Recently the US Food and Drug Administration released a guide to clarify good manufacturing practice for API production and distribution
The US Food and Drug Administration (FDA) recently released a 21 page set of questions and answers for its Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs), clarifying many facets of good manufacturing practice for API production and distribution.
Intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturer of APIs under an appropriate system for managing quality, with mention of relabelling and outsourcing of process steps.
It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.
When the International Council for Harmonisation (ICH) guidance on GMP for the manufacturing of APIs was finalised, there were many questions from industry on real-world implementation.
The guidance offers an annex with a chart that illustrates the link between each Q&A and the relevant sections of ICH Q7 and other ICH guidance documents.
While there aren’t any questions under the section on packaging and labelling APIs and intermediates, the document identifies the following areas that discuss packaging, repackaging, labelling and distribution:
Lab Controls: the guidance defines what is meant by “completely distributed” because reserve/retention samples should be retained for 3 years after this complete distribution.
Contract Manufacturers: the guidance describes the outsourced activities that are covered. Manufacturing includes “all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of APIs and related controls.”
Agents, Brokers, Traders, Distributors, Repackers, and Relabellers: the document spells out that a distributor of an API cannot use a contract manufacturer for production steps. If they do contract out production, the distributor becomes a manufacturer, subject to all guidance in ICH Q7.
The guidance also answers whether it is permissible to replace the original label in the case of repackagers. Relabelling operations are considered manufacturing, so they should be performed under appropriate GMP controls.
The full guidance is available to download here: click here.