About the Author: Regulatory Editor
During the SFDA drug registration in Saudi Arabia, the pharmaceutical manufacturers will undergo an SFDA inspection on Good Manufacturing Practices (GMP) standards. The ones that pass by closing all quality findings will receive a GMP certificate from the Saudi FDA.
Table of contents
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, premises, and equipment to staff training and 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. This means it is a parallel registration where manufacturer GMP inspection, file assessment, and approval are part of the drug product evaluation process. Therefore, the manufacturer will share the same SFDA timeframe.
The SFDA inspection team will request a site visit to perform a thorough GMP evaluation on the production lines while 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.
Also, manufacturer registration and related GMP inspection can occur during drug variation when the MAH adds a new manufacturing site to the drug application.
Finally, the inspection, evaluation report, and issue of the SFDA GMP certificate will all be finalized before the end of the product review.
SFDA GMP Requirements
In addition to the GMP inspection by SFDA, the manufacturers need to submit the following documents:
- Site Master File (SMF)
- GMP Audit reports from local and international agencies.
- List of manufactured drugs.
- Payment of the SFDA fees.
What type of manufacturers require GMP?
It is required in Saudi for the manufacturers that produce the following types of products:
- Pharmaceuticals
- Biologicals
- Health products
- Herbal products
- Supplements (Some, not all)
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