PIC/S Guide to GMP PE009-13 Key Changes to Chapters 1 & 2 Neale Baldwin Senior GMP Inspector Manufacturing Quality Branch June 2018
Key changes to chapter 1 - Pharmaceutical quality system • Title change - to reflect ICH Q10 – Recognising that quality systems for medicines manufacture are very specific • Most of the changes in PE009-13 originate from ICH Q10 requirements – Quality System – Knowledge management 2
Chapter 1 - Pharmaceutical quality system PE009-13 Clauses Comments 1.3 The size and complexity of the company’s activities should be Previous requirement taken into consideration when developing a new Pharmaceutical Important to scale the system for the size Quality System or modifying an existing one. The design of the and complexity of the manufacturer system should incorporate appropriate risk management principles including the use of appropriate tools. While some aspects of the system can be company-wide and others site-specific, the effectiveness of the system is normally demonstrated at the site level. 1.4(i) Product realisation is achieved by designing, planning, Development and identification of CQA’s implementing, maintaining and continuously improving a system Product Lifecycle approach that allows the consistent delivery of products with appropriate quality attributes . 3
Chapter 1 - Pharmaceutical quality system PE009-13 Clauses Comments 1.4(viii) A state of control is established and maintained by Defined CQA’s and CPP’s developing and using effective monitoring and control systems Ongoing process monitoring for process performance and product quality . 1.7 The Pharmaceutical Quality S ystem should be defined and Established Quality manual (as per ICH Q10) documented. A Quality M anual or equivalent documentation should be established and should contain a description of the quality management system including management responsibilities. 4
Chapter 1 - Quality Manual - ICH Q10 • A Quality Manual or equivalent documentation approach should be established and should contain the description of the pharmaceutical quality system. The description should include: a) The quality policy (see clause 2.4); b) The scope of the pharmaceutical quality system; c) Identification of the pharmaceutical quality system processes, as well as their sequences, linkages and interdependencies. Process maps and flow charts can be useful tools to facilitate depicting pharmaceutical quality system processes in a visual manner; d) Management responsibilities within the pharmaceutical quality system. 5
Chapter 1 - Product lifecycle approach PE009-13 clauses: Comments Clause 1.2: GM P applies to the lifecycle New clause, but equivalent Design stages from the manufacture of requirements in PE009-08 Clauses investigational medicinal products, 1.1i and 1.1ii technology transfer, commercial manufacturing through to product Discontinuation Clinical research discontinuation. Commercial Clause 1.4(ii): Product and process New clause, but equivalent manufacture knowledge is managed throughout all requirements in PE009-08 Clause lifecycle stages 1.1i and 1.1ii 6
Chapter 1 - Continuous improvement PE009-13 clauses: Comments 1.4(ix) The results of product and processes monitoring are taken into New clause, but equivalent account in batch release, in the investigation of deviations, and, with a requirements in PE009-08 Clauses 1.1iv, view to taking preventive action to avoid potential deviations occurring in 1.2vi and 1.3iv the future. 1.4(xi) Continual improvement is facilitated through the implementation New clause, but equivalent of quality improvements appropriate to the current level of process and requirements in PE009-08 Clause 1.2i product knowledge. 7
Chapter 1 - Senior management PE009-13 Comments Clause 1.5: Senior management has the ultimate responsibility to New clause, similar requirements in ensure an effective Pharmaceutical Quality S ystem is in place, PE009-08 Chapter 1 Principle adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management ’s leadership Demonstrated Senior M anagement and active participation in the Pharmaceutical Quality S ystem is involvement and leadership essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality S ystem. 8
Chapter 1 - Management reviews PE009-13 clause: Comments Clause 1.6 There should be periodic management review, New clause – no direct equivalent in PE009-8. with the involvement of senior management, of the However, PE009-8 Principle does require the operation of the Pharmaceutical Quality S ystem to effectiveness of the quality system to be monitored. identify opportunities for continual improvement of These new requirements require a formal and products, processes and the system itself. systematic approach to management reviews. ICH Q10 requirements for management review 9
Chapter 1 - Product quality reviews PE009-13 clause: Comments Clause 1.10(i) A review of starting materials including M anufacturer should already have an understanding of packaging materials used in the product, especially the supply chain for API’s as required by the supplier those from new sources and in particular the review qualification process. However, this information will of supply chain traceability of active substances . have to be included in the PQR. Refer TGA guidance for Supplier Qualification 13
Summary • Some clarity of expectations as opposed to PE009-08 – Change management moved from Annex 15 – Deviation management clarified • ICH Q10 aligned – Product lifecycle management – Continuous improvement • Focus on Senior Management involvement in the management of the Pharmaceutical Quality System – Management review of PQS performance • PQR requirement to review supply chain traceability 14
PIC/S Guide to GMP PE009-13 Key Changes to Chapter 2 - Personnel Neale Baldwin Senior GMP Inspector Manufacturing Quality Branch June 2018
Chapter 2 - Senior Management PE009-13 clause: Comments Clause 2.4: Senior management involvement Senior management has the ultimate responsibility to ensure an and commitment to the PQS now effective Pharmaceutical Quality System is in place to achieve the specified. quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Quality Policy should be available Senior management should establish a quality policy that describes the and endorsed by senior overall intentions and direction of the company related to quality and management. should ensure continuing suitability and effectiveness of the Pharmaceutical Quality System and GM P compliance through participation in management review . 17
Chapter 2 - Responsibilities for the PQS PE009-13 Comments 2.9 The heads of Production, Quality Control and where relevant, Head of Additional Quality Assurance or Head of Quality Unit , generally have some shared, or responsibilities for jointly exercised, responsibilities relating to quality including in particular the Quality and Production design, effective implementation, monitoring and maintenance of the nominees Pharmaceutical Quality System . These may include, subject to any national regulations: Updated job descriptions xii. Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality S ystem and advocating continual improvement; xiii. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management . 20
Key changes to chapter 2 - Consultants PE009-13 Comments 2.23 Consultants should have adequate education, training, Assessment of consultants are now and experience, or any combination thereof, to advise on the required, and records of the assessment subject for which they are retained. Records should be kept, including any training required maintained stating the name, address, qualifications, and type of service provided by these consultants. Contracts (Ch7) should be in place for consultants working in GM P space. 21
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