The World Health Organization is revising its guidance to industry on good manufacturing practices for investigational drug products, including new recommendations for quality risk management.

The draft working document, which was released in November 2020, is open for public comment until 6 January 2021. The draft is expected to be revised and go through a second round of public comment before being presented to the WHO’s Expert Committee on Specifications for Pharmaceutical Preparations in late 2021. The draft guideline is an update to recommendations issued by WHO in 1996.

The guideline update comes at the request of the WHO’s Prequalification Team – Inspections Services, in part to account for new manufacturing situations arising from the production of COVID-19 therapeutics.

“The objective of this update is to bring the guideline in line with current expectations and trends in good manufacturing practices and to harmonize the text with the principles from other related international guidelines,” according to the WHO draft guideline.

The draft guideline, which applies to investigational products that may not fall under the same legal umbrella as licensed products, covers quality management, quality risk management, personnel, documentation, premises, equipment and utilities, materials, production, quality control, qualification and validation, complaints, recalls, returns, shipping, and destruction.

In the guideline, manufacturers are tasked with establishing a system for quality risk management. “The system for quality risk management should cover a systematic process for the assessment, control, communication and review of risks to the quality of the product and, ultimately, to the protection of the trial subject and patient,” according to the WHO draft guideline.

The risk management system should ensure that the risk evaluation is based on science and experience with the process and the product. WHO also calls on manufacturers to retain records related to risk management and to match the formality of the program to the level of risk. Quality risk management “should be applied both proactively and retrospectively,” WHO wrote.

The draft guideline also notes that risk assessment should guide the scope of qualification and validation required for investigational products.

The guideline also beefs up recommendations related to managing complaints, including calling on manufacturers to establish a written procedure for how complaints are managed, and for complaints to be recorded and investigated. Manufacturers should inform competent authorities if they are considering taking any action following identification of a serious quality problem.

Manufacturers should also establish a written procedure describing the management of any recall of an investigational product, the draft guideline said.

WHO