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.
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