Our Quality Assurance

At BAP Pharma we have implemented (and continue to maintain) a robust quality management system. This ensures we can deliver all our operations to our exacting standards. Our bespoke quality management system has been designed to support the complexities of supply chains, ensuring we always provide the best possible service to our clients.

 

BAP Pharma UK Operations

BAP Pharma are fully certified and authorised.

Firstly, our operations have been authorised by the MHRA for both GMP & GDP activities, enabling us to operate in a fully licensed manner. In addition, we also hold a Home Office Controlled Drugs Licence (Schedules 1 to 5). This ensures we can handle controlled drugs in a safe and compliant manner. Furthermore, we have an Investigational Medicinal Product (IMP) licence which allows us to import products from outside the EU.

The UK Operation holds the following authorisations: –

  • Manufacturers Import Authorisation MIA(IMP)
  • Wholesale Dealers Authorisation WDA(H)
  • UK Home Office Controlled Drugs Licence (Schedules 1 to 5)
  • ISO9001:2015

 

BAP Pharma US Operations

The BAP Pharma US operations are fully licensed by the New Jersey Department of Health to carry out procurement, storage, and distribution of comparator products.

In addition, we also hold the following authorisation:

  • Drug and Medical Device Certificate of Registration from the New Jersey Department of Health Consumer and Environmental Health Service
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Product Suppliers and Transport Service Providers

At BAP Pharma, we have a rigorous supplier qualification process which is fully documented within our bespoke Quality Management System. The qualification is carried out across multiple phases, which include an on-site inspection as necessary.

In addition, all our suppliers are periodically reviewed to ensure they remain compliant not only to regulatory requirements, but also to BAP Pharma’s exacting standards.

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Documentation

At BAP Pharma, our bespoke Quality Management System has been harmonised across both the UK and US operations.

To guarantee quality and transparency in all our operations, we have Standard Operating Procedures (SOPs) in place for all elements across both operations.

A Registered Responsible Person (RP) oversees all BAP Pharma activities with a full Recall Procedure. Furthermore, in adherence with requirements, we have a Qualified Person (QP) to oversee operations.

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