Showing posts with label GMP news. Show all posts
Showing posts with label GMP news. Show all posts
Friday, 6 December 2013
Friday's Round Up
Locals Laws & the QP
Industry responses to the draft annex 16 suggest that the requirement for QPs to know all the local laws in all markets is unrealistic. That maybe so but the QP legal duties defined in 2001/83/EC are pretty clear....
Drug Alert - Sodium Bicarbonate
BBraun has issued a class 4 drug alert for a number of batches of sodium bicarbonate due to the presence of precipitation within retained samples. This appears to be caused by defect in the rubber stoppers. A great example of how changes to primary containers/closures can have a significant effect on product quality that may not manifest itself for a number of years (batch was distributed March 2012). Another interesting point is the statement explaining that a recall is not an option at this time due to the potential of product shortage within the market. It will be interesting to see if these batches will be recalled at a later date once additional supply has been introduced into the market.
Rapid Drug Quality testing
An article describing an innovative technology that can be used to test for active ingredient concentrations within finished products. This technology is being targeted for use by clinicians to help in the fight against counterfeit medicines.
ICH steering committee
Details from November's ICH steering committee.
EMA offers greater orphan incentives
Orphan drugs are rarely out of the news but despite the huge increase in orphan development and huge returns for those companies developing them, the EMA is applying even more incentives for orphan drugs.
Drug shortages causing patient harm
An interesting article describing how drug shortages within the UK is having a direct effect on patient health. Something to ponder during your viva scenarios when deciding whether to recall or not.
Micro OOS webinar
A free on-demand webinar (once your details are submitted) on managing out of specification investigations originating from the micro lab.
Happy Reading!
Friday, 29 November 2013
Friday's Round Up
GSK continues with UK manufacturing investment
News that GSK is ploughing further investment into its UK manufacturing arms. After recent investments into their Ulverston site there is a further £23million for expansion of their Montrose facility in Scotland. Great to see GSK bucking the trend of outsourcing UK manufacturing.
Boot's Pharmaceuticals recall - Oral liquids
A company led recall issued by Boot's via the MHRA website. Remember these recalls are considered low risk and hence are not disseminated via the Drug Alert system. The recall is due to potential faulty tamper seals on a range of their liquid formulations.
New Drug Target for Malaria
Novartis has published data on a novel drug target and new class of antimalarial compounds in the journal Nature.
Baxter recalls Nitroglycerin Injection
Another recall due to potential particulate contamination within a sterile product. A good reminder to revise the tests used for both visible and subvisible particles in finished products.
US Congress gives more power to FDA over compounders
Following the fallout from the NECC compounding disaster from 2012, Congress has finally reached an agreement to update the legislative framework overseeing this high risk activity. The revised bill gives the FDA more power and establishes a voluntary program for compounders to register with the FDA and agree to meet relevant quality standards.
API catalysis
An interesting article describing the advances in the use of catalysts in both chemical and biological API production. A good prompt to revise the recently published draft ICH guidelines on elemental impurities.
FDA/EMA QbD Q&As
The FDA and EMA have published an update to their joint guidance document on quality by design.
Comments on Annex 16 published
The EC yesterday published comments on the proposed update to Annex 16.
Update to GDP Guidelines
A new version of the GDP guidelines has been published to correct some factual errors and give a formal date of coming into operation (24th November 2013)
Happy Reading!
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.
Sunday, 3 November 2013
Friday's Round Up
A little late this week....
Counterfeit Xanax uncovered
More counterfeit drugs have been seized in Zurich. It appears to have come from China and analysis of the products showed no active ingredient in them at all.
Thalidomide Overview
A great article describing the history of this well known drug and how it has been developed into treatments for cancer and leprosy.
Imigran Recall (UK)
A class 2 recall in the UK for the migraine treatment Imigran due to protruding needles. A good example of how medicinal products are often combined with medical devices (eg needles/syringes) for drug delivery purposes. Defects in these devices can be as significant as those to the drug itself so you need to be aware of the relevant functional testing of the finished product and delivery systems.
Paracetamol Suspension Recall (USA)
Another example of how a defect in a co-packaged medical device leads to a product recall. The risk of overdose in paracetamol without graduated syringe markers is severe, hence the recall. What would be your actions if this product was life critical with no alternatives?
Novomix Insulin Recall (UK)
A class 2 recall issued due to potential for variance in fill levels of insulin cartridges. The drug alert is very comprehensive and provides detailed information for both patients and clinicians with regards to this recall.
Happy Reading!
Counterfeit Xanax uncovered
More counterfeit drugs have been seized in Zurich. It appears to have come from China and analysis of the products showed no active ingredient in them at all.
Thalidomide Overview
A great article describing the history of this well known drug and how it has been developed into treatments for cancer and leprosy.
Imigran Recall (UK)
A class 2 recall in the UK for the migraine treatment Imigran due to protruding needles. A good example of how medicinal products are often combined with medical devices (eg needles/syringes) for drug delivery purposes. Defects in these devices can be as significant as those to the drug itself so you need to be aware of the relevant functional testing of the finished product and delivery systems.
Paracetamol Suspension Recall (USA)
Another example of how a defect in a co-packaged medical device leads to a product recall. The risk of overdose in paracetamol without graduated syringe markers is severe, hence the recall. What would be your actions if this product was life critical with no alternatives?
Novomix Insulin Recall (UK)
A class 2 recall issued due to potential for variance in fill levels of insulin cartridges. The drug alert is very comprehensive and provides detailed information for both patients and clinicians with regards to this recall.
Happy Reading!
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, 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!
Friday, 21 June 2013
Friday's Round Up
From next week the USA will be on the EU's white list regarding written confirmation of API imports from 3rd countries. The USA now joins Australia, Japan & Switzerland on the white list.
Potential lack of sterility assurance was the typically vague
term used by the DMRC in describing the reason behind this recall. Unfortunately no
further information is provided but it
is worth considering the possible causes such as primary container defects,
media fill results, PV complaints….
Ambisome is a critical product so a recall indicates the severity of the
problem.
An example of segregation/line clearance error during
packaging. The aspirin bottle actually
contained paracetamol tablets. This
should immediately draw your attention to the potential extent of the problem – ie where have the
aspirin tablets gone? (in the paracetamol labelled container perhaps? which would have the greatest risk to patients? - this is where your medicinal chemistry should help in your assessment!)
These guidelines build on Q9 and provides more detailed information regarding the implementation of QRM.
EMA clarifies the point at which bioburden testing should be
performed (immediately prior to filtration) and bioburden limit (10cfu/100ml). This is part of the ongoing GMP Q&A section of the EMA website that gets updated periodically but without much fanfare.
This provides some details on the letter of access that API
manufacturer’s use to give the regulatory authority permission to review all
the commercially sensitive data regarding the API manufacturing process. The withdrawal of access letter has been
given more guidance for when API manufacturer changes or the ASMF is replaced by
the CEP.
A useful insight to the disposable systems in use for biotechnology manufacture. These remove the need for cleaning
validation, reduce contamination and saves significant time where cleaning of
multi use biotech equipment can significantly reduce the available manufacturing capacity.
Pharmafile provides a nice overview of MHRA action regarding API importation (as
mentioned in last week’s post)
Subscribe to:
Posts (Atom)