Expert Team of German Medicines Manufacturers' Association Develops Quality System Manual

GMP News
6 February 2008
 

Expert Team of German Medicines Manufacturers' Association Develops Quality System Manual

 
The new Guideline ICH Q10 "Pharmaceutical Quality System" defines that a documented Quality System should be established. Such a quality system should consider not only the GMP requirements but also further standards such as the ISO Standard 9001.

The Quality System shall ensure conformity of each manufactured medicinal product with the quality as specified in the product's marketing authorisation / registration.

The quality manual developed by a team of experts of the German Medicines Manufacturers` Association illustrates the QM-system of company "Example" in a one-level form with the effect that the manual may also be handed to customers or external parties upon request.

The structure is based on ISO 9001. Elements like Corrective and Preventive Action (CAPA) and Continual Improvement are covered as well as Management responsibilities and Design Control. In addition to the manual you will also find examples of job descriptions for Qualified Person, Head of Quality Control and Head of Production. The appendix also includes exemplary forms for the review by management.
 

The quality manual is a very helpful tool for all personnel involved in Quality Assurance activities. All participants of the ICH Q10 Training Course in Munich, Germany, on March 13-14 will receive a complementary copy of the manual.


Author:
Oliver Schmidt
On behalf of the European Compliance Academy (ECA)
 

The following table of contents provides an overview about the topics covered.

Table of Contents  

9 Table of contents
13 Reference matrix

"Chapters in the standards vs. the relevant chapters in the GMP-Guide"

19 Change history
22 0 Introduction
23 1 Scope of application
23 1.1 General
23 1.2 Application
23 1.2.1 Medicinal products
24 1.2.2 Medical devices
25 1.2.3 Foodstuffs
26 1.2.4 Cosmetics
26 1.2.5 Conclusion
26 2 References
27 3 Terms and definitions
29 4 Quality management system
29 4.1 General requirements
32 4.2 Documentation requirements
32 4.2.1 General
33 4.2.2 Quality management manual
34 4.2.3 Control of documents
35 4.2.4 Control of records
35 5 Management responsibility
35 5.1 Management commitment
36 5.2 Customer focus (needs and expectations)
36 5.3 Quality policies
36 5.4 Planning
36 5.4.1 Quality objectives
37 5.4.2 Quality management system planning
38 5.5 Responsibilities, authority and communication
38 5.5.1 Responsibilities and authority
38 5.5.1.1 Company structure and organisational structure
46 5.5.1.2 Duties and organisation of the areas
49 5.5.1.3 Responsible persons acc. to Drug Law (AMG)
52 5.5.1.4 Responsible person acc. to Medical Device Law (MPG)
52 5.5.1.5 Responsible person acc. to Law on Foodstuff (LFGB)
52 5.5.1.6 Responsible persons acc. to the Regulation on Cosmetics
53 5.5.1.7 Further responsible persons
53 5.5.2 Management representative
54 5.5.3. Internal communication
55 5.6 Management review
55 5.6.1 General
55 5.6.2 Review input data
55 5.6.3 Review output
56 6 Resource management
56 6.1 Provision of resources
56 6.2 Human resources
56 6.2.1 General
56 6.2.2 Competence, awareness and training
58 6.3 Infrastructure
59 6.4 Work environment
61 7 Product realization
61 7.1 Planning of product realization
62 7.2 Customer-related processes
62 7.2.1 Determination of requirements related to the product
63 7.2.2 Review of requirements related to the product
64 7.2.3 Customer communication
64 7.3 Design and development
65 7.3.1 Design and development planning
66 7.3.2 Design and development inputs
66 7.3.3 Design and development outputs
66 7.3.4 Design and development review
67 7.3.5 Design and development verification
67 7.3.6 Design and development validation
67 7.3.7 Control of design and development changes
68         Example of a development project (medicinal product)
69         Example of a development project (medical device closely related to a medicinal
        product)
73 7.4 Purchasing
73 7.4.1 Purchasing process
76 7.4.2 Purchasing information
77 7.4.3 Verification of purchased products
81 7.5 Production and service provision
81 7.5.1 Control of the production and service provision
81 7.5.1.1 General requirements
88 7.5.1.2 Particular requirements (standard for medical devices DIN EN ISO 13485 only)
88 7.5.2 Validation of processes for production and service provision
90 7.5.3 Identification (labelling) and traceability
90 7.5.4 Customer property
91 7.5.5 Preservation of product (maintenance of product conformity)
92 7.6 Control of monitoring and measuring devices (monitoring of analytical equipment)
94 8 Measuring, analysis and improvement
94 8.1 General
94 8.2 Monitoring and measuring
94 8.2.1 Customer satisfaction
95 8.2.2 Internal audits
96 8.2.3 Monitoring and measuring of processes
96 8.2.4 Monitoring and measuring of the products
97 8.3 Control of nonconforming product
98 8.4 Analysis of data
98 8.5 Improvement
98 8.5.1 Continual improvement / General
99 8.5.2 and 8.5.3

        Corrective action and preventive action (CAPA)

101         Appendix
          Exemplary job descriptions of the responsible persons acc. to AMG (see
        also chapter 5.5.1.3 of the QM-Manual):
103         Qualified Person – Q.P. (for GMP)
109         Head of Production
115         Head of Quality Control
121         Q.P. for Pharmacovigilance
127         Information Manager
131         Exemplary job description of an area head
        (see also chapter 5.5.1.7 and chapter 6.2.1)

137

139

        Exemplary forms for the review by management (see also chapter 5.6 of
        the QM-Manual):

        Format of an annual report incl. evaluation / review

        Checklist of the quality-ensuring measures in year 200x

145         Flow chart ‛Processes in company "Example" '
149         Reference matrix <Standard DIN EN ISO 9001: 2000 vs. the SOPs of
        company "Example" and the BAH-books related to company "Example">

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