence of ink within the space for the batch number. A more complex optical character verification system may have prevented this error.
Poland's human tissue legislation not good enough
The EC has taken Poland to court as their transposition of EU directives surrounding the quality & safety of human tissues. I wonder where this leaves the QP's responsibility? If for example a UK IMP QP was certifying ATMPs manufactured in Poland.....
ATMPs on the radar
Only the 3rd ATMP application to the CAT and the 1st to include non-clinical data and eludes to more ATMP applications on the horizon. It is worth mentioning that a new MIA has established as part of ATMP manufacturing in a hospital setting. The MIA is termed 'MeAT'
FDA recall (Budesonide)
More sterility assurance issues with compounders in the States. This time a bottle of budesonide has been contaminated with fungal spores.
Medical Device Safety
The EC has introduced more measures to improve the safety of medical devices. This appears to focus the attention on the oversight of the Notifying Bodies. Yet more work for the MHRA.......
Happy Reading!
Friday, 6 September 2013
Friday's Round Up
Teva Ranitidine Recall
The FDA has issued a recall for 5 batches of ranitidine tablets due to raw material contamination with a Pseudomonas species. This shows that recalls can still be required for microbial contamination of non-sterile dosage forms. A good chance to review the likely sources of Pseudomonas within a solid dosage form. Purified water? Tablet coating? Is Pseudomonas an objectionable organism for oral preparations according to the BP?
Process Validation Guidelines from Asia
Draft PV guidelines have been published within the Asian area which are largely based on the FDA and EMA guidance already in circulation.
Inhaled Insulin
Phase 3 studies have shown some promising results for insulin delivery via the inhaled route. A good time to review the pros and cons of s/c protein suspensions vs powder protein for inhalation with regards stability, manufacturing, patient concordance etc
Risk of CJD found in medical devices
A report from the USA that describes patients put at risk from contaminated medical devices infecting patients with CJD. It is interesting to note that the sterilisation process utilised within the hospitals were incapable of killing the prions responsible and that there is no diagnostic test for CJD.
GSK's long term plan for China
Following on from GSK's bribery case in China the pharmaceutical giant is said to be contemplating its future presence within China. There is also rumours that GSK is poised to sell off some of its iconic consumer brands Lucozade and Ribena to focus on its core pharmaceutical business.
Sterile compounder recall
Yet another recall issued from a US steriles compounder due to questions over contract sterility testing methods.
Free Webcast - containment strategies in high-potency manufacture
The cost of Drug Development
An interesting article where NICE is questioning Pfizer's estimate of the cost of bringing a drug to the market. The quote from the NICE chief exec sums it up nicely:
will QbD bring about a reduction in these costs?
Spanish Pharmacy Debt
Bail outs are often associated with the financial sector so this article came as a surprise to me. As a potential QP releasing product to Spain you should be aware of these policies as it may affect your market. If pharmacies do close down will there be an increase in demand? Will this increase lead to counterfeit risk? Will patients turn to the internet? Will this manifest as a change in your PV complaints from this market?
Hospira Recall
Hospira has issued a recall of Aminosyn II sterile infusion due to the presence of a human hair within the product. This should make you question the gowning requirements for aseptic filling. How would you tackle this as a potential scenario?
New Herceptin Formulation
Roche has received approval for a sub-cutaneous version of Herceptin. This will help offset the risk of patent expiry of the IV formulation for a few more years. A good time to review the administration risks of SC vs IV. It is also worth considering how the IV version is actually administered to patients. Read section 6.6 of the SPC and see for yourself! Hopefully the SC formulation will be easier to administer.
QP as leaders
A great article examining the role of leaders within the ever changing world of biotechnology. QPs should be leaders and 'change agents' not only within the quality department but throughout the entire organisation. These soft skills are an essential element to your QP training.
Happy Reading!
The FDA has issued a recall for 5 batches of ranitidine tablets due to raw material contamination with a Pseudomonas species. This shows that recalls can still be required for microbial contamination of non-sterile dosage forms. A good chance to review the likely sources of Pseudomonas within a solid dosage form. Purified water? Tablet coating? Is Pseudomonas an objectionable organism for oral preparations according to the BP?
Process Validation Guidelines from Asia
Draft PV guidelines have been published within the Asian area which are largely based on the FDA and EMA guidance already in circulation.
Inhaled Insulin
Phase 3 studies have shown some promising results for insulin delivery via the inhaled route. A good time to review the pros and cons of s/c protein suspensions vs powder protein for inhalation with regards stability, manufacturing, patient concordance etc
Risk of CJD found in medical devices
A report from the USA that describes patients put at risk from contaminated medical devices infecting patients with CJD. It is interesting to note that the sterilisation process utilised within the hospitals were incapable of killing the prions responsible and that there is no diagnostic test for CJD.
GSK's long term plan for China
Following on from GSK's bribery case in China the pharmaceutical giant is said to be contemplating its future presence within China. There is also rumours that GSK is poised to sell off some of its iconic consumer brands Lucozade and Ribena to focus on its core pharmaceutical business.
Sterile compounder recall
Yet another recall issued from a US steriles compounder due to questions over contract sterility testing methods.
