For active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs): Any manufacturer of active pharmaceutical ingredients (APIs) and/or finished pharmaceutical products (FPPs) can express an interest in having its API or FPP products evaluated by WHO, provided those products are eligible for assessment. FPPs eligible for evaluation include both generic and innovator FPPs, and FPPs that contain just one active ingredient or that combine several.
The following is a simplified overview of the prequalification process for APIs and FPPs.
- The manufacturer verifies that the API or FPP that it wants to submit for evaluation for prequalification is included in the relevant Invitation to Manufacturers to Submit an Expression of Interest for Evaluation.
- The manufacturer submits an application to WHO in accordance with the prequalification procedure for the product (either API or FPP).
- WHO reviews the information submitted for evaluation for prequalification. This review may include a request or requests for additional information. Inspection of the manufacturing site(s), and, if relevant, of the contract research organization that performed a related study, may also be necessary.
- If the API or FPP has already been approved by a stringent regulatory authority, the applicant may choose to make a submission for abbreviated assessment.
For medicines quality control laboratories (QCL): Medicines quality control laboratories (QCLs) that undertake chemical and microbiological (including bacterial endotoxins) testing of medicines are also eligible to apply for prequalification.
The process for prequalification of QCLs is similar to that for APIs and FPPs, consisting of the following steps:
- The QCL consults the Invitation to Manufacturers to Quality Control Laboratories to Submit an Expression of Interest for Prequalification, to verify that it is eligible for prequalification.
- The QCL submits an application — which will include a laboratory information file — to WHO, in accordance with the prequalification procedure for QCLs.
- WHO reviews the laboratory information file (or quality manual). It may request submission of additional information and it may also stipulate inspection of the QCL.
Once an API, FPP or QCL has met prequalification requirements it is added to the relevant WHO list.
The standards against which WHO evaluates finished pharmaceutical products, active pharmaceutical ingredients and quality control laboratories are based on the principles and practices agreed by the world’s leading regulatory agencies and adopted by the WHO Expert Committee on Specification for Pharmaceutical Preparations.
PQTm staff responsible for assessments and inspections are generally recruited from regulatory agencies. They work with regulators from stringent regulatory authorities (SRA) (for example, SRA assessors attend the assessment sessions held in Copenhagen, adn SRA inspectors join WHO inspections as co-inspector) or to ensure that their levels of knowledge and expertise in medicines regulation and pharmaceutical science are maintained. They also work with regulators from low-income countries where the medicines will be used, to ensure that the process and results are understood and trusted by those countries.
Additionally, the assessment and inspection groups include rotational staff from low-income regulatory agencies. The rotational staff work with PQTm for several months and then return to their agency. Upon their return home they share the knowledge and experience they have acquired with colleagues and also serve as an ambassador for WHO prequalification.