17/18 April 2024
The Guideline of Good Storage and Distribution Practices (GSDP) of the Saudi Food & Drug Authority (SFDA) was issued in 2014. Recently, a translation into English was published.
The GSDP rules defined in this Guideline are pretty close to the ones in the EU. Also a "qualified person" is required "for ensuring that a quality system is implemented and maintained" (6.3). Pharmaceutical products under quarantine will require release for dispatch by this person. However for other tasks, it is not clearly stated that this "qualified person" has the sole responsibility.
When it comes to a recall, designated person(s) are responsible. The same when it comes to the handling of returned products: "The necessary assessment and decision regarding the disposition of such products must be made by a suitably authorized person". Also "Self-inspections should be conducted in an independent and detailed report by a designated, competent person."
It is assumable that the "qualified person" described in chapter 6.3. will also take care of these tasks and responsibilities but it is not necessarily required.
The "Terms and Requirements of Good Storage for Third Parties" were issued in 2015 and are now also available in English. They are basically defining terms and conditions to be considered in the Contract between different parties and the respective liability.
Another interesting document is the "Guidance for the Storage and Transport of time- and temperature-sensitive pharmaceutical Products". This 46 page document sets out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSPPs). They are based upon existing regulations and best practice guidance from a wide range of international sources. But they are mainly adapted from WHO Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products.