Free Webcast - containment strategies in high-potency manufacture
The cost of Drug Development
An interesting article where NICE is questioning Pfizer's estimate of the cost of bringing a drug to the market. The quote from the NICE chief exec sums it up nicely:
“if it really does cost £1.2 billion to develop a new drug, the
question the pharmaceutical industry must be able to answer is this: are
you absolutely confident that it needs to?”
will QbD bring about a reduction in these costs?
Spanish Pharmacy Debt
Bail outs are often associated with the financial sector so this article came as a surprise to me. As a potential QP releasing product to Spain you should be aware of these policies as it may affect your market. If pharmacies do close down will there be an increase in demand? Will this increase lead to counterfeit risk? Will patients turn to the internet? Will this manifest as a change in your PV complaints from this market?
Hospira Recall
Hospira has issued a recall of Aminosyn II sterile infusion due to the presence of a human hair within the product. This should make you question the gowning requirements for aseptic filling. How would you tackle this as a potential scenario?
New Herceptin Formulation
Roche has received approval for a sub-cutaneous version of Herceptin. This will help offset the risk of patent expiry of the IV formulation for a few more years. A good time to review the administration risks of SC vs IV. It is also worth considering how the IV version is actually administered to patients. Read section 6.6 of the SPC and see for yourself! Hopefully the SC formulation will be easier to administer.
QP as leaders
A great article examining the role of leaders within the ever changing world of biotechnology. QPs should be leaders and 'change agents' not only within the quality department but throughout the entire organisation. These soft skills are an essential element to your QP training.
Happy Reading!
Friday, 30 August 2013
Friday's Round Up
Rapid Micro ID
BioMerieux has received FDA approval for their Vitek Mass spec system for rapid identification of organisms. The main advantage of this over the traditional Vitek system is that no culturing or gram staining is required before identification. Organisms can be taken straight from the agar plate, mixed with a solvent and injected into the mass spec. Results are compared against a database and usually given within 30mins.
More US compounding woes
This time the focus is on inadequate sterility testing performed by a contract laboratory.
CEP database
Although this database has been available for some time now, I only discovered this recently so I thought I'd share in case some of you haven't seen it before. A useful link for checking the CEP status of your relevant APIs.
FDA Inspection Reports
A good overview of the 3 main inspection reports issued during FDA inspections. Useful information if, like me, you dont have the pleasure of hosting FDA inspections.
Pharmacogenomics Webinar
A free webinar on the use of pharmacogenomic profiling during drug development. Pharmacogenomics involves the profiling of patients' genetic or proteomic profiles in order to tailor their treatments to those drugs with highest probability of being clinically effective. This is often associated with the term personalised therapy.
FDA Recall - Glass particles
A recall for daptomycin due to the presence of glass particles in a number of batches. A useful reminder to review the methods for visible & sub visible particle inspection in final product testing.
New caps for tylenol
This news article shows how J&J are trying to reduce the risks of overdose with tylenol (aka paracetamol). I've posted this just to get you thinking about how you would manage this change control as a QP. Apart from the obvious regulatory variations etc, think about the practical issues such as how to reconcile the old caps from warehousing before bringing in the new caps; how will the cap changeover occur - run down old stock before introducing new caps or full changeover on a single date?
21 CFR 11 overview
A useful overview of the impact of 21 CFR 11 compliance.
BioMerieux has received FDA approval for their Vitek Mass spec system for rapid identification of organisms. The main advantage of this over the traditional Vitek system is that no culturing or gram staining is required before identification. Organisms can be taken straight from the agar plate, mixed with a solvent and injected into the mass spec. Results are compared against a database and usually given within 30mins.
More US compounding woes
This time the focus is on inadequate sterility testing performed by a contract laboratory.
CEP database
Although this database has been available for some time now, I only discovered this recently so I thought I'd share in case some of you haven't seen it before. A useful link for checking the CEP status of your relevant APIs.
FDA Inspection Reports
A good overview of the 3 main inspection reports issued during FDA inspections. Useful information if, like me, you dont have the pleasure of hosting FDA inspections.
Pharmacogenomics Webinar
A free webinar on the use of pharmacogenomic profiling during drug development. Pharmacogenomics involves the profiling of patients' genetic or proteomic profiles in order to tailor their treatments to those drugs with highest probability of being clinically effective. This is often associated with the term personalised therapy.
FDA Recall - Glass particles
A recall for daptomycin due to the presence of glass particles in a number of batches. A useful reminder to review the methods for visible & sub visible particle inspection in final product testing.
New caps for tylenol
This news article shows how J&J are trying to reduce the risks of overdose with tylenol (aka paracetamol). I've posted this just to get you thinking about how you would manage this change control as a QP. Apart from the obvious regulatory variations etc, think about the practical issues such as how to reconcile the old caps from warehousing before bringing in the new caps; how will the cap changeover occur - run down old stock before introducing new caps or full changeover on a single date?
21 CFR 11 overview
A useful overview of the impact of 21 CFR 11 compliance.
Friday, 23 August 2013
Friday's Round Up
Webinar: QC testing of culture media
An on-demand webinar covering the use of control strains for QC testing of culture media.
Soliris Recall
A recall of Alexion's orphan drug soliris due to particulate contamination identified in vials. Interesting that the particles were identified following routine testing of retained samples. Did the CMO have a validated method for particulate testing? If not, then where was the QP oversight?
