PIC/S Guide to GMP PE009-13 Key Changes to Chapters 1 & 2 Neale - - PowerPoint PPT Presentation
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
Neale Baldwin Senior GMP Inspector Manufacturing Quality Branch June 2018
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1.3 The size and complexity of the company’s activities should be taken into consideration when developing a new Pharmaceutical Quality System or modifying an existing one. The design of the 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.
Previous requirement Important to scale the system for the size and complexity of the manufacturer
1.4(i) Product realisation is achieved by designing, planning, implementing, maintaining and continuously improving a system that allows the consistent delivery of products with appropriate quality attributes.
Development and identification of CQA’s Product Lifecycle approach
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1.4(viii) A state of control is established and maintained by developing and using effective monitoring and control systems for process performance and product quality.
Defined CQA’s and CPP’s Ongoing process monitoring
1.7 The Pharmaceutical Quality S ystem should be defined and
should be established and should contain a description of the quality management system including management responsibilities.
Established Quality manual (as per ICH Q10)
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Clause 1.2: GM P applies to the lifecycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation.
New clause, but equivalent requirements in PE009-08 Clauses 1.1i and 1.1ii
Clause 1.4(ii): Product and process knowledge is managed throughout all lifecycle stages
New clause, but equivalent requirements in PE009-08 Clause 1.1i and 1.1ii
Design Clinical research Commercial manufacture Discontinuation
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1.4(ix) The results of product and processes monitoring are taken into account in batch release, in the investigation of deviations, and, with a view to taking preventive action to avoid potential deviations occurring in the future.
New clause, but equivalent requirements in PE009-08 Clauses 1.1iv, 1.2vi and 1.3iv
1.4(xi) Continual improvement is facilitated through the implementation
product knowledge.
New clause, but equivalent requirements in PE009-08 Clause 1.2i
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Clause 1.5: Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality S ystem is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management ’s leadership and active participation in the Pharmaceutical Quality S ystem is
commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality S ystem.
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Clause 1.6 There should be periodic management review, with the involvement of senior management, of the
ystem to identify opportunities for continual improvement of products, processes and the system itself.
New clause – no direct equivalent in PE009-8. However, PE009-8 Principle does require the effectiveness of the quality system to be monitored. These new requirements require a formal and systematic approach to management reviews. ICH Q10 requirements for management review
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Clause 1.10(i) A review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review
M anufacturer should already have an understanding of the supply chain for API’s as required by the supplier qualification process. However, this information will have to be included in the PQR. Refer TGA guidance for Supplier Qualification
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Neale Baldwin Senior GMP Inspector Manufacturing Quality Branch June 2018
Clause 2.4: Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management should establish a quality policy that describes the
should ensure continuing suitability and effectiveness of the Pharmaceutical Quality System and GM P compliance through participation in management review. Senior management involvement and commitment to the PQS now specified. Quality Policy should be available and endorsed by senior management.
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2.9 The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. These may include, subject to any national regulations:
quality and of the Pharmaceutical Quality S ystem and advocating continual improvement;
exists to raise quality issues to the appropriate levels of management. Additional responsibilities for Quality and Production nominees Updated job descriptions
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2.23 Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants. Assessment of consultants are now required, and records of the assessment kept, including any training required Contracts (Ch7) should be in place for consultants working in GM P space.
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