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 manufacturerson 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 assignmentsinvolving review of:

  • Change control and Deviations,
  • Analytical incidences
  • OOS& OOT
  • Root cause analysis&CAPA follow up
  • Stability studies- ICH approach, data review, trending, chambermanagement
  • Product Quality Review
  • Customer complaints

Implementation of laboratory Quality Assurance system
Data integrity management
Software validation approach