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6.3.1

6.3.2

Buildings and Facilities The prevention of contamination should be considered in the design of the manufacturing processes and facilities, particularly where the excipient is exposed. Buildings and facilities used in the production, processing, packaging, testing or storage of an excipient should be maintained in a good state of repair and should be of suitable size, construction and location to facilitate cleaning, maintenance and correct operation appropriate to the type of processing.

Manufacturing processes associated with the production of highly sensitising or toxic products (for example herbicides, pesticides etc.) should be located in dedicated facilities or use equipment separate from that used for excipient manufacture. If this is not possible then appropriate measures (for example cleaning, inactivation) should be implemented to avoid cross-contamination. The effectiveness of these measures should be demonstrated.

There should be adequate facilities for the testing of raw materials, packaging components, intermediates and finished excipients.

Equipment Equipment used in the production, processing, packaging, testing or storage of an excipient should be maintained in a good state of repair and should be of suitable size, construction and location to facilitate cleaning, maintenance and correct operation, depending on the type of processing (for example batch versus continuous).

Equipment should be commissioned before use to ensure that it is functioning as intended.

Where equipment is located outdoors there should be suitable control to minimise the risk to excipient quality from the environment (for example processing within a closed system).

6.3.2.1 Equipment Construction Process equipment should be constructed so that contact surfaces will not be reactive, additive or absorptive and thus not alter the quality of the excipient. Substances required for operation, such as lubricants or coolants, should preferably not come into contact with raw materials, packaging materials, intermediates or finished excipients. Where contact is possible, substances suitable for use in food applications should be utilised.

Equipment should be designed to minimise the possibility of contamination caused by direct operator contact in such activities as the unloading of centrifuge bags, use of transfer hoses (particularly those used to transfer powders) and the operation of drying equipment and pumps. The sanitary design of transfer and processing equipment should be evaluated. Equipment with moving parts should be assessed with regard to the integrity of seals and packing materials to control the risk of contamination.

6.3.2.2 Equipment Maintenance Documented procedures should be established and followed for maintenance of critical equipment used in the production, processing, packaging, testing or holding of the excipient. There should be records of the use and maintenance of

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

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