The European Medicines Agency (EMA) has updated guidance on good manufacturing and distribution practices (GMP/GDP), adding questions and answers on the basic requirements for active substances used as starting materials.
 
EMA added two questions about third-party audit reports. In its first response, the agency clarified that manufacturers “may contract with third parties to undertake relevant audits.” The law supports the use of third parties because manufacturers may lack the expertise or resources to conduct their own audits.
 
The second response covers the content of the written final assessments of third-party audit reports. EMA said the qualified person is ultimately responsible for ensuring audit reports are “properly evaluated when the audit is performed by a third party.” The written final assessment text should provide a “comprehensible summary” of the evaluation and be readily shared with authorities.
 
EMA said assessments should include “all expected elements of the auditing process and audit report(s) identified before, during, and after the audit.” EMA emphasized certain elements that need to be covered.
 
“This includes verification of contractual arrangements, scope and appropriate duration of audit, adequate competence of auditors considering the scope of the audit, planned audit frequency, and CAPAs whether adequate and how these are to be followed up,” EMA said. “Any conflicts of interest identified should be discussed.​” [EMA Q&A - GMP]