MHRA publish GxP flexibilities for maintenance and calibration during COVID-19 outbreak
The MHRA has published guidance in regards to allowing some alternative courses of action for manufacturing or laboratory equipment maintenance and calibration during the COVID-19 outbreak.
This includes clear guidance on measures to take:
How can Biomap help?
Biomap engineers remain available to attend sites where calibration is required. We have added additional Health & Safety Risk Assessments for every site visit, which includes considerations of social distancing and PPE to reduce potential exposure to all personnel where possible.
For clients wishing to avoid engineer visits, we can offer tailored plans to calibrate equipment back at the Biomap facility (where possible) or provide support with Risk Assessments for postponements. Also, we can provide calibrated hardware to cover areas monitored by expiring equipment.
Contact us for further information – info@biomap.co.uk
See full MHRA release:
Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak – https://bit.ly/2WN1u5v
MHRA publishes GDP flexibilities for Qualification & Validation work during COVID-19 outbreak
The MHRA has published guidance concerning some flexibilities in Good Distribution Practice during the COVID-19 pandemic. This includes some exceptional allowances within the supply chain, transportation, and storage. One particular area is regarding the benefit of retrospective Qualification and Validation work but must be carefully recorded and supported by a risk assessment.
“Storage and distribution equipment may be used with limited qualification and validation to allow equipment to be used as soon as possible. This should be supported by a risk assessment and additional mitigating measures where necessary. Remaining qualification and validation work should be completed retrospectively, with delay minimised as much as possible”
How can Biomap help?
Biomap can support the Risk Assessment process if projects need to be postponed, and retrospective validation will be carried out later on due to the pandemic. We can assist with collating the required information and presenting it in the correct formats. For example:
Alternatively, Biomap can also offer a range of remote qualification kits for clients to continue to execute their validation schedules as planned (without the need of an engineer on site) https://biomap.co.uk/covid19-remote-validation-service/
Contact us for further information – info@biomap.co.uk
See full MHRA release: “Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak”: https://bit.ly/2YBuNch
Biomap will be exhibiting at the 2nd Pharma Logistics Day in Basel, Switzerland, on Wednesday of 25th September this year.
This year’s event is being held in parallel to ILMAC (24-27 September) at Messe Basel. The one-day event is being staged in Hall 2.0. It has been relocated to Basel in order to better exploit synergies, strengthen the Pharma Logistics Day and expand ILMAC.
Come and see us on the day, by buying a ticket from the official site.
Our Director, Kane Edgeworth, spoke at this year’s GDP for beginners seminar on the 4th – 5th February in Prague.
At the seminar, experienced speakers shared their expert knowledge about all relevant aspects regarding the current GMP and GDP requirements and current developments in storage, transportation and Cold Chain Management of medicinal products. Attendees learned how these requirements evolve and how they can be implemented efficiently.
Kane will be presented on Temperature Mapping (Warehouse, Cold Storage & Vehicle Studies) including protocol preparation, consideration of seasonal variations & impact tests as well as results and final reporting.
Further details on all the speakers and the full programme, visit ECA Academy.
Alternatively, download the conference overview.