cGMP audit services

Any multinational company; willing to outsource a product from India or China would like to ensure that its supplier is capable enough to meet supply chain & GMP standards or needs to get audit done for their existing suppliers. Only auditor with local base and extensive knowledge on industry can provide right solution. CRMO has both the qualities – understanding of local situations and aware about International bench marks. CRMO has been appointed by US and European Pharma companies as third party GMP auditors and monitor for GMP compliance at their suppliers manufacturing sites in India on their behalf.

CRMO also welcomes the companies; wanting their suppliers to achieve GMP.

The range of audit services provided by CRMO is as follows

Internal cGMP Audits

  • GLP Audits
  • Contract Manufacturers Audit
  • Quality systems Evaluation
  • Compliance gap assessments
  • Mock FDA audits
  • Pre Approval Inspection Support
  • API and Formulation cGMP Audits
  • Labelling and Packaging Audits
  • Supplier Audits
  • Surveillance Audits
  • Validation Audits
  • Training Audits
  • Designing training programs
  • cGMP compliance services

    For any manufacturing company; wishing to supply its products to multinational companies, it is essential to equip plants up to GMP compliance. Going through the tangle some process to achieve GMP standard becomes easy journey with CRMO. The company has already executed many successful projects for such companies to set up from scratch to WHO, USFDA, EDQM and other regulatory authorities’ inspectable levels. It also provides external support to the companies wanting to improve their existing GMP system. CRMO is proud to get appointed by USAID to work for some East African companies to upgrade their GMP system to meet the level of WHO GMP.

    Quality Management Services

    CRMO assist companies in

  • The development of GMP Quality Systems including Standard Operating Procedures (SOPs), batch records, change control, revalidation, documents management, complaints management, annual product reviews, Quality Control specifications, test methods and validation protocols, etc.
  • Assessment of GMP compliance to International Regulatory Standards Reviews, development and implementation of plans for new facilities and proposed facility upgrades to ensure cGMP requirements are met. This covers Buildings layout and internal construction/surface finishes, Materials flow and personnel movement, Product and materials storage, Equipment and utilities ,HVAC Systems and associated controllers, Water Systems Water systems including USP, RO/DI, and WFI ,Sterilization Systems, etc.
  • Development of maintenance and equipment calibration programs Conducting mock GMP audits, prior to regulatory authority audits to assess the level of GMP compliance.
  • Participation in GMP audits by regulatory agencies and post audit follow up activities, such as the preparation of a response to any issued audit report. CRMO can carry out supplier/vendor audits, contract laboratory audits, and general GMP compliance auditing. Audits are tailored to meet the specific needs of your company
  • Validation and Qualification

    CRMO is one of the leading GMP consulting company involved in the preparation and execution of IQ, OQ, and PQ protocols and final reports for equipment, utility systems, laboratory instruments, processes, and computerized systems. CRMO offers services like preparation of Analytical method validation protocols and Analytical method validation reports including reviews of data, Cleaning Validation ,Product Validation , Stability studies, etc.

    Regulatory Agency Documentation

    CRMO can assist your company with FDA pre and post approval inspections, QA/QC documentation review, regulatory interpretation, and submissions such as Drug Master Files for submission to the United States FDA and the European Community, Dossiers for Certificate of Suitability of monographs of the European Pharmacopoeia, Responses to audit reports and follow up activities,-Site Master Files .CRMO can also help companies in Resolving Compliance Issues such as FDA Form FD-483 Response, Warning Letter Response, Application/Data Integrity Issues, Disqualification Letter Responses & Strategies, etc

    QA & RA set up support

    The team of experts at CRMO assists the manufacturers to implement their GMP set ups. The service includes of all SOP’s, validation & qualification, protocols, BMR’s, training and records of training.

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