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Audits

GMP/ GLP/GAMP/ GDP

Looking for a third-party audit? 

 

Let's guide you with our various consulting services.

 

  • We do support in Plant Qualification / Validation services.

  • Obtaining regulatory accreditations : UK-MHRA and EU, gateway to all regulated markets coming under PIC/S.

  • We perform QMS audits of,

    • APIs​/ Intermediates manufacturing sites

    • Primary & Printed packaging material manufacturer sites

    • Process Equipment manufacturers

    • Purified Water system providers

    • HVAC component manufacturers

    • Third-party Quality Control labs

    • Manufacturers of Finished Dosage Formulations 

The services include site audits, follow-up of CAPAs with the audit sites and preparing the close-out reports.

Find Out More

FAQ

How do I know if my facility complies to the EU-GMP guidelines?​

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?

If your facility is fully complying, it takes around 8-10 months to get your facility approved by the competent national authority.

What is an EU-GMP approval? 

An approval given by the competent national authority of any of the member states of EU, for e.g., MHRA in the UK.

Can ProLife support us in getting a PIC/S accreditation?

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. 

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?

Yes, we can.