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How do you perform batch record review of batches produced in China, when they are not bilingual or translated?

20/07/2021 | 2761

Similar question:

Reply:

There must be a Technical Agreement and a recent audit of the company. If the company is supplying a finished drug product into the EU which needs a QP certification, a translation of one batch record as an example and a summary of each batch will be required together with a CoA. It is important that the QP can understand the process and whether there was any excursions/CAPA’s /changes etc. and what they were and how they were concluded. If this was a new company to the QP, and especially if supplying parenteral drugs, I would initially want an audit at least every 12 months until the relationship was fully established.
If the company is supplying APIs, the Technical Agreement and audit requirements and ability to understand any changes/excursions will still apply. I would also want to see a copy of the process flow document together with all the critical process parameters and be able to identify these comply on a batch to batch basis together with a CoA. The companies would also need to comply with all aspects of 2011/62/EU to the satisfaction of the QP and be accompanied by a written ation the competent authority of the exporting third ry which s that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU (unless a waiver has been granted).

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  • GMPc Vietnam JSC
  • Head Office: No. 18, Mang Cam 1 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
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  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
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  • Contact
 
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