WHO publishes draft documents on medicinal gases, IPs and development facilities
The WHO has published three GMP-relevant draft documents in recent weeks:
- WHO good manufacturing practices for investigational products
- WHO good manufacturing practices for medicinal gases, Rev.1
- WHO good practices for research and development facilities of pharmaceutical products
WHO good manufacturing practices for investigational products, Rev1
The principles in this guideline should be considered in early phase clinical manufacture and are mainly applicable to investigational products for human use. The guideline covers a wide scope of GMP issues including quality management, quality risk management, personnel, and documentation considerations. Issues related to manufacturing premises, equipment and utilities, materials and production are also addressed.
WHO good manufacturing practices for medicinal gases, Rev.1
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). The focus of the guideline is on production, control, storage and distribution of medicinal gases. It does not cover medicinal gases in hospitals or at home for personal use, although the principles may be implied to ensure appropriate quality standards.
WHO good practices for research and development facilities of pharmaceutical products
The document 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 focus 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.
Excluded are whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), medicinal gases, radiopharmaceuticals and gene therapy products.
The deadline for comments for all three draft documents is August 31, 2021.
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