All the Pharmaceutical Manufacturing Activities are carried out as per Schedule-M of the Indian Drug . Licensing and Regulatory activities are controlled by Drug Controlled and License Authority, Drug Controller Punjab, Food & Drug Administration Kharar Punjab. Copy of Manufacturing license is attached in.The products covered under the drug license no. 1994-OSP and 2054-B issued by the Competent authorities are Tablet, Capsule, Syrups , Beta Lactum (cephalosporins and cephamycins (cephems) and Dry Powder Injection. At present the items being manufactured at site are as per-
Other Manufacturing Activities Carried Out On the Site: Products other than approved by licensing authority for our site are not manufactured. The Quality Management System of the Manufacturer Purpose of the Quality Management System is to ensure compliance of cGMP requirements as enforced by National and International Regulatory Bodies.
The Quality Management System ensure that all activities related to manufacturing of Drug Products in compliance with cGMP are controlled by Standard Operating Procedure, so that the end product meets all the Predefined Specifications ensuring the Identity, Strength, Safety & Purity of the Products Quality Policy: We at Bionial Healthcare Pvt. Ltd. deliver customer satisfaction with a team of motivated, empowered and trained professionals. We ensure value for money by developing innovative, safe, effective and consistent quality products through stringent implementation of cGMP, cGLP with emphasis on continuous improvement.
We at Bionial Healthcare Pvt. Ltd are committed to
- To implement and maintain quality system as per ISO and GMP standards and improve system continuously.
- Understand and meet the customers’ expectations.
- To ensure pollution free environment.
- To ensure safety of all employees at works.
Department Staff Workers Total
| S. No. | Departments | Number of Employee |
|---|---|---|
| 1 | Quality Assurance | 9 |
| 2 | Quality Control | 8 |
| 3 | Production Department | 50 |
| 4 | Personnel & Administration | 6 |
| 5 | Engineering | 10 |
| 6 | Security | 6 |
| 7 | Warehouse | 6 |
| 8 | Housekeeping | 10 |
Competent Technical Personnel in various departments like
Production Block And Entry To The Core Area
- Ground Floor comprises general Tablet,capsule
- Second Floor comprises Dry powder injection and Betalactum tablet
- Third floor comprises Laboratory,water treatment plant, sampling area and quality assurance
Nature of Construction
The entire building is constructed by using CC and is adequate and suitable for manufacturing of drugs. Excellent Ventilation, Cooling and Air Conditioning is provided. Water, Waste Water Removal, Electricity, Fuel Services and Utility deliveries are easily obtained. All the Utility facilities like Filtered Water, Soft Water, Purified Water Plants, Boiler house, Generators, Air Compressor Plant, and Chilling Plant etc. are kept separate from main building and have adequate capacity.
Kota is a naturally available stone in India having very high abrasion strength and once polished gives very smooth surface finish, dust-free, easy to clean floor. These Kota tiles are fixed in Corridors Canteen and Toilets only. Epoxy Flooring: All Core Areas, Dispensing Area, Sampling Area, Microbiology Lab, Packing Area and Production areas have continuous epoxy flooring. Epoxy floor gives a smooth finish without joints, Coving: To avoid Vertical Joints between Floor to Wall, Wall to Wall, Wall to Roof Epoxy Coving has been done which minimizes the risk of Dust Deposition and Microbial Growth. Painting: Acrylic Emulsion is used in Entrances, Toilets, Change Rooms, Passages and Storage Areas. Epoxy Paint is applied in all core Processing Area, Sampling, Dispensing and Primary Packing Area.
Epoxy paint is characterized by excellent chemical, Oil, Water Resistant, Smooth Finish and Excellent Algae and Fungi Growth Resistance. External paint is Cement based Water Repellent Paint. Door & Windows: All Doors are made of Aluminum with View Panel and inter locking mechanism in the Area Specific Storage Conditions: Manufacturing site is well equipped for storage of Drug Substances and Products which require cold Room Storage at 2 °C to 8 °C. 4.2 Brief description of Air Handling Unite and air-conditioning (AHU) system All the areas are provided with appropriate Ventilation System to maintain the required room condition with respect to the Temperature, Relative Humidity. Particulate Matter Count and Potential Risk of Airborne Contamination. To maintain proper Ventilation System in the plant 49 AHUs are provided. The area for handling Sterile Products meets Class-A requirements. The background of the Class-A area meets the requirement of Class-B and all Manufacturing Area meets Class-D requirements.