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GMP Training AcademyChange Control
Templates

The templates the course is built on

Structure and guidance for every section, free. The sections that carry the most weight in an inspection show their heading and a summary here; the full guidance, the worked examples and the editable files are in the course.

Module 2 · used by Change owners, QA, engineering, IT

Change request form

The record that opens a change: what is proposed, why, what it is expected to touch and how it is classified, written before anything is altered so that the assessment can be an assessment rather than a justification.

  1. 1. Identification

    Change number, date raised, site, area, system or equipment, products and processes initially in scope, change owner, QA contact.

  2. 2. Current state and proposed state

    Full version in the course

    What exists now, by document number, version, model, parameter or configuration, and what it will be after the change. Written in the future tense. If the change has already been made, stop and raise a deviation.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  3. 3. Reason for the change

    The problem the change solves or the benefit it brings, with the evidence: deviation reference, CAPA number, trend, obsolescence notice, regulatory commitment or business case.

  4. 4. Change type and classification

    Full version in the course

    Like-for-like, minor or major, decided against defined criteria with the rationale written out. Like-for-like requires a documented equivalence assessment, not a tick.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  5. 5. Regulatory assessment

    Full version in the course

    Whether the change touches a registered particular in any market, with the variation category under Regulation (EC) 1234/2008 and the classification guideline, or the notified body notification for devices, and whether prior approval is needed before implementation.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  6. 6. Preliminary impact and functions to consult

    Which functions must assess: validation, QC, regulatory, supply, quality agreements and customers, documentation, training, IT. Each named function is a required signature on the impact assessment.

    • Which validated systems, processes or methods reference the thing being changed?
    • Which customers or contract givers have a quality agreement that mentions it?
    • Which procedures, batch records or training will need to change?

  7. 7. Pre-approval

    QA approval to proceed to assessment and planning. Not approval to implement. Dated, and earlier than any action on the change.

Module 3 · used by Validation, QC, regulatory, supply chain, QA

Cross-functional impact assessment

The assessment each consulted function completes for a change, with the evidence for every 'no impact' conclusion, so that the record shows the impact was assessed rather than asserted.

  1. Validation and qualification

    Full version in the course

    Which qualified equipment, validated processes, cleaning validations and computerised systems the change touches; whether requalification or revalidation is required; the protocol or the rationale for not needing one.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  2. Analytical methods and stability

    Full version in the course

    Whether any test method, specification or stability commitment is affected, and whether a stability study or method verification is needed before or after implementation.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  3. Quality agreements, customers and suppliers

    Every quality agreement that mentions the item, whether notification or prior approval is required, and the date the customer was told. 'Not applicable' requires the list of agreements checked.

    • Which agreements were reviewed, by reference?
    • Which clause requires notification, and what is the notice period?

  4. Supply and materials

    Effect on approved suppliers, material specifications, incoming testing, lead times and stock of the current item. Whether both states will be in use at once, and how they will be distinguished.

  5. Documentation and training

    Every procedure, batch record, specification, drawing and form that must change, and who must be trained before go-live. Listed by document number.

    • Which documents reference the current state?
    • Who performs the task and how will they be trained before the change is live?

  6. Risk assessment

    Full version in the course

    The risk the change introduces and the risk it removes, assessed with a documented tool proportionate to the classification, with the controls that bring residual risk to an acceptable level.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  7. Functional sign-off

    Each consulted function signs its own assessment. A 'no impact' with no name against it is an assertion, not an assessment.

Module 4 · used by Change owners, QA, validation

Implementation and effectiveness plan

Defines, before approval, what must be done, in what order, what must be complete before the change goes live, how it will be verified, and how you will know it worked.

  1. Action plan

    Every action with its owner and due date, marked as pre-requisite (must be complete before go-live) or post-implementation. Documents, training, qualification, customer notification and regulatory submission are almost always pre-requisites.

  2. Go-live gate

    Full version in the course

    The list of pre-requisites QA checks as complete, with evidence, before implementation approval is given. The gate is the difference between a change control and a to-do list.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  3. Implementation approval

    A second, separate approval, dated after the pre-requisites are complete and before the change is made. Distinct from pre-approval.

  4. Verification of implementation

    Full version in the course

    Evidence that what was implemented is what was approved: the installed part number, the final parameter, the deployed version, the effective document. Checked by someone other than the implementer.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  5. Effectiveness check design

    Full version in the course

    What will be measured, over what period or number of batches, against what acceptance criterion, by whom and when. Defined when the change is raised, not at closure.

    The course adds the full guidance, the questions this section must answer, a weak and a defensible worked example, and the reviewer's notes.

  6. Closure

    Closed on the effectiveness result, not on completion of the actions. If the check fails, the record stays open and the follow-up change or deviation is referenced.

The full versions

9 sections are summarised above. The course opens all of them.

When the course opens you get the three templates as editable files, every section with full guidance and worked examples, three complete practice change records, the assessment and the certificate. 2.5 hours, self-paced.

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