QP review of BMRs
An interesting overview by the ECA on the expectation of the QP on reviewing BMRs prior to certification
APIC guideline for contracted QC
This guideline covers the management & qualification of contract QC labs
Monoject Recall - FDA
A recall of flush syringes used to maintain paucity of patient infusion lines. Major failures in segregation and sterilisation control are obvious.
FMD finally transposed
I'm sure you have heard about this already but worth looking at an alternative view regarding changes to professions who can now legally prescribe and supply your products.
Webinar: RA for global registrations
Webinar: GMP for EM systems
FDA's lack of power over compounders
An interesting article highlighting the limits of the FDA's authority over compounders in the USA. Looks like the FDA is stuck between a rock and a hard place.....
BFS overview
A short youtube clip showing the process of blow-fill-seal technology. Youtube is an excellent source for getting overviews of processes not familiar to you and for preparing for your visits.
How the FDA assesses defect reports
A great insight into how the FDA assesses defect reports. I'm sure the DMRC will have a similar process.
The role of Microbial Testing in Biotech
A comprehensive article exploring the microbial testing requirements for biotech products.
Happy Reading!
An on-demand webinar covering the use of control strains for QC testing of culture media.
Soliris Recall
A recall of Alexion's orphan drug soliris due to particulate contamination identified in vials. Interesting that the particles were identified following routine testing of retained samples. Did the CMO have a validated method for particulate testing? If not, then where was the QP oversight?
QP review of BMRs
An interesting overview by the ECA on the expectation of the QP on reviewing BMRs prior to certification
APIC guideline for contracted QC
This guideline covers the management & qualification of contract QC labs
Monoject Recall - FDA
A recall of flush syringes used to maintain paucity of patient infusion lines. Major failures in segregation and sterilisation control are obvious.
FMD finally transposed
I'm sure you have heard about this already but worth looking at an alternative view regarding changes to professions who can now legally prescribe and supply your products.
Webinar: RA for global registrations
Webinar: GMP for EM systems
FDA's lack of power over compounders
An interesting article highlighting the limits of the FDA's authority over compounders in the USA. Looks like the FDA is stuck between a rock and a hard place.....
BFS overview
A short youtube clip showing the process of blow-fill-seal technology. Youtube is an excellent source for getting overviews of processes not familiar to you and for preparing for your visits.
How the FDA assesses defect reports
A great insight into how the FDA assesses defect reports. I'm sure the DMRC will have a similar process.
The role of Microbial Testing in Biotech
A comprehensive article exploring the microbial testing requirements for biotech products.
Happy Reading!
Tuesday, 20 August 2013
Transposition of FMD into UK Law
Today saw the amendment to the Human Medicines Regulations come into force following the falsified medicines directive (2011/62/EU). This was the first time that the UK missed a deadline for transposition of EU directives and I covered this in detail in a previous post.
As of today written confirmations for API importation from 3rd countries is now a legal requirement in the UK. The only aspect remaining of the FMD that requires transposition is the introduction of safety features & associated serialisation.
Aside from the obvious inclusion of brokers, GDP, wholesaling, API importation, QP declaration etc there are a couple of additional points to consider that may have flown under the radar:
Why is this important to QPs? Well, prescribers directly influence how your products are used. Do podiatrists have the knowledge and skills to understand the stability implications for mixing certain medicines? Do physiotherapists fully understand the potential for complex pharmacological interactions with other medicines? Pharmacists & doctors are no longer the primary gatekeepers of your prescription only medications. These new pathways will need to be covered in communication of future recalls. Also, could these changes lead to a change in the baseline level of complaints received by your PV department?
Summary
New legislation on FMD transposition is finally with us. It is important to consider the wider implications of new legislation and look beyond the obvious headlines of GDP & written confirmations. Having this wider appreciation of updates and how they may impact your area of practice is a key skill for the QP.
As of today written confirmations for API importation from 3rd countries is now a legal requirement in the UK. The only aspect remaining of the FMD that requires transposition is the introduction of safety features & associated serialisation.
Aside from the obvious inclusion of brokers, GDP, wholesaling, API importation, QP declaration etc there are a couple of additional points to consider that may have flown under the radar:
- MHRA Guidance on FMD
- New Prescribers
Why is this important to QPs? Well, prescribers directly influence how your products are used. Do podiatrists have the knowledge and skills to understand the stability implications for mixing certain medicines? Do physiotherapists fully understand the potential for complex pharmacological interactions with other medicines? Pharmacists & doctors are no longer the primary gatekeepers of your prescription only medications. These new pathways will need to be covered in communication of future recalls. Also, could these changes lead to a change in the baseline level of complaints received by your PV department?
Summary
New legislation on FMD transposition is finally with us. It is important to consider the wider implications of new legislation and look beyond the obvious headlines of GDP & written confirmations. Having this wider appreciation of updates and how they may impact your area of practice is a key skill for the QP.
Friday, 16 August 2013
Friday's Round Up
The Buccal Route
I came across this paper this week and, although fairly old, it still provides a good overview of the buccal route for systemic drug absorption. All relevant stuff for your formulation & medicinal chemistry modules.
Yet another FDA 483 for compounders
Following on from previous 483s for drug compounders, Speciality Compounding were inspected in March this year and this only came to my attention following their product recall last week. The FDA are now taking some flak for the delay between the 483 and issuing the recall. This 483 should be useful for solid dose trainees as an introduction to poor sterile manufacturing practice.
