Product Catalog
Product List

Quality Control is very comprehensive & well controlled to avoid any ambiguity and uncertainty in the Plant. Bionial Healthcare Pvt. Ltd, is maintaining all the documents as per requirements of Quality Management System as a means of ensuring that products manufactured conforms to specified requirements. Major documents include Validation Master Plan, Quality Manual, Training Manual, Master Formula of Products, Standard Operating Procedure and supporting records Preparation Revision and Distribution of

Documents Master Formula: Product Information. Packing Information, Composition. Processing, Manufacturing. In process checks and other instructions, testing etc. are mentioned in all Master Formulas for individual products. These Master Formulas are approved by Head QA. The same contains specimen of Packing Material etc.

Quality System Manual Covers The Following Areas

  • Premises
  • Personnel Hygiene
  • Cleaning & Sanitation
  • Training
  • Introduction parameters for Quality System
  • Good Laboratory Practices & Laboratory Safety
  • Calibration
  • Contamination Control
  • Validation Policy
  • Water for Pharmaceutical Use
  • Warehousing
  • Laboratory Controls
  • Packaging and labeling
  • Release of Semi-Finished and Finished Goods
  • Stability Studies
  • Vendor Approval
  • Change Control Deviations
  • Annual Product Review
  • Product Recall & Market Complaints
  • Documentation
  • Self-Inspection

Validation Master Plan Validation Master Plan is available which covers all the aspects of Qualification of facilities, equipment’s, Process, Calibration and Revalidation etc. and documented for future reference. Revision of Validation Master is done in every Two years or whenever is required. All the documents are Controlled by QA Department with regulated distribution as per the Standard Operating Procedure.

Documentation has categorized & like, Product /Process Specification, Raw Material Specifications, Packaging Component specifications, Standard Process Instructions including Packaging, Batch Manufacturing Records and Packaging Records, Analytical Methods, Validation and Qualifications Documents etc. Training: All the personnel working in the plant and whose job is directly or indirectly associated with Product Quality are given continuous cGMP training appropriate to their respective job activities. The Head QA in consultation with the Head Production as well as Head HR develop comprehensive training modules and programs for employees at all levels.

Following Types Of Training Are Conducted In Bionial Healthcare Pvt. Ltd

  • Internal Training
  • Induction Training
  • On the Job Training
  • CGMP Technical Training
  • Refresher Training
  • External Training
  • Training Needs Identification
  • Re-training Documentation

The documentation of different type of training departments as mentioned below Induction

  • Behavioral Training
  • HRR Department On the Job Training
  • Concerned Department cGMP Technical Training
  • Concerned Department Re-training
  • Refresher Training
  • External Training
  • Training Needs Identification
  • Re-training Documentation