SFDA GMP: Manufacturer Registration in Saudi Arabia

During the SFDA registration of pharmaceutical products in Saudi Arabia, the manufacturers will undergo an SFDA GMP inspection. The sites that pass and able to close all the quality findings will receive a certificate of Good Manufacturing practices (GMP) from the Saudi FDA.

The GMP is the implementation of proactive quality measures to ensure the safety and efficacy of drugs and other products. It is a quality system that encompasses all production details from starting materials, premises, and equipment to staff training and personal hygiene. Detailed quality procedures are required for each process with documentation that proves it is consistently implemented.

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

The abbreviation cGMP might be also used as an alternative to GMP, the letter C stands for “current”. It means manufacturers have to 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. Meaning, that it is a parallel registration where manufacturer GMP inspection, files assessment, and approval are part of the drug product evaluation process.

The SFDA inspection team will request a site visit to perform a thorough GMP evaluation on the 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.

Finally, the inspection, evaluation report, and the issue of the SFDA GMP certificate are all will be finalized before the end of the product review.

SFDA GMP Registration Requirements

Manufacturers need to submit the following documents ahead of the SFDA GMP visit:

  • Site Master File (SMF)
  • GMP Audit reports from local and international agencies.
  • List of marketed drugs or intended to be marketed in Saudi Arabia.
  • Payment of the SFDA fees.

What type of manufacturers requires GMP?

It is required in Saudi for the manufacturers that produce the following types of products:

  • Pharmaceuticals
  • Biologicals
  • Health products
  • Herbal products
  • Supplements (not all, criteria are applied)
  • Cosmetics (Not all, criteria are applied)

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