manufacture and distribution of medicine
Comprehensive Pharmaceutical GMP/GDP Quality System Services
The IPS team provide a range of support to your Quality Function. Outsourcing to the UK-based IPS team works very well for new pharmaceutical companies or storage and distribution facilities in urgent need of a Quality Function, looking after any GMP and GDP requirements.
For more established companies, we provide a temporary over-flow service. Our Regulatory Affairs consultants are on hand to provide any strategic support and to provide advice and assistance. This is particularly useful where workloads vary throughout the year. Excess work can be managed simply and effectively by enlisting the help of our team – on a weekly or monthly basis, as and when required.
Pharmaceutical Quality Assurance Services:
- Finished Product Batch Documentation Review (GMP).
- There is a fixed fee per batch reviewed for this service.
- GMP/GDP Quality Management System
- Preparation and review of Standard Operating Procedures pertaining to both GMP and GDP requirements
- Management of Product Technical Complaints
- Preparation of Annual Product Reviews/ Product Quality Reviews
- Implementation of site Risk Management Policy and its application
- Implementation of a Quality Management System for a virtual pharmaceutical company
- Handling Deviations and completion of CAPA reports
- Drafting and issuing Quality Technical Agreements
Pharmaceutical Regulatory Affairs Services:
- Regulatory NeeS submissions for MHRA portals
- Responsible Person Services for the Provisions of GDP (please see section on Responsible Person Services)
- Preparation of cover letters with CTD modules for Pharmaceutical medicines