GMP Auditing

We conduct high standards of GMP audits of different types of suppliers across the globe as per different regulatory standards (i.e. EU GMP, ICH Q7, 21 CFR 210/211, ISO etc. for GMP) as requested by the clients; we also perform the tailor made/customized audits as per the customer's requirement including specific focused areas, specific standards, specific product/system, criticality or even for cause audits.

Our audit reports are very detailed and top quality hence well accepted globally by regulators, QPs, subject matter experts etc. We conduct GMP audits of following different types of suppliers, 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
• Distributors; GDP
• Packaging materials
• Components used in the pharmaceutical industries
• Processing sites (i.e. micronization, sterilization, radiation etc.)

Depending upon customers' request, our Quality auditing service can start from initiating the audit with the supplier upto providing complete AUDIT REPORT PACKAGE to our client which includes all the below steps:

We provide the comprehensive AUDIT REPORT PACKAGE maximum within 4-5 weeks post audit, in case of customer's urgency, reporting can be expedited much before standard timeline; Click here to see what the REPORT PACKAGE includes. WE ARE INDUSTRY LEADER IN GMP AUDITING AND PROVIDING READY AUDIT REPORTS with respect to Quality of Audit Reports and Cost effective Price of the Audit/Reports.

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.