Good Manufacturing Practice

Safety and Efficiency

Good Manufacturing Practice (GMP) audits are essential for ensuring the quality and safety of life science products. Pharmatek’s experienced GMP auditors provide
comprehensive assessments to identify and address potential issues within your manufacturing processes, facilities, and quality management systems.

As regulatory scrutiny intensifies, GMP compliance has become more critical than ever. Our team of experts is well-versed in the latest industry standards and regulations (ICH Q7, 21 CFR 210/211, EU GMP, ISO) and can conduct thorough audits to ensure your operations meet the highest standards.

Pharmatek offers a comprehensive range of GMP auditing services, tailored to your specific needs. Our expertise covers all aspects of the manufacturing process, from drug products and substances to intermediates, excipients, warehousing, and packaging.

Pharmatek’s GMP audits also extend to your supply chain. We evaluate suppliers, subcontractors, and service providers to ensure they meet the necessary quality standards and contribute to the overall safety and efficacy of your products.

Manufacturing audit services include
Vendor/Supplier Audits
Mock Pre-Approval Inspections (PAI) and Mock FDA Audits
GAP Analysis

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