GMP consultancy

IPM helps those companies willing to enter in regulated and semi-regulated market for preparing documents, its implementation, training , facing audits and subsequent approval.

IPM will work from the ground level and bring the organization to comply with the desired regulatory standards in the areas of QC, QA, Process Development, Plant Design of industries related to the manufacture of API, Intermediates, Excipients and Finished Dosage Forms

We work on the following requirements:

  • Getting certification as per various regulatory norms
  • GMP compliance for API & Formulation – as a complete project
    • Facility and Quality Management system audit [gap analysis] and action plan
    • Execution of plan; facility modification, upgrading documents, preparing new documents, training, implementation and monitoring
    • Mock audits
    • Witnessing audit and approval from authorities
  • Audit:
    • Qualifying vendors of raw material and primary packaging material.
    • Third party manufacturers on behalf of clients in India & Abroad
    • Preapproval audit
  • Validation
    • Planning and execution
    • Water system
    • HVAC
    • Cleaning
    • Manufacturing process
    • Software validation
  • Set up of new QC laboratory/ Upgradation of existing QC laboratory
    • Design, procurements, qualification, documentation/SOPs, training and Implementation
    • Pre-audit and action plan
    • Revision of documents/SOPs
  • Special assignments involving review of:
    • Change control and Deviations,
    • Analytical incidences
    • OOS & OOT
    • Root cause analysis & CAPA follow up
    • Stability studies- ICH approach, data review, trending, chamber management
    • Product Quality Review
    • Customer complaints
  • Implementation of laboratory Quality Assurance system
  • Data integrity management
  • Software validation approach