Pharmaceutical Remote Audit Process

When access to your supplier’s facilities is limited or not permitted, how can you assure yourself of the quality standards in operation to provide continuity of supply of medicinal products, while meeting regulatory requirements and protecting the patient?

Using our network of international GMP experts, e-rooms and videoconferencing, NSF has developed a four-step approach to allow for remote and virtual GMP auditing which helps you to unlock supply chains and meet cGMP needs in clinical trial supply or routine commercial operations. This hybrid risk-based approach will help provide interim or conditional approval of facilities during periods of uncertainty or governmental restrictions.

Our approach can be applied to manufacturers of raw materials, GMP components, drug substances and drug products for key services including packaging, QC laboratories, warehousing, distribution and pharmacovigilance along with outsourced activities such as technical support, engineering contractors and QC release/stability testing.

Step 1: Risk Assessment

Risk assessment of the operation to determine if a remote audit is feasible and justifiable to enable interim approval of your supplier, CMO or partner. Use the risk-based assessment checklist below for guidance.

Example Key Areas

• Site activities
• Regulatory oversight
• Licenses/registrations
• Inspection history
• Recalls
• Product/material assessment
  

Step 2: Remote Review of PQS

Remote review of the pharma quality system by expert evaluation of the supplier’s key policies and procedures against internationally recognized quality and cGMP expectations.

Example Key Areas

• Site master file
• Management oversight
• Management review
• Product review
• Quality risk management
• Investigation processes
• Supplier management
• Contamination control

Step 3: Remote Audit

Remote review and video conferencing session with subject matter experts to evaluate the evidence of implementation of the key policies and procedures.

Example Key Areas

• Batch records
• PQR reports
• Investigation reports
• Quality agreements
• Audit schedule adherence
• Contamination control strategy
• Virtual facility tour

Reporting

After steps 2 and 3, the NSF expert will prepare a detailed written report of findings and recommendations with an aim of allowing interim approval where justified and warranted.

CAPA Review

Where observations have been raised, the NSF expert will review the responses, CAPA plans and effectiveness checks to ensure they are appropriate.

Step 4: On-Site Assessment

Delivery of an on-site audit, to complete the formal GMP assessment. This can be an abbreviated review, given the comprehensive nature of steps 2 and 3.

Example Key Areas

• Physical observation of the facility to ensure appropriate, design, maintenance, hygiene and compliance to GMP
• Site culture
• Follow-up on evidence and CAPA plan implementation