ISPE Guide bridges traditional Qualification and risk- and science-based Qualification

In last week's news we talked about an ISPE Mapping Document that illustrates relationships to other ISPE Guides on qualification. One of these ISPE Guides, the ISPE Good Practice Guide "Applied Risk Management for Commissioning and Qualification" is used as bridge in order to connect traditional qualification approaches according to ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&Q) to a modern risk- and science-based qualification approach. Following you can read a summary of this Good Practice Guide.

The document is very comprehensive, containing 136 pages. It is divided into 13 chapters including 6 appendices.

1. Introduction
2. Fundamentals of Applied Risk Management for Commissioning and Qualification
3. Operation and Continual Improvement
4. Supporting Practices
5. Quality Risk Management
6. Cost Control and Process Performance
7. Applications and Considerations for Speciality Facilities
8. Appendix 1 - Development of Appropriate User Requirements
9. Appendix 2 - C&Q Plans
10. Appendix 3 - Organizational Maturity Models
11. Appendix 4 - Commissioning
12. Appendix 5 - References
13. Appendix 6 - Glossary

The introduction refers to the "new" way of thinking concerning facilities, systems and equipment. The aim is to prove "suitability for intended use" by means of a science- and risk-based approach. The Guide is intended to build a bridge from traditional Commissioning and Qualification (C&Q) to a science- and risk-based approach. A graphic in the Guide clearly shows this. The US, EU and Japanese Regulations as well as ICH Q9 also form the basis of ASTM Guide E2500. And ASTM E2500, on the other hand, directly influences this Good Practice Guide. The ISPE Baseline Guide Volume 5 (C&Q), the ISPE FSE Guide and the GAMP Guide have an impact, too. The Applied Risk Management for Commissioning and Qualification Guide is thus directly influenced by four other guidelines.

The primary objectives of the Guide are to:

• provide a "roadmap" for possible strategies for a migration from traditional qualification practices towards science- and risk-based approaches to qualification 
• link the traditional qualification practices (e.g. in ISPE Baseline Guide Volume 5) to the verification approaches and terminology (e.g. in the ISPE FSE Guide and ASTM E2500) 
• describe practical methods for applying Quality Risk Management to equipment, systems, and facilities with regard to minimizing costs and time and with regard to the organizational impact of a transition to science- and risk-based approaches.

According to the Guide, steps taken on the way to cross the "bridge" could be:

• to introduce Good Engineering Practice (GEP) 
• a re-focus of the Quality Unit 
• to establish Quality Risk Management as the basis for the extent of verification activities 
• to structure verification documentation to be sufficiently flexible to be synchronized with the project progress rather than to rigidly dictate the project execution 
• establish a Project Change Mangement process in accordance with the project execution 
• introduce a Subject Matter Expert (SME) concept 
• leverage results from different activities (such as design reviews, commissioning, qualification) to support the "suitable for their intended use" evaluation

The Guide is intended to have a wide applicability, including drug substances, drug product, and biopharmaceuticals. It may also be applicable to medical devices or in the area of blood products. The Guide applies to new equipment/facilities or it can be used during changes/modifications to equipment/facilities. Because of the absence of process knowledge, the Guide does not cover product development activities. And out of scope of the Guide are non-GMP aspects (environmental protection, safety, ...)

Key concepts are:

• science-based quality risk management 
• product and process understanding as its basis 
• focus on achieving suitability for intended use 
• flexible approaches to risk management and qualification 
• focus only on value-added activities 
• well defined roles and responsibilities that allow each party to contribute from its area of expertise, without being expected to stand in for other disciplines.

The chapters 2-6 intensively cover the subject quality risk management in theory and practice with regard to commissioning and qualification. Aspects of cost control are also mentioned. The Guide explicitly emphasises the (new) roles and responsibilities of quality assurance and "Subject Matter Experts". The last chapters address special firms that frequently do not have defined processes - as R&D labs, pilot sites, manufacturer of investigational medicinal products etc. Following six appendices (development of appropriate user requirements, C&Q plans, organisation models for implementation, commissioning, references, glossary) comprising helpful tables complete the previous chapters.

Conclusion
The document is very comprehensive, containing 136 pages. It is not easy to read. Some of the contents seem to be rather abstract. The Guide is more helpful when talking about concrete issues, such as in the concrete tables in the single chapters and appendices.

Unfortunately the Guide is not free of charge. You can order it on the ISPE website.

A detailed summary - also including the single chapters - will be available in the coming issue of the GMP Journal.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)