Always Label In-Process Samples with Date and Initials
Remember: In-process samples must be clearly labeled with the sampling date and initials of the person who collected them.
Why This Matters in GMP
In-process samples provide real-time insight into product quality at different stages of manufacturing. Without proper labeling, these samples become unverifiable and unusable, undermining the entire quality monitoring system. The absence of a date or initials can cause confusion about who took the sample, when it was collected, and whether it meets test criteria. This lapse may result in mix-ups, repeat sampling, batch delays, or regulatory flags. GMP principles demand traceability at every step. Labeling with the sampler’s initials and collection date ensures accountability, enables root cause analysis in case of deviations, and aligns with ALCOA+ data integrity principles.
Regulatory and Compliance Implications
FDA 21 CFR Part 211.160 and 211.165 require documented in-process sampling with sufficient details for traceability. EU GMP and WHO guidelines mandate that samples be labeled accurately for identification, status, and personnel involved. Schedule M insists on complete identification of materials and samples at every stage. Non-compliant labeling is considered a data integrity failure and may lead to audit observations or enforcement actions. Inspectors review sample labels and associated records to confirm that the data generated is reliable, attributable, and compliant with internal SOPs.
Implementation Best Practices
- Use pre-printed sample labels with fields for date, initials, time, and sample point.
- Incorporate labeling steps into in-process control SOPs and batch records.
- Train personnel on correct labeling practices and enforce visual checks.
- Use waterproof markers or printed labels to ensure data legibility.
- Review labeled samples during daily GMP walkarounds and QA line clearance.
Regulatory References
- FDA 21 CFR Part 211.160 – General Requirements for Laboratory Controls
- FDA 21 CFR Part 211.165 – Testing and Release for Distribution
- EU GMP Chapter 6 – Quality Control
- WHO GMP – Section 9: Sampling
- Schedule M – Sampling and Testing Protocols