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GMP Consulting

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Establish A Qualified GMP Center

Many of our consultants are industry pharmacists and specialists who are familiar with the applicable quality standards and can help you design or adapt your quality and safety processes in order to minimize the risks involved in (bio) pharmaceutical production. Through these specialists, Tigermed is able to provide GMP consulting services to ensure US cGMP, EU-GMP, WHO GMP and Chinese GMP compliance. Our services cover the entire life cycle of the GMP system, which including:

Our GMP service covers all quality aspects of a new constructed /renovated plant/workshop, which includes:

  • GEP consulting
  • Drafting or review of URS
  • Qualification and validation
  • Establishment of GMP related systems
  • GMP training
  • Pre-auditing or internal audit
  • Third-party auditing
  • Supplier auditing
  • Computerized system validation
  • Data integrity compliance
  • Onsite technical support for official GMP inspection
  • Translation/interpretation during GMP inspections
  • CAPA response and findings closure
  • Warning letter or 483 report closuer

 

Chinese GMP Compliance

  • Compliance with the latest version of Chinese GMP
  • GMP compliance during the construction of new plants and renovation of old plants
  • Chinese GMP training
  • NMPA overseas inspection support.
  • Translation/interpretation during GMP inspections
  • CAPA support
  • GMP Non-compliance closure
  • GMP compliance for veterinary drug plants

 

Global GMP Compliance

We are able to perform gap analyses and bridge GMP gaps during pre-audits, third-party audits, onsite GMP supports, and also provide English-Chinese interpretation for GMP inspections conducted by overseas authorities. By doing so, we enable pharmaceutical companies to pass:

  • US-FDA GMP inspection
  • EU-GMP inspection
  • USP verification program for dietary supplements
  • TGA inspection
  • WHO GMP inspection
  • US NSF certification
  • US NPA certification

 

Features and Advantages

*As of Q1 2020
  • Over 80 full-time staff, professional experiences, professional operations and supports from field experts.
  • 22 years experiences, thousands of projects experiences, various project types, and capabilities to foresee the possible key points.
  • Good communication with authorities, closely following-up the updated industry trends, fully-fledged information and documents database, and strong information integrating and analyzing capabilities.
  • Covering the establishment of R&D system, guidance for R&D, IND application and CT, Registration, GMP compliance support.

Project Experience

*As of Q1 2020
  • 500+ GMP Compliance cases, incl 100+ cases for EU/FDA/TGA inspections, product dosage forms covering SVPs/LVPs, lyophilized powder for injection (incl biologics and blood products), solid dosage forms, non-sterile APIs & sterile APIs, inhalant, topical formulations;
  • 50+ FDA inspections, incl 10 cases passed with “Zero deficiency”;
  • 50+ EU inspections;
  • 10+ Aus TGA inspections;
  • 15+ NMPA overseas inspections to foreign manufacturers, incl resuming import;

GMP Compliance cases

NMPA overseas inspections

FDA inspections

EU inspections

Aus TGA inspections