Showing posts with label recalls. Show all posts
Showing posts with label recalls. 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!
Saturday, 12 October 2013
Friday's Round Up
Recall - glass particles
Hospira have recalled two injection products due to a defect in the primary container leading to a risk of glass particles within the solution. There are a number of issues to think about here with regards to QP study. Firstly was the AQL sampling of the primary containers at a suitable level? What type of glass is used (type 1/2?) A new component supplier? Automated inspections for particles & ampoule integrity will not detect these types of defects. This is also a good example of considering the extent of the defect as clearly the same primary containers are used for more than 1 product. What would you response be to this - increased AQL sampling? For cause audit? Additional QC testing on container receipt?
Safety Reporting requirements of new CT Regulation
A good article highlight the proposed changes to the safety reporting requirements for investigators & sponsors.
Medical Device EU Safety Update
The EC has introduced two new safety measures for medical devices. The new rules are focused on the notified bodies with regards to their auditing & assessment of manufacturers and clarifying the criteria these NBs need to meet.
FDA 483 for Indian API site
An interesting 483 report highlighting the deficiencies of an Indian API site. For each audit observation it is good practice to talk through how you would take these findings forward if you were auditing this site as an API supplier of your finished product.
PV Black Triangle video
The EMA have published a patient-focused video describing the introduction of the black triangle system for medicines subjected to intensive PV monitoring.
Update to EU-Japan MRA
The EMA has updated the MRA with Japan to permit the sharing of GMP data between manufacturers. This means that the Japanese regulatory authority can accept reference to the EudraGMDP certificates.
Sterilisation & Disinfection Standards
A comprehensive list of all standards relating to sterilisation & disinfection. A useful reference.
Doxil Drug Shortages
Yet more fall out from the ongoing issues surrounding J&J's Ben Venue facility in the USA. A good reminder of the requirement for MAHs to inform the competent authority in all markets when drug shortages are expected. Something to consider during your recall scenarios.
Hospira Recall - Particle contamination
A recall of a sterile injection due to a report of a dark particulate contaminant. This has been identified as oxidized stainless steel. What would be the likely source? 100% inspection performed manually or via automatic camera detector - one of the methods failed in this case.
Changing manufacturing facilities
Following the ongoing issues Ranbaxy is having with their existing sites in India the company is looking at purchasing a new site and transferring production. This is a good example of a common scenario question of a change in supplier or site. As a QP what would you need to see before manufacturing at the new site is started? A change control would be a good starting point.....
EMA PV signals
The EMA have begun publishing PV signals reviewed by the PRAC.
Malaria Vaccine
GSK look set to apply to the EMA for approval of their malarial vaccine during 2014. It is not clear if this product is to be manufactured within GSK's new Ulverston site.
Happy Reading!
Hospira have recalled two injection products due to a defect in the primary container leading to a risk of glass particles within the solution. There are a number of issues to think about here with regards to QP study. Firstly was the AQL sampling of the primary containers at a suitable level? What type of glass is used (type 1/2?) A new component supplier? Automated inspections for particles & ampoule integrity will not detect these types of defects. This is also a good example of considering the extent of the defect as clearly the same primary containers are used for more than 1 product. What would you response be to this - increased AQL sampling? For cause audit? Additional QC testing on container receipt?
Safety Reporting requirements of new CT Regulation
A good article highlight the proposed changes to the safety reporting requirements for investigators & sponsors.
Medical Device EU Safety Update
The EC has introduced two new safety measures for medical devices. The new rules are focused on the notified bodies with regards to their auditing & assessment of manufacturers and clarifying the criteria these NBs need to meet.
FDA 483 for Indian API site
An interesting 483 report highlighting the deficiencies of an Indian API site. For each audit observation it is good practice to talk through how you would take these findings forward if you were auditing this site as an API supplier of your finished product.
PV Black Triangle video
The EMA have published a patient-focused video describing the introduction of the black triangle system for medicines subjected to intensive PV monitoring.
Update to EU-Japan MRA
The EMA has updated the MRA with Japan to permit the sharing of GMP data between manufacturers. This means that the Japanese regulatory authority can accept reference to the EudraGMDP certificates.
Sterilisation & Disinfection Standards
A comprehensive list of all standards relating to sterilisation & disinfection. A useful reference.
Doxil Drug Shortages
Yet more fall out from the ongoing issues surrounding J&J's Ben Venue facility in the USA. A good reminder of the requirement for MAHs to inform the competent authority in all markets when drug shortages are expected. Something to consider during your recall scenarios.
Hospira Recall - Particle contamination
A recall of a sterile injection due to a report of a dark particulate contaminant. This has been identified as oxidized stainless steel. What would be the likely source? 100% inspection performed manually or via automatic camera detector - one of the methods failed in this case.
Changing manufacturing facilities
Following the ongoing issues Ranbaxy is having with their existing sites in India the company is looking at purchasing a new site and transferring production. This is a good example of a common scenario question of a change in supplier or site. As a QP what would you need to see before manufacturing at the new site is started? A change control would be a good starting point.....
EMA PV signals
The EMA have begun publishing PV signals reviewed by the PRAC.
Malaria Vaccine
GSK look set to apply to the EMA for approval of their malarial vaccine during 2014. It is not clear if this product is to be manufactured within GSK's new Ulverston site.
Happy Reading!
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