Quality Risk Management (QRM) is a GMP compliance requirement for Pharmaceutical organisations. The ICH Q9 guideline on Quality Risk Management (Annex 20 of the PIC/S GMP Guide) is expected to be adopted by manufacturers to ensure compliance with clauses 1.12 and 1.13 of Part I of the PIC/S GMP Guide:
1.12 Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.
1.13 The principles of Quality Risk Management are that:
(i) The evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient;
(ii) The level of effort, formality and documentation of the Quality Risk Management process is commensurate with the level of risk.
You must have a comprehensively designed and correctly implemented Pharmaceutical Quality System (PQS) incorporating Good Manufacturing Practice (GMP) and Quality Risk Management (QRM). The intent of QRM is to help improve decision-making for issues related to Production, Quality Assurance (QA), Validation and any other GMP area.
Do you know how to apply risk management principles, techniques and tools in your GMP environment?
SeerPharma helps pharmaceutical companies with appropriate GMP risk management including but not limited to:
- Application of Risk Management to Quality Systems and Compliance
- Understanding concepts within ICH Q9 – Quality Risk Management Guideline
- Implementing risk management in GxP compliance programs
- Auditing compliance using risk-based principles
- Applying Practical Risk Management Tools
- Understanding ICH Q9 / Annex 20 recommendations and the various approaches to developing risk profiles and the different tools that are applicable to different situations
- Implementing the right risk management practices for each business process
- For example, Failure Modes Effects Analysis (FMEA) tools can be useful for analysing product design risks, but Hazard Analysis and Critical Control Point (HACCP) tools may be best for process risk analysis. Knowing when to apply qualitative or quantitative analyses is an important skill to master. Different tools may be applicable to risk management for risk identification, risk assessment, risk control and post-market feedback.
- Applying Risk Management to Product and Process Design
- Understanding concepts within ICH Q8(R2) – Pharmaceutical Development Guideline – and the principles within 21 CFR Part 820.30 (design control)
- Applying risk assessment in product and process design and development
- Using HACCP techniques as a means to evaluate the risks associated with processes and unit operations
- Applying Risk Management to Validation
- Understanding the newer validation paradigm, based on the ASTM E2500 standard and the FDA guidance for process validation
- Applying risk assessment techniques applicable to equipment qualification and process validation
Contact us to explore your GMP risk management needs and how SeerPharma can help.
