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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
  • Standard Operating Procedures (SOPs)
  • Site Master File, Validation Master Plan, Quality Manual
  • Risk Management System
  • Management Review Meeting System
  • Training Management System
  • Self-Inspection System
  • Vendor Management System
  • Specification of all Materials & Finished Products
  • Test Procedures & Protocols
  • Stability Study
  • Master Formula Records
  • Batch manufacturing record & Batch Packing Record
  • Disposal Records
  • Release Records & Distribution Records

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, Microbiology & MLT Room

STABILITY CHAMBER

Instrument
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