Focusing primarily on specified starting materials, those used as, or in the production of, active pharmaceutical ingredients (API), the document aims to offer a global approach to defining quality.
The World Health Organization (WHO) believes it is important quality standards are achieved without overburdening companies with regulations. This would drive up prices and could lead to people using cheaper counterfeit or substandard drugs, according to the guidance.
Consequently, the document states it is unhelpful to uniformly apply good manufacturing practices (GMP) to specified starting materials. Instead, the WHO recommends manufacturers decide what level of quality is required based on the guidance or risk assessments if appropriate.
The guidance document details quality levels for some materials and states that for others a risk assessment, considering factors such as the number and nature of synthesis steps, may be suitable.
However, formal risk assessments are sometimes inappropriate and unnecessary, according to the guidance. In these cases informal risk assessments, using empirical tools or internal procedures, may be considered acceptable.
When establishing quality control levels certain factors, such as impurity profile and isomers, are critical. Consequently, standards should be designed to detect isomeric or other impurities which are potentially reactive and could impact on the final product.
The WHO recommends that this threat is discussed and controlled with suitably validated methods if appropriate. Furthermore, acceptance criteria should be established based on the fate of impurities in the starting material following normal synthesis or process.
Comments on the document can be submitted until May 1 and those received by April 23 could be discussed at the consultation on paediatrics and generic guideline development.