(1999; 168 pages) [Spanish]
7.3.4 Quality records and retention samples
The manufacturer should establish and maintain procedures for identification, collection, indexing, filing, storage, maintenance and availability of quality records. Quality records should be maintained to demonstrate achievement of the required quality and the effective operation of the quality system. These data should include pertinent subcontractor quality records.
All quality records should be legible and identifiable to the product involved. Quality records should be stored and maintained in such a way that they are readily retrievable, in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss. Retention times of quality records should be established and recorded. Where agreed contractually, quality records should be made available for evaluation by the purchaser or the purchaser's representative for an agreed period.
All appropriate records relating to inspection and testing must be available for review. Where the process is continuously monitored, acknowledgement must be made of this and the results of the monitoring should be available.
Reserve samples of the released excipient should be retained for one year after the expiry or re-evaluation date, or for one year after distribution is complete. Sample size should be twice the amount required to perform release specification testing.