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QC/QA/RA Related

Activity

Preparation of Master Batch Record

  • SOP’s, Monthly report, Production planning, vessel- Utilization report, Raw material planning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ) for different production related equipment
  • Drugs Master File (DMF) for production related documents. Preparation of Facility Qualification (FQ), APQR,PVR,PVP, Site Master file, CTD
  • Handling of documents, change control, OOS, Product failure investigation, deviation, vendor questionnaire & Market complain

Preparation of gap analysis for regulatory submitted product

  • Preparation & review of Validation protocols and reports (Process Validation, Pulverizing validation, Drying Validation, Blending Validation, Analytical Method Validation & Cleaning Validation)
  • Reviewing of specification,STP,analytical template,stability protocol for QC.

Services

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