GMP Audit
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 auditor/consultant. Our GMP Audit Reports are also very detailed and acceptable globally.
We can help you build a road map on how to remediate and enhance your facility and QMS/PQS to ensure compliance. We have pharmaceutical engineers and architects experienced in GMP related remediation projects to support our GMP / QA consultants in offering cost and timeline advice.
Following are types of suppliers we conduct GMP audits for, but not limited to:-
• Formulated medicinal products; sterile/non-sterile
• API/API intermediates; sterile/non-sterile
• 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