April 2020

· 5 min read

Pharmaceutical Remote Audit Process

NSF’s remote and virtual auditing service can help to unlock supply chains and meet cGMP needs in clinical trial supply or routine commercial operations. Find out about the four-step process and get insight into the risk-based assessment criteria to determine what information is required.
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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

Risk-Based Assessment

Background InformationInformation Required
Site Location
  • Physical address of the site providing the service
Key Contact
  • Name and contact details
Site AssessmentInformation Required
Regulatory Oversight
  • Is the facility subject to local authority oversight?
  • Has the facility been inspected by competent authorities or a certification organization, e.g. EMA, U.S. FDA, ANVISA, etc.?
Licenses/Registrations
  • Obtain copies of latest official documents and verify scope
Inspection History
  • Date of last inspections and outcomes
Recalls
  • Has the site had any significant recalls or restrictions placed on it?
Company Profile
  • Is the operation part of a larger organization?
  • Does the facility operate to a common company PQS?
  • Is there evidence of corporate oversight, e.g. audits of facility by a central team?
Site Activities
  • What activities will the site be performing, e.g. total manufacture, partial manufacture, packaging only, testing, stability?
Size of Location
  • Number of employees at site
Cross-Contamination Risk
  • What other products/materials are manufacture at the site?
Product AssessmentInformation Required
Nature of Product/Material – Dose Forms
  • ATMP/biologic/aseptic/sterile
  • Liquid/cream/ointment
  • Solid oral dose
  • Packaging only
  • Process critical material, e.g. excipient, active, process aid
Stage of Development for Product
  • R&D
  • Early phase development (Phase 1/2 clinical trials)
  • Phase 3 clinical trials
  • Commercial supply

Ready to Begin the Process?

Contact us and get your questions answered.