With an ever-increasing awareness of the risks in pharmaceutical production and control and the lifecycle approaches being followed, greater emphasis is being placed on ensuring that the research and development of products are appropriately controlled and documented.
Consequently, it is necessary that manufacturers of pharmaceutical products are able to submit all relevant data and information related to their development, including the facilities used, the experimental designs employed in the validation of manufacturing processes, and quality control procedures, to the regulators, where required, for review.
This is to ensure that the facilities, quality systems, data and information meet the appropriate standards and applicable good practices. This document intends to provide guidance on good practices to research and development facilities.
- It aims to ensure that the correct systems are followed, ensuring appropriateness, reliability and the quality of products, processes, procedures and data.
- This further helps to ensure that products meet the requirements for safety, efficacy and quality that they purport to possess.
- In addition to product development, other activities – including the production of pilot scale batches, process validation, cleaningprocedure development, cleaning validation studies, and stability studies – are often undertaken in such facilities.
Major Discussion Topics
- Quality management
- Quality risk management
- Sanitation and hygiene
- Qualification and validation
- Outsourced activities
- Self-inspection and quality audits
- Personne
- Training
- Premises
- Equipment and instruments
- Materials
- Documentation
- Processing and process design
- Quality contro
- Stability studies
- Analytical procedure development
- Technology transfer
- Life cycle approach
The World Health Organization (WHO) document WHO good manufacturing practices for investigational products specifically addresses the requirements and recommendations for products used in clinical trials.
Other WHO guidelines address specific requirements and recommendations, including data integrity, stability testing, analytical method validation, cleaning validation and technology transfer (see references and further reading sections at end of document).
This document should be read in conjunction with other WHO guidelines on good manufacturing practices (GMP), where appropriate and where applicable, as referenced in the relevant documents.
This guide is not intended to define registration requirements or modify pharmacopoeial requirements or other guideline recommendations. For details on process development, it is recommended that other guidelines, such as those published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), be read in conjunction with this document.
This guide excludes whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), medicinal gases, radiopharmaceuticals and gene therapy products.
Reference: WHO Technical Report Series, No. 1044, 2022, Annex-6