Patch in a Can
An interesting new development in transdermal drug delivery.
Biobetters Vs Biosimilars
Teva has announced new EU drug approvals for 'biobetters' which apparently improves on the original innovator product on which this new product is based.
South Africa MRA on the Horizon?
Legislative changes in South Africa may provide the potential for future MRAs with EU and FDA
Counterfeit seizure in Ukraine
A large counterfeiting operation has been uncovered in Ukraine.
EMA Paper on Nanotechnology coating
Novel Endotoxin testing
Something new to me this week following some revision of the standard endotoxin tests. This test method is based on bacteriophage binding to LPS and removes the requirement for LAL.
Revised PDA technical report
An updated revision of the PDA's technical report into dry heat sterilisation & depyrogenation methods.
P&G recall
Although for dog food these recalls can still provide useful scenario questions. In this case, what is the potential sources of salmonella, clinical impact of salmonella, microbiology of salmonella etc
Happy reading!
I came across this paper this week and, although fairly old, it still provides a good overview of the buccal route for systemic drug absorption. All relevant stuff for your formulation & medicinal chemistry modules.
Yet another FDA 483 for compounders
Following on from previous 483s for drug compounders, Speciality Compounding were inspected in March this year and this only came to my attention following their product recall last week. The FDA are now taking some flak for the delay between the 483 and issuing the recall. This 483 should be useful for solid dose trainees as an introduction to poor sterile manufacturing practice.
Patch in a Can
An interesting new development in transdermal drug delivery.
Biobetters Vs Biosimilars
Teva has announced new EU drug approvals for 'biobetters' which apparently improves on the original innovator product on which this new product is based.
South Africa MRA on the Horizon?
Legislative changes in South Africa may provide the potential for future MRAs with EU and FDA
Counterfeit seizure in Ukraine
A large counterfeiting operation has been uncovered in Ukraine.
EMA Paper on Nanotechnology coating
Novel Endotoxin testing
Something new to me this week following some revision of the standard endotoxin tests. This test method is based on bacteriophage binding to LPS and removes the requirement for LAL.
Revised PDA technical report
An updated revision of the PDA's technical report into dry heat sterilisation & depyrogenation methods.
P&G recall
Although for dog food these recalls can still provide useful scenario questions. In this case, what is the potential sources of salmonella, clinical impact of salmonella, microbiology of salmonella etc
Happy reading!
Friday, 2 August 2013
Friday's Round Up
Teva UK Warfarin Recall
A class 3 recall was issued this week following ongoing stability issues surrounding degradation products for Teva UK's warfarin tablets. Interestingly only the 3mg tablets are affected and not the 0.5mg, 1mg or 5mg tablets. For all you non-pharmacists it is worth learning about warfarin as it is a somewhat unique drug in terms of its ongoing patient monitoring, side effects and drug-drug & food-drug interactions.
Now that's what I call a recall (FDA)
Probably the largest multi product recall I have ever come across. This recall is from a USA Pharmacy drug compounder and the FDA has obviously uncovered some serious failures in their sterility assurance. This echoes the previous case of the NECC from earlier this year.
Benztropine Recall (FDA)
Visible particulate matter within the vial is the reason behind this recall. The FDA provides a useful overview of the risks of injecting particulate matter into the body.
Cold Chain Presentation by Ian Holloway
This presentation covers the cold chain distribution, deviation management, use of MKT, calibration certificates & investigation practice. A very useful 30 minutes and will provide a great deal of information surrounding potential scenario questions on temperature deviations within the supply chain.
NB: This link will require registration with the website to watch the full length video. There is no confirmation email so any email can be stated on the registration form.
Cosmetic GMP Guidelines
The FDA has published draft guidelines for GMP for cosmetic products.
Update to CEP guidelines
This follows on from last week's update surrounding the changes to the format of the CEP to include all manufacturers. The guidance document provides a good overview of the requirements for informing the EDQM of revisions/renewals to the CEP.
Hitting 2 birds with 1 stone
An interesting article highlighting Genentech's progress in their research division.
Webinar - QC testing of Culture Media
A webinar on the use of control strains in the QC testing of culture media. 14th August 2013 @ 4pm (BST)
Medical Device Application process
A nice diagrammatic representation of the process of the medical device approval process. Medical devices are a relatively hot topic lately as the EU has issued proposals to tighten up the regulatory oversight of medical devices following the PIP scandal. Further information on these changes can be found here
Danish Regulatory API confirmation Q&As
Another competent authority's take on the written confirmation requirements for API importation.
Death Row & the FDA
A very interesting article surround the FDA's earlier decision to import unlicensed thiopental into the USA to alleviate drug shortages. This has been successfully challenged by a number of death row inmates.
Acetaminophen & risk of skin disorders
The FDA has issued a warning regarding the potential for Steven's Johnson syndrome with acetaminophen use. This drug is known as paracetamol within the UK and in my previous life as a pharmacist I have never encountered this effect. I've added this alert to highlight the need to be aware of PV issues surrounding products that are well established on the market.
Happy Reading!
