Dealing with Warehouse Logistics Audit Failures in the Pharmaceutical Industry

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In this discussion, we will be focusing on dealing with audit failures and the top reasons why pharma manufacturers, logistics firms, and warehouse firms fail audits. We will also discuss the top 10 GMP audit citations from FDA and TGA inspections.

  1. Dealing with Audit Failures Interviewer: What should be done when a pharma manufacturer, logistics firm, or warehouse firm fails an audit? Brij Suri: When a company fails an audit, they should assess the audit findings and take corrective actions to address any issues identified. This may involve implementing new processes, procedures, or training to ensure compliance with GMP regulations. The company should also follow up with the auditor to demonstrate that corrective actions have been taken.
  2. Top 10 GMP Audit Citations: FDA & TGA Inspections
  1. Interviewer: What are the top 10 GMP audit citations from FDA and TGA inspections? Brij Suri: The top 10 GMP audit citations from FDA and TGA inspections include inadequate validation of processes, inadequate documentation, inadequate training of personnel, inadequate cleanliness and sanitation, inadequate controls for environmental conditions, inadequate controls for materials and components, inadequate equipment design and maintenance, inadequate complaint handling procedures, inadequate change control procedures, and inadequate deviation handling procedures.
  • Top Five Reasons Pharma Manufacturers Fail Audits
  1. Interviewer: What are the top five reasons pharma manufacturers fail audits? Brij Suri: The top five reasons pharma manufacturers fail audits include inadequate process validation, inadequate documentation, inadequate training of personnel, inadequate cleanliness and sanitation, and inadequate controls for materials and components.
  • Top Five Reasons Pharma Logistics Firms Fail Audits
  1. Interviewer: What are the top five reasons pharma logistics firms fail audits? Brij Suri: The top five reasons pharma logistics firms fail audits include inadequate temperature control, inadequate shipping documentation, inadequate training of personnel, inadequate cleanliness and sanitation, and inadequate security.
  • Top Five Reasons Pharma Warehouse Firms Fail Audits
  1. Interviewer: What are the top five reasons pharma warehouse firms fail audits? Brij Suri: The top five reasons pharma warehouse firms fail audits include inadequate temperature control, inadequate documentation, inadequate training of personnel, inadequate cleanliness and sanitation, and inadequate controls for materials and components.

 

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