Compliance in an Outsource Manufacturing Model: What to Look For - Pharmaceutical Technology

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Compliance in an Outsource Manufacturing Model: What to Look For
The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.

Pharmaceutical Technology

Additional questions

  • If a stability program exists, are there adequate policies, procedures, and study protocols?
  • Are storage areas sized and organized to prevent mix-ups? Is general housekeeping neat and orderly?
  • Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use?
  • Are all materials handled in such a way to prevent contamination and mix-ups?
  • Are materials spaced to allow for cleaning and inspection?
  • Are rejected components, material, and containers quarantined and clearly marked to prevent their use?


During the course of routine production, and as governed by the quality agreement, the sponsor will perform routine audits to ensure continued compliance. With a solid baseline established during the selection phase, the sponsor can then focus on areas where risk to product quality is highest. By properly selecting, evaluating, and monitoring a third-party supplier, the sponsor can ensure continued compliance over the longterm.

Tim Keutzer* is the director of project management at Cubist Pharmaceuticals, 65 Hayden Ave., Lexington, MA 02421, tel. 781.860.8331, fax 781.860.1131,
. Howard Silver is the manager of GMP compliance at Cubist Pharmaceuticals.

*To whom all correspondence should be addressed.


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