We perform supplier audits as well as internal audits against most recognised pharmaceutical standards. We use specialist sector-specific auditors as needed, including experience IT/ Computer System auditors.
We help get sites ready for Regulatory and Corporate inspections, including working with groups to get their own areas ready. We can also assist behind the scene during the inspection itself.
Not all audits go well, and we can help get sites that have had poor inspections back on their feet.
Qualified Person release
Many of our consultants are eligible to act as Qualified Persons (QPs), and so we can provide locum QP support when needed.
Recent projects have included:
Selecting possible new manufacturing site in Asia
- 5 sites in Malaysia were identified as possible manufacturing sites for a new medicinal product.
- All were audited to GMP (to look for compliance), suitable technology transfer skills and the ability to supply product on time.
- A short list was created and on-going partnership discussions continue.
Selecting possible supplier of an Active Pharmaceutical Ingredient
- A number of potential sites in Asia were identified.
- All were audited to API GMP.
- A short list was created and business discussions continue.
Support for development of European QA Managers
- A number of new QA Managers at Country Business Units (Affiliates) around Europe have been supported over the past 5 years.
- Many were new to GMP.
- Included audits of their offices and gap analysis against company requirements.
- Followed by support and ongoing training and development.
- QA Managers now have a much greater appreciation of the rules and regulations of EU GMP.
If you would like to find out more please send an email with your details and we will be in touch.