Services
Martand Life Care Private Limited (MLC) conducts GMP, GCP, GLP, GTP, DEA, and QSR audits worldwide. We have auditors on the ground in the US, Canada, China, Europe, India, and South America. Our experienced team of auditors can:
Audit and qualify CMOs Assist in setting up CAPA programs Audit packaging and labeling contractors Audit toxicology and analytical labs Audit facilities for DEA compliance Audit client sites or device developers for QSR compliance Conduct Due Diligence audits
• Audits of contract manufacturing, testing, packaging, labeling and distribution facilities
• Sponsor - MLC can help prepare your company for FDA and EU inspections by: o Conducting mock audits o Pre-Approval Inspections (PAI) audits o Preparing a CAPA program, if needed.
• Toxicology labs, facilities, studies and reports
• Analytical labs and associated data
• Evaluation of the receipt, storage, handling, shipping, security, documents and record keeping (including SOPs)
o Design history file
o Quality Systems
o Design controls
We can also conduct audits of your site to determine your company's readiness for an FDA inspection.
In addition to our outstanding credentials, we have the following systems in place to ensure quality
• Validation programs in place • Equipment qualifications IQ,OQ,PQ • Strict process controls • Master procedure documentation and control • Specifications development and management • Work flow control: receiving, production and shipping • Batch record development and documentation • CAPA program (corrective and preventive action) • Personnel training program – dedicated trainers • Robust in-process testing • Rigorous management of change control
