Good Manufacturing Practice

GMP Audits and Compliance

Audits are an integral part of supplier qualification irrespective of the services or products sourced. Based upon accepted standards and current legal requirements, Nuvo GMP experts shall conduct independent and competent audits – worldwide. This service is offered without limitation to every participant of the supply chain e.g.

  • Pharmaceutical companies
  • (Contract) Manufacturers
  • Distributors
  • Manufacturing Authorisation Holders
  • Suppliers
  • Traders
  • Consultants or other interested parties

We perform compliance and auditing all types of components in Value chain:

  • Formulation
  • API
  • Intermediates
  • Key Raw materials
  • Excipients
  • Packaging

 Following are brief list of services we offer:

  • GMP Audits for API and Starting materials
  • Vendor Audits and Excipients Audits
  • Packaging Material Audits
  • Identification, execution of Third party manufacturing for site transfer and technological transfer of products.(API and Formulation)
  • Conduct of GMP Audit for third party manufacturers
  • Conducting trainings on behalf of MA holders
  • Complete GMP QMS documents implementation
  • Conducting onsite GMP trainings
  • Function as delegated QP and to review compliance of batches exported to MAH/ANDA holders.
  • SOP Services
  • GAP assessment audit services
  • Bioequivalence studies monitoring and CRO /study audits
  • Data Integrity compliance and Supporting Document s Auditing
  • Qualification and cleaning validation as per latest ADE/PPE concept.
  • Inspection Readiness / Pre-Approval GMP Inspection Audits
  • Serving for your External audit observations compliance and Monitor the CAPA
  • GMP Quality Systems improvement As per ICH Q8;Q9;Q10 (PQS)

Manufacturing Authorisation Holders (MAH) is responsible for compliance with the Good Manufacturing Practices (GMP) throughout their process chain. These audits can be conducted by qualified persons or outsourced to qualified third parties.

High-quality audits

Nuvo GMP experts conduct, inter alia, GMP, GDP and GLP audits worldwide. Check out the great variety of our service offerings, high quality standards and custom-tailored service.

In line with our accreditation, we offer customised third-party audits for all areas of pharmaceutical industry.  Our services encompass product-specific compliance audits as well as reviews of system conformity and customised expert opinions, such as:

  • API GMP audits,
  • QM system audits
  • GAP analysis and mock audits
  • GDP and GLP audits etc.
  • cGMP consultants for high level strategic consulting on GMP compliance
  • Consultants to advise on the continuous improvement of manufacturing processes
  • Onsite cGMP consultants to design and implement GxP-compliant processes and systems
  • Training on regulatory GMP compliance
  • Resources to design and complete qualification & validation tasks
  • GMP facility design and construction

Quality management

Pharmaceutical companies face ever-changing market forces and statutory regulations. Hence, they must demonstrate increasingly systematical risk management and consistent GMP compliance. We offer support and guidance in pharmaceutical quality management.

  • Independent inspection of supplier quality for optimum authority acceptance
  • Assignment of specialist auditors with experience in the relevant processes/technologies
  • Reduction of work-load for in-house QP´s
  • Reduction of audit expenses (absence of in-house QP, travel or translation costs, etc.)
  • Unbiased assessment against established standard
  • GAP assessment Audit, compliance solutions and providing documents and templates; sops; protocols and conducting GMP latest and data integrity Trainings; GMP trainings ;GLP and GCP trainings; QMS trainings

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