FAQs

 

We always try and provide advice against the latest regulatory requirements.

We also cover current topics in our Blogs but if you have any other questions please use the Contact Form and we will be happy to help.

Do you conduct GDP audits and pre-inspection audits?

Yes! We provide Audits for:

  • Pre-inspection review of your site and processes

  • Contractor audits

  • Full GDP audits of your site and processes

  • Third party site audits

  • Supplier audits

Contact us for more information.

Can you help with SOPs?

As part of our services we can provide advice and guidance to help you design and implement effective SOPs. We can also provide templates and help you design your SOPs from the ground up.

Obtaining a WDA?

If your business is looking to obtain a WDA and you need any advice or support in this respect, we can help. From application to inspection and through to retention and re-inspection we have a number of solutions to enable the optimisation of this process.

Who needs GDP training?

Everyone working in the pharmaceutical wholesale environment needs to be aware of GDP to a lesser or greater extent, depending on their role. We provide bespoke training to suit your business for anyone from operational staff through to senior management. We also offer extensive and bespoke RP training. We also offer training on a range of more specific topics such as Quality Risk Management, Root Cause Analysis or Effective Transport Provision. Please Contact us to discuss your needs.

Can you provide RP/RPi services?

Yes! We offer contract RP/RPi services.

A contract RP/RPi is generally not based onsite full-time. The contracted RP/RPi has oversight and responsibility for Good Distribution Practice within the wholesale operation, as well any interactions or approvals of third parties that the licence holder deals with.

Peter and Claire are very highly experienced and can act effectively as an RP/RPi in any size or type of WDA holder currently operating in the UK.
Please Contact us for an informal discussion.

Who are the MHRA?

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA is an executive agency of the Department of Health and Social Care.

The MHRA has three centres:

  • The Clinical Practice Research Datalink (CPRD), a data research service that aims to improve public health by using anonymised NHS clinical data;

  • The National Institute for Biological Standards and Control (NIBSC), a global leader in the standardisation and control of biological medicines; and

  • The MHRA, the UK’s regulator of medicines, medical devices and blood components for transfusion, responsible for ensuring their safety, quality and effectiveness.

The agency is responsible for:

  • ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy;

  • ensuring that the supply chain for medicines, medical devices and blood components is safe and secure;

  • promoting international standardisation and harmonisation to assure the effectiveness and safety of biological medicines;

  • helping to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use;

  • supporting innovation and research and development that’s beneficial to public health; and

  • influencing UK, EU and international regulatory frameworks so that they’re risk-proportionate and effective at protecting public health.

What is GDP?

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.

Compliance with GDP ensures that:

  • medicines in the supply chain are authorised in accordance with European Union (EU) legislation;

  • medicines are stored in the right conditions at all times, including during transportation;

  • contamination by or of other products is avoided;

  • an adequate turnover of stored medicines takes place;

  • the right products reach the right addressee within a satisfactory time period.

The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.

GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients and other ingredients used in the production of the medicines.

What is a QMS?

A QMS is a Quality Management System. In GDP terms, it is the combination of your people, process, facilities, equipment and IT, not just a set of SOPs. Maintaining an effective QMS keeps you on the right side of compliance. It should tie in all the aspects of GDP in your business and allow you to effectively trend your compliance and effect change as a result. MHRA Inspectors will always be mindful of a well implemented QMS.

We offer a QMS design and Audit service. if you need more information or would like to discuss this service please contact us.

What is EUDRA?

Do you deal with European suppliers or customers? if so you will need to check EUDRAGMDP. Eudra is the European repository of licences and (non) compliance certificates for manufacturers and wholesale dealers.

It is an extremely useful tool for checking bona fide status.

What is customer/supplier qualification?

As a WDA holder you are required to carry out qualification checks on your suppliers and customers. This is to ensure that they are operating safely and in accordance with regulations and to maintain the legal supply chain. This involves you carrying out your due-diligence checks. There are main three steps to effectively qualifying suppliers and customers:

  • Authorised supplier/customer holds a manufacturing or wholesale dealers licence or is otherwise entitled to receive medicinal products

  • Authorised supplier/customer complies with GDP (GDP certificate available)

  • Due diligence checks (including evaluation of on-site audits, where applicable)

For more information check our blogs.