Glossary
Say what the inspector means
The vocabulary of change control, grouped by stage of the process. Definitions are ours; the source clause is given where one exists.
Scope
- Change control
- The system for the prospective evaluation, approval, implementation, verification and effectiveness review of planned changes to anything with an approved, validated or registered state. Part of the pharmaceutical quality system, not of engineering or IT.EU GMP 1.4(xi); Annex 15 s.11; ICH Q10 3.2.3
- Change management
- The ICH Q10 term for the same system, emphasising evaluation, approval and post-implementation review across the product lifecycle rather than the site record alone.ICH Q10 3.2.3
- Planned change
- An intended alteration to a material, process, equipment, facility, method, document, system or organisation. The trigger for a change control. Distinguished from an unplanned departure, which is a deviation.Annex 15 11.2
- Like-for-like replacement
- A replacement identical in form, fit, function, material of construction and manufacturer part number, so that all existing qualification evidence applies without argument. The only legitimate exemption from formal change control, and only when the equivalence is documented.Annex 15 11.2; EU GMP 3.34
- Equivalence assessment
- A documented comparison of a replacement item with the original against form, fit, function, material and performance, concluding whether the existing qualification evidence still applies. Required for any replacement that is not strictly like-for-like.
- Planned deviation
- A pre-approved, temporary, one-off departure from a procedure. Frequently misused to make changes without change control. If permitted, needs a risk assessment, QA approval and a hard end date; a repeated planned deviation is a change.EU GMP 5.15; Annex 15 s.11
- Temporary change
- A change approved through the change control system for a defined period with a defined reversal. The controlled alternative to a planned deviation.
- Validated state
- The condition in which a process, system or method is demonstrated to perform as intended, as documented in its validation report. Maintained through the lifecycle only if every subsequent change is assessed against it.Annex 15 s.5; Annex 11 4.2
Classification
- Minor change
- A change with no credible impact on a critical quality attribute, a validated state or a registered particular. Assessed by QA and the owning function with a proportionate action plan.ICH Q9 (R1)
- Major change
- A change with credible impact on product quality, patient safety, a validated state, the registered dossier or a quality agreement. Requires cross-functional assessment, formal risk assessment, regulatory assessment and a defined effectiveness check.Annex 15 11.3; ICH Q9 (R1)
- Emergency change
- A change made to keep a batch, utility or system running before the full assessment is complete. Legitimate only if recorded at the time, assessed within a short defined period afterwards, and monitored so the emergency route does not become the normal one.
- Registered particular
- Any detail described in the marketing authorisation dossier, for example the active substance manufacturer, process parameters, specifications, methods, batch size, shelf life or packaging. Changing one requires a variation of the appropriate type before the change is used for commercial supply.Reg. (EC) 1234/2008; Directive 2001/83/EC Article 23
- Variation, Type IA / IB / II
- EU categories for changes to a marketing authorisation. Type IA: minor, notified within twelve months of implementation (or immediately for IA IN). Type IB: minor, submitted before implementation and implementable if no objection within 30 days. Type II: major, requires prior approval.Reg. (EC) 1234/2008 Articles 8 to 10
- Variations classification guideline
- The Commission guideline published under Article 4 of Regulation (EC) 1234/2008 that lists changes to a marketing authorisation by category, assigns each a type (IA, IA IN, IB or II), and states the conditions to be met and the documentation to be submitted. Changes not listed default to Type IB unless the authority says otherwise.Reg. (EC) 1234/2008 Article 4, Article 5 and Annex II
- Substantial change (devices)
- Under the MDR, a change to the design or intended purpose of a device, or to the quality management system, that the manufacturer must notify to its notified body and that may require approval before implementation. MDCG 2020-3 gives the criteria for devices supplied under legacy certificates.MDR 2017/745 Annex IX 2.4 and 4.10; MDCG 2020-3
- Design change
