Never Conduct Sampling Without Wearing Clean Area Garments

Wear Clean Area Garments While Performing Sampling

Remember: Sampling without proper clean area garments introduces contamination—GMP mandates full gowning compliance during all sampling activities.

Why This Matters in GMP

Sampling is a critical step in verifying the quality of raw materials, intermediates, or finished products. It often involves direct or indirect product contact. Conducting sampling without wearing clean area garments such as coveralls, caps, gloves, and masks can introduce contaminants from skin, clothing, or the external environment. This may result in microbial or particulate contamination, leading to inaccurate results or batch rejection. Gowning acts as a barrier, especially when sampling from sterile or sensitive materials. GMP guidelines require strict adherence to gowning protocols for any cleanroom or sampling room activity to ensure sample integrity and product safety.

Also Read: The Role of Health Canada GMP Regulations in Clinical Trials

Regulatory and Compliance Implications

FDA 21 CFR Part 211.28 and 211.67 emphasize the importance of hygiene and contamination control during product-related operations. WHO GMP and Schedule M require personnel to wear appropriate protective clothing during sampling. EU GMP Annex 1 mandates gowning for any activity within controlled environments, including sampling zones. Auditors frequently inspect sampling logs, gowning practices, and training records. Non-compliance may lead to contamination risks, audit observations, or rejection of sampled lots. Proper gowning during sampling ensures traceability and protects both product quality and analyst safety.

Implementation Best Practices

Include gowning steps as part of sampling SOPs for each product and area classification.
Train personnel on proper donning and doffing techniques for clean area garments.
Provide dedicated gowning supplies in sampling booths or controlled environments.
Verify gowning compliance during internal audits or QA walkthroughs of sampling areas.
Establish gown change frequency based on sampling volume, product type, and classification of the area.

Also Read: How to Use Statistical Process Control (SPC) for Continuous Improvement in GMP

Regulatory References

FDA 21 CFR Part 211.28 – Personnel Responsibilities
FDA 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
EU GMP Annex 1 – Cleanroom and Aseptic Practices
WHO GMP – Sampling and Personal Hygiene
Schedule M – Sampling and Clean Area Protocols