For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699

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  – General  – 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.


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 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.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

Our 2-day course is updated for Annex 1 changes

Related Articles

Find out about our course ranges

GMP Training


QMS Training


GDP/RP Training


GMP Compliance


QP Training


GDP Compliance


Free Taster courses

To try a free taster of our online courses to see if they are of interest visit this page.