In its Inspectorate Blog the MHRA published a post on temporary changes in Good Distribution Practice (GDP) entitled “How to manage temporary GDP process changes and risks through the COVID-19 pandemic“.
The MHRA also published a Guidance on “Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak”. The guidance contains a list of temporary regulatory flexibilities that will be allowed to address the current exceptional circumstances.
In addition, the post published in the MHRA Inspectorate Blog points out once again that during the Covid-19 pandemic, it might be necessary to adjust how companies operate, e.g. using temporary process deviations and temporary staff. “Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles as described in the EU Guidelines on Good Distribution Practice for finished products. The ultimate aim should be to ensure the medicines provided to patients remain safe and effective and the integrity of the supply chain is maintained.”
The following areas are covered:
- Supply chain
- Responsible Person (RP)
- Facilities and equipment
For example, “non-temperature-controlled transport may be used when the ambient temperature is less than 20 °C”. Furthermore, Responsible Persons (RP) “may act as RP for another company within the same group of companies without variation, provided they have an RP registration number issued by MHRA.” Concerning facilities and equipment, “storage and distribution equipment may be used with limited qualification and validation to allow equipment to be used as soon as possible.” Wholesalers who want to use the flexibilities should record the decision with a brief explanation of why this was necessary. To make use of the regulatory flexibilities does not require prior approval but must, however, be reported to MHRA.