Speaker in this video:
Mr Vidwans Rajendra Ramachandra, Senior Consultant – GMP, QA, in Sterile, Non-sterile dosage forms, GAP & Consultant, Ami Polymer
Topic: Audit observations in injectable dosage forms
Key Highlights:
[1] Standard Operating Procedures are overly brief and vague. They fail to provide sufficient guidance for consistent execution of critical processes
[2] Though alarms are defined in SOPs, there is a failure to monitor or respond to them, undermining real-time quality control and risk management
[3] The ‘Data Integrity Program’ SOP lacks essential details such as responsibilities, frequency, and procedures for audit trail reviews, jeopardising data reliability and compliance.
[4] OOS investigations were often not completed, lacking depth or proper root cause analysis, which weakens the overall quality system