GDP and QMS Consultancy

Laing Pharma is a member of the Chartered Quality Institute (CQI) and specialises in QMS project and Good Distribution Practise (GDP) under the provisions of the EU GDP Guidelines (2013/C 343/01). We can work with you to improve your QMS and in turn the operational efficiency of your site. 

An effective Quality Management System (QMS) is critical to ensuring your GDP and regulatory compliance. It must lay out all your processes and procedures, personnel, operations, outsourced activities, such as transport, and even your equipment. Failures in Quality System are common, and they were the number one deficiency reported by the MHRA during GDP inspections with over 20% of majors relating directly to it. At Laing Pharma, we understand that building an effective QMS can be daunting, especially when combining it with the difficult balance of ensuring all boxes are ticked for compliance whilst maintaining an efficient operational activity. We aim to make building your QMS and compliance as easy as possible, ensuring procedures are in place that are right for your business and not just there regardless of your business model. Gaps in 

We can visit your site, or work with you remotely, to assist you with your Quality System and compliance to the Good Distribution Practice guidelines and MHRA regulations. We offer a variety of services that include:

- Audits

- Bespoke SOP

- Bespoke Quality Manual

- GDP training plans for personnel

- MHRA inspection preparation

- MHRA inspection remediations, including NOPS responses 

- Quality system and GDP gap analysis

- Contract RP's

Contact us to discuss your requirements and to see what service is right for you.