Quality Policy
At Prudence Lifecare Pvt. Ltd., we are committed to manufacturing and supplying the highest quality Active Pharmaceutical Ingredients (APIs) and advanced intermediates that meet all pharmacopoeial and regulatory requirements while ensuring customer satisfaction, competitive pricing, and on-time delivery.
Our continuous focus is on innovation, quality enhancement, and system improvement through the adoption of current Good Manufacturing Practices (cGMP) and a robust Quality Management System (QMS). We strive to continually upgrade our process technologies, employee competence, and operational standards to deliver products that consistently meet global pharmaceutical quality benchmarks.
Quality Assurance
We are following GMP, ICH & ISO guidelines to maintain robustness of quality management system. As a part of it, all the key elements as mentioned below (but not limited to) are being well maintained.
| Quality System / Documentation | Associated Records & Procedures |
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Quality Control
Prudence Lifecare Pvt. Ltd. has a well-equipped quality control laboratory to carry out all major analysis as per different pharmacopoeias. Environment Monitoring and Microbiological Analysis are also carried out in-house.
The QC lab is divided into:
- Wet Lab
- Hot Zone
- Instrument Room – GC-HS / HPLC / UV-VIS Spectrophotometer
- Stability, Microbiology & MLT Room
Stability Chamber
| Equipment Name | Capacity | Study | Set Parameter | ICH Zone |
|---|---|---|---|---|
| Stability Chamber | 500 L | Long Term | 30°C ± 2°C / 65 ± 5% RH | IV-A |
| Stability Chamber | 325 L | Accelerated | 40°C ± 2°C / 75 ± 5% RH | IV |
| Stability Chamber | 500 L | Long Term | 30°C ± 2°C / 75 ± 5% RH | IV-B |
| Sr. No. | Instrument / System Name | Nos. |
|---|---|---|
| 01 | GC (Gas Chromatography) | 01 |
| 02 | HPLC (High Performance Liquid Chromatography) | 02 |
| 03 | UV–VIS Spectrophotometer | 01 |
| 04 | Incubator | 04 |
| 05 | Auto Titrator | 01 |
| 06 | Karl Fischer Titrator (KFT) | 01 |
| 07 | Stability Chamber | 03 |
| 08 | Autoclave | 02 |
| 09 | Milli-Q Water Purification System | 01 |
| 10 | Biosafety Cabinet | 01 |