Bionial Healthcare Pvt. Ltd., meets all the requirements of Schedule-M of the Drugs , 1940 and Rules there under and other global regulatory guidelines with Current Good Manufacturing Practices. Head Production is professionally qualified experience of techniques and operations of production. He takes every measure to pervert and avoid errors by means of continuous check of the process. As the batch manufacture progresses the related Batch Manufacturing Records are filled Online and completed at every stage as and when the process is completed. The manufacture of batch is carried out in accordance with Master Formula Record (MFR). Only after the clearance of the packaging line by QA, the new batch is taken for packaging. Reconciliation is done at critical steps of manufacturing and completion of Packaging Operations
| S. No. | Medicine | Annually |
|---|---|---|
| 1 | General Tablet Section | 60.00 million |
| 2 | Hard Gelatin Capsule Section | 90.00 million |
| 3 | Syrups Section | 15.00 million |
| 4 | Dry Powder Injection Section | 30.00 million |
| 5 | Beta Lactum Section | 200.00 million |
Quality Control System The Quality Control System is an integral part of cGMP and ensures that the necessary and relevant tests are performed. Quality Control Department is independent of Production Area. Quality Control Department has the responsibility and authority to approve or reject all Components, Drug Product Containers, Closures, Packing Material, Labelling and Drug Products. Quality Control shall be concerned with Sampling, Specifications, Testing, Documentation, release procedure which ensure that the necessary and relevant test is actually carried and that the materials are not released for use or products not released for Sale / Supply until their quality has been judged to be satisfactory.
The Quality Assurance Department conducts the Stability Studies of the product to ensure and assign their Shelf Life at the prescribed conditions of storage at Central Stability Study Centre. All record of Stability Studies is maintained in QA Documentation Room.