Did you attend the MHRA update talk which included the top deficiencies seen in WDA inspections at Making and Distributing Pharmaceuticals?
This was our first year attending with our own stand and we were delighted with the response and the networking opportunities, with the added benefit of growing our CPD.
The MHRA outlined the GDP Inspection Deficiency data for 2025/2026 at the show, which I wanted to share with you. The Top 5 are as follows –
- Documentation and Records (4.2)
- Quality Management System (1.2)
- Quality Risk Management (1.5)
- Outsourced Activities (7.2)
- Transportation of Medicinal Products (9.2)
When did you last review your QMS, is it effective, has anything changed recently that needs to be reflected in your QMS.
When did you last review your Risk Assessments do they cover the licence activities and product scope.
Do you have outsourced activities, are they defined in your QMS and have a Technical Agreement in place, to make sure responsibilities of all parties are detailed and clear.
When did you last validate your transport routes, to make sure products remain within the required conditions.
The show was a great opportunity to enhance our knowledge and review procedures in place to make sure we continue to provide our customers with an exceptional service.
Pharmacy Consulting can help with all aspects of the QMS, would you be ready for an inspection if it was called tomorrow. Have you considered booking a benchmark audit to ensure you are inspection ready and identify your gaps? Please get in touch if you would like to discuss further how Pharmacy Consulting Ltd can support your business and keep you compliant.