GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

This document was written with the aim of:

Providing guidance for inspectorates in the interpretation of GMP/GDP requirements in relation to data integrity and the conduct of inspections.

Providing consolidated, illustrative guidance on risk-based control strategies which enable the existing requirements for data integrity and reliability as described in PIC/S Guides for GMP2 and GDP3 to be implemented in the context of modern industry practices and globalised supply chains.

Facilitating the effective implementation of data integrity elements into the routine planning and conduct of GMP/GDP inspections; to provide a tool to harmonise GMP/GDP inspections and to ensure the quality of inspections with regards to data integrity expectations.

This guidance, together with inspectorate resources such as aide memoire (for future development) should enable the inspector to make an optimal use of the inspection time and an optimal evaluation of data integrity elements during an inspection.

Guidance herein should assist the inspectorate in planning a risk-based inspection relating to data integrity.

This guide is not intended to impose additional regulatory burden upon regulated entities, rather it is intended to provide guidance on the interpretation of existing PIC/S GMP/GDP requirements relating to current industry practice.

 The principles of data integrity apply equally to both manual and computerized systems and should not place any restraint upon the development or adoption of new concepts or technologies. In accordance with ICH Q10 principles, this guide should facilitate the adoption of innovative technologies through continual improvement. 3.6 This version of the guidance is intended to provide a basic overview of key principles regarding data management and integrity. The PIC/S Data Integrity Working Group will periodically update, amend and review this guidance in light of inspectorate feedback, experience in using the guide and any other developments

  

DATA GOVERNANCE SYSTEM

 What is data governance?

Data governance is the sum total of arrangements which provide assurance of data integrity. These arrangements ensure that data, irrespective of the process, format or technology in which it is generated, recorded, processed, retained, retrieved and used will ensure a complete, consistent and accurate record throughout the data lifecycle.

The data lifecycle refers to how data is generated, processed, reported, checked, used for decision-making, stored and finally discarded at the end of the retention period. Data relating to a product or process may cross various boundaries within the lifecycle. This may include data transfer between manual and IT systems, or between different organizational boundaries; both internal (e.g. between production, QC and QA) and external (e.g. between service providers or contract givers and acceptors).

Data governance systems

Data governance systems should be integral to the pharmaceutical quality system described in PIC/S GMP/GDP. It should address data ownership throughout the lifecycle, and consider the design, operation and monitoring of processes / systems in order to comply with the principles of data integrity, including control over intentional and unintentional changes to, and deletion of information.

The data governance system should ensure controls over data lifecycle which are commensurate with the principles of quality risk management. These controls may be:

· Organizational

o procedures, e.g. instructions for completion of records and retention of completed paper records;

o training of staff and documented authorization for data generation and approval;

o data governance system design, considering how data is generated recorded, processed retained and used, and risks or vulnerabilities are controlled effectively;

o routine data verification;

o periodic surveillance, e.g. self-inspection processes seek to verify the effectiveness of the data governance policy.

· Technical

o computerized system control,

o automation

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Revision of PIC/S GMP Guide PE 009-13 GUIDE TO GOOD MANUFACTURING PRACTICE

Geneva, 22 December 2016: the following Chapters of the PIC/S GMP Guide have been revised:

• Chapter 1 on “Quality Management” (which has become “Pharmaceutical Quality Systems”); 
• Chapter 2 on “Personnel”;
• Chapter 6 on “Quality Control”; 
• Chapter 7 on “Contract Manufacture and Analysis” (which has become “Outsources Activities”).

The revised Chapters 1, 2, 6 & 7 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. Chapters 1, 2 & 7 have been aligned to ICH Q10 and the principles of “Pharmaceutical Quality System” have been integrated. A section on consultants has been added in Chapter 2. The scope of Chapter 7 has been expanded beyond the scope of “contract manufacture and analysis”. Both Chapters 1 and 7 have been renamed to reflect the changes. In Chapter 6, all sections have been reviewed and amended and a new section on “Technical transfer of testing methods” has been added.

The revision has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). The revised GMP Guide (PE 009-13) will enter into force on 1st January 2017. All non-EEA Participating Authorities of PIC/S (and Applicants) have been invited to transpose the revised Chapters of the PIC/S GMP Guide into their own GMP Guides.

1.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

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2.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

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3.GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS       

   ANNEXES

1.    Annex 1 (Manufacture of sterile medicinal products)

2.    Annex 2 (Manufacture of biological medicinal substances and products for human use)

3.    Annex 3 (Manufacture of radiopharmaceuticals)

4.    Annex 4 (Manufacture of veterinary medicinal products other than immunologicals)

5.    Annex 5 (Manufacture of immunological veterinary medical products)

6.    Annex 6 (Manufacture of medicinal gases)

7.    Annex 7 (Manufacture of herbal medicinal products)

8.    Annex 8 (Sampling of starting and packaging materials)

9.    Annex 9 (Manufacture of liquids, creams and ointments)

10. Annex 10 (Manufacture of pressurised metered dose aerosol preparations for inhalation)

11. Annex 11 (Computerised systems)

12. Annex 12 (Use of ionising radiation in the manufacture of medicinal products)

13. Annex 13 (Manufacture of investigational medicinal products)

14. Annex 14 (Manufacture of medicinal products derived from human blood or plasma)

15. Annex 15 (Qualification and validation)

16. Annex 16 [Qualified person and batch release]*

17. Annex 17 (Parametric release)

18. Annex 18 [GMP Guide for active pharmaceutical ingredients]**

19. Annex 19 (Reference and retention samples)

20. Annex 20 (Quality risk management)***

·         Appendix I: Risk Management Methods and Tools Basic Risk Management Facilitation Methods

·         Appendix II: Potential Applications For Quality Risk Management

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Download Zip: GMP Guide (PE 009-13).zip

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