Good Manufacturing Practice (cGMP) audit and inspections for pharmaceutical industry remain a critical part of the drug development and manufacturing process. GMP audits are conducted to ensure that products are made in accordance with quality standards and the best industry practices. It is to identify if the pharma company has full control over processes, facility, and quality management system (QMS).

As regulations continue to strengthen, authorities are demanding increased vigilance of the pharmaceutical supply chain and emphasizing the need for compliance audits. Our team of professional GMP auditors, who are located around the world, have in depth experience of conducting GMP audits against applicable regulatory and industry standards (ICH Q7, 21 CFR 210/211, EU GMP,ISO etc.)

Pharmatek GMP experts have accomplished several audits of drug product, drug substance, intermediates, excipients, warehouse facilities, packaging material facilities for pharmaceutical, biotechnology and medical device Industry. Our quality auditing service starts from initiation to closure of audit which includes all the steps such as audit preparation, auditing, reporting, CAPA plan follow-up, CAPA reviewing and audit closure.

Our GMP auditors evaluate and monitor your suppliers, subcontractors, and service providers supporting your pharmaceutical product lifecycle.

Pharmatek provides a wide range of audit services to clients as per their specific needs.

Range of services

Vendor/supplier audits

• Drug Product (DP)
• Drug Substance (DS)
• Intermediates
• Excipients
• Warehouse Facilities,
• Packaging Material Facilities
• Contract testing Laboratories

Mock Pre-Approval Inspections (PAI) and mock FDA audits

GAP Analysis