Audits
GAMP/ GDP/GLP/ GMP
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We do support in Plant Qualification / Validation services.
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Obtaining regulatory accreditations : UK-MHRA and EU, gateway to all regulated markets coming under PIC/S.
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We perform GMP-QMS audits of,
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APIs​/ Intermediates manufacturing sites
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Pharmaceutical Excipients manufacturing sites
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Primary & Printed packaging material manufacturer sites
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Process Equipment manufacturers
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Purified Water system providers
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HVAC component manufacturers
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Third-party Quality Control labs
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Manufacturers of Finished Dosage Formulations
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Batch control sites (Commercial labs)
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Batch release sites (MIAH)
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Wholesale dealer licensed warehouses (WDL)
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The services include site audits, follow-up of CAPAs with the audit sites and preparing the close-out reports.
Ram Iyer
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FAQ
How do I know if my facility complies to the EU-GMP guidelines?​
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Simple, drop us an email with your company details and we shall get in touch with you. We can perform a facility audit and issue an audit report with our findings and recommendations.
How long does it take to get an EU-GMP approval?
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If your facility is fully complying, it takes around 8-10 months to get your facility approved by the competent national authority.
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What is an EU-GMP approval?
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An approval given by the competent national authority of any of the member states of EU, for e.g., MHRA in the UK.
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Can ProLife support us in getting a PIC/S accreditation?
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There is no such thing called PIC/S accreditation. If a manufacturing site gets approved by any of the PIC/S participating regulatory authority, this shall be mutually recongnised by all the participating countries, though there is no obligation on any regulatory authority to do so.
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We have a manufacturing facility that caters to Indian market and few Asia-Pacific & African markets; can ProLife upgrade this facility and make it complying to the EU-GMP norms?
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Yes, we can.