WHO: Three new draft guidelines for commentary

In May 2020, the WHO published the following three drafts for commentary: 

• Good reliance practices in regulatory decision-making: high-level principles and recommendations   

Objective: The document aims to promote a more efficient approach to the regulation of medicinal products and to strengthen the overarching principles in the field of pharmacovigilance. It is to be seen as a guideline for the harmonisation of the regulatory landscape and provides definitions and key concepts. A " reliance toolbox " of practical instructions, case studies and comprehensive examples completes the document.  

• Points to consider on the different approaches – including HBEL – to establish carryoverlimits in cleaning validation for identification of contamination risks when manufacturing in shared facilities 

Objective: This document offers several possible approaches to limit the carryover during manufacture in shared facilities. This also concerns health-based exposure limits (HBEL). In addition, clarification on cleaning validation is given as well as important points to be considered when reviewing the current status and the approaches to cleaning validation in multiproduct facilities. The principles should be applied to the manufacturing of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs). PIC/S has also published two new documents dealing with HBELs (we reported).  

• Good manufacturing practices: water for pharmaceutical use 

Objective: This document deals with the production, storage and distribution of water for pharmaceutical purposes (WPU) in bulk form. It provides guidance on the quality management of water systems, water storage and distribution systems, water treatment systems as well as on qualification and validation, sampling, testing and routine monitoring of water. The WHO document "Production of water for injection by means other than distillation" (Annex 3) from the Technical Report Series No. 1025 will also be included in this guideline (we reported).  

All three documents can be commented from August to September 2020. From September to October 2020, the consolidation of the comments and the revision of the working documents are planned. From October 12 to 16, the presentation to the Expert Committee on Specifications for Pharmaceutical Preparations with the proposal for approval will take place. 

Sources:

WHO: Current Projects