A class 3 recall was issued this week following ongoing stability issues surrounding degradation products for Teva UK's warfarin tablets. Interestingly only the 3mg tablets are affected and not the 0.5mg, 1mg or 5mg tablets. For all you non-pharmacists it is worth learning about warfarin as it is a somewhat unique drug in terms of its ongoing patient monitoring, side effects and drug-drug & food-drug interactions.
Now that's what I call a recall (FDA)
Probably the largest multi product recall I have ever come across. This recall is from a USA Pharmacy drug compounder and the FDA has obviously uncovered some serious failures in their sterility assurance. This echoes the previous case of the NECC from earlier this year.
Benztropine Recall (FDA)
Visible particulate matter within the vial is the reason behind this recall. The FDA provides a useful overview of the risks of injecting particulate matter into the body.
Cold Chain Presentation by Ian Holloway
This presentation covers the cold chain distribution, deviation management, use of MKT, calibration certificates & investigation practice. A very useful 30 minutes and will provide a great deal of information surrounding potential scenario questions on temperature deviations within the supply chain.
NB: This link will require registration with the website to watch the full length video. There is no confirmation email so any email can be stated on the registration form.
Cosmetic GMP Guidelines
The FDA has published draft guidelines for GMP for cosmetic products.
Update to CEP guidelines
This follows on from last week's update surrounding the changes to the format of the CEP to include all manufacturers. The guidance document provides a good overview of the requirements for informing the EDQM of revisions/renewals to the CEP.
Hitting 2 birds with 1 stone
An interesting article highlighting Genentech's progress in their research division.
Webinar - QC testing of Culture Media
A webinar on the use of control strains in the QC testing of culture media. 14th August 2013 @ 4pm (BST)
Medical Device Application process
A nice diagrammatic representation of the process of the medical device approval process. Medical devices are a relatively hot topic lately as the EU has issued proposals to tighten up the regulatory oversight of medical devices following the PIP scandal. Further information on these changes can be found here
Danish Regulatory API confirmation Q&As
Another competent authority's take on the written confirmation requirements for API importation.
Death Row & the FDA
A very interesting article surround the FDA's earlier decision to import unlicensed thiopental into the USA to alleviate drug shortages. This has been successfully challenged by a number of death row inmates.
Acetaminophen & risk of skin disorders
The FDA has issued a warning regarding the potential for Steven's Johnson syndrome with acetaminophen use. This drug is known as paracetamol within the UK and in my previous life as a pharmacist I have never encountered this effect. I've added this alert to highlight the need to be aware of PV issues surrounding products that are well established on the market.
Happy Reading!
Thursday, 1 August 2013
Study Toolbox Part 6: Teleconferences
Throughout my QP training process teleconferences have been a regular and enjoyable way to assess my knowledge and progress towards submission.1 to 1 teleconferences
The secret behind arranging teleconferences is your ability to network within your peers. Networking via training courses, conferences, social media and within your company is key to identify potential candidates to arrange teleconferences with. The ideal candidate will be one who is at a similar stage in their QP training and works in an area different from your own. Your sponsor should be able to provide you with potential contacts to get you started.
1 to 1 teleconferences give you the ability to dictate what topics are discussed and will provide less nervousness if giving incorrect answers. My weekly chat is with a trainee QP from 'big pharma' who specialises in solid dose manufacture. As my background is small scale sterile IMP manufacturing the contrasts are apparent and I certainly have gained great detailed knowledge into solid dose manufacturing just from these 30minute weekly sessions. A common theme for the discussions is to talk through lists of previous viva questions & scenarios. This provides a good insight into each other's thought processes and techniques in dealing with scenarios. This arrangement came about after a chance meeting at a PQG seminar last year. Therefore don't be afraid to approach people even if your introverted tendencies maybe telling you otherwise.
Multi person teleconferences
Multi person teleconferences are obviously harder to arrange. If your network is large enough then this should not be too difficult to arrange yourself using popular teleconference software such as PowWowNow & free conference call. With an increase in numbers comes an increase in opinions and diversity of relevant topics. Occasionally you may have to listen to discussions surrounding topics that are not relevant to you. Multi person teleconferences can be more intimidating especially if you are a new addition to the regulars and you don't want to come across as a complete fool! Often you will find someone who 'chairs' the conference call to ensure all callers are included in the discussions and know when to move onto a different topic. Knowing that there are multiple callers means you can take a backseat to absorb what is being discussed without having to do any preparation before hand. This is useful for the initial few calls but to gain the most out of teleconferences you have to get involved and put your thoughts across. You really do get out what you put in.There are a few established teleconferences that occur regularly throughout the working week. Alex at QPQuandary arranges 2 calls per week on Mondays and Fridays and often attracts wide range of callers most weeks. This is coupled to an extensive email network that provides a good forum for requests and follow up discussion if particularly interesting points are raised during the call. For me these have been an essential part to my QP training because the majority of callers are from commercial pharma so I can gain valuable information into the way commerical trainees handle scenarios and issues relevant to their practice. Over time I have manage to contribute from alternative angles (eg NHS, small scale IMP manufacturing) which hopefully has increased the awareness of other areas of practice for callers.
Summary
Teleconferences, either 1 to 1 or multiple person, can offer a great forum for discussion surrounding new GMP updates, scenarios or just to hear someone else's point of view other than your sponsor! In this age of email communication don't forget the faithful old telephone still has a huge part to play in your QP training journey.
