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WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fiftieth report
World Health Organization Technical Report Series
|August 13, 2016
Summary
The Expert Committee on Specifications for Pharmaceutical Preparations has released new guidelines to ensure medicine quality. These standards cover pharmacopoeial practices, manufacturing, data management, and distribution for pharmaceutical products.
Area of Science:
- Pharmaceutical Quality Assurance
- Medicinal Standards Development
- Global Health Regulations
Background:
- The Expert Committee on Specifications for Pharmaceutical Preparations facilitates the creation of practical standards for medicine quality assurance.
- International consensus and worldwide consultation are integral to the Committee's standard-setting process.
Purpose of the Study:
- To adopt and recommend new guidelines for pharmaceutical quality assurance.
- To provide practical standards for various aspects of pharmaceutical development, manufacturing, and distribution.
Main Methods:
- Adoption of new guidelines through international consensus-building.
- Worldwide consultation among stakeholders in pharmaceutical quality assurance.
Main Results:
- New guidelines adopted include good pharmacopoeial practices, FIP-WHO technical guidelines for pediatric preparations, good manufacturing practices for biological products, and inspection report guidance.
- Further guidance covers data management, trade and distribution of starting materials, quality surveys, collaborative procedures for WHO prequalification, bioequivalence studies, and variations to multisource products.
Conclusions:
- The newly adopted guidelines aim to enhance the quality assurance of medicines globally.
- These standards provide a framework for regulatory authorities and healthcare professionals to ensure safe and effective pharmaceutical products.
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