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Quality-critical materials used in the manufacture of an excipient should be tested or otherwise verified prior to use. Verification should include availability and a check of the supplier certificate of analysis and, wherever feasible, at least an identification test. Testing schedules should be organised to separate those tests that are routine from those that are performed infrequently or only for new suppliers.

Bulk deliveries should have additional controls to assure material purity and freedom from contamination (for example dedicated tankers, tamper-evident seals, a certificate of cleaning, analytical testing and/or audit of the supplier).

These procedures, activities and results should be documented.

    • 7.5

      Production and Service Provision

      • 7.5.1

        Control of Production and Service Provision Production activities should be carried out under controlled conditions (see also section

      • 7.1)


Specific examples of important controls, some of which may not be applicable to all excipient manufacturers, are illustrated in the following sections. Production Instructions and Records Production instructions and records are required but may differ for the type of operation, for example batch versus continuous processes.

There should be a controlled document that describes how the excipient is produced (for example master production instructions, master production and control records, process definitions etc.).

For batch processes an accurate reproduction of the appropriate master production instructions should be issued to the production area. For continuous processes a current processing log should be available.

Records should be available for each batch of excipient produced and should include complete information relating to the production and control of each batch. For continuous processes the batch and its records should be defined (for example based on time or defined quantity). Records may be in different locations but should be readily retrievable. Records for both batch and continuous processing, where critical to excipient quality, should include:

  • date/time each step was completed or date/time log of key parameters,

  • identification of persons performing and directly supervising or checking each significant step, operation or control parameter,

  • identification of major equipment and lines used,

  • material inputs to enable traceability, for example batch number and quantities of raw material/intermediate, time it was added, etc.,

  • in-process and laboratory control results,

  • the quantity produced for the defined batch and a statement of the percentage of theoretical yield, unless not quantifiable (for example as in some continuous processes),

  • inspection of the packaging and labelling area before and after use,

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

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