Change control
Change control is the documented process for proposing, evaluating, approving, implementing and reviewing changes to processes, equipment, systems and documents. ICH Q10 asks for risk-based evaluation and post-implementation review; 21 CFR 211.100(a) requires production procedure changes to be approved by the quality control unit.
On this page · 7 sections
How does Change control apply to your shop floor?
Pick your industry and scale — Ask V5 rewrites the definition in your context, gives a worked example, and shows what V5 does on day one.
01What change control covers
ICH Q10 says CAPA, process monitoring and improvement drive change, and a change management system should give a high degree of assurance there are no unintended consequences. In U.S. drug CGMP, 211.100(a) requires written production procedures, including changes, to be drafted, reviewed and approved by appropriate units and reviewed and approved by the quality control unit. Annex 11 clause 10 applies the same idea to computerised systems and configurations.
02The four ICH Q10 elements
| ICH Q10 3.2.3 | What it means in practice |
|---|---|
| (a) Quality risk management | Effort and formality match the risk of the change |
| (b) Evaluate against the marketing authorisation | Decide whether a regulatory filing change is needed |
| (c) Expert team evaluation | Manufacturing, quality, regulatory and others assess; criteria set up front |
| (d) Post-implementation evaluation | Confirm objectives met and no harm to product quality |
03Change vs deviation
A change is planned and approved before it happens. A deviation is an unplanned departure; 211.100(b) requires any deviation from written procedures to be recorded and justified. The two follow different paths: a deviation is investigated and dispositioned on its own record, and if the investigation shows the procedure itself should change, that proposal enters change control and is assessed and approved before the new way of working is used. Recording an unplanned departure as an after-the-fact change would skip the prior evaluation and approval that change control exists to provide.
04Worked example
Illustrative only — the conditions are one site's decision, not a requirement. A site proposes a new mixer speed. The request records the reason, a risk assessment flags blend uniformity, regulatory affairs confirms no filing change, QA approves with a condition of three monitored batches, the master record is revised and approved, operators are trained, and a post-implementation review confirms uniformity results before the change is closed.
05Common failure modes
- Changes implemented before approval.
- Impact assessments that skip training, labels or validated systems.
- No effectiveness check after implementation.
- System configuration edited outside the procedure.
06Questions to ask a system supplier
- Can a change be blocked from taking effect until every required approval is recorded?
- Does the impact assessment prompt for affected documents, training, validated systems and regulatory filings?
- Is the post-implementation review a tracked step with its own owner and due date?
- When a document revision is approved, how are users trained before they work to it?
- Are configuration changes to the system itself recorded through the same process?
07Where V5 fits
V5's product reference lists change control with impact assessment and approvals, controlled document revisions with training gating, and risk management aligned to ICH Q9. Customers decide which records and processes are in scope, write the procedures and approve the outcomes; using V5 does not by itself establish compliance or a validated state. IQ/OQ documentation and validation support are offered on the Enterprise plan; the customer performs PQ and owns validation and approvals.
Frequently asked questions
Q.Is change control required by law?+
In U.S. drug CGMP, 211.100(a) requires approval of production procedure changes by the quality unit. ICH Q10 and Annex 11 are guidelines that describe expected systems.
Q.Does every change need a regulatory filing?+
No. ICH Q10 asks for an assessment of whether a filing change is required under regional rules.
Q.Who approves a change?+
People: the appropriate organisational units and the quality unit, per your procedures.
Q.What happens after a change is implemented?+
ICH Q10 expects an evaluation confirming objectives were met with no harmful impact on quality.
Primary sources
Further reading
Explore this topic
Change control sits inside 4 overlapping topic clusters in our glossary. Every neighbour is one click away.
Electronic records, signatures, audit trail and ALCOA+ data-integrity principles.
ICH Q8/Q11/Q12 toolkit — Quality by Design, design space, control strategy, CPV and lifecycle management.
URS-through-PQ lifecycle, GAMP 5 categorisation and CSA's modern alternative.
HCT/Ps, blood cGMP, donor eligibility, ISBT 128 labeling and forward-tracing lookback.
Want to see how Change control could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.