GDP Inspection Preparation
Are you ready for your MHRA inspection? GDP Inspection Preparation.
We believe all Wholesale Distribution Licence holders should be inspection ready at all times.
Most organisations are ill-prepared due to poor time management, procrastination, lack of knowledge and taking on too much work without building organisational capacity.
MHRA Inspections should be a breeze if you keep your records up to date.
Since 2009, the MHRA has been taking a risk based approach when it considers the frequency of inspections and therefore predicting a visit has become a little bit more complex.
The MHRA uses a complex algorithm with the data collected from various sources and this is what drives the prioritisation and frequency of future inspections.
It is considered that risk-based inspections are dependent upon the regulated organisation taking responsibility for compliance with the regulations. While the company or organisation has always had legal responsibility for compliance, the notice of inspection has for some been a trigger for compliance assessment instead of a continuous compliance programme being in place.(MHRA)
The type of data considered by the MHRA includes:
- Responsible Person turnover
- Complexity of the business model
- Result of the last inspection
- Customer and supplier complaints, and
- Whistleblowing GDP Inspection Preparation
Extra visits Cost Money and Add Risk
Poor compliance with the Good Distribution Practice guidelines can trigger further unnecessary inspections which can be costly.GDP Inspection Preparation.
MHRA – Full Day Rate (2015) £1936
It is not uncommon to see non-compliance in the following critical areas:
- Poor Quality System in place
- Missing or inadequate SOPs
- Inadequate bona-fide checks
- Poor temperature mapping and / or monitoring
- Missing SOPS
- Failure to carry out self inspections
- Inadequate training (RP and staff)
The above list is not exhaustive.
How Pharma Experts can help
Our GDP Inspection preparation audit helps take the strain out of preparing for the big day.
Our overarching aim is to support you through the process and ensure you maintain your WDL status and your GDP certification.
Our standard GDP Inspection Preparation audit focuses on:
- GAP analysis of your Quality System against the EU Good Distribution Practice guidelines
- Development of a organisation specific action plan
Optional elements which may be commisioned include:
- Quality Risk Assessment
- Review and preparation of any missing Standard Operating Procedures
- Backroom organisation and preparation (retrieval of documentation)
- Front room preparation including coaching with Q&A sessions
- Mock inspection visit
- GDP and RP training
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.