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quality-critical equipment. These records can be in the form of a log, computer database or other appropriate documentation. Computer Systems Computer systems that may impact upon excipient quality should have sufficient controls for operation and maintenance and to prevent unauthorised access or changes to computer software, hardware or data, including:

    • systems and procedures that show the equipment and software are performing as intended,

    • procedures for checking the equipment at appropriate intervals,

    • retention of suitable back-up or archival systems such as copies of the program and files,

    • assurance that changes are verified and documented and only made by authorised personnel.

      • 6.3.3


Utilities (for example nitrogen, compressed air, steam etc.) used in the production, storage or transfer of materials that could impact excipient quality should be assessed and appropriate action taken to control the risk of contamination and cross-contamination.


Water Water used in the manufacture of excipients should be demonstrated to be of a suitable quality for its intended use. Unless otherwise justified process water should, at a minimum, meet WHO guidelines for drinking (potable) water quality.

If drinking (potable) water is insufficient to assure quality or tighter chemical and/or microbiological water quality specifications are required, appropriate controls and specifications should be set, for example physical and chemical attributes, total microbial counts, limits on objectionable organisms and/or endotoxins.

Where water used in the process is treated by the manufacturer to achieve a defined quality the treatment process should be specified and monitored with appropriate action limits.

Water that comes into contact with the excipient should be supplied under continuous positive pressure (or other means of preventing back flow) in a system free of defects to control the risk of contamination to the excipient.

6.4 Work Environment

Where the excipient is exposed during manufacture it should be in an appropriate environment to minimise contamination. The manufacturer should apply suitable controls to maintain that environment.


Air Handling Where an air handling system is installed to provide protection excipient manufacturer should demonstrate its effectiveness.





Excipient production unit air handling systems should be designed to prevent cross- contamination. For dedicated areas processing the same excipient it is permissible to recycle a portion of the exhaust air back into the same area. The adequacy of such a

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

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