Documentation Supports

We help the firms in designing their documentation system to meet international standards of US FDA, WHO, EU, PICS, TGA, ICH Q7, MHRA, PMDA,EDQM.MCC, The documents shall include QMS, Batch documentation, Validation, Recording forms and formats and SOPs and all relevant /associated GMP documentation.
We review the firms SOPs for performance and compliance. We provide the firm’s prototypes (templates) of few SOPs based on which the firms are expected to prepare and expand their SOPs.
We also assist the firm in preparing master GMP documentation where required and review the documents for their completeness and compliance.

  • Standard Operating Procedures
    (R&D, ADL, QC, QA, Warehouse ,Engineering, Microbiology, Manufacturing, HRD,
    and Regulatory Affairs)
  • Validation Master Plan
  • Mater Production and Control Record(MPCR)/ Batch Production and Control Records
  • Specifications and Analytical Test Procedures(Raw Materials, In-process Controls,
    Intermediates, Packaging Materials, Finished Products, Stability Study, Working
    Reference Standards)
  • Validation Protocols
  • Technology Transfer Documentation
  • Process Development Reports
  • Method Development Reports
  • GMP Check Lists
  • Quality Contract, Quality Agreement, Technical Agreements
  • Site Master File
  • Quality Manual
  • Stability Study Plan/Program
  • Preventive Maintenance Program
  • Quality System Procedures and Documentation
  • Change Control Documentation
  • Deviation Control Documentation
  • Customer Complaint Handling Documentation
  • Annual Product Review
  • Logbooks for Equipments/ Facilities and Utilities
  • CAPA Documentation
  • Label Design
  • GMP Poster Development for QMS awareness
  • NABL Accreditation Documentation
  • Manufacturing Site Registration/ Accreditation Documentation
  • WHO GMP related Documents
  • USFDA Related Documents
  • EU-GMP and EDQM Documents
  • EHS Documentation
  • PMDA,Japan GMP documents
  • ASEAN GMP Documents