As part of a new programme aimed at sharing expertise with clients and industry partners, our team is putting together a series of guides to help you plan and optimise your drug development projects.
Each guide will quite simply include 10 top tips and is aimed at providing you with some insights based on our experience. At worst, they will just give you a mini checklist to ensure you’ve covered the main areas.
We kick things off with our guide to preparing and implementing a new development GMP campaign. We hope you’ll find it of use and feel free to add your own views at the bottom!
- Check your supplier has full regulatory approval (e.g. MHRA GMP certificate)
- Certify they comply with ICHQ7A and EUGMP guidelines
- Make sure the company has direct expertise and relevant experience in dealing with GMP projects
- Verify they have a track record in GMP
- Ensure they have suitable support services such as QC, Stability, Solid State, etc
- Audit the firm yourself in advance of any project and meet their team
- Confirm the QA manager is independent of production
- Make sure suitable analytical methods are validated
- Ensure you check batch procedures and records in advance
- Select a partner that has an organisational culture that matches yours