GMP SERVICES

• Supplier Qualification Audits

  
  

  - 360 degree audit approach to evaluate the capabilities and quality systems of suppliers and out-sourcing partners

  Pre-inspection Audits

  
  

  - To identify and resolve non-compliances in advance of a visiting regulatory agency

  Combination Audit (Remote + Onsite)

  
  

  - And when on-site visits are not feasible, our flexible delivery model allows us to guarantee business continuity and the lowest possible impact on all auditing operations, we perform audits remotely via documentation reviews and SME discussions as per Pharmexpert methodology. And When onsite audit feasible, We plan for onsite audit.

  QMS / GAP Audit:

  
  

  - Review of all Systems for GMP Compliance & efficiency

  Root Cause Audit

  
  

  - To investigate a process/Lab failure/OOS/OOT and determine the root cause and CAPA

  Due – Diligence Audit

  
  

  - To evaluate the quality systems for sustainability

  CSV/ Part 11 AUDITS

  
  

  - To ensure systems are 21 CFR Part 11 compliant and have undergone sufficient validation

  Medical Devices Audit

  
  

  - To evaluate facility’s compliance as per regulatory standards set forth in 21 CFR Part 820, ISO 13485 and EU medical device (EMD)

  Laboratory System and GLP Audits

  
  

  - To ensure R&D and Analytical Laboratory compliance as per GLP standards & 21 CFR part 11 compliance

  INDEPENDENT GMP AUDIT PROGRAM (IGAP) (SPONSORED / PARTNERSHIP)

  
  

  - We frequently carry out suppliers audits worldwide to ensure regulatory compliance.

  - Joining our IGAP program/ Audit report library is free for suppliers/manufacture. Our experienced and qualified auditor will perform full site audit of supplier covering large number of molecules/products (if not already performed) with no charge to supplier and detailed audit report shall be prepared.

  - The audit report shall be then available in our Audit report database which can be accessible to any of your clients. We will obtain permission of the supplier before sharing reports to the clients.

  
  

  Win-win Situation For All

  - Sponsor benefit

  
  

  - When report needed on urgent basis to support the supply, regulatory submissions etc., When manufacturing site can’t accommodate the audit due to busy schedule, When travel restriction; Sponsor can get benefits by purchasing our IGAP reports from our report database, moreover our clients only spend a small fraction of the costs usually associated with conducting a supplier audit. Our Quality system ensure that our clients receive personalized reports with areas most relevant to their operations.

  - Supplier benefit

  
  

  - Only one audit to be faced which will be valid for next 3 years. It will reduce your efforts and manpower involved hosting numbers of audits and implementing the ample no. of CAPAs generated through the multiple audit observations. Our cGMP Auditors qualified under Pharmexpert’s Methodology apart from having International certifications from APIC, IRCA-CQI, ECA and other and available locally across the globe including India, China, Japan, Korea, Canada, Europe, US, Taiwan, Malaysia, etc. We have completed more than 700+ Vendor/Supplier Qualification audits. Locally based consultants in wider geography so effective quality of work without language barrier and travel restrictions.

  
  
  

  Our Auditors/Consultant Global Presence

  

Our Audit reports are very detailed and comprehensive and accepted by all the regulatory authorities USFDA, EMA, PICs, WHO. The Audit report package includes Audit agenda, Audit Report, Auditors CV, CAPA Report, Audit Closure Letter, No conflict of interest statement by Auditor.

- Procuring ready audit report available from our Audit report database

- Sponsor can join Pharmexpert audit program –IGAP