Recently, the WHO Expert Committee on Pharmaceutical Standards (ECSPP) released its 55th technical report
In October 2020, ECSPP held its 55th annual meeting in the form of a virtual meeting.
This report is a summary of relevant discussions and follow-up work of the meeting
Through a series of guides
ECSPP is one of the earliest committees established by WHO.
The scope of ECSPP's work has also been continuously expanded.
It involves GMP, technical guidance documents for drug management, quality control laboratory quality management (GPCL), and counterfeit and substandard drugs.
Processing and other links
ECSPP has also formulated a large number of special guidelines related to GMP and quality systems.
In this technical report, ECSPP has adopted a series of guidelines in this regard, including:
Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation;
GMP (Good manufacturing practices: water for pharmaceutical use)
Guideline on data integrity;
WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce (WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce);
Good reliance practices in the regulation of medical products: high-level principles and considerations;
Good regulatory practices in the regulations of medical products
Data Integrity Guidelines
Among the guidelines adopted above, the data integrity guidelines have been significantly updated compared to the previous version
This guidance replaces the 2016 “WHO Guidance on good data and record management practices” (WHO Guidance on good data and record management practices).
The main reason is that the 2016 guidance was considered too lengthy, and many other institutions have recently expressed interest in this topic.
The new guidelines will better reflect current expectations and focus on necessary information
The content of the new guidelines is as follows.
The requirements for data integrity are described in 10 main areas (Parts 4-10).
The appendix contains 10 examples of data integrity management, from quality risk management to data entry, change and control.
Introduction and background
Quality risk management
Data, data transfer and data processing (Data, data transfer and data processing)
Good documentation practices
Data review and approval
Corrective and preventive actions (Corrective and preventive actions)
Appendix 1: Examples in data integrity management Appendix 1: Examples in data integrity management
Between November 2019 and January 2020, the first draft of the new guidelines was open for comments.
This version and the more than 440 comments received were discussed at the virtual inspector meeting in June 2020
Since then, the draft guidelines have been revised and public comments have been requested again
During the second comment period, the WHO Secretariat received approximately 650 comments.
The suggestions included:
Reorganize the content of the "Introduction" section;
Add information about "Data Governance", "Data Transmission" and "Computerized Systems";
Expand the content of the "Quality Risk Management Control" section;
Clarify the management review system and actions in case of non-compliance;
Add a new section "Data Review and Approval";
Improve some examples and make some editorial revisions
The guidance document was revised accordingly in accordance with the above recommendations and submitted to ECSPP
ECSPP then reviewed the latest amendments and discussed related issues, including compliance with data protection regulations and best times, data retention schedules, and data transmission requirements
In addition, ECSPP also discussed the scope of the document, such as the value of covering relevant content: vector control products, safety and efficacy data generated in clinical research under good clinical practice
Therefore, ECSPP members proposed new wording for the scope of application and suggested adding the term "medical products" to the glossary
In general, the committee of experts expressed strong support for the new data integrity guidelines and pointed out that the guidelines are comprehensive and greatly improved
ECSPP members agreed that the new guidelines will be of great value to the industry and inspectors
: TRS 1033-55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations.
WHO Technical Report Series 1033.
25 March 2021.