Pharmacy Courses

Data Integrity Regarding Printout or Photocopy of the Raw Data

FAQ: Is a copy of a GMP record (e.g. printout of the raw data or photocopy/scan copy of a original record) itself considered a GMP document?

On a daily basis, there are many valid reasons why a firm may wish to make copies of GMP records, including records that contain a lot number, batch-specific data, test results, or other data. For example, firms may make a copy of a batch record to provide to a Technical Services group to conduct an investigation. Especially in light of recent 483 observations that highlight documents with batch information found in a shredder, it is unclear under what conditions it is permissible to treat copies of GMP records as uncontrolled, non-GMP records. Requiring that the issuance, management, and destruction of all of these documents be controlled by the Quality Unit imposes an unnecessary burden on industry. The key is for firms to be able to show how they assure that an original record is the original record and that the data in the record satisfy ALCOA principles.

As long as firms have full control over original GMP documents and the original GMP document is retained as required by the firm’s procedure, copies can be created and destroyed as needed. A copy of a GMP record need only be retained if additional GMP information (e.g., raw data) is recorded on the document copy. As a part of maintaining control over GMP records, it is advisable to make sure that copies can be readily distinguished from originals (e.g., copies are stamped as “copy” and/or originals are stamped as “original”).

Reference: PDA Journal

Read also: Data Integrity Checklist for Pharmaceutical Industry

Previous Post Next Post