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Where manufacturing, testing or other operations that could affect excipient quality are outsourced the responsibility for quality remains with the excipient manufacturer and control measures should be defined (see also 7.4.2).

    • 4.2

      Documentation Requirements

      • 4.2.1

        General

The excipient manufacturer should have a system in place to control documents and data that relates to the requirements of the quality management system.

4.2.2

Quality Manual The excipient manufacturer should prepare a quality manual describing the quality management system, the quality policy and the commitment of the excipient manufacturer to applying the appropriate GMP and quality management standards contained in this Guide. This manual should include the scope of the quality management system, reference to supporting procedures and a description of the interaction between quality management processes.

4.2.3

Control of Documents The excipient manufacturer should establish and maintain procedures for the identification, collection, indexing, filing, storage, maintenance and disposition of controlled documents, including documents of external origin that are part of the quality management system.

Procedures used in the manufacture of excipients should be documented, implemented and maintained. In addition, there should be formal controls relating to procedure approval, revision and distribution. These controls should provide assurance that the current version of a procedure is being used throughout the operational areas and previous revisions of documents have been removed.

Documents and subsequent changes to documents should be reviewed and approved by designated qualified personnel before issuance to the appropriate areas, as identified in the documents. Documents that impact product quality should be reviewed and approved by the quality unit (see also 5.5.1).

Controlled documents may include a unique identifier, date of issue and revision number to facilitate identification of the most recent document. The department with the responsibility for issuing the documents should be identified. Where practical, changes and the reasons for the change should be documented.

Electronic documentation should meet the requirements for the document control system stated above. If electronic signatures are used on documents, they should be controlled to provide equivalent security to that given by a hand written signature. Electronic documents and signatures may also need to satisfy local regulatory requirements.

4.2.4

Control of Records The excipient manufacturer should establish and maintain procedures for the identification, collection, indexing, filing, storage, maintenance and disposition of records.

Records should be maintained to demonstrate achievement of the required quality and the effective operation of the quality management system. Records should be legible and

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

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