Workshop: C. System. Implementation of ICH Q8, Q9, Q10

Transcription

1 Implementation of ICH Q8, Q9, Q10 Workshop: C Pharmaceutical Quality System International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

2 Disclaimer i General on this presentation Feedback from the facilitated discussions See it as a brainstorming from the breakout discussion slide 2

3 Are we clear with the key messages? People generally understand what a quality system is and the benefits. Good involvement of senior management who understand quality systems will use them to challenge people to make improvements and reduce errors/complaints/waste, drive process efficiency, increase competitive edge, and return on investment over the product lifecycle. Senior management means CEO, General Director, etc and not person in charge of QMS or batch release. slide 3

4 Are we clear with the key messages? Basic quality management principles are reinforced: facilitates a more proactive approach to GMP conformance, continual monitoring and feedback loops, drive continual improvement of the product. Consistency of approach, terminology and systems is promoted by Q10, which serves both industry and regulators by operating on a common platform. Improving technology transfer reduces risk (e.g. recall of batches) PQS supports robust change management slide 4

5 Are we clear with the key messages? Knowledge management and performance monitoring can reduce poor quality, before there is a crisis that causes a financial impact. - PQS should allow a company to discover problems with its products, rather than its customers/ patients Should drive continual improvement of product and innovation. Communication is a key component of the PQS: development-transfer-manufacture slide 5

6 Are we clear with the key messages? Yes, it is clear that PQS is mandatory for GMP, but ICH Q10 is not. Keep in mind that t Q10 is going beyond GMP and is focused on the lifecycle of a product. Considering PIC/S GMP guide, it is/ will be updated for taking into consideration some elements coming from ICH Q10 as outsourcing (revision i of chapter 7, part 1) and senior management (revision of chapter 2, part 1). PQS must be built defining first vision on what to achieve with the PQS and allocated resources which will be dedicated di d to define, implement and monitor it. slide 6

7 Are we clear with the key messages? QRM and PQS are inter-related together. QRM help to define the implementation of PQS along the lifecycle of a product. QRM must be supported by a strong PQS. Interfaces of PQS between the different stages of the lifecycle of a product should be clearly defined The same for outsourced activities (written contracts and on site audits). Keep in mind that if PQS is not designed appropriately, it can be counterproductive. slide 7

8 Are we clear with the key messages? Scope of ICH Q10 is API and pharmaceutical products. It could be used for excipients and preservatives but was not intended for. One of the main goals of ICH Q8, 9 and 10 is for having better confidence between regulators and industry. Moving from regulatory compliance to science and risk based decision. But they are not a way for missing GMP compliance. slide 8

9 Are there practical concerns on implementation? i There is a difference between ICH Q10 and ISO norms 9001 series approach for quality system? No. ICH Q10 is based on these ISO norms. Lack of practical experience and fear of unknown both in industry and regulators (PQS for the lifecycle of the product instead of PQS only for manufacturing activities). PQS may be part of the culture in large multinationals l with adequate resources but probably less so in smaller organisations. Keep in mind that a PQS could be simple, without tons of fsop. Senior management needs to act as catalyst, not as a limiting factor. slide 9

10 Are there practical concerns on implementation? i Training of regulators on ICH Q10 is a key factor for avoiding different interpretations Improving communication between assessor and inspector/ auditor as well between development and manufacturing. Need to understand business operations before designing/refining PQS. Global corporate PQS should be adapted to the local situation including local culture, background. slide 10

11 Where is more clarification required for practical harmonised implementation? Is Site Master File (used by inspectors) the place for a general PQS description? PIC/S is on the way to update its SMF format including chapter related to description of the PQS. Quality manual created for ISO 9001 certification are suitable for quality manual as defined in ICH Q10. Continual improvement e of the products does not obligatory mean variation of the marketing authorisation but decreasing of quality issues as e.g. batch recall slide 11

12 Where is more clarification required for practical harmonised implementation? Product discontinuation is when a marketing authorisation is no longer used for putting medicinal products on the market (decision taken by the MA holder for economical reasons, withdrawal of the MA by the competent t authority..). Product discontinuation is not due to formulation changes, variations. slide 12

13 Where is more clarification required for practical harmonised implementation? Knowledge management has to be defined by industry. There is no requirement/ guidance to define how to handle it. But it has to be built in a systematic and understandable way. PQS has to be appropriate and proportionate to the lifecycle stage of the product. There is no regulatory model/ guidance for defining that. It is up to the pharmaceutical aceut ca company to justify it. slide 13

14 THANK YOU slide 14