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7.3 Design and Development

ISO 9001 includes requirements for ensuring control over design and development activities. Companies involved in such activities are recommended to follow the requirements of ISO 9001. Full GMP is not always applicable during the design and development of new excipients and/or manufacturing processes. However, development batches of excipients that are intended for use in drug products should be manufactured in accordance with the applicable provisions of this Guide.

    • 7.4


      • 7.4.1

        Purchasing Process

Excipient manufacturers should have a system for selecting and approving suppliers of quality-critical materials and services (for example subcontract manufacturers and laboratories). Supplier approval by the quality unit should require an evaluation of the supplier’s quality management system, including adequate evidence that they can consistently meet agreed requirements. This may require periodic audits of the supplier’s manufacturing facility. Records of these activities should be maintained.

Materials should be purchased against an agreed specification from approved suppliers.


Purchasing Information Purchasing agreements should describe the material or service ordered including, where critical to excipient quality, the following:

    • the name, type, class, style, grade, item code number or other precise identification traceable to the raw material and packaging specifications,

    • drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel,

    • adherence to the appropriate sections of this Guide for relevant contract manufacturers or laboratories,

    • a statement to notify the excipient manufacturer of significant changes in quality- critical raw materials.

      • 7.4.3

        Verification of Purchased Product There should be procedures for the approval and release of quality-critical material.

Upon receipt, quality-critical materials should be placed in quarantine and should not be used prior to acceptance. Effective quarantine can be established with suitable identifying labels, signs and/or other manual documentation systems. When quarantine and stock control are managed with computer systems in lieu of a physical stock control, then system controls should prevent the use of unreleased material.

Quarantine may not be feasible for materials supplied via pipelines. In these cases the excipient manufacturer should establish an agreement with the supplier so that they are notified of material that does not meet specification.

Sampling activities should be conducted under defined conditions, in accordance with a defined sampling method and using procedures designed to prevent contamination and cross-contamination.

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

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