Study Toolbox Part 1: The Onion
Study Toolbox Part 2: Introduction to Mindmaps
Study Toolbox Part 3: Keeping up to date
Study Toolbox Part 4: Training Courses
Study Toolbox Part 5: Visits
Friday, 26 July 2013
Friday's Round Up
Wockhardt 483
Following on from my previous post regarding the multi product recall of Wockhardt products. This informative warning letter really opens your eyes to the observed actions within the factory. You have to ask where the QP oversight was and how these issues were not picked up during routine self inspection
GSK trial data issues
Yet more problems for GSK's China operations. In addition to the well publicised bribery case issues have now been raised with clinical trial activity within China. Namely the lack of pre-clinical data before products were given to human subjects.
Fresenius 483
Another revealing warning letter regarding an Indian manufacturing site. The attempt at hiding documents by stuffing them into pockets is a particular highlight. As with all these warning letters it is useful to get into the habit of using them as possible scenarios and how you would tackle them as a QP
TOC for Cleaning Validation
A useful 30min presentation/webinar on the benefits of using TOC for cleaning validation. You'll need to submit details to access the presentation (there is no confirmation email so you can put any email in the box)
Top 20 Orphan Products
As mentioned previously orphan drugs are rarely out of the news. Here is a great list showing the potential behind these lucrative drugs.
One for the Coffee Connoisseurs
Hence the reason copious amounts of coffee are available during DBA courses!
Happy Reading!
Following on from my previous post regarding the multi product recall of Wockhardt products. This informative warning letter really opens your eyes to the observed actions within the factory. You have to ask where the QP oversight was and how these issues were not picked up during routine self inspection
GSK trial data issues
Yet more problems for GSK's China operations. In addition to the well publicised bribery case issues have now been raised with clinical trial activity within China. Namely the lack of pre-clinical data before products were given to human subjects.
Fresenius 483
Another revealing warning letter regarding an Indian manufacturing site. The attempt at hiding documents by stuffing them into pockets is a particular highlight. As with all these warning letters it is useful to get into the habit of using them as possible scenarios and how you would tackle them as a QP
TOC for Cleaning Validation
A useful 30min presentation/webinar on the benefits of using TOC for cleaning validation. You'll need to submit details to access the presentation (there is no confirmation email so you can put any email in the box)
Top 20 Orphan Products
As mentioned previously orphan drugs are rarely out of the news. Here is a great list showing the potential behind these lucrative drugs.
One for the Coffee Connoisseurs
Hence the reason copious amounts of coffee are available during DBA courses!
Happy Reading!
Friday, 19 July 2013
Friday's Round Up
API Importation Flow Chart
A good overview of the written confirmation requirements of API imports and a useful flowchart which outlines the process
CEP Update
The EDQM has updated the CEP certificate with regards to the listing of manufacturing sites. From the 15th July the CEP certificate will carry details of all manufacturing sites involved in the manufacture of the API. This includes sites performing packaging, micronisation, sterilisation & QC.
Diovan Data Fabrication
Genentech Data Issues
Yet more reports of falsified data relating to drug development. Repeated reports should be making you think of potential viva scenario questions relating to this and how you would tackle it.
Certificates of Medicinal Products
I came across the term CMPs for the first time this weeks. CMPs are issued by the EMA to confirm the marketing authorisation status and the GMP status of the manufacturing site. The appear to be primarily used for export to 3rd countries to support regulatory approval within that 3rd country.
Supplement Recall (FDA)
A recall for supplements containing medicinal active ingredient sildenafil. A good example of how API supply chains are being compromised but will the FMD prevent this from happening in the UK?
Orphan Updates
Orphan drugs are rarely out of the news. The EMA has updated its guidance on orphan applications and sponsorship transfer. This document provides a good overview of the expectations of the EMA for orphan applications.
Insects in vials (FDA 483)
More issues highlighted by the FDA relating to an Indian & New York CMO. Insects within vials is certainly something I haven't come across before. When you read about deficiency reports such as this it is good to get into the habit for thinking through your response if this was a potential QP scenario.
FDA guidance on Technical Agreements
The FDA provide a good guideline on the requirements of TAs and scenarios where TAs have been deficient.
Lucentis & Avastin Equal in Efficacy
A study by the UK government to determine if these two treatments are equally effective for macular degeneration. This is likely to further the debate between the NHS & pharma where use of a drug off-label (Avastin) instead of the approval licensed product (Lucentis) has been justified on cost despite questions over the legality of this approach.
Happy reading!
A good overview of the written confirmation requirements of API imports and a useful flowchart which outlines the process
CEP Update
The EDQM has updated the CEP certificate with regards to the listing of manufacturing sites. From the 15th July the CEP certificate will carry details of all manufacturing sites involved in the manufacture of the API. This includes sites performing packaging, micronisation, sterilisation & QC.
Diovan Data Fabrication
Genentech Data Issues
Yet more reports of falsified data relating to drug development. Repeated reports should be making you think of potential viva scenario questions relating to this and how you would tackle it.
Certificates of Medicinal Products
I came across the term CMPs for the first time this weeks. CMPs are issued by the EMA to confirm the marketing authorisation status and the GMP status of the manufacturing site. The appear to be primarily used for export to 3rd countries to support regulatory approval within that 3rd country.
