Compliance and Quality

The Compliance and Quality department provide comprehensive services including QP led auditing, batch release services, establishment of quality management systems, vendor qualification and supply chain compliance activities.

 

Qualified and Responsible Person Services

We offer a range of Qualified Person and Responsible Person services to meet the compliance needs for products across the product lifecycle. Our services include:

  • Provision of contract QP services in compliance with EU Directives for the manufacture and release of finished pharmaceuticals and GMP
  • QP services for the batch release of IMPs for clinical trial
  • Provision of contract RP services in compliance with EU Directives for the wholesaling of medicinal products and GDP
  • RP services for quality defects and product recalls of your Marketing Authorisation (MA) applications.
 

Product Lifecycle Management

Our QPs provide support throughout the lifecycle for a product by evaluating and leading in the management of third party vendors, internal quality practices, and overall validation activities. Our services include:

  • Supply chain compliance
  • Vendor auditing and evaluation
  • Quality validation activities
  • Supply chain compliance quality training
  • MAA compliance
 

Audits and Inspections

Our team of QPs and QA professionals are experts in leading Audits and Inspections. Our QPs have a long history in providing global coverage for compliance surveillance to ensure that manufacturing sites are meeting expectations for the entry of products into the EU. Our services include:

  • QP led audits and inspections
  • Inspection preparedness
  • Quality systems auditing and review
  • Computer system audits
  • General cGMP compliance audits
  • MAA compliance audits
Case Study

Compliance And Quality Division

Diamond Pharma Services offers GMP and GDP compliance services from clinical development to commercial distribution of the products’ lifecycle.