Do Not Use Handwritten Labels on Released Pharmaceutical Goods
Remember: GMP prohibits handwritten labeling for released products—printed, validated labels ensure traceability and eliminate confusion.
Why This Matters in GMP
Labels are essential for product identification, batch traceability, and regulatory compliance. Handwritten labels are prone to legibility issues, transcription errors, and lack of validation. They undermine quality assurance, increase the risk of product mix-ups, and compromise recall effectiveness. GMP mandates that all released goods—finished products, intermediates, or bulk items—carry standardized, printed labels with approved formats. Even temporary or internal-use labels must be controlled. Using handwritten identifiers reflects poor document control and can lead to major deviations or product misidentification.
Regulatory and Compliance Implications
FDA 21 CFR Part 211.130 and 211.122 require labeling control and prevention of mislabeling. EU GMP Chapter 4 and WHO GMP specify that labels must be printed, approved, and clearly legible. Schedule M mandates a label control system, with batch number, expiry date, and storage instructions. Auditors inspect labeling procedures, label approval logs, and complaint records. Handwritten labels, especially on released products, are treated as critical observations and potential data integrity issues. Labeling accuracy is central to product safety and regulatory conformance.
Implementation Best Practices
- Use validated label printing systems with version control and template standardization.
- Restrict manual labels to emergency or in-process use only, and only with QA approval.
- Ensure all labels carry key details: product name, strength, batch number, expiry, storage conditions.
- Implement barcode or RFID systems for tracking released goods and minimizing errors.
- Train packaging and warehouse personnel on label usage and handling protocols.
Regulatory References
- FDA 21 CFR Part 211.130 – Packaging and Labeling Operations
- FDA 21 CFR Part 211.122 – Labeling Issuance
- EU GMP Chapter 4 – Documentation
- WHO GMP – Labeling and Identification Requirements
- Schedule M – Labeling Procedures for Released Goods