Supplement Recall (FDA)
A recall for supplements containing medicinal active ingredient sildenafil. A good example of how API supply chains are being compromised but will the FMD prevent this from happening in the UK?
Orphan Updates
Orphan drugs are rarely out of the news. The EMA has updated its guidance on orphan applications and sponsorship transfer. This document provides a good overview of the expectations of the EMA for orphan applications.
Insects in vials (FDA 483)
More issues highlighted by the FDA relating to an Indian & New York CMO. Insects within vials is certainly something I haven't come across before. When you read about deficiency reports such as this it is good to get into the habit for thinking through your response if this was a potential QP scenario.
FDA guidance on Technical Agreements
The FDA provide a good guideline on the requirements of TAs and scenarios where TAs have been deficient.
Lucentis & Avastin Equal in Efficacy
A study by the UK government to determine if these two treatments are equally effective for macular degeneration. This is likely to further the debate between the NHS & pharma where use of a drug off-label (Avastin) instead of the approval licensed product (Lucentis) has been justified on cost despite questions over the legality of this approach.
Happy reading!
Saturday, 13 July 2013
GMP Principles in Principalities
Following on from my previous post on the entry of Croatia to the EU this post aims to give an overview of how the small principalities within Europe are integrated within the EU. As a trainee QP you will need to know how the EU operates and importantly know sufficient information to enable you to provide answers to the round-the-world supply chain viva scenario questions. These scenarios often involve complex virtual supply chains throughout and outside the EU.
I'm sure many of you are aware of the EFTA & EEA countries but how would you handle a scenario question that included importing medicines from Monaco, San Marino or Andorra? This post will aim provide you with the information required to answer that potential scenario.
Monaco
Famous for its grand prix, casino and tax exiles, Monaco is a small principality on the Mediterranean coast bordered by France. It is the most densely populated country in the world with a population of ~36,000 squeezed into a land area of 2sqKm.
Monaco is not a member of the EU, EFTA or EEA and has no MRA in place with the EU. Hence it can be considered, at face-value, to be a 3rd country with regards to medicine legislation. However, since 2003 Monaco has a formal agreement with the EU regarding legislation for medicines for human & veterinary use as well as medical devices and cosmetics. The formal agreement stipulates that certain EU legislation shall apply within the principality of Monaco and includes a number of familiar EU directives.
EU directives relevant to QP that are incorporated into Monaco law:
I'm sure many of you are aware of the EFTA & EEA countries but how would you handle a scenario question that included importing medicines from Monaco, San Marino or Andorra? This post will aim provide you with the information required to answer that potential scenario.
Monaco
Famous for its grand prix, casino and tax exiles, Monaco is a small principality on the Mediterranean coast bordered by France. It is the most densely populated country in the world with a population of ~36,000 squeezed into a land area of 2sqKm.
Monaco is not a member of the EU, EFTA or EEA and has no MRA in place with the EU. Hence it can be considered, at face-value, to be a 3rd country with regards to medicine legislation. However, since 2003 Monaco has a formal agreement with the EU regarding legislation for medicines for human & veterinary use as well as medical devices and cosmetics. The formal agreement stipulates that certain EU legislation shall apply within the principality of Monaco and includes a number of familiar EU directives.
EU directives relevant to QP that are incorporated into Monaco law:
- 2001/83/EC
- 2001/82/EC
- 2001/20/EC
- 2002/98/EC (blood directive)
- 91/356/EEC (previous GMP directive, 2003/94/EC not explicitly stated)
- 91/412/EEC (Vet GMP)
It is important to remember that these agreements with Monaco do not remove the requirement for auditing any relevant site within Monaco to determine compliance with EU GMP.
Andorra & San Marino
Both the Principality of Andorra and the Republic of San Marino are 3rd countries. They are not part of the EEA or EFTA therefore access to the EU internal-market is limited. They each have bilateral agreements in place with their immediate neighbours but they do not cover any EU medicine legislation. The EU has produced a concept paper stating that inclusion of Andorra & San Marino to the EFTA and then EEA is a viable option that should be explored in order to better integrate both countries into the EU framework.
Currently
Andorra and San Marino does not have any mutual recognition with regards to
pharmaceuticals. As a result movement of pharmaceuticals between the EU
and San Marino
is restricted and importation requirements as for other 3rd countries will apply.
Summary
Understanding the intricacies of the EU is a vital part of your law & admin module of the study guide. Expanding your knowledge into very specific areas & countries such as Monaco should give you more confidence during your viva supply chain scenarios.
Of the 3 countries mentioned only Monaco has implemented EU legislation regarding medicines and hence can be deemed as a 'quasi-EEA' member. Both Andorra & San Marino have not implemented any relevant EU legislation and are therefore true 3rd countries.
Summary
Understanding the intricacies of the EU is a vital part of your law & admin module of the study guide. Expanding your knowledge into very specific areas & countries such as Monaco should give you more confidence during your viva supply chain scenarios.
Of the 3 countries mentioned only Monaco has implemented EU legislation regarding medicines and hence can be deemed as a 'quasi-EEA' member. Both Andorra & San Marino have not implemented any relevant EU legislation and are therefore true 3rd countries.
Thursday, 4 July 2013
Friday's Round Up
Tuesday saw the deadline for written confirmations of APIs imported from 3rd countries not on the 'White list'. This overview provides resource for these requirements and covers potential problems with German custom officials. UK Law has yet to incorporate this requirement, as detailed here.
