Never Use Photocopies as Originals for GMP Quality Documents

Do Not Use Photocopies as Original GMP Quality Documents

Remember: Only approved, controlled originals should be used for GMP activities—photocopies are not acceptable as quality documents.

Why This Matters in GMP

Using photocopied documents introduces the risk of working with outdated, unauthorized, or modified content. Without proper document control, personnel may follow incorrect instructions, leading to deviations, product defects, or non-compliance. GMP requires a system of version-controlled, authorized documents that are tracked from issuance to archiving. Photocopies can’t be reliably traced and often lack approval signatures, version numbers, or watermark protections. This creates ambiguity and weakens audit trails. Furthermore, uncontrolled documents are difficult to recall or revise when updates occur. Ensuring only master-controlled documents are used maintains data integrity and enforces a consistent quality standard across operations.

Also Read: Maintain Access Logs for Electronic GMP Systems to Ensure Accountability

Regulatory and Compliance Implications

FDA 21 CFR Part 211.100 and 211.180 emphasize the use of approved written procedures and accurate records. WHO GMP and EU GMP Chapter 4 stress document control and revision tracking. Schedule M mandates issuance of controlled, numbered SOPs and records. Use of photocopies may lead to regulatory citations for inadequate documentation systems and process deviations. Regulatory inspectors frequently examine document control systems, issuance logs, and document integrity. The absence of version control or unauthorized document use is a common cause of data integrity observations.

Implementation Best Practices

Establish a document control system with a unique number, version, and issuance log for each SOP or record.
Distribute only printed originals with control stamps or watermarks for GMP use.
Restrict access to master documents and prohibit unauthorized photoing or scanning.
Train employees to verify document versions before use and report any discrepancies.
Audit departments periodically for use of unauthorized or photocopied documents.

Also Read: The Role of EMA GMP in the Manufacture of Controlled Substances

Regulatory References

FDA 21 CFR Part 211.100 – Written Procedures; Deviations
FDA 21 CFR Part 211.180 – General Requirements
EU GMP Chapter 4 – Documentation
WHO GMP – Documentation Practices
Schedule M – SOP and Record Control Requirements