Change control request generator
Prepare a complete change control request: describe the current and proposed state with a justification, answer an impact checklist that adapts to the type of change, score the risk (severity × occurrence × detectability), see a suggested category with its reasons, and build the pre- and post-implementation action plan. Export it with approval blocks for your QA system.
Change control request
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Request
Why this matters
A change management system evaluates proposed changes for their impact, approves them before implementation, and evaluates them after implementation to confirm the objectives were achieved without an adverse impact on product quality.
Source: ICH Q10 Pharmaceutical Quality System (2008)Current vs proposed
Impact assessment
Risk assessment
Why this matters
Use quality risk management to decide how much assessment and testing a change needs. The scoring scales and bands in this tool are an example in-house criterion; edit them to match your SOP.
Source: ICH Q9(R1) Quality Risk Management (2023)Why this matters
Risk priority number (RPN) = severity × occurrence × detectability. Scales (1–5) and bands are example in-house criteria in the spirit of ICH Q9(R1); RPN is one tool among many and is subjective, so record the reasoning behind each score.
Source: ICH Q9(R1) Quality Risk Management (2023)Classification and actions
Report text and export
Frequently asked questions
How does the impact checklist adapt?
The type of change (equipment, process, facility, supplier, specification, method, document or software) highlights the areas usually affected — for example validation and cleaning for equipment, or computerised system validation for software. You answer every area yes, no or N/A.
How is the risk scored?
Severity × occurrence × detectability on 1–5 scales gives a risk priority number (RPN) and a low/medium/high band. The scales and bands are an example in-house criterion in the spirit of ICH Q9(R1); you can edit the bands.
How is the change category suggested?
A change is suggested as major if it has regulatory or validation impact, a high risk band, a widened specification limit or a new supplier; like-for-like for a same-model equipment replacement with no such impact; otherwise minor. This is an example in-house criterion — your SOP decides.
Does it decide if I must notify the regulator?
No. It asks you to record yes, no or “to assess”. Regulatory affairs should assess each change against the marketing authorisation and local rules.
Can a CAPA raise this change control?
Yes. Choose “Raised from: CAPA” and the CAPA number from this session is filled in.
Related guides on pharmaguideline.net
- Change Control in Pharma: Complete Guide to Process and Approval
- SOP on Change Control in Pharmaceutical Manufacturing
- Quality Risk Management in Pharma (ICH Q9 R1) Explained
- SOP for Risk Management Using FMEA (Example Template)
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