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cGMP

The Company follows the current GMP ( Good manufacturing practices) as per revised Schedule M requirement under the provision of Indian Drugs & Cosmetics Act 1940 and rules thereunder. The Facility has been certified by FDA, Maharashtra for compliance with regards to requirement of Current GMP ( Good manufacturing practices ).

Quality Policy

Bionext Pharma , a manufacturing facility for Liquid Orals is pledged to ethics for manufacturing of quality drug products that consistently meet the laid down standards by adhering to current Good Manufacturing Practices (cGMP) in its facility, endeavors to delight the customers through its unique and cost effective formulations and timely quality services” .

QUALITY MANAGEMENT

Quality Management system is in place with proper organization structure and responsibilities to achieve the goal of providing consistent quality in terms of efficacy, purity, quantity and delivery. Quality Management comprises of Quality Assurance Department, Quality Control Department and Regulatory affairs department.

Quality Assurance

qaQuality Assurance Department is headed by QA Manager and assisted by well trained qualified staff.

Responsibilities Include
  • Monitoring of compliance to GMP requirements.
  • Preparation and control of clearly defined production and control procedures in the form of:
    • 1. Master Production & Control Records (MPCR) .
    • 2. Batch Production & Control Records (BPCR) .
    • 3. Material specifications and Test Methods.
    • 4. Product Specifications and Test Methods.
    • 5. Standard Operating Procedures.
    • 6. Training Records.
    • 7.Relevant Departmental Documents.
  • The approval and monitoring of vendors of starting materials.
  • The monitoring of storage conditions for materials and products as designated.
  • To approve or reject starting materials, packaging materials, and intermediate bulk, and finished products.
  • To approve sampling instructions, specifications, test methods, and other quality control procedures.
  • To check the maintenance of the department, premises and equipment.
  • To ensure that all necessary testing is carried out.
  • To evaluate batch records.
  • The inspection, investigation, and sampling, in order to monitor factors that may affect product quality.
  • The retention of records as per statutory guidelines.
  • To approve and monitor analysis carried out under contract.
  • Monitoring and approval of Validation processes.
  • Monitoring and approval of Calibration processes.
  • Monitoring of Stability programme and to monitor factors that may affect product quality.

Quality Control

quality1Quality Control Department is headed by QC Manager and is assisted by well trained qualified staff.

Responsibilities Include
  • Monitoring Chemical Analysis.
  • PMonitoring Instrumental Analysis.
  • Monitoring Microbiological Analysis.
  • Monitoring Packaging Material Testing.
  • Monitoring Retention of Control Samples.
  • Monitoring Stability Testing Programme.
  • Issue of Certificate of Analysis.

Regulatory Affairs

Regulatory affairs Department is headed by Manager Regulatory Affairs and is assisted by well trained qualified staff.

Responsibilities Include
  • Preparation of relevant statutory documents like Manufacturing licenses.
  • Co-ordinate with FDA department for grant and renewal of regulatory licenses.
  • Preparation of Export related documents like
    • 1. Preparation of registration dossiers.
    • 2. Filing of dossiers for registration of products to various drug regulatory authorities as per party’s requirement.
  • Finalization of artworks and text matter with respect to requirement of the party for design and country specific regulatory requirement.
  • Followups with the party and the regulatory authorities with respect to compliance of querries raised by the respective regulatory authorities.