- The device term for a change to a design output or its inputs. Reviewed, verified, validated as appropriate and approved before implementation, including the effect on constituent parts and product already delivered.ISO 13485:2016 7.3.9; MDR 2017/745 Annex IX 4.10
Assessment
- Impact assessment
- The prospective, cross-functional evaluation of what a change could affect: product quality, validation, regulatory status, documentation, calibration, maintenance, quality agreements, supply, training and any other system. Every answer, including 'no', cites what was checked.Annex 15 11.3; ICH Q10 3.2.3
- Quality risk management
- The systematic process for assessing, controlling, communicating and reviewing risks to quality. Applied to changes in proportion to their uncertainty and potential impact, and never used to justify a decision already taken.ICH Q9 (R1)
- Regulatory impact assessment
- The comparison of a proposed change with the registered dossier in each market, made by regulatory affairs, concluding the variation or supplement category and the constraint it places on implementation timing.EU GMP 1.4(xi)
- Quality agreement
- The written agreement between a contract giver and contract acceptor defining GMP responsibilities, including which changes must be notified or approved by the other party before implementation.EU GMP Ch. 7; ICH Q10 2.7
- Comparability
- Demonstration that product made before and after a change is sufficiently similar in quality attributes that safety and efficacy conclusions still apply. The formal framework for biologics is ICH Q5E.ICH Q5E
- Design space
- The multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality. Movement within an approved design space is not a regulatory change; movement outside it is.ICH Q8 (R2)
Implementation
- Pre-approval
- The first approval in a change control: QA and the affected functions accept the assessment, classification, risk assessment and action plan. Nothing is changed yet.
- Go-live approval
- The second approval: QA confirms every gating action is complete with evidence and any regulatory or customer constraint is satisfied, and authorises use of the change. The date after which the change may appear in commercial product.EU GMP 1.4(xi); Annex 15 11.4
- Action plan
- The list of actions a change requires, with owners, dates and a distinction between those that gate go-live (qualification, document approval, training, regulatory clearance, notifications) and those that follow it.
- Verification
- Confirmation, immediately after implementation, that what was implemented matches what was approved: the right part, value, version or revision, evidenced by a report, drawing, configuration record or signed inspection. Not the same as the effectiveness check.Annex 15 11.4
- Requalification / revalidation
- Repeating the relevant part of qualification or validation after a change to demonstrate the validated state is maintained. Scope determined by the impact assessment, not by default.Annex 15 s.5, 11.4
- Regression testing
- Testing of functions that were not changed to confirm a change has not broken them. For computerised systems, scoped by risk assessment and including interfaces.Annex 11 s.5, s.10; GAMP 5
- Configuration change
- A change to settings a computerised system was designed to expose (workflows, limits, roles, master data, reports). Explicitly within change control under Annex 11, and the commonest uncontrolled system change.Annex 11 s.10
- Audit trail
- The secure, computer-generated record of who changed what, when and from what to what in a computerised system. The primary verification evidence for a system change.Annex 11 s.9
Closure
- Effectiveness check
- The post-implementation evaluation confirming the change achieved its objective and had no unintended effect. Defined when the change is raised with a measure, criterion and window; passed on evidence, not on completion.Annex 15 11.5; ICH Q10 3.2.3(e)
- Closure
- The QA decision that all actions are complete with evidence, verification is documented, the effectiveness check has passed or been waived with a reason, documents are at their new revision and regulatory and customer obligations are satisfied.
- Extension
- A documented, QA-approved revision of a change control's target date with a rationale. Late with an extension is controlled; late without one, or closed early to meet a metric, is a finding.
- Periodic review
- The scheduled review of a computerised system confirming it remains in a validated state, including reconciliation of change records against current documentation and the IT change log.Annex 11 s.11
- Product quality review
- The annual review of each product that must include all changes to processes and analytical methods in the period, their regulatory status and whether any trend coincides with a change.EU GMP 1.10(vi)