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    • Home
    • Services
    • Audits
    • Regulatory Compliance
    • FAQ
    • Contact Us
  • Home
  • Services
  • Audits
  • Regulatory Compliance
  • FAQ
  • Contact Us

Audits

In the critical realm of pharmaceutical manufacturing, supplier audits play a pivotal role in safeguarding the safety, efficacy, and unwavering quality of pharmaceutical products. These comprehensive assessments evaluate the adherence of suppliers to Good Manufacturing Practices (GMPs) and other pertinent standards, ensuring the integrity of procured materials and components that form the foundation of drug manufacturing. By conducting regular supplier audits, pharmaceutical companies proactively maintain control over their supply chain, effectively minimizing potential risks and fostering the delivery of safe and effective products to patients.

Independent, Contract Audits

Supplier audits conducted by third-party organizations provide pharmaceutical companies with a valuable tool to assess and maintain supplier compliance, ensuring the quality, safety, and efficacy of their products. By outsourcing audits to qualified third-party providers, companies can leverage expertise, efficiency, and objectivity to strengthen their supply chains and uphold the highest standards of pharmaceutical manufacturing.

  • APIs
  • Excipients
  • Packaging materials
  • Medical devices
  • Medicinal products
  • subcontracted laboratory
  • GDP, GCP, GLP,...
  • Food safety
  • For-cause-audits
  • FDA-readiness audits
  • GAP analysis audits
  • GMP audits focus on specific areas
  • Process/product audits
  • Data integrity audits

Audit Process

Audit request

Audit preparation & planning

Audit preparation & planning

  • Receipt supplier & product information
  • Confidentiality& service agreement
  • Agree on audit scheduling & price

Audit preparation & planning

Audit preparation & planning

Audit preparation & planning

  • Determination of audit purpose, Type & scope
  • Auditor selection
  • Logistics planning
  • Preparation of audit plan & checklists
  • Communication & distribution of the audit plan

Audit performance

Audit preparation & planning

Audit performance

  • Audit execution as per the plan
  • Assessment of all the systems (Quality, Production, Material, Packaging & labelling, Facilities &equipment, Laboratory controls)
  • Audit data collection & analysis

Audit reporting

Audit follow-up & Closure

Audit performance

  • Report preparation
  • Audit reports are 6C’s compliant (complete, correct, concise, Clear, Categorized, Confirmable)
  • Review & finalize audit results
  • Report approval by client / audit manager

Audit follow-up & Closure

Audit follow-up & Closure

Audit follow-up & Closure

  • Review of the corrective action plan
  • Verification of the corrective actions
  • Follow-up of ineffective corrective actions
  • Audit closure

Our audit methods

On-site audit

Virtual/Remote audit

Virtual/Remote audit

We can execute the audit at the manufacturing site with our local qualified auditors.

Virtual/Remote audit

Virtual/Remote audit

Virtual/Remote audit

In case on-site audits are not possible due to restrictions applied to local personnel movement also, We can execute virtual/remote audits to allow for your business continuity and ensure that critical suppliers continue to function within a state of compliance.

Desk Audit

Virtual/Remote audit

Desk Audit

Desk audits or document review verifies that documents meet requirements specified in the audit criteria or standard.

Contact Us

If you are looking for a trusted audit service provider to help you in your supplier audits, please contact us today. We would be happy to discuss your needs and how we can help you achieve your audit requirements.

Learn more

Empowering Organizations Through Comprehensive Audits

FAQ

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