CRED Managing Variations Effectively

Reducing Post-Approval Regulatory Burden….Some top tips ● Avoid unnecessary levels of detail or use flexible wording when describing e.g: – Manufacturing process – Apparatus – Methods of analysis ● Avoid repeat of information in different files, to avoid need to maintain several sections, which increase chances of missing updates resulting in inconsistencies in the file ● Avoid GMP type info: e.g. testing of incoming drug substance at DP site, stability protocols for annual testing of GMP batches ● You should include any aspect which may impact on Quality, Safety or Efficacy