A lot has been said about ISO 9001 in the pharmaceutical industry. With pros and cons and comparisons to GMP made all the time. This will be discussed more in a later article, but as a starter I have listed the clauses of ISO 9001:2015 below. Those in green text are requirements of ISO that are not specifically mentioned in EU GMP. From this list you can see that there are a number of areas that ISO covers that are not covered by GMP. Those familair with ICH 10 and the FDA Quality Systems GMP Guidance documents will see how ISO has obviously had an input into the design of these two quality documents.
Section 1 – Scope
Section 2 – Normative Reference
Section 3 – Terms and Definitions
Section 4 – Context of the Organisation
4.1 – Understanding the organization and its context
4.2 – Understanding the needs and expectations of interested parties
4.3 – Determining the Scope of the Quality Management System
4.4 – Quality Management System and its Processes
Section 5 – Leadership
5.1 – Leadership and commitment
5.1.1 – General
5.1.2 – Customer Focus
5.2 – Policy
5.2.1 – Establishing the Quality Policy
5.2.2 – Communicating the Quality Policy
5.3 – Organisational roles, responsibilities and authorities
Section 6 – Planning
6.1 – Actions to address risks and opportunities
6.2 – Quality Objectives and planning to achieve them
6.3 – Planning of Changes
Section 7 – Support
7.1 – Resources
7.1.1 – General
7.1.2 – People
7.1.3 – Infrastructure
7.1.4 – Environment for the operation of processes
7.1.5 – Monitoring and measuring resources
7.1.5.1 – General
7.1.5.2 – Measurement Traceability
7.1.6 – Organisational knowledge
7.2 – Competence
7.3 – Awareness
7.4 – Communication
7.5 – Documented information
7.5.1 – General
7.5.2 – Creating and updating
7.5.3 – Control of documented information
Section 8 – Operation
8.1 – Operational Planning and Control
8.2 – Requirements for Products and Services
8.2.1 – Customer Communication
8.2.2 – Determination of requirements for products and services
8.2.3 – Review of the requirements for products and services
8.2.4 – Changes to requirements for products and services
8.3 – Design and Development of Products and Services
8.3.1 – General
8.3.2 – Design and Development Planning
8.3.3 – Design and Development Inputs
8.3.4 – Design and Development Controls
8.3.5 – Design and Development Outputs
8.3.6 – Design and Development Changes
8.4 – Control of Externally provided processes, products and services
8.4.1 – General
8.4.2 – Type and Extent of Control
8.4.3 – Information for External Providers
8.5 – Production and Service provision
8.5.1 – Control of production and service provision
8.5.2 – Identification and Traceability
8.5.3 – Property belonging to Customers or External Providers
8.5.4 – Preservation
8.5.5 – Post-delivery activities
8.5.6 – Control of Changes
8.6 – Release of Products and Services
8.7 – Control of Nonconforming Outputs
Section 9 – Performance Evaluation
9.1 – Monitoring, Measurement, Analysis and Evaluation
9.1.1 – General
9.1.2 – Customer Satisfaction
9.1.3 – Analysis and Evaluation
9.2 – Internal Audit
9.3 – Management Review
9.3.1 – General
9.3.2 – Management Review Input
9.3.3 – Management Review Output
Section 10 – Improvement
10.1 – General
10.2 – Nonconformity and Corrective Action
10.3 – Continual Improvement
From the above you will see that there are certainly some areas where ISO can be used to enhance a GMP based Quality System.
THIS ARTICLE WAS FIRST PUBLISHED IN 2012 AND HAS BEEN UPDATED ON OCTOBER 6TH 2022.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy Martin
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
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I really like the customer-focussed elements of ISO 9001. GMP is definitely lacking in this area, yet who are we ultimately making our drug products for? Customers!
The inclusion of elements of ISO 9001 in a supplier audit gives a much more ’rounded’ audit.
Hey there – I am looking from the exactly other way. Our company is working acc. to ISO 9001 and has some parts where GxP is relevant. Honestly GxP describes much more about what has to be done IN A CERTAIN WAY but therefor lacks in “management responsibilities”. Generally the combination of both is a really good idea as ISO concentrates on Quality Assurance and GMP explains how to reach that. Unfortunatelly FDA should start involving of pharma and supplying companies when creating new requirements as some of them are not relevant or give much too much information of suppliers which (which may be not relevant as well but make it impossible to work acc. to economic points of view.