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News

  • New Product

    3 new products are schedule to launch for Anti fungal, Laxative and Respiratory

    2019-03-28 12:42:30

  • Plant 3

    OSD and Injectable Oncology - Verna, Goa - Installation completed and under process validation

    2019-04-08 14:55:31

  • Plant 1

    OSD, Syrup & Ointment - Atgaon, Thane is an ISO 9001:2015

    2019-03-28 12:34:13

  • Plant 2

    OSD - Skidel, Belarus Inaugurated on 7-Mar-19

    2019-04-08 14:55:05

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MANUFACTURING UNIT ATGAON FORMULATION QA/ QC
Quality Control (QC)

The Quality control department is separate wing, equipped with latest sophisticated instruments like UV, FTIR, HPLC, UPLC and many more. Entire facility is divided into three main sections

  • Wet Analysis Lab
  • Instrumentation Lab
  • Microbiology Lab

Rigorously follow the cGMP norms to ensure that the people, process and technology are aligned in order to achieve international standard quality with affordability and easily access towards Caring a Human health and respect the environment

Quality Assurance (QA)

Department dedicated to meet the most stringent quality requirements in compliance with cGMP – Schedule ‘M’ as per Indian Drug Law, WHO – GMP, GLP, Other regulatory requirements and Stability Studies.
Waterfall Methodology are in practice to have complete control and governance towards operation.

Document Control
  • Preparation
  • Review
  • Approval
  • Distribution
  • Retrieval
  • Archival
  • Destruction
  • Periodic Review
Training
  • Induction
  • QA Systems
  • GMP
  • OJT
  • SOP
  • Safety
  • External Training
  • HR Training
Monitoring
  • Enviroment
  • Temperature Mapping
  • Celibration
  • Retention Sample Inspection
  • Stability Studies
  • Product Quality Review
  • Management Review Meetings
Audit
  • Internal Audits
  • Internal Safety Audits
  • Regulatory Audits
Deviation Control
  • Initiation
  • impact Assessment
  • QA Verifiction
  • Dept Review
  • Deviation & Classification Allocation
  • Customer Approval (Critical)
  • Corrective & preventive Action
  • Assessment for Changes
  • Deviation Closure
Change Control
  • Initiation
  • impact Assessment
  • QA Verifiction
  • Allocation of Change no. & Classification
  • Customer Approval (Critical)
  • Change Execution
  • Review of Supporting Data
  • Change Closure