EU GMP ANNEX 1

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Author: Mr. Pravin Manker

(Technical Director-Prescription Pharma Support Pvt. Ltd.)

Good Manufacturing Practice has always occupied the Quality Management teams’ attention and has been a continuous source of headaches for the regulators. The directives and guidelines are simple to understand and yet difficult to implement due to a variety of factors. Chief among the factors are the volatility of the human being in understanding and obeying.

EU GMP Annex 1 is revised in the year 2022 and it is one more attempt to amplify the areas of weakness and simplify the instructions so that there is a better compliance with the regulatory directives and hopefully an improved level of safety and efficacy of the drug product.

Annex 1 deals with sterile products which are the most difficult to be manufactured and tested for consistency in the prescribed quality. There is a conscious effort to correlate ICH Q9 and Q10 recommendations with the manufacture of sterile products. While Quality Risk Management (QRM – ICH Q9) and Quality Management System (QMS – ICH Q10) were good stand-alone modules, they were surprisingly not adopted in the manufacturing activity as conscientiously and widely as was expected. They were considered good material for creating documents that would please the regulators.

Better late than never, it has dawned on the authorities that there are two separate communities operating in the manufacturing sector of the pharmaceutical industry. One community deals with the actual manufacture and the deals with the paperwork associated with the manufacture. To borrow the famous quote of Rudyard Kipling “East is East and West is West and never the twain shall meet” seemed to apply to these two communities to a certain extent. Things should now change!

While the eleven (11) sections of Annex 1 are clearly titled, their content is now more specific with respect to Contamination Control Strategy. The scope has expanded to areas that were hitherto peripheral or dealt with cursorily; gowning being one such area. The “Principle” section clearly references ICH Q9 – QRM and Q10 – QMS. The “Premises” section now includes the isolators and Restricted Access Barrier Systems (RABS), a clear emphasis on area classification and the need to be able to observe Class A and B from outside.

While the more established and conscious organizations were proactive the lesser and smaller organizations were struggling to comply. Some feigned ignorance or lack of understanding while others lacked resources to comply.

This is yet another dawn in the industry. Hope it leads to bright sunshine!