The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation (MA) and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance (QA) incorporating Good Manufacturing Practice (GMP), and thus Quality Control (QC) and Quality Risk Management (QRM). It should be fully documented and its effectiveness monitored.
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2.2 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. The quality risk management system should ensure that: - 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; - the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.
2.3 The harmonised tripartite quality guidelines ICH Q8(R1): Pharmaceutical Development, ICH Q9: Quality Risk Management and ICH Q10: Pharmaceutical Quality System form a set of three documents representing a new approach to pharmaceutical development, manufacturing and distribution, often referred to as the paradigm shift initiated by the ICH.
2.4 ICH Q9 was adopted in November 2005 as a step 4 document and consecutively on 14 February 2008 introduced as a voluntary Appendix 20 into the EU GMP Guide and on 15 January 2009 into the PIC/S GMP Guide. At the corresponding dates principles of Quality Risk Management (QRM) were in addition introduced in Chapter 1 of both guides. Chapter 2 in EU GMP Part II was updated with QRM requirements on 31 July 2010.
2.5 The primary objective for implementing ICH Q9 was to improve the implementation of risk based approaches / the principles of quality risk management within the pharmaceutical industry and regulatory environment.
3. Purpose
3.1 The purpose of this document is to assist GMP inspectors in the assessment of QRM implementation in industry during regulatory inspections. Parts of this Aide-Memoire may also be useful (with suitable modification) during other GXP inspections where similar principles of QRM also apply.
3.2 This Aide-Memoire should also contribute to a harmonised approach for inspection of QRM in industry between the different PIC/S Members.
4. Scope
4.1 At the time of issue, this document reflected the current state of the art. It is not intended to be a barrier to technical innovation or the pursuit of excellence.
4.2 QRM aspects should be an integrated part of the planning and content of all GMP inspections (including for final products as well as for active pharmaceutical ingredients). The existence of this separate Aide-Memoire document does not suggest that specific inspections for QRM systems are performed.
4.3 As Annex 20 represents a voluntary standard, this Aide-Memoire relies mainly on the corresponding mandatory articles of Chapter 1 and Annex 15 of the PIC/S GMP Guide.
5. Aide-Memoire
5.1 The Aide-Memoire should be used with the following general comments:
- During an inspection dedicated time is required to be allocated to review the QRM system.
- During a general inspection the inspector should be able to review how the company has integrated QRM without allocating further specific time to the QRM
aspects of the inspection. - References to the GMP Guide given in the row “Reference” refer to the PIC/S GMP Guide Part I.
5. Aide-Memoire
5.1 The Aide-Memoire should be used with the following general comments:
- During an inspection dedicated time is required to be allocated to review the QRM system.
- During a general inspection the inspector should be able to review how the company has integrated QRM without allocating further specific time to the QRM
aspects of the inspection. - References to the GMP Guide given in the row “Reference” refer to the PIC/S GMP Guide Part I.
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