Article 9 Documentation
1. The manufacturer shall be obliged to establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed. The documentation system shall ensure data quality and integrity. Documents shall be clear, free from error and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch. That set of documents shall enable the history of the manufacture of each batch to be traced.
The manufacturer shall be required to retain the batch documentation for at least 1 year after the expiry date of the batches to which it relates or at least 5 years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall be required to first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage. Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities upon request. The electronically stored data shall be protected, by techniques such as duplication or back-up and transfer to another storage system, against unlawful access, loss or damage of data, and audit trails shall be maintained.