Development Pharmaceutics and process Validation

Abstract

A resume is presented of the guideline on the data required under Part I.A.4. of the Annex to European Directive 75/318/EEC covering the choice of composition of a medicinal product, supported by data on development pharmaceutics. The broad areas of development studies cover the function and compatibility of active ingredients and excipients, the development of liquid, semi-solid and solid dosage forms and the suitability of containers.

The guideline aims also to cover general aspects of process validation. The principles laid down in the Guideline are compared with those of FDA guideline on process validation which are much more detailed, but share the same overall aim.

One of the fundamental aims of the regulatory control of medicinal products is to ensure the correct purity, potency and consistency of manufacture of each product according to the quality appropriate for its intended use. While Good Manufacturing Practice is essential for quality assurance, other factors such as product design and development may also influence quality, and therefore must be studied and controlled. With this in mind, the Regulatory Authorities of the European Community have produced a guideline to the types of studies that should be undertaken in the development of a medicinal product, and which should be presented in support of application for marketing authorisation. A properly presented section on Development Pharmaceutics at the beginning of a dossier is extremely useful, if not essential, in explaining the rationale behind a particular product and giving the reviewer a clearer understanding of the data presented in support of product quality.

Quality Assurance of every product must be demonstrated, and validation is the key to its demonstration, put simply, validation is the act of proving that a process works. Thus the manufacturing methods and controls specified in an application should follow on from the development studies, and be based on valid principles. Demonstration of the validity of the manufacturing process should be provided as should the validation of the analytical methods used to control the process and therefore the product. Thus process validation should be seen as being strongly supported on the one hand by development pharmaceutics, and on the other by analytical validation.