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.
Friday 30 August 2013
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 9 August 2013
Friday's Round Up
Teva UK Temazepam Recall
An example of a company-led recall as opposed to the recalls issued via the Drug Alert mechanism. Company led recalls do not have a classification to portray the patient risk (eg class 1, 2 etc) and are therefore considered to be generally low risk to patient safety. There appears to be 2 issues with the batches in question. Firstly 2 batches have been released into the UK market incorrectly and secondly the final release testing for dissolution is at the lower end of specification.
Overview of worldwide serialisation deadlines & methods
A nice pdf overview of the different serialisation methods in the pipeline across the world & their proposed implementation deadlines. Worldwide harmonisation on serialisation looks extremely remote!
Annex 16 update webinar
NSF-DBA are hosting a webinar on the changes to the draft annex 16 update on 9th September 2013 @ 16:00 GMT
US supplements with undeclared API
The FDA has issued a recall for sleep supplements containing undeclared doxepin & chlorpromazine. The FDA have issued a number of similar recalls but I cannot remember anything similar arising from the UK via the MHRA. Perhaps this highlights the scope of the FDA's testing programme within the USA.
Self Expiring Packaging
An interesting design to highlight when blister packs expire. I cant see this being particularly important for patients with chronic conditions as blister packs are typically used within a month. This will more likely highlight those old packs of paracetamol at the back of the cupboard for that occasional headache! Once the packaging has expired will it still be in compliance with both the MA and legal requirement for labelling?
Trends in USA Drug Approvals
An interesting overview of the numbers of new drug approvals in the USA between 1987 and 2011. Hopefully the upward trend since 2005 continues and is replicated within the EU?
Counterfeit Drugs in Clinical Trials
A slightly naive post regarding the risk of counterfeit drugs entering clinical trials. Given that comparators are sourced on the open market and pressures to source the cheapest product then this risk is fairly obvious. Although the FMD does not apply directly to IMPs it will apply to comparator products which may reduce this risk if sourced from the EU wholesale distribution network.
Not one to read over dinner
everyday is a school day after all, this was certainly something I'd never heard of before!
Finally.....
An interesting time lapse video of fungi growing on culture media. At around 0.50 you can clearly see sporulation during the growth phase. Certainly not something you want in your product or clean room.
Happy Reading!
An example of a company-led recall as opposed to the recalls issued via the Drug Alert mechanism. Company led recalls do not have a classification to portray the patient risk (eg class 1, 2 etc) and are therefore considered to be generally low risk to patient safety. There appears to be 2 issues with the batches in question. Firstly 2 batches have been released into the UK market incorrectly and secondly the final release testing for dissolution is at the lower end of specification.
Overview of worldwide serialisation deadlines & methods
A nice pdf overview of the different serialisation methods in the pipeline across the world & their proposed implementation deadlines. Worldwide harmonisation on serialisation looks extremely remote!
Annex 16 update webinar
NSF-DBA are hosting a webinar on the changes to the draft annex 16 update on 9th September 2013 @ 16:00 GMT
US supplements with undeclared API
The FDA has issued a recall for sleep supplements containing undeclared doxepin & chlorpromazine. The FDA have issued a number of similar recalls but I cannot remember anything similar arising from the UK via the MHRA. Perhaps this highlights the scope of the FDA's testing programme within the USA.
Self Expiring Packaging
An interesting design to highlight when blister packs expire. I cant see this being particularly important for patients with chronic conditions as blister packs are typically used within a month. This will more likely highlight those old packs of paracetamol at the back of the cupboard for that occasional headache! Once the packaging has expired will it still be in compliance with both the MA and legal requirement for labelling?
Trends in USA Drug Approvals
An interesting overview of the numbers of new drug approvals in the USA between 1987 and 2011. Hopefully the upward trend since 2005 continues and is replicated within the EU?
Counterfeit Drugs in Clinical Trials
A slightly naive post regarding the risk of counterfeit drugs entering clinical trials. Given that comparators are sourced on the open market and pressures to source the cheapest product then this risk is fairly obvious. Although the FMD does not apply directly to IMPs it will apply to comparator products which may reduce this risk if sourced from the EU wholesale distribution network.
Not one to read over dinner
everyday is a school day after all, this was certainly something I'd never heard of before!
Finally.....
An interesting time lapse video of fungi growing on culture media. At around 0.50 you can clearly see sporulation during the growth phase. Certainly not something you want in your product or clean room.
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
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