Competency information
Details
Identify the critical individual steps required for analytical method validation and revalidation requirements.
Considerations
- How to identify the major parts of a quality management system.
- Regulatory requirements for out-of-specification (OOS) results.
- Reporting processes.
- How to carry out investigations, informing the relevant parties including the Defective Medicines Reporting Council (DMRC), the Medicines and Healthcare products Regulatory Agency (MHRA), customers and recalls procedures.
- Regulatory requirements and guidelines for method validation International Committee for Harmonisation (ICH), Yellow Cover Documents (YCD).
- The importance of method validation, with respect to quality assurance and suitability of testing.
- Why equipment validation is necessary.
- How to identify key pieces of equipment with respect to EU Good Manufacturing Practice regulations.
- How to identify key stages in processes, and risk assessments of equipment to identify validation requirements and control measures.
- Use and benefits of product quality review (PQR), including the component parts, how it is designed to give information on the continued validity of the product with respect to safety, efficacy and cost.
- Interpretation of the data from a PQR and recommendations on required changes/developments.
- How the information is passed on to the relevant parties.
- Trend analyses of the control of the product.
- How a recommendation is made to improve a product from a PQR.
- The actions carried out after a PQR has been completed.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 | Outcome Identify specific quality control functions that feed in to the quality management system to provide assurance that all activities within the unit are adequately controlled to provide valid and reliable results to allow for safe release of product(s). |