GMP & ISPE GAMP validation vs. new ISO 9001:2015 (draft)

The proposed timeline for the development of the new ISO 9001:2015 is January 2015 – it will be published in September 2015.  Those businesses currently registered to ISO 9001:2008 will then have 3 years to make the transition. The next approval stage of ISO 9001:2015 will be in July 2015. ICH Q10 – Pharmaceutical Quality Systems and e.g. ISPE GAMP 5 reference to ISO 9001. Some new key elements if  ISO 9001:2015 are compared with GMP regulations and standards:

  • Risk based thinking and decisions as a basis for the management system: Compared with ICH Q9 – QRM and GAMP 5 – risk-based approach

  • Stronger emphasis on leadership and commitment from top management to take accountability for the effectiveness of the quality management system:  EU GMP – Chapter 2 – senior management

  • More focus on objectives as drivers for improvements, and related planning needed to achieve the goals: refer to ICH Q10 – Enablers – Chapter 1.6

  • The standard provides more detailed attention to the control of externally provided processes, products and services: Refer to EU GMP Chapter 7

  • Process Mapping and Validation mandatory: Process-oriented approach – GMP requirement

  • Document and Records Management changed to Information and – brand-new – Knowledge Management: Refer to ICH Q10 – Knowledge Management

  • More emphasis on planning and control of changes, including required changes in processes and needed changes to the management system: Refer EU GMP Chapter 1 and ICH Q10

The term “validation” (of processes, products, services) is used in ISO 9001 chapters: 8.3.2; 8.3.4; 8.5.1 (may be subject to change); in an almost identical way as in ISPE GAMP 5. The new ISO 9001:2015 standard will be highly welcome, which also makes audits and verifications of suppliers and vendors easier.

Contact us today for more information: