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South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for the API Master File (APIMF) Procedure."


An Active Pharmaceutical Ingredient Master File (APIMF) contains all the required information for the quality evaluation of an API.

The APIMF contains two parts:

The open part: The applicant must have access to this information, and it must be sufficient for the applicant to ensure the suitability of the API used in the finished pharmaceutical product (FPP).

The closed part: The applicant does not have always access to this information, which is confidential intellectual property of the API holder, including a detailed description of the manufacturing process (with individual steps4 ), manufacturing quality control procedures, process validation etc.


The purpose of this guideline is to provide recommendations for applicants looking to submit applications for registration of medicines and variations.


It also ensures that API holders' proprietary information is handled confidentially from beginning to end and that one API evaluation from a specific manufacturing facility can be used across multiple finished pharmaceutical product (FPP) evaluations, thus reducing the time taken to evaluate quality.


The APIMF holder, is responsible for keeping the content of their APIMF updated with respect to the actual synthesis / manufacturing process and controls.


Click this LINK to know more about the submission requirements for New registrations and variations in detail.

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