© CMBarnett Pharma Services Ltd 2008-2011
- Do the Quality Systems of the manufacturers meet regulatory expectations?
- Does this cover all markets?
- Will you need to help a manufacturer prepare for a Regulatory Inspection?
- What is the relationship like with the Regulatory Authorities?
- What do the Product Quality Reviews tell you?
- What is the complaints record like?
- Has the product ever had to be recalled?
- Have there ever been any quality “near misses”?
Management Team and Structure
- Are the right people in place, and will they continue to be in place for
- Are they properly trained, and is this adequately recorded?
Buildings and Equipment
- Are they properly designed and constructed?
- Are they qualified and properly maintained?
- Are IT systems secure and fit for purpose?
- Are all relevant systems validated according to regulatory expectations?
- Will you inherit any potential future Health, Safety or environmental