GMP Audit & Compliance Services, GMP Consulting Services

CRMO will assist your company 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.

cGMP

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 & 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.