Good Documentation Practice in Pharma (EU GMP Chapter 4)

In short: Chapter 4 of EU GMP (EudraLex Volume 4, Part I, January 2011) treats documentation as the backbone of the quality system: if it is not written down correctly, it did not happen. Documents are either instructions (what to do) or records and reports (what was done). This page explains the types of GMP documents and the day-to-day habits expected of everyone who writes in them.

Why documentation matters

Good documentation is part of quality assurance. It lets a manufacturer define, control, monitor and record every activity that can directly or indirectly affect product quality. The documents may be on paper, electronic or photographic media, but the quality system must define which are used and how they are controlled. The aim is that a person who was not present can understand what was required and what actually happened.

Chapter 4 expects documents to be accurate, legible, available when needed and protected against loss or unauthorised change. “Written” does not mean paper only: it means recorded on a medium from which the information can be read by a person.

Two families of GMP documents

Instructions (directions and requirements)

Records and reports

For electronic records, the user should decide which data count as raw data. At a minimum, all data on which quality decisions are based should be defined as raw data.

Controlling documents

• Define every document type and follow the definition. The requirements apply equally to paper, electronic and hybrid systems.
• Hybrid systems (part paper, part electronic) need clear rules on the relationship between master documents, official copies, data handling and records.
• Prepare with care. Documents should be designed, prepared, reviewed and distributed carefully and must agree with the product specification file and the marketing authorisation dossier where relevant. Copying working documents from masters must not introduce errors.
• Keep them current. Documents in the quality system should be reviewed regularly and kept up to date; instruction documents should be approved by suitably authorised people.
• Do not hand-write the document itself. Documents should be generated rather than written by hand, but where data must be entered, leave enough space for the entry.

Good documentation habits for everyone

1. Write clearly, legibly and in indelible ink (Chapter 4, clause 4.7).
2. Record at the time the action is taken, so that all significant manufacturing activities are traceable (clause 4.8).
3. Correct a mistake by a single line through the entry, with signature and date, so the original stays readable; give the reason where appropriate (clause 4.9).
4. Do not overwrite, use correction fluid, or backdate entries.
5. Do not leave blanks where an entry is expected; write “NA” with initials and date if a field does not apply (example in-house practice).
6. Sign only for what you did or checked yourself.

These habits are often summarised as ALCOA (attributable, legible, contemporaneous, original, accurate). The acronym comes from data-integrity guidance rather than from Chapter 4 itself; Chapter 4 describes the same ideas in its own words.

Retention of records

Clause 4.11 sets the rule for batch documentation: keep it for one year after the expiry of the batch it relates to, or at least five years after certification of the batch by the Qualified Person, whichever is longer. In the United States, 21 CFR 211.180(a) likewise requires production, control and distribution records to be kept at least one year after the batch expiry date.

The rule to apply is therefore: keep GMP records at least 1 year after the expiry date of the respective product batch, and longer where local law or the marketing authorisation requires. Other documents, such as validation or stability raw data supporting the marketing authorisation, are kept for as long as the authorisation remains in force (clause 4.12). The record must also be kept secure and readable throughout the retention period (clause 4.10).

Frequently asked questions

Is a SOP an instruction or a record? A SOP is an instruction. The completed logbook page or batch record that shows the SOP was followed is a record.

Can records be electronic? Yes. Chapter 4 applies to all media. Electronic systems must also meet the access, audit trail and validation expectations of EU GMP Annex 11.

What is raw data? It is the original record of an observation or measurement from which other records are produced. The user must define which data are raw data, and at least all data supporting quality decisions must be covered.

Is Chapter 4 being revised? Yes, but the revision is not yet in force. Draft revisions of Chapter 4 and Annex 11, together with a draft new Annex 22 on artificial intelligence, went to a joint European Commission and PIC/S stakeholder consultation from 7 July to 7 October 2025. The Chapter 4 draft focuses on electronic records, signatures and data integrity. As of October 2026 no revised text has been adopted: the Commission’s EudraLex Volume 4 page still lists Chapter 4 and Annex 11 in their January 2011 versions, which are the ones described here. Watch that page for the final texts and their date of coming into operation.

See also

• Good documentation practices for BMR, BPR, processing, packaging and testing records
• Good documentation practice: specifications, packaging materials and retention
• Example SOP for documentation control
• Example SOP on data integrity

References

1. European Commission, EudraLex Volume 4, Good Manufacturing Practice, Part I, Chapter 4: Documentation (revision January 2011).
2. European Commission, EudraLex Volume 4, Annex 11: Computerised Systems (revision January 2011).
3. US FDA, 21 CFR 211.180(a), General requirements for records and reports (eCFR, current).
4. European Commission, Stakeholders’ consultation on EudraLex Volume 4: Chapter 4, Annex 11 and new Annex 22 (consultation 7 July to 7 October 2025, closed).