SFDA GMP: Manufacturer registration Process

To market pharmaceutical products in Saudi Arabia, SFDA requires manufacturers to adhere to Good Manufacturing Practice (GMP). It is basically the implementation of proactive quality measures to ensure the safety and efficacy of drugs and other products.

Quality manufacturing eliminates or minimizes the chances of contamination and errors to protect the patient 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.

GMP might be referred to by cGMP which stands for “current”. It means manufacturers have to comply with up to date regulations by employing the latest technologies and machinery.

GMP 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.

How to register a drug manufacturer in SFDA?

SFDA incorporates the drug manufacturer registration into the drug registration process. Meaning, it is a parallel registration where manufacturer assessment is being performed with the product evaluation at the same time.

The SFDA inspection team will request a site visit where a thorough evaluation of GMP implementation will take place in addition to inspecting the production line while in action.

Sites should expect 3 days of stringent assessment of every part and procedure in the site with many 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 manufacturer inspection, evaluation inquiries, and the issue of SFDA GMP certificate are all normally 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 inspection fees which ranges from SAR 33,000 ($8800) to SAR 184,000 ($49,066.6).

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