7 September 2022
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document to clarify the interpretation of the new EU Good Distribution Practice (GDP) Guideline. The document should be read alongside with the GDP Guide for better understanding.
In the following we have summarized a few points from the MHRA document:
Chapter 3.3. Equipment
The EU GDP Guide provides a very general definition that all equipment impacting storage and distribution of medicinal products should be designed, located and maintained to a standard which suits its intended purpose.
The MHRA has made concrete statements to this point: "Temperature should be recorded in degrees Celsius. Any temperature monitoring equipment should have a resolution of 0.1degree Celsius (C) and the calibrated accuracy of the equipment should be +/- 0.5 C for cold stores, refrigerators and controlled temperature environments. For temperate areas, a calibration accuracy of +/- 1.0 C is acceptable."
Chapter 5.2. Qualification of suppliers
Paragraph 3 of the EU GDP Guidelines covers the situation when medicinal products are obtained from another wholesale distributor. Here, the MHRA recommends: "To check if a supplier complies with GDP, a company should obtain a GDP certificate where available. - Check the Eudra GMDP date base, (this will take a full inspection cycle to fully populate) or otherwise verify compliance by way of requesting evidence of a satisfactory regulatory inspection outcome."
Chapter 9.1. Principles (Transportation)
The EU GDP Guide states that it is the responsibility of the supplying wholesale distributor to ensure that temperature conditions are maintained within acceptable limits during transport. The MHRA clarifies the words 'acceptable limits' to be interpreted as the storage temperature parameters as stated on the labels of the medicines being transported.
Chapter 9.2. Transportation
This chapter has caused some intensive discussion within the industry because it was not clear when a hub or delivery point should fully comply with the GDP Guide. The MHRA clearly states: "where a hub or delivery point has a refrigerator for the storage of medicinal product, the site should be named on a WDA and be under full GDP control." Moreover, the MHRA gives a concrete number of hours when storage facility is still considered to be a "temporary storage". This is the case if storage doesn't exceed 36 hours.
Whilst this is UK MHRA's interpretation of the new GDP document, we suppose that other member state authorities will have a similar understanding of the requirements. We will endeavor to bring you any information published by the authorities in this subject.
In a second document published on the MHRA webpage, information is provided regarding cases if returns of non defective ambient and refrigerated (2c - 8c) medicinal products take place.