GMP Audits

GxP Audit

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 types of suppliers we conduct GMP audits for, but 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 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.

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    Audit Report Package

    Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:

    • Full Audit Report.
    • Auditor’s CV.
    • Auditor’s non-conflict of interest declaration.
    • CAPA plan with evidence, as applicable.
    • Audit closure signed by Lead Auditor, with CAPA review confirmation.
    • Attachments including lists, certificates, licenses, layout etc.
    • Additional documents such as SMF, SOP index, Site presentation etc. as available.