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 awareness about International bench marks.
CRMO has been appointed by international 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.
Internal cGMP Audits
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.
Quality Management Services
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.