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GMP Documentation: Specifications and Retention

Last reviewed 16 Oct 2026 · 5 min read

Contents
  1. Scope and current references
  2. Document control and good documentation practice
  3. Specifications for materials and products
  4. Batch documentation and retention
  5. Related guides
  6. Frequently asked questions
  7. What should a packaging-material specification include?
  8. Can GMP records be handwritten?
  9. How long should batch documentation be retained?
  10. Does EudraLex Chapter 4 still cover EU veterinary medicines?
  11. References

In short: GMP documentation connects approved instructions, specifications and manufacturing records to each batch. This guide summarizes controls for creating and correcting records, setting material and product specifications, and retaining batch documentation. Retention rules differ by jurisdiction, so apply the requirement that governs the product and site.

Scope and current references

This article paraphrases EudraLex Volume 4, Part I, Chapter 4, “Documentation” (January 2011), which the European Commission currently lists under GMP requirements for human medicines. EU veterinary GMP is now set out separately in Commission Implementing Regulation (EU) 2025/2091, applicable from 16 July 2026. Do not assume Chapter 4 is the current veterinary rule after that date.

India’s revised Schedule M and US current Good Manufacturing Practice rules have their own documentation and retention requirements. The sections below identify the jurisdiction alongside each retention period rather than presenting the EU period as universal.

Document control and good documentation practice

Define the documents used in the quality system and how each record is connected to an activity and stored. Controls apply across paper, electronic and hybrid records. Complex electronic systems should be understood, documented and validated as appropriate, with safeguards that protect record integrity throughout the retention period. (EudraLex Volume 4, Part I, Chapter 4 §§4.1 and 4.10, January 2011.)

Instruction documents should be approved, signed and dated by authorised personnel, have clear and uniquely identifiable content, and state when they take effect. Keep controlled documents current and make them easy to check. Chapter 4 says instruction documents should not be handwritten; where a record requires handwritten entries, those entries should be clear, legible and indelible. Complete records as each action occurs so that significant manufacturing activities can be traced. (EudraLex Volume 4, Part I, Chapter 4 §§4.2–4.8, January 2011.)

When correcting a record, sign and date the change, leave the original entry readable and record the reason where appropriate. (EudraLex Volume 4, Part I, Chapter 4 §4.9, January 2011.)

Specifications for materials and products

Maintain authorised and dated specifications for starting materials, packaging materials and finished products. Where relevant, starting- and packaging-material specifications identify the material and its internal code, refer to a pharmacopoeial monograph if one applies, identify approved suppliers and, where reasonable, the original producer, and include a specimen of printed materials. They also describe sampling and testing, quality requirements and acceptance limits, storage conditions and precautions, and the maximum storage period before re-examination. (EudraLex Volume 4, Part I, Chapter 4 §§4.13–4.14, January 2011.)

Specifications should also be available for intermediates and bulk products at critical processing steps, or when those materials are purchased or dispatched. Finished-product specifications identify the product and code, formula, dosage form and pack details, sampling and testing directions, quality requirements with acceptance limits, storage or handling conditions, and shelf-life. (EudraLex Volume 4, Part I, Chapter 4 §§4.15–4.16, January 2011.)

Batch documentation and retention

Batch-processing and batch-packaging records document how the approved manufacturing or packaging instructions were followed. EudraLex Chapter 4 §§4.20–4.21 describe information for these records, including batch identity, process or packaging dates, operator identification, in-process checks, results and any authorised deviation. Keep associated records identifiable and retrievable during their applicable retention period.

Retention periods depend on jurisdiction and record type:

  • India: Revised Schedule M, Part I §17.2.7, notified by G.S.R. 922(E) (2023), requires records to be retained for at least one year after the finished product’s expiry date.
  • EU human medicines: EudraLex Volume 4, Part I, Chapter 4 §4.11 (January 2011) sets one year after batch expiry or five years after Qualified Person certification, whichever is longer. For investigational medicinal products, the chapter specifies at least five years after completion or formal discontinuation of the last clinical trial in which the batch was used.
  • United States: 21 CFR Part 211 §211.180(a), current eCFR as of 14 October 2026, requires at least one year after expiry for batch-associated production, control or distribution records. Certain OTC products exempt from expiry dating have a separate three-year-after-distribution period.

For other EU documentation, Chapter 4 §4.12 bases retention on the activity supported. Critical documentation, including raw data supporting the marketing authorisation, should be retained while that authorisation remains in force. Retiring superseded data requires a documented justification and consideration of the retention period for the batches it supports. Apply any longer period required by applicable local law or the marketing authorisation.

Frequently asked questions

What should a packaging-material specification include?

EudraLex Chapter 4 §4.14 lists identification and code, supplier information where applicable, sampling and testing, acceptance limits, storage conditions and precautions, and the maximum period before re-examination. Printed materials also need a specimen or reference.

Can GMP records be handwritten?

EudraLex Chapter 4 §§4.6–4.7 distinguishes instruction documents from entries: instruction documents should not be handwritten, while required handwritten entries should be clear, legible and indelible.

How long should batch documentation be retained?

Use the rule for the relevant jurisdiction. For example, India Schedule M Part I §17.2.7 sets at least one year after finished-product expiry; EU human GMP and US 21 CFR §211.180(a) have their own terms and exceptions.

Does EudraLex Chapter 4 still cover EU veterinary medicines?

The Commission’s Volume 4 page lists Chapter 4 for human-use GMP and identifies Commission Implementing Regulation (EU) 2025/2091 as the veterinary GMP regulation applicable from 16 July 2026.

References

  • European Commission, EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part I, Chapter 4: Documentation, January 2011, §§4.1–4.21. Official Chapter 4 PDF · Official Volume 4 index
  • European Commission, Commission Implementing Regulation (EU) 2025/2091, 17 October 2025, GMP for veterinary medicinal products; applicable from 16 July 2026, as listed on the official EudraLex Volume 4 page.
  • Government of India, Ministry of Health and Family Welfare, Drugs (Second Amendment) Rules, 2023, G.S.R. 922(E), 28 December 2023, Revised Schedule M, Part I §17.2.7. Official CDSCO Gazette PDF
  • Government of India, Ministry of Health and Family Welfare, corrigendum to G.S.R. 922(E), G.S.R. 666(E), 25 October 2024. Official CDSCO Gazette PDF
  • United States, 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, §211.180(a), eCFR current as of 14 October 2026. Official eCFR text

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