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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.

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