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7.5.2 In-process Control In-process inspection and testing should be performed based upon monitoring the process or actual sample analysis at defined locations and times. Sampling methods should be documented to ensure that the sample is representative and clearly labelled.

In-process samples should not be returned to production for incorporation into the final batch.

The results of in-process tests should be recorded and should conform to established process parameters or acceptable tolerances. Work instructions should define the procedure to follow and how to utilise the inspection and test data to control the process. There should be defined actions to be taken when the results are outside specified limits.

Where approval to continue with the process is issued within the production department, the specified tests should be performed by trained personnel and the results recorded. Packaging and Labelling Procedures should be employed to protect the quality and purity of the excipient when it is packaged and to assure that the correct label is applied to all containers. Packaging and labelling operations should be designed to prevent mix-ups.

Procedures should be implemented to ensure that the correct labels are printed and issued and that the labels contain the correct information. The procedure should also specify that excess labels are immediately destroyed or returned to controlled storage. Excess labels bearing batch numbers should be destroyed. Packaging and labelling facilities should be inspected immediately before use to ensure that materials that are not required for the next packaging operation have been removed.

Where excipients are labelled on the packaging line, packaged in pre-printed bags or bulk-shipped in tank cars there should be documentation of the system used to satisfy the intent of the above procedures. Records of Equipment Use Records of quality-critical equipment use should be retained. These records should allow the sequence of cleaning, maintenance and production activities to be determined.

Validation of Processes for Production and Service Provision An important factor in the assurance of product quality includes the adequate design and control of the manufacturing process because product testing alone is not sufficient to reveal variations that may have occurred. Each step of the manufacturing process should be controlled to the extent necessary to ensure that the excipient meets established specifications.

The concept of process validation is a key element in ensuring that these quality assurance goals are met. The process reactions, operating parameters, purification steps,

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

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