Contract RP's

Issues with a Licence Holder's RP resulted in the third most common reason for Major deficiencies in MHRA GDP inspections, with this reportly increasing year on year. The role of the RP is complex and it is no longer sufficient to just have the licence holder or another member of the team named as RP if they are not sufficiently qualified and meet the conditions provided for by the MHRA which include adequate experience within the GDP environment alongside full training. At Laing Pharma, our experienced RP's are fully trained with comprehensive CPD and training records, alongside up to date industry and regulatory knowlegde. As members of the CQI (Chartered Quality Institute) at Practioner level, we put quality at the forefront of our operation. 

The cost of hiring a full-time RP is prohibitive to many Pharmaceutical Wholesalers and typically once a solid QMS is in place, it would not be a full-time role for smaller sites. The benefits of using our Contract RP's is that we can join you for short or long-term projects, and can work with you to ensure your Quality System is where it should be, not only improving your compliance but also your operational efficiency which in turn will improve your business margins. During our time with you, we will work with a Deputy RP from your team and assist in their training to become an offical RP, meaning you can bring the role in house once again and that they can perform the role successfully alongside their day to day role, whilst being confident that they will pass the MHRA inspection. 

Under the GDP guidelines (2013/C 343/01), the responsibilities of the Laing Pharma Conract RP include:

Ensuring that a quality management system is implemented and maintained 

Focusing on the management of authorised activities and the accuracy and quality of records 

Ensuring that initial and continuous training programmes are implemented and maintained 

Coordinating and promptly performing any recall operations for medicinal products - a bespoke 

Ensuring that relevant customer complaints are dealt with effectively; 

Ensuring that suppliers and customers are approved; 

Approving any subcontracted activities which may impact on GDP; 

Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place; 

Keeping appropriate records of any delegated duties; 

Deciding on the final disposition of returned, rejected, recalled or falsified products; 

Approving any returns to saleable stock; 

Ensuring that any additional requirements imposed on certain products by national law are adhered to. 

Additionally, a strong Quality Management System will be built so that once the role of the RP is taken back in-house, the Quality System can continue to work effectively and efficiently. 

laingpharma@gmail.com?subject=Contract%20RP" rel="">Contact us to discuss your requirements and to see if this service is right for you.