GMP Services

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RGI team  supports for GMP Up gradation services in compliance with guidelines USFDA, EMA, ​

WHO, PICS :-​

• GMP gap analysis as per regulatory requirements​
• Facilitation in setting QMS for new facilities​
• Vendor audit (API/Excipients /Packaging material)​
• Manufacturing site audits on behalf of third parties in India and abroad. ​
• Arranging audits by an EU QP. ​
• Arranging EU Authorities audits for manufacturing sites. ​

Documents​

• Site Master File Preparation, review of SOPs and related documents. ​
• Sterility assurance package​

Response writing and CAPA​

• USFDA 483 observation​
• WHO​
• EU/MHRA observation​
• PICS/Others