Achieve and maintain stringent cGMP standards in a manufacturing facility, as per Global regulatory authorities viz. USFDA, EU-Agencies, Health Canada, ANVISA, TGA, MCC is a great challenge for Pharmaceutical and Lifesciences Companies.
Deren Pharma provide services ranging from audit of a manufacturing facility, Gap Analysis to Regulatory Compliances as per the country specific cGMP norms. We help our clients to prepare and meet global cGMP regulatory standards.
Our services include:
- Pre GMP audits for manufacturing sites.
- Manufacturing site audits on behalf of third parties.
- Co-ordinate for FDA inspection.
- Facility and Quality Management system audit [gap analysis] and action plan.
- Arranging audits of manufacturing sites by an EU QP.
- Arranging EU Authorities audits for manufacturing sites globally.
- Site Master File Preparation, review of SOPs and related documents.
- Preparation of responses to GMP Inspection.
- Review of your ready responses to GMP Inspection before submission.
- Facility and Quality Management system audit [gap analysis] and action plan.
- Qualifying vendors of raw material and primary packaging material.
- Third party manufacturers on behalf of clients in India & Abroad.
- GMP compliance for API & Formulation.
Special assignments involving :
- Review and Revision of documents/SOPs.
- Review of:
- Change control and Deviations, OOS & OOT.
- Analytical incidences.
- Root cause analysis & CAPA follow-up.
- Stability studies- ICH approach, data review and trending.
- Product Quality Review.
- Customer complaints.