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 below. Those in purple text are requirements of ISO that are not specifially 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. NOTE – THIS ARTICLE WAS WRITTEN BEFORE RECENT UPDATES TO EU GMP CHAPTERS 1 AND 2 AND SO HAS SOME ASPECTS THAT ARE NOW OUT OF DATE.
Section 1 – Scope
Section 2 – Normative Reference
Section 3 – Terms and Definitions
Section 4 – Quality Management System
4.1 – General Requirements (Process Approach)
4.2 – Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
Section 5 – Management Responsibility
5.1 – Management Commitment
5.2 – Customer Focus
5.3 – Quality Policy
5.4 – Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System planning
5.5 – Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 – Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
Section 6 – Resource Management
6.1 – Provision of Resources
6.2 – Human Resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 – Infrastructure
6.4 – Work Environment
Section 7 – Product Realization
7.1 – Planning of Product Realisation
7.2 – Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer Communication
7.3 – Design and Development
7.3.1 Design and Development Planning
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Control of Design and Development changes
7.4 – Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product
7.5 – Production and Service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 – Control of Monitoring and Measuring Equipment
Section 8 – Measurement, Analysis and Improvement
8.1 – General
8.2 – Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of processes
8.2.4 Monitoring and Measurement of product
8.3 – Control of nonconforming product
8.4 – Analysis of Data
8.5 – Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
Note – there is only passsing reference to Corrective and/ or Preventivie Actions in GMP and certainly no mention of CAPA’s.
From the above you will see that there are certainly some areas where ISO can be used to enhance a GMP based Quality System.
What are your thoughts on this? Please make a comment.
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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.