【原创】WHO偏差处理和质量风险管理-中英文版

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罗伊鲱

原文：https://www.who.int/immunization ... /risk_july_2013.pdf

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罗伊鲱

Deviation handling and quality risk management

During the normal process of vaccine manufacture, deviations from documented, approved processes may occur. These may be planned or unplanned. Although manufacturers do their best to avoid these deviations they are naturally unavoidable. These deviations may impact on the quality of the product. It is important for a manufacturer to have a documented and systematic approach to deviation handling and assessing risk to the quality of the product.

In response to requests to WHO from manufacturers, this document on "Deviation handling and quality risk assessment" has been developed. There have already been several rounds of invited consultations with GMP experts, vaccine manufacturers, National Regulatory Authorities and WHO staff and public comment was invited on the July 2013 version. A new version is under development.

The current document is a guidance to manufacturers of prequalified vaccines and as a complement to the Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies, WHO TRS 978, Annex 6 .
(effective date: February 2012) . It provides guidance on approaches to handling planned or unplanned deviations and assessing and managing quality risks.

It is recognized that it is not an all-inclusive document. If there are matters that not clear to manufacturers from the document, further discussion with WHO may be requested by emailing vaccprequalification@who.int

• Deviation Handling and Quality Risk Management
  pdf, 708kb
  

罗伊鲱

Guidance on reporting variations to a prequalified vaccine

The current procedure for WHO prequalification (PQ) of vaccines was endorsed by the WHO's Expert Committee on Biological Standardization (ECBS) in October 2010. WHO TRS 978, Annex 6 (effective date: February 2012). Sections 7 and 8 include information regarding manufacturers’ post-prequalification obligations regarding variations. This guidance document provides further information.

After the PQ of a vaccine, manufacturers may introduce or plan to introduce changes in the manufacturing &/or quality control of the product. Many of these changes are introduced to improve the quality profile of the vaccine, the efficiency of the manufacturing process, to alter the labelling, the scheduling, or they could be made for marketing reasons. Changes may impact on the quality, safety and efficacy of the vaccines.

WHO has developed a guideline on regulation of post approval changes to vaccines. (TRS 993, annex 4). That guideline is to assist National Regulatory Authorities (NRAs) in the development of national requirements to deal with the post-approval changes to vaccine.

Vaccines that have been WHO prequalified have received national registration under the oversight of a NRA that has been assessed as functional. Therefore variations submitted to WHO for prequalified vaccines have already been reviewed and approved by the NRA in the country of manufacture. Therefore there may be differences, in reporting timing and processes of variation management by the NRA and WHO PQT and a separate guidance document has been prepared to guide manufacturers of prequalified vaccines on how and when to report variations to WHO PQT.

Following consideration of comments on the draft document posted on this site in February 2013, this new version has been prepared and published.

Where a planned variation is not described in this guidance, manufacturers are advised to discuss such changes with the Prequalification Secretariat at WHO by emailing vaccprequalification@who.int .

• Guidance on reporting variations to a prequalified vaccine
  pdf, 799kb
  

罗伊鲱

Environmental monitoring of clean rooms in vaccine manufacturing facilitiesPoints to consider for manufacturers of human vaccines

Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities - Points to consider for manufacturers of human vaccines, is a document aimed at providing non-binding guidance to manufacturers who intend to submit vaccines for prequalification. It was prepared as a result of consultations held at the beginning of 2010 in close consultation with a group of technical and regulatory experts actively participating in assessing prequalification applications. During the second part of 2010 the document underwent a further public consultation round and it has now been updated according to the comments and observations made by experts in the field.

This paper presents how a group of technical and regulatory experts, active in assessing prequalification applications, interprets current WHO requirements for clean rooms and environmental monitoring (EM) as they are applied to the production of human vaccines. As such, the analysis may be helpful to manufacturers and inspectors of prequalified vaccines in understanding how current WHO requirements are being interpreted. Readers are cautioned that views provided here are non-binding and subject to change over time; the official WHO requirements continue to be those approved by the WHO Expert Committee on Biological Standardization and by the WHO Expert Committee on Specifications for Pharmaceutical Products published in the respective WHO Technical Report Series (e.g.: TRS 957, Annex 4).

• Environmental monitoring of clean rooms in vaccine manufacturing facilities. Draft document: points to consider for manufacturers of human vaccines
  pdf, 455kb
  

Last updated: 29 November 2012

申嘉樊

丑小蛋 发表于 2021-4-20 11:25
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