FDA: Packaging Implications in the New API Guidance

The FDA released a Q&A-style guidance that clarifies many facets of good manufacturing practice for API production and distribution throughout the supply chain, with mention of relabeling and outsourcing of process steps.

If you’re involved in the manufacture, use or distribution of active pharmaceutical ingredients (APIs) anywhere in the supply chain, take note: The FDA recently released a new set of questions and answers for its guidance, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

When the International Council for Harmonisation (ICH) guidance on good manufacturing practice (GMP) for the manufacturing of APIs was finalized, there were many questions from industry on real-world implementation. This new 21-page guidance is intended to respond to those requests, ultimately helping to ensure that APIs meet reported quality and purity characteristics.

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. The introduction informs readers of the importance of reading the full Q7 document, regardless of their role in the supply chain “to fully understand the linkages between certain sections and successfully implement appropriate [GMPs] at all stages of the active pharmaceutical ingredients (API) supply chain, including distribution.”

Packaging notes

While there aren’t any questions under the section on packaging and labeling APIs and intermediates, the document identifies the following areas that discuss packaging, repackaging, labeling and distribution:

Lab Controls - The guidance defines what is meant by “completely distributed” because reserve/retention samples should be retained for three years after this complete distribution. It “refers to the distribution of the entire batch of the API by the API manufacturer to the next party in the supply chain,” with the intent being that samples are available as long as the API could be on the market (unless a retest date is scheduled for longer than three years, in which case samples should be held for that longer time period.) 

This section also explains that more protective packaging can be used for reserve/retention samples because any future evaluations would be used to determine the quality of the original batch (including in evaluations of counterfeits) and not to determine the stability of products in the marketplace.

Contract Manufacturers (Including Laboratories) - The guidance describes which outsourced activities are covered. Manufacturing includes “all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage, and distribution of APIs and related controls.”

Agents, Brokers, Traders, Distributors, Repackers, and Relabelers - 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. Relabeling operations are considered manufacturing, so they should be performed under appropriate GMP controls. 

As the guidance notes, “With appropriate justification, manufacturers including repackagers and relabelers may replace the original label, so long as information about the original manufacturer is provided to the customers (ICH Q7, paragraph 17.61) and the traceability of the supply chain needs is maintained (ICH Q7, section XVII.B (17.2)). The new label should contain information as per ICH Q7, paragraphs 9.42, 9.43. However, distributors should not remove an original label, but only add additional labels.”

View the full guidance here: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients — Questions and Answers

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