Friday's Round Up

Ben Venue Closure

Boehringer Ingelheim have finally decided to close their Ben Venue site in the USA following a number of quality problems.  Closure of facilities has been asked in QP vivas in the past and it is a good opportunity to consider your plan to manage this change.

Wockhardt Troubles continue

The MHRA have revoked their GMP certificate for another one of Wockhardt's manufacturing sites in India.   As a result the the facility will no longer be able to supply products to the UK.

Wockhardt Recall

Following the MHRA's action to revoke their GMP certificate a multi product recall was always on the cards. 

Recall following media fill fail

A recall of a sterile inhalation solution due to a media fill failure.  A good reminder to review your microbiology module and annex 1 for the requirements of media fills in sterile manufacturing and how you would handle a potential failure.

Actavis Bioequivalence problem

An interesting read regarding a failure of bioequivalence data for an existing product.

USP draft for non-sterile product bioburden

Bioburden is generally considered for sterile manufacturing.  Of note is the list of non sterile products in order of their potential risk of microbiological contamination:

• metered-dose and dry powder inhalants
• nasal sprays
• otics
• vaginal suppositories
• topicals
• rectal suppositories
• oral liquids (aqueous)
• liquid-filled capsules
• oral tablets and powder-filled capsules

Irish Rx charge increase 

The Irish government has announced  a 66% increase in prescription charges.  Will this increase the demand of patients seeking to find cheaper alternatives and hence lead to an increase in counterfeit risk in Ireland?

MHRA Q&A for MS holders

An interesting article for those who have little experience or appreciation of how aspects of the EU GMP guide is applied to MS (specials) manufacturers.

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!