How to Obtain an SFDA GMP License for Pharma Manufacturers?

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Regulatory Editor

Published by regulatory affairs team in PharmaKnowl, Riyadh office.

During the SFDA drug registration process in Saudi Arabia, pharmaceutical manufacturers will undergo an SFDA inspection to ensure compliance with Good Manufacturing Practices (GMP) standards. The ones that pass and close all quality findings will receive a GMP certificate from the Saudi FDA.

In this post, we will discuss the GMP licensing process, requirements, and timelines.

What is GMP?

Good Manufacturing Practices (GMP) involve implementing proactive quality measures to ensure the safety and efficacy of drugs and other products. This quality system encompasses all production details, from starting materials and premises to equipment and staff training, as well as personal hygiene. Detailed quality procedures are required for each process, and documentation proves they are consistently implemented.

Quality manufacturing eliminates or minimizes the chances of contamination and errors to protect patients from ineffective or harmful drugs. Therefore, failure to comply with GMP standards could result in severe consequences. For example, the SFDA might recall products, apply fines, cancel the GMP license, or even prosecute in some cases.

The abbreviation cGMP might also be used as an alternative to GMP. The letter C stands for “current.” Manufacturers must comply with up-to-date regulations by employing the latest technologies and machinery.

SFDA Drug Manufacturer Registration

SFDA incorporates the manufacturer registration process within the drug application review. It is a parallel registration process in which the manufacturer’s GMP inspection, file assessment, and approval are integrated into the evaluation of the drug product. Therefore, the GMP granting will follow the same timeframe as the SFDA drug registration.

The SFDA inspection team will request a site visit to conduct a thorough GMP evaluation of the related production lines while they are operating. Manufacturing sites should expect 3 to 5 days of stringent assessment that generates considerable notes to respond to after the inspection.

However, not all manufacturing sites must be visited. The authority will make a risk-based assessment to determine the need for the GMP visit.

Additionally, manufacturer registration and related GMP inspections can occur during a drug variation, such as when the MAH adds a new manufacturing site to the drug application.

Finally, the inspection, evaluation report, and issuance of the SFDA GMP certificate will all be finalised before the end of the product review.