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DEFINITIONS (SEE ALSO APPENDIX B)

GENERAL GUIDANCE

International regulations governing drugs require that they be produced, processed, packed and stored in accordance with GMP. Unlike pharmaceutical products and APIs, there was previously little guidance that specifically addresses the manufacture of pharmaceutical excipients.

3.1 Pharmaceutical Excipients

Pharmaceutical excipients are substances other than the API, which have been appropriately evaluated for safety and are intentionally included in a drug delivery system.

For example excipients can:

  • aid in the processing of the drug delivery system during its manufacture,

  • protect, support or enhance stability, bioavailability or patient acceptability,

  • assist in product identification,

  • enhance any other attribute of the overall safety, effectiveness or delivery of the drug

during storage or use.

3.2 Excipient GMP Implementation

The application of GMP is relevant once it has been determined that a chemical is intended for use as a component of a drug product. Excipient manufacture should be carried out in accordance with the GMP concepts consistent with this Guide. The objective of excipient GMP is to ensure that the manufacture of an excipient results in a consistent material with the desired quality characteristics. The emphasis of GMP for excipients is to assure product integrity, avoid product contamination and ensure that records are maintained.

As the excipient manufacturing process progresses the degree of assurance concerning the quality of the product should increase. Manufacturing processes should be controlled and documented. However, at some logical processing step, as determined by the manufacturer, the GMP as described in this Guide should be applied and maintained.

Judgement based on risk analysis and a thorough knowledge of the process is required to determine from which processing step GMP should be implemented. This is usually well before the final finishing operation and for example may be identified using methods such as HACCP (Hazard Analysis and Critical Control Point), FMEA (Failure Mode and Effects Analysis) or a detailed process flow diagram. Consideration should also be given to other factors such as batch versus continuous processing, dedicated versus multi-purpose equipment, open versus closed processes. (see also Appendix A for further examples).

QUALITY MANAGEMENT SYSTEM- EXCIPIENT QUALITY SYSTEMS 4.1 General Requirements

The principles outlined in this Guide provide a comprehensive basis for the quality management system used in the manufacture of pharmaceutical excipients. Excipient manufacturers should identify the quality management processes required to assure excipient quality.

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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