impurities and key tests needed for process control should be documented, thus providing the basis for validation.
The full validation program that is typically performed in the pharmaceutical industry may not always be carried out by the excipient manufacturer. However, the excipient manufacturer should demonstrate the consistent operation of each manufacturing process, for example through process capability studies, development and scale-up reports etc.
Identification and Traceability
Quality-critical items, for example raw materials, packaging materials, intermediates and finished excipients should be clearly identified and traceable through records. These records should allow traceability of the excipient both upstream and downstream. Identification of raw materials used in batch production processes should be traceable through the batch numbering system or other appropriate system. Identification of raw materials used in excipients produced by continuous processing should indicate the timeframe during which a particular batch of raw material was processed through the plant.
Raw materials, including solvents, are sometimes stored in bulk tanks or other large containers, making precise separation of batches difficult. Nevertheless, the use of such materials should be documented in production records.
22.214.171.124 Inspection and Test Status There should be a system to identify the inspection status of quality-critical items including raw materials, packaging materials, intermediates and finished excipients. Whilst storing materials in identified locations is preferred, any means that clearly identifies the test status is satisfactory. Continuously-fed materials may need special consideration in order to satisfy these requirements.
126.96.36.199 Labelling Labelling for excipient packages is subject to national and international regulatory requirements, which may include transportation and safety measures. As a minimum, labels should include:
the name of the excipient and grade if applicable,
the excipient manufacturer’s and/or distributor’s name,
the batch number from which the complete batch history can be determined,
special storage conditions, if applicable.
The excipient manufacturer should establish and maintain procedures for verification, storage and maintenance of customer-supplied materials intended for incorporation into the customer's excipient. Verification by the manufacturer does not relieve the customer of the responsibility to provide an acceptable material. Material that is lost damaged or is otherwise unsuitable for use should be recorded and reported to the customer. In this case, procedures should be in place for acceptable disposition and replacement of the material. The manufacturer should also make provisions to protect other real and intellectual property that is provided by the customer (for example test equipment, test methods and specifications).
Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group