Effective Pharmaceutical GMP Audits and Self-Inspections

Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. FDA and other regulators have contributed to and endorsed ICH Q10, Pharmaceutical Quality System, which explicitly recommends audits as a key element in the review of process performance and product quality, as well as, in the management of outsourced activities and purchased materials.

Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regulations before an FDA audit occurs. There are several problems with this approach, however. The auditors may not fully understand the regulations and may not have been trained in audit techniques. Another impediment is that an internal auditor is monitoring his/her friends. It is very difficult to point out errors committed by a friend since calling attention to a lack of compliance may be interpreted as “telling on” the friend and possibly causing a problem for them.

This webinar will provide you with the knowledge, understanding, skills, and confidence to audit all aspects of pharmaceutical manufacture and control, whilst retaining the cooperation and respect of the other auditors.

Understand the GMP context for pharmaceutical quality system lead auditors

• Plan, conducted, reported, and follow up on an audit of a GMP PQS
• Provide guidance for auditors of suppliers, contractors, CMO service providers, outsourced activities and self-inspectors
• Drive continuous improvement of systems and processes
• Drive continuous improvement of auditors and audit systems

Principles and Audit Planning

• Planning and preparation
• Audit types and techniques
• Internal vs. external audits
• The audit processes

Auditor Skills and Competencies

• What makes a good auditor
• Managing audits

Initiating, Preparing, and Conducting the Audit

• Materials management
• Documentation systems
• Pharmaceutical quality systems

• Quality Assurance
• Logistics, Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Regulatory and Compliance Management
• VPs of manufacturing or Quality
• Contract manufacturing organizations
• API suppliers, Excipient suppliers
• Packing component suppliers
• Service providers