QC Laboratory Records: Control and Retention

In short: A QC laboratory needs controlled procedures for creating, identifying, retrieving, protecting and retaining its records. Test records should preserve the original data and calculations needed to understand, review or repeat the work, while retention periods follow the applicable guidance, law and contract.

Control records throughout their lifecycle

Describe in an approved procedure how records are identified, collected, indexed, retrieved, stored, backed up, accessed, maintained and disposed of. The procedure should cover paper, electronic and hybrid records. Keep records legible and retrievable, protect them from loss or deterioration, and restrict access to authorized personnel. WHO TRS 1052, Annex 4, §§3.19 and 3.27–3.28 (2024)

For electronic records, define access controls, backup frequency and type, and how data restoration is performed. Protect systems against unauthorized changes and data loss. Where required by the system and intended use, document validation or verification, maintain an audit trail, and periodically review it. WHO TRS 1052, Annex 4, §§3.30–3.35 (2024)

Make analytical records complete and traceable

Retain original observations, calculations, derived data, calibration, validation and verification records, and final results. A test record should link the sample to the method, analyst, preparation, raw data, calculations and reported result. Include enough information to reconstruct the work or recalculate the result. In the United States, 21 CFR Part 211 also specifies laboratory-record content for covered drug products, including complete test data, instrument records, calculations, results, performer identity and independent review. WHO TRS 1052, Annex 4, §§3.20–3.23 (2024); 21 CFR §211.194(a) (current eCFR)

WHO guidance describes analytical worksheets as containing details such as the sample, test procedure, reagents, standards, materials, calculations and results, with the raw data. Paper worksheets should connect to their supporting records, such as chromatograms and spectra; controlled forms should have issuance and reconciliation controls where required. WHO TRS 1052, Annex 4, §§3.21–3.22 and 6.33 (2024)

Example in-house criterion (not a pharmacopoeial requirement): a controlled worksheet template can prompt the analyst to record the sample identifier, method, reagent and standard references, original observations, instrument-file location, calculations, result, date and reviewer. Adapt the fields to the work and applicable requirements.

Quality-management records may include audit and inspection reports, management reviews, risk assessments, complaints and investigations, and corrective or preventive actions. Keep records associated with legal proceedings according to applicable legal requirements. WHO TRS 1052, Annex 4, §§3.24 and 3.29 (2024)

Apply the correct retention period

WHO guidance for pharmaceutical QC laboratories says original observations and related records should follow national law or contractual agreements and be retained for at least five years. It separately recommends retaining tested samples for shelf-life plus one year for marketed pharmaceutical products and for 15 years for investigational products, unless a stricter national rule or contract applies. Sample retention and record retention are different controls. WHO TRS 1052, Annex 4, §§3.20 and 3.26 (2024)

Batch documentation within EU GMP scope must be retained for at least one year after the expiry of the related batch or at least five years after Qualified Person certification, whichever is longer. For investigational medicinal products, EU GMP gives a separate minimum of five years after completion or formal discontinuation of the last clinical trial using the batch. Under US cGMP, batch-associated production, control or distribution records required by 21 CFR Part 211 must be retained for at least one year after the batch expiry, subject to the regulation’s specific exceptions. Apply any longer period required by the product, local law or contract. EU GMP Part I, Chapter 4, §4.11 (January 2011); 21 CFR §211.180(a) (current eCFR)

See also the SOP for data integrity, control of documentation and good documentation practices.

Frequently asked questions

What should a QC laboratory test record contain?

It should identify the sample and method and preserve the original test data, supporting records, calculations, result and personnel involved. Additional particulars depend on the applicable procedure and rules. WHO TRS 1052, Annex 4, §§3.21–3.23 (2024); 21 CFR §211.194(a) (current eCFR)

Can laboratory records be stored electronically?

Yes, WHO guidance discusses paper, electronic and hybrid records. Define access, backup, restoration and data-integrity controls for the system, and meet applicable electronic-record requirements. WHO TRS 1052, Annex 4, §§3.19 and 3.30–3.35 (2024)

Is the sample retention period the same as the record retention period?

No. WHO TRS 1052 Annex 4 §3.20 addresses records, while §3.26 separately addresses tested samples. Use the correct schedule for each item and check whether local law or an agreement requires longer retention.

References

• World Health Organization. WHO good practices for pharmaceutical quality control laboratories. WHO Technical Report Series No. 1052, Annex 4, 2024, §§3.19–3.35 and 6.33.
• European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part I, Chapter 4: Documentation, §4.11, revision 1, January 2011. Official Chapter 4 PDF.
• United States. Code of Federal Regulations, Title 21, Part 211, §§211.180(a) and 211.194(a), General requirements and Laboratory records, current eCFR, accessed 16 October 2026. §211.180(a) · §211.194(a).