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      • 7.5.5

        Preservation of Product

        • 7.5.5.1

          Handling, Storage and Preservation Excipients, intermediates and raw materials should be handled and stored under appropriate conditions of temperature, humidity and light so that their identity, quality and purity are not affected. Outdoor storage of raw materials (for example acids, other corrosive substances or explosive materials) or excipients is acceptable provided the containers give suitable protection against deterioration or contamination of their contents, identifying labels remain legible and containers are adequately cleaned prior to opening and use. Records of storage conditions should be maintained if they are critical for the continuing conformance of the material to specification.

7.5.5.2 Packaging Systems An excipient packaging system should include the following features:

  • documented specifications and examination or testing methods,

  • cleaning procedures where containers are reused,

  • tamper-evident seals,

  • containers that provide adequate protection against deterioration or contamination of the excipient during transportation and recommended storage,

  • containers that do not interact with or contaminate the excipient,

  • storage and handling procedures which protect containers and closures and minimise the risk of contamination, damage or deterioration and which will avoid mix-ups (for example between containers that have different specifications but are similar in appearance).

If returnable excipient containers are re-used, previous labelling should be removed or defaced. If the containers are repetitively used solely for the same excipient, previous batch numbers or the entire label should be removed or completely obliterated.

7.5.5.3 Delivery and Distribution Identification and traceability of quality-critical aspects are required of excipient manufacturers. Distribution records of excipient shipments should be kept. These records should identify, by excipient batch, where and to whom the excipient was shipped, the amount shipped and the date of shipment so as to facilitate retrieval if necessary. Where excipients are handled by a series of different distributors, it should be possible to trace them back to the original manufacturer and not just to the previous supplier.

The manufacturer should maintain the integrity and the quality of the product after final inspection and test. Where contractually specified, this protection should be extended to include delivery to the final destination. Excipients should only be supplied within their expiry and/or retest period.

7.6 Control of Measuring and Monitoring Devices

Measuring and test equipment, including computerised systems, identified as being quality- critical should be calibrated and maintained. This includes in-process instruments as well as test equipment used in the laboratory. The control program should include the standardisation or

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

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