WHO draft revised guidance on GMP for investigational products

The World Health Organisation (WHO) has released a draft working document to the industry for public consultation on good manufacturing practices (GMP) for investigational medicinal products (IMP).

“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.”

The draft guideline applies to investigational products and 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.

The guideline makes enhanced recommendations for manufacturers on establishing a system for quality risk management. It recommends that the quality risk management system (RMS) should cover a systematic process for the assessment, control, communication and review of risks to the quality of the product and to the protection of the trial subjects. The RMS should also ensure that risk evaluation is based on scientific experience with the process and the product.

Manufacturers are also advised to retain records related to risk management. The draft guideline also notes that risk assessment should guide the scope of qualification and validation required for investigational products.

Recommendations related to managing complaints include establishment of a written procedure for how complaints are managed. 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 detailing the management of any product recalls.

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