GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES DRAFT FOR COMMENT
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2015/09 [pdf] 原文地址 Working document QAS/15.624
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SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/15.624: GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES
Proposal and need for new guidance document discussed at the informal consultation on inspection, good 28–30 April 2014 manufacturing practices and risk management guidance in medicines'manufacturing Concept paper drafted and proposal presented by Mr I. 13–17 October 2014 Thrussell, Expert Inspector, Prequalification Team (PQT)-Inspection to the forty-ninth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Preparation of draft document by Mr I. Thrussell in close cooperation with colleagues from PQT-Inspection and a October 2014–June 2015 drafting group, including Ms M. Cahilly and national inspectors Draft discussed at consultation on data management, bioequivalence, good manufacturing practices and medicines' inspection Revised draft document prepared by the authors, the drafting group, based on the feedback received during the July–August 2015 consultation and the subsequent WHO workshop on data management Document sent out for comments Compilation of comments received Submission to fiftieth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Any further action, as needed and recommended by the 12–16 October 2015 September 2015 November 2015 29 June–1 July 2015 WHO Expert Committee on Specifications for Pharmaceutical Preparations 目录 [隐藏] BACKGROUND 1. INTRODUCTION AND BACKGROUND 2. AIMS AND OBJECTIVES OF THIS GUIDANCE 3. GLOSSARY 4. PRINCIPLES 5. QUALITY RISK MANAGEMENT TO ENSURE GOOD DATA MANAGEMENT 6. MANAGEMENT GOVERNANCE AND QUALITY AUDITS 7. CONTRACTED ORGANIZATIONS, SUPPLIERS, AND SERVICE PROVIDERS 8. TRAINING IN GOOD DATA AND RECORD MANAGEMENT 9. GOOD DOCUMENTATION PRACTICES o o o o o Attributable. Legible, traceable and permanent Contemporaneous Original o Accurate 10. DESIGNING SYSTEMS TO ASSURE DATA QUALITY AND RELIABILITY 11. MANAGING DATA AND RECORDS ACROSS THE DATA LIFE CYCLE 12. ADDRESSING DATA RELIABILITY ISSUES 13. REFERENCES AND FURTHER READING BACKGROUND
During an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines’ manufacturing held by the World Health Organization (WHO) in Geneva in April 2014 a proposal for new guidance on good data management was discussed and recommended to be developed. The participants included national inspectors and specialists in the various agenda topics, as well as staff of the Prequalification Team (PQT)–Inspections.
The WHO Expert Committee on Specifications for Pharmaceuticals Preparations received feedback from this informal consultation during its 49th meeting held in October 2014. A concept paper was received from PQT–Inspections for a proposed structure of a new guidance document which was discussed in detail. The concept paper consolidated existing normative principles and gave some illustrative examples on their implementation. In the Appendix to the concept paper extracts from existing good practices and guidance documents were combined to illustrate the current relevant guidance on assuring the reliability of data and related GxP matters. In view of the increasing number of observations made during inspections regarding data management practices the Committee endorsed the proposal.
Following this endorsement, a draft document was prepared by the colleagues from PQT- Inspection and a drafting group, including national inspectors. This draft was discussed at a consultation on data management, bioequivalence, good manufacturing practices and medicines' inspection held 29 June–1 July 2015.
A revised draft document was subsequently prepared by the authors, the drafting group, based on the feedback received during this consultation and the subsequent WHO workshop on data management.
Collaboration is being sort with other organizations towards future convergence in this area.
This first draft is presented herewith for comments.
1. INTRODUCTION AND BACKGROUND
Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is a trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable. Data on which these decisions are based should therefore be complete as well as being accurate, legible, contemporaneous, original and attributable ; commonly referred to as “ALCOA”.
These basic ALCOA principles and the related good practice expectations that assure data reliability are not new. Much high- and mid-level normative guidance already