GMP Audits

GMP Audits

We provide the GMP Auditing Services with a high level of GMP audits of different types of suppliers as per different regulatory standards (i.e. EU GMP, ICH Q7, 21 CFR 210/211, ISO, etc. for GMP); the audits against the local country standards are also performed by our experienced auditors such as Brazil, Mexico, Canada, Australia/ NZ, China, etc. Our GMP Audit Reports are also very detailed and acceptable globally.

Following are the types of suppliers we conduct GMP audits for, but are not limited to:

• API/API intermediates; sterile/non-sterile
• Formulated medicinal products; sterile/non-sterile
• Biological, fermentation-based APIs and formulation products
• Excipients/ Key Starting Materials (KSMs)/ raw materials/ cosmetics
• Contract testing Laboratories
• Different services providers in pharmaceutical companies
• Distributors; GDP
• Packaging materials
• Components used in the pharmaceutical industries
• Processing sites (i.e. micronization, sterilization, radiation, etc.)

Our Quality auditing service starts from initiating the audit with the supplier to providing a complete AUDIT REPORT PACKAGE to our client which includes all the steps such as audit preparation, traveling, auditing, reporting, CAPA plan follow-up, CAPA reviewing, and Audit Closure. Our AUDIT REPORT PACKAGE is much detailed; Click here to know about what it includes.

We are one of the top Third-Party Auditing Services Providers for GMP/Quality Audits.