Environmental monitoring of clean rooms in vaccine manufacturing facilities
Points 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
Last updated: 29 November 2012