Good Manufacturing Practice - Safety and Efficiency
Good Manufacturing Practice audits and inspections for the life sciences industry are a critical part of the therapy development and manufacturing processes. GMP audits are conducted to ensure that products are made in accordance with quality standards and the best industry practices. We work with our partners to identify and correct issues with processes, facilities, and quality management system (QMS).
As regulations continue to strengthen, authorities are demanding increased vigilance of the life science supply chain and are emphasizing the need for compliance audits. Our team of professional GMP auditors have in-depth experience conducting GMP audits against applicable regulatory and industry standards (ICH Q7, 21 CFR 210/211, EU GMP, ISO etc.)
Pharmatek GMP experts have experience performing audits for all levels of the manufacturing process, including drug product, drug substance, intermediates, excipients, warehouse facilities, and packaging material facilities. Our quality auditing service is customized to our client’s needs and includes audit preparation, auditing, reporting, CAPA plan follow-up, CAPA review, and audit closure.
Our GMP auditors evaluate and monitor suppliers, subcontractors, and service providers supporting your therapy’s lifecycle.
Our range of Manufacturing audit services includes:
- Drug Product (DP)
- Drug Substance (DS)
- Warehouse Facilities,
- Packaging Material Facilities
- Contract testing Laboratories
Mock Pre-Approval Inspections (PAI) and mock FDA audits