WHO outlines proposed Good Pharmacopoeial Practice (GPhP)
These proposed guidelines aim to promote harmonisation of pharmacopoeial monographs.
These proposed guidelines aim to promote harmonisation of pharmacopoeial monographs.
Genzyme
are recalling a batch of thymoglobuline due to stability issues. This
is an example of a company led recall as opposed to the standard ‘Drug
Alert’
response. Note these recalls do not have a statutory time limit for
action and as they are not as well distributed through primary/secondary
care they can often go unnoticed.
Fresenius
Kabi are recalling a number of batches due to presence of glass
particles within the vials. The FDA recall alert provides a good
overview of the risks
of injecting glass particles. Compare the risks to the patient if the
product were an oral liquid. You may have more to consider then just
the affect to the internal organs – think about patient compliance &
confidence in your product.
Another good overview of how bacteria adhere to surfaces and formation of biofilms.
MSD are recalling a single batch due to potential for cracked vials. As with all sterile products once you have a defect that reduces your sterility assurance level a recall is pretty much a given.
My Sponsor discovered this site recently which provides a good selection of public WHO inspection reports for a number of finished product manufacturers, API manufacturers, QC laboratories and CROs. The audits are based on relevant WHO guidelines for countries generally outside of ICH. The API manufacturer inspection reports are particularly useful and relevant now that the EMA has stated on the API written confirmation template that WHO GMP guidelines are considered equivalent to EU GMP.
Wednesday, 3 July 2013
Written Confirmations – confirmed in writing?
This week saw the deadline for written confirmations for
APIs imported into the EU from 3rd countries as part of the measures included
within the falsified medicines directive (2011/62/EU). The FMD states that all APIs imported from 3rd
countries that are not on an approved list (‘White list’) require a written
confirmation from the manufacturer’s competent authority for each batch stating
the API has been manufactured according to equivalent EU GMP and that the
manufacturing site is subject to unannounced inspections. A template of the written confirmation can
be found in EU GMP Part III.
Legal Basis
As you are aware EU directives are required to be transposed
into UK law within a specific time frame.
The FMD is an update to 2001/83/EC which is transposed into UK law via
the Human Medicines Regulations 2012 (SI 2012/1916). SI 2012/1916 was active as of August 2012 and
since then no updates to this legislation have occurred (except for an update
regarding fees). As a result, SI
2012/1916 (as it stands on 2nd July) does not include the
requirement for written confirmations.
All references to API manufacture within this legal document refer to
the requirement for API GMP and quotes the GMP directive
(2003/94/EC) for guidance. The FMD does
not update 2003/94/EC therefore the UK law does not incorporate the requirements
of the FMD. As a QP in the UK one of your legal duties states; ‘….each batch has
been manufactured in accordance with these regulations…..’ (ie SI 2012/1916)
not 2001/83/EC.
A draft amendment to SI 2012/1916 is
available on the MHRA website which does incorporate the requirement for the
written confirmation (Chapter 4, Paragraph 45P) as well as the other
requirements under FMD (e.g. GDP for API).
As of today (2nd July) this draft has not been incorporated
into UK law.
Summary
The written confirmation deadline for APIs has come and
gone. As we currently stand the UK law
does not match the requirement within the falsified medicines directive with
regards to the written confirmations of imported APIs.
During this intervening time while we await
an update to SI 2012/1916 what should the UK QPs be doing - following FMD or UK Law? It might make for a good scenario question................
Friday, 28 June 2013
Friday's Round Up
Counterfeit seizure by MHRA
The MHRA announced the seizure of over £12million worth of counterfeit medicines within the UK this week. The types of medicines seized included weight loss, hair less and erectile dysfunction. This operation also involved the closure of nearly 10,000 online pharmacies who were selling counterfeit or unlicensed medicines – will the EU-wide pharmacy symbol following FMD really stop these sites from emerging?
Class 2 recall for HES (MHRA)
All remaining stock of Hydroxyethyl Starch (HES) is being recalled due to results from clinical trials showing increased risk of patient mortality when HES is administered. HES is given intravenously as a volume expander in critically ill patients following blood loss or trauma. This is a good example of a recall initiated following ongoing PV rather than the more commonly observed quality defect.
This
interesting article describes how NASA has been investigating the potential for
using 3D inkjet printing to manufacture drugs to sustain long space
expeditions. This technology has already
shown promise with research from UCL & School of Pharmacy. Will each space shuttle need an MIA and what
legal jurisdiction is space……!!
This
error identified packs of furosemide containing zopiclone that was packaged
within Teva’s site near Paris. The
article describes the investigation into this and a potential root cause of sabotage. What
would your thoughts be as a QP if you uncovered or suspected this activity
within your organisation?
This
article describes a scheme within California that collects unwanted medicines
from care homes and re-distributes them to clinics in order to provide assistance
to those patients who cannot afford the cost of healthcare in the States. As a QP do you know the fate of your medicines
within the UK? What happens to patient’s
medicines that are returned to pharmacies or hospitals?
This comes on the back of 2 other reports of companies generating fraudulent data in both USA and Scotland. Could this be a potential QP viva question? How would you as a QP tackle this issue if brought to your attention?
Happy Reading!
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