GDP guide · Sources checked October 2026
GDP deviation and CAPA records: what to record
GDP deviation records and CAPA records document what went wrong against an established procedure, how it was investigated and which corrective and preventive actions were taken: the EU GDP guidelines say deviations must be documented and investigated and appropriate CAPA taken in line with quality risk management. The guidelines do not set a format for either record.
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GDP CAPA records: what the guidelines say
Where deviations and CAPA appear in the EU GDP guidelines
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| Where | What the guideline says | Source |
|---|---|---|
| Quality system | The quality system should ensure records are made contemporaneously, deviations from established procedures are documented and investigated, and appropriate CAPA are taken to correct deviations and prevent them | EU GDP guidelines, section 1.2, checked October 2026 |
| Change control | A change control system should be in place, using quality risk management principles and proportionate and effective | EU GDP guidelines, section 1.2, checked October 2026 |
| Management review | Performance indicators for review include complaints, deviations, CAPA and changes to processes; the outcome of each review is documented and communicated | EU GDP guidelines, section 1.4, checked October 2026 |
| Equipment qualification | Deviations seen during validation or qualification are documented, with further actions decided to correct them and avoid recurrence; CAPA principles are applied where necessary | EU GDP guidelines, section 3.3.2, checked October 2026 |
| Complaints | Where necessary, follow-up actions including CAPA are taken after a complaint is investigated | EU GDP guidelines, Chapter 6, checked October 2026 |
| Self-inspection | Where deficiencies are found, their cause should be determined and CAPA documented and followed up | EU GDP guidelines, section 8.2, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
GDP deviation records
What a deviation and CAPA record should show
A practical reading of the guidelines, not a legal test: the guidelines say what should happen, not which fields to use.
Sources: EU GDP guidelines, Chapters 1 and 4, checked October 2026. For record format rules, read GDP documentation requirements.
- What happened, when, where and who found it, written at the time (the guidelines ask for contemporaneous records).
- The procedure it deviated from, by reference and version.
- Which products, batches, customers or suppliers were affected.
- Immediate action taken, such as quarantine, and who decided it.
- The investigation and the root cause, or why none was found.
- Each corrective and preventive action with an owner and a due date, and evidence it was done.
- A check that the action worked, and sign-off by the Responsible Person or their delegate.
- A link to any change control raised and to management review.
GDP inspection findings on deviations and CAPA
What the MHRA has cited
Examples from the MHRA’s published 2016 deficiency data, paraphrased. It is a sample of past inspections, not a prediction.
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| Finding (paraphrased) | Why it matters for the record | Source |
|---|---|---|
| Deviation closed before CAPA was done | A record showing complete while actions were still outstanding. Close only when the action has been completed and checked | MHRA GDP deficiency data 2016, checked October 2026 |
| Cold chain deviations without CAPA | Recording the event was not enough; there was no CAPA report | MHRA GDP deficiency data 2016, checked October 2026 |
| Deviations missing from management review | Management review did not include deviation analysis or visibility of deviation detail | MHRA GDP deficiency data 2016, checked October 2026 |
| Deviation record not made at the time | A report of missing stock was not completed contemporaneously | MHRA GDP deficiency data 2016, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; your Responsible Person and the MHRA decide what applies to your licence.
Worked example (fictional)
One deviation from report to closure
A fictional wholesaler and event, for illustration only. It is not advice on what your procedures need.
1
Report
At Example Medicines Wholesale Ltd, a picker supplies a pharmacy with the wrong strength of a product. The customer reports it the next morning and the warehouse logs a deviation the same day.
2
Contain
Remaining stock of both strengths is checked and segregated, the customer returns the item, and the Responsible Person decides what happens to it.
3
Investigate
The team finds two strengths shelved next to each other with similar labels, and records that as the root cause.
4
Act
Corrective action: relocate one strength. Preventive action: add a check to the pick procedure and brief staff. Each has an owner and a date.
5
Close and review
The Responsible Person checks, a month later, that no repeat has occurred, signs the record off, and the deviation appears in the next management review.
Related guides
Deviations in context
Temperature events are the most common deviation in cold chain operations.
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FAQ
Common questions
What is a CAPA in GDP?
CAPA stands for corrective and preventive action. The EU GDP guidelines say appropriate CAPA are taken to correct deviations and prevent them, in line with quality risk management.
Does every deviation need a CAPA?
The guidelines say deviations are documented and investigated and that appropriate CAPA are taken. What is appropriate depends on the risk; that is for your quality system and Responsible Person to decide.
Is there an official deviation form?
No form was found in the guidelines or MHRA guidance. The record should meet the documentation rules in Chapter 4.
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