The European Commission (EC) proposed changes to Annex 16 of the EU good manufacturing practices guidelines (GMP) in July, explaining that changes were needed to reflect globalisation of pharmaceutical supply chains and the introduction of new quality control strategies.
“The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products, and to implement ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the MIA interpretation document, as applicable. Also, some areas, where the interpretation by member states has not been consistent, have been clarified.”
Many of the proposed changes relate to the activities of the Qualified Person (QP) that drugmakers in the European Union employ at manufacturing facilities to certify the quality of drugs made for trials or for commercial sale. One revision in particular – section 2.2 – generated a lot of feedback.
“The responsibility for ensuring that a particular batch has been manufactured in accordance with its marketing authorisation, with EU GMP, or equivalent, and that it is in compliance with the laws in force in the Member State where certification takes place and of the destination country of the medicinal product, lies with the QP certifying that batch as being suitable for release.”
Industry response
Industry group EFPIA was one of the first to comment. It suggested that while, the revisions reflect the realities of the global supply chain, requiring QPs who work for global drugmakers to know the differing quality rules in place in each European Economic Area (EEA) member state is unrealistic.
“Due to the lack of harmonisation of international regulations, it is very unrealistic that the Qualified Person can certify that the batch has been manufactured in compliance with laws of the destination country of the medicinal product.”
Instead EFPIA said that QPs should be required to certify that drugs are produced in compliance with EU standards.
Similar recommendations were made by the Association of the European Self-Medication Industry (AESGP), Germany industry group BPI, the European Generic medicines Association (EGA) , the European QP Association, France’s LEEM and Austria’s Pharmig
The Austrian Qualified Person Association (AQPA) also said that asking QPs to make such certifications is unrealistic and suggested that asking them to signifying “the batch [of drug product] is in compliance with EU GMP and the requirements of its marketing authorisation” would be preferable.
While Section 2.2 attracted the most comments, other parts of the proposed revision to Annex 16 were discussed.
The European Fine Chemical Industry Council ‘s (Cefic) active pharmaceutical ingredients committee (APIC) suggested that section 3.2, which states that QPs should have detailed knowledge of all processes at all manufacturing facilities was also unrealistic.
The EC has not commented on the responses.