Qualified Person (QP) & Responsible Person (RP) Services
Companies that intend to manufacture, import, sell or distribute pharmaceutical products in the EU require a MIA license and a designated Qualified Person (QP) and Responsible Person (RP), to oversee the product quality throughout the quality assurance (QA) process. Acting as an extension to your organisation, our QA consultants bring a deep understanding of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) processes. They work with your team to ensure compliant manufacturing and distribution of products.
Pharmareg have access to a panel of highly experienced QPs and RPs with knowledge of a wide range of dosage forms and processes such as:
- Wholesale Dealers Authorisations (WDA / WDL)
- Manufacturers Import Authorisations (MIA)
- Cold Chain / Controlled Drugs
- Support for clinical trail and post marketed products
- Active Pharmaceutical Ingredient (API) Audits performed by an EU Qualified Person – QP
- Excipient Manufacturers
- Packaging Vendors and partners
- Contract Manufacturing Organisations (CMO’s) including sterile and non sterlile facilities
- Storage and Distribution Facilities
- Our team of experienced QPs can act as contractors named on your Manufacturers Import Authorisation to facilitate release of products to market.
- Batch review
- Deviation investigation report
- Change Management
- Technology Transfers
- Generation of Technical Agremeents Templates
- QA/QP review of technical agreements
- Vendor Management Schedules
- Ad-Hoc QP Consultancy Support
- Quality Defects and Recalls including CAPA generation
- Gap assessments
- Support with new or impending regulatory updates
- Full development of a Quality Management System (QMS) bespoke to company requirements
- Development of Site Master Files (SMFs) and Quality Manuals (QM’s)
- Development of Standard Operating Procedures (SOPs)
- Performing Internal/External Audits and self-inspections
- Performing “mock” regulatory inspections and support and training in the inspection readiness process
- Our RPs are approved by the MHRA to act as a Contract Responsible Person for Wholesale Distribution of Medicines the UK and are also registered as Pharmacists with the GPhC.
- Our Contract Responsible Person will be named on your existing Wholesale Dealers Licence. A Technical Agreement can be drawn up between both party’s and will outline the duties of each organisation including the roles and responsibilities of the Contract Responsible Person.
- Performing internal pharmacovigilance audits
- Performing GAP assessments
- ‘Mock’ inspections