July 2021 had plenty of updates in the pharmaceutical space from the World Health Organization. As part of its weekly update for members and the general public, PQG provides a summary of these below.
Back in 2020, the WHO published draft documents on ‘Good Manufacturing practices for medical gases’, ‘Good Manufacturing Practices for Investigational Products’ and ‘WHO Good Practices for Research and Development Facilities of Pharmaceutical Products’.
After the consolidation of comments received and a review of the feedback, revised versions of the three guidelines have now been published for the second round of public consultation. (check links for each draft guideline)
The deadline for comments is 31 August 2021. You can have your say by using the enclosed template.
These along with other WHO publications can be found at the WHO Medicines website under ‘Working Documents in Public Consultation’.
The need for a ‘GMP for medical gases‘ comes from increased demand for medicinal gases, in particular the use of oxygen in the treatment of patients with Coronavirus disease 2019 (COVID-19). As a result of this, the World Health Organization (WHO) Health Products Policy and Standards Department (formerly Essential Medicines and Health Products) and other departments involved in the supply of oxygen and the inspection of production sites of medicinal gases, raised the urgency for the preparation of the WHO good manufacturing practices for medicinal gases guidance text.
This guideline focuses on the production, control, storage and distribution of medicinal gases, however, it does not cover the manufacturing of medicinal gases in hospitals or at home for personal use. Despite this, the principles contained in this document may be applied in those instances to ensure that oxygen generated at hospitals or at home are suitable for their intended use and meet the appropriate quality standards.
When it comes to the draft guideline on ‘WHO good manufacturing practices for investigational products‘, the recommendations are mainly applicable to investigational products for human use; its principles should be considered in early phase clinical manufacture.
‘WHO good practices for research and development facilities of pharmaceutical products‘ is specifically applicable to research and development facilities of pharmaceutical products procedures, processes and data that are intended for transfer and submission for approval in marketing authorization applications, process validation, TOT-related activities, validation, quality control laboratory activities such as stability testing and development, and validation of cleaning procedures.
The main focus of this document is to provide for GxP in the production and control of pre-clinical and not for human use batches, manufactured in pharmaceutical formulation and development facilities, where these are directly supporting.
The principles described in this document may be applied in facilities where other products, such as biopharmaceutical products, vaccines and medical devices, are manufactured.
This guide excludes whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), medicinal gases, radiopharmaceuticals and gene therapy products.
The GxP outlined below are to be considered general guides and they may be adapted to meet individual needs. The equivalence of alternative approaches, however, should be demonstrated.