Commission Delegated Regulation (EU) 2017/1569Dangos y teitl llawn

Article 8 U.K. Documentation

1. The manufacturer shall establish and maintain a documentation system recording the following, where appropriate having regard to the activities undertaken:

(a) specifications;

(b) manufacturing formulae;

(c) processing and packaging instructions;

(d) procedures and protocols, including procedures for general manufacturing operations and conditions;

(e) records, in particular covering the various manufacturing operations performed and batch records;

(f) technical agreements;

(g) certificates of analysis;

The documents specific to any investigational medicinal product shall be consistent with the product specification file as relevant.

2. The documentation system shall ensure the data quality and integrity. Documents shall be clear, free from error and kept up to date.

3. The manufacturer shall retain the product specification file and batch documentation for at least five years after the completion or discontinuation of the last clinical trial in which the batch was used.

4. When documentation is stored using electronic, photographic or other data processing systems, the manufacturer shall first validate the systems to ensure that the data will be appropriately stored during the period of storage laid down in paragraph 3. Data stored by those systems shall be made readily available in readable form.

5. The electronically stored data shall be protected against unlawful access, loss or damage of data by techniques such as duplication, back-up and transfer onto another storage system. Audit trails, meaning records of all relevant changes and deletions in those data, shall be maintained.

6. The documentation shall be provided to competent authority upon request.