GMP consulting services

One-stop consulting service·Solve all kinds of professional problems

Our advantage

GMP consulting service team：
★ Regulatory guide / technical standard drafter
★ Consultant with experience of drug supervision and management inspector
★ Foreign consultant、Famous consultant of domestic pharmaceutical industry
★ GMP consultants from senior executives of many pharmaceutical enterprises
★ More senior engineers who have participated in the front-line work of project construction and production operation in pharmaceutical enterprises

Quality management system(QMS) construction:

  • The six basic modules based on FDA guidelines
    • QA
    • QC
    • Plant facilities and equipment management
    • Material management
    • Production management
    • Packaging and labeling management
  • Integration and Optimization based on specific management content
    • Quality risk management system
    • Drug R & D management system
    • Technology transfer management system
    • Confirmation and verification management system
    • Computerized system management system
    • Data integrity management system
    • Pharmacovigilance management system

Quality management system(QMS) optimization

  • step 1: Quality management gap analysis
    • Review of quality management system documents
    • Production site hardware and management audit
    • Issue of gap analysis report
  • Step 2: quality management system upgrading
    • Identify problem solutions
    • Determine the person in charge and rectification plan
    • Implementation of rectification
    • Scalability check and continuous optimization
  • step 3:Acceptance of quality management improvement results
    • Simulation inspection on GMP compliance
    • Consolidate optimization results

 

More GMP consulting services

More consulting services:

— Quality management training

— Solve all kinds of problems

— Regular / irregular on-site audit / communication

— Customized preparation of quality management documents



More exclusive consulting services:

— NMPA GMP technical support on site

— EU GMP technical support on site

— FDA GMP technical support on site

— Consulting service on rectification of various inspection defects

— More

Inspection contents about gap analysis/simulation:

  • During project construction
    • Design audit on GMP compliance—Conceptual design
    • Design audit on GMP compliance—Basic design
    • Design audit on GMP compliance—Detailed design
  • Simulated inspection of drug administration supervision
    • Production site inspection on drug registration
    • Pre approval inspection (PAI) required by FDA
    • Production site verification: quality and efficacy consistency assessment
    • Inspection on GMP compliance
  • Quality management inspection
    • Gap analysis of total quality management
    • Gap analysis of production hardware management
    • Gap analysis of quality management documents
    • CRO / CMO entrusted inspection
    • Supplier audit commission inspection

Process about gap analysis/simulation review:

  • Remote preparation
    • Set up gap analysis team
    • Prepare checklist and inspection plan
    • Internal meeting and work arrangement of gap analysis group
  • On site audit
    • First meeting, clear inspection plan
    • Production site hardware audit
    • Review of quality management documents and records
    • gap analysis group internal meeting, problem summary
    • Final meeting, delivery inspection issues
  • Deliverables
    • Prepare gap analysis report
    • Review and confirm electronic documents
    • Print / stamp, deliver physical Report