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Washing and Toilet Facilities Adequate personal washing facilities should be provided, including hot and cold water, soap or detergent, air dryers or single service towels and clean toilet facilities easily accessible to working areas. Adequate facilities for showering and/or changing clothes should be provided, where appropriate.

PRODUCT REALISATION 7.1 Planning of Product Realisation

The excipient manufacturer should plan and develop the processes and controls needed for product manufacture.

These plans and controls should be appropriate to the production process, excipient specification, equipment and facilities used in the manufacture of the product.

Key aspects of the planning of a suitable process and its controls should include as appropriate:

  • documented testing programs for quality-critical materials including excipients that include appropriate specifications, sampling plans, test and release procedures,

  • generation and maintenance of records (see also 4.2.4) that provide evidence that these plans have been realised as intended and that enable traceability to be demonstrated (see also



  • provision of resources to implement these plans,

  • environmental and hygiene control programs to minimise contamination.

    • 7.2

      Customer-related Processes

      • 7.2.1

        Determination of Requirements Related to the Product The excipient manufacturer should determine the excipient quality, labelling and delivery requirements of the customer. Additional requirements, whether customer-specific, legal or regulatory (for example pharmacopoeia material and general monographs), should be agreed by both parties. Requirements not stated by the customer but necessary for specified or intended use, where known, should be considered.

      • 7.2.2

        Review of Requirements Related to the Product The excipient manufacturer and customer should mutually agree upon the requirements identified in 7.2.1 before supply commences. The manufacturer should have the facility and process capability to meet consistently the mutually agreed specifications. Where the requirements determined in 7.2.1 are changed this review should be repeated before supply recommences.

      • 7.2.3

        Customer Communication

There should be provision for providing accurate and pertinent communication to the customer. Master copies of documents such as specifications and technical reports should be controlled documents. Provision should be made for replying to customer enquiries, contracts and order handling requirements. Customer feedback and complaints should be documented. Customers should be notified of significant changes (see also 4.3). For additional change notification information refer to IPEC-Americas Significant Change Guide for Bulk Pharmaceutical Excipients.

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

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