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cGMP Compliance Consulting

蓝钟咨询提供的cGMP认证咨询服务主要根据美国FDA的cGMP要求(21 CFR Part 210&211和/或ICH Q7及其解释),从硬件设施、管理体系和人员三个方面,全方位地指导和帮助企业建立起一套符合cGMP要求的质量体系。cGMP认证项目在具体实施上,主要通过阶段性的现场指导和非现场文件材料审阅反馈相结合的方式提供咨询服务,服务内容包括GMP审计、GMP培训、GMP咨询等。

The cGMP compliance consulting will be conducted in accordance with FDA’s requirements (21 CFR Part 210 & 211 with its interpretations
for dosage forms and ICH Q7 for APIs). We will support our clients in building an overall cGMP - compliant quality system in terms of
hardware, software, and personnel. Our experienced consultants will conduct on-site consultation in conjunction with off-site document review.

  • cGMP Compliance Audit on Quality System and Gap Analysis
    • General GMP audit
    • Special GMP audit (in particular aspect)
    • Audit on contractors
  • cGMP Compliance Review of Facility Design and Construction
    • Guide GMP requirements for facilities
    • Review design drawings
    • Audit on constructions
  • Validation System
    • Master validation plan and project plan
    • Design and review validation protocols
    • Review validation results and reports
  • Documentation System
    • Corporate level documents and master record
    • Management level documents
    • Operational level documents and batch record
  • Laboratory Control System
    • In-process material control tests
    • Product final release tests
    • Validation of analytical methods
    • Housekeeping and management of lab operations
  • Production and Process Control System
    • Equipment qualification and process validation
    • Environment and process monitoring
    • Calibration and maintenance
    • Batch records and SOPs
  • Quality Assurance System
    • Change control
    • Product annual review
    • GMP and SOP-based job function training
    • Batch record review
    • Deviation and investigations
    • OOS and investigations
  • Material Control System
    • Vendor evaluation and control
    • Material incoming, storage, and dispatching
Other Services
  • cGMP Compliance Audit on Quality System and Gap Analysis
  • Mock FDA Routine Inspections
  • Response to FDA 483s
  • Response to FDA Warning Letters