Patrick Hoet, a freelance consultant with extensive pharma experience, explained to in-PharmaTechnologist that nobody knows what the European Commission (EC) will do next after it dropped the directive.
The good manufacturing practice (GMP) directive was dropped by the EC in June; a move that Hoet believes was made because of resistance from some excipient manufacturers.
Many excipients have applications in areas other than pharma, such as food, which have different production standards and Hoet believes this played a role in some manufacturers resisting the directive.
The directive also came under attack in March 2008, when a review from European Economics concluded that introducing GMP for excipients would represent an unnecessary burden.
This conclusion was reached after performing a cost-benefit analysis. It went on to say that there was no evidence that continuing with the current setup would “present a major risk to patients”.
Although some raised doubts about the figures used in the analysis, and bodies including the European Fine Chemicals Group (EFCG) backed GMP, the EC eventually opted to drop the directive.
Without the enforcement of GMP, and none envisaged in the short term, Hoet is nonetheless advising clients to keep a record of information relating to manufacturing standards.
What would it have meant?
The directive would have made good manufacturing practices (GMP) mandatory for certain excipients, including those derived from transmissible spongiform encephalopathies- (TSE) relevant animals, excluding lactose and those claiming to be endotoxin / pyrogen controlled.
In addition the directive covered excipients claiming to be sterile, those from animal or human material at risk of viral contamination and specific excipients, such as glycerol