Quality Management System
Ensuring global pharmaceutical compliance and reliability
Built for Global Compliance
Our QMS aligns fully with ICH guidelines and is 21 CFR compliant. We perform in-house Analytical Method Validation (AMV), Process Validation (PV), stability and hold-time studies across APIs and intermediates.
ICH & 21 CFR Compliance
Meeting the toughest international standards
AMV & PV
We validate and confirm every process
Stability Studies
Long and short-term stability with hold-time studies
QA + QC Integration
Advanced QC lab; QA oversight for precision
Accreditation
Recognized and compliant with global regulatory bodies and certifications
WHO GMP Certificate
ISO 9001:2015 Certificate
ISO 14001 Certificate
Quality Control and Quality Assurance
Quality Control (QC)
Quality Control at Karunesh Remedies ensures that all APIs meet defined quality, safety, and regulatory requirements through systematic testing and evaluation.
QC activities include:
- • Raw material testing and qualification
- • In-process controls and monitoring
- • Finished product analysis and testing
- • Long-term and short-term stability studies
- • Data review using validated analytical methods and calibrated instruments
The QC function conducts in-house Analytical Method Validation (AMV) to establish the accuracy, precision, specificity, robustness, and reliability of analytical methods.
QC supports and executes Process Validation (PV) activities by performing analytical testing for validation batches, ensuring that manufacturing processes consistently produce APIs meeting predetermined quality attributes. All activities are documented to maintain data integrity, traceability, and regulatory compliance.
Quality Assurance (QA)
Quality Assurance at Karunesh Remedies is responsible for maintaining an effective quality management system in compliance with cGMP and WHO guidelines. QA oversees documentation control, validations, change management, deviations, CAPA, audits, and batch release, ensuring quality is embedded throughout the product lifecycle.
Quality Excellence
Our team excels in implementing and maintaining rigorous QMS knowledge that drive
QC
✦21CFR Part 11 compliant
✦State-of-the-art QC Department with latest equipment's like IR / GC / HPLC / UV and Karl Fischer
✦In-house Long term and Short term stability studies
✦Drug Master File supported by our Quality Control division
ADL
✦In-house Analytical Method Validation for APIs & Intermediates
RA & QA
✦Robust Regulatory and QA department ensures stringent quality control
✦APIs are manufactured as per ICH Q7A guidelines / GMP norms
✦ISO 9001-2015 certified
✦ISO 14001-2015 certified
✦Written confirmation certificates
✦WHO GMP certified
Our QA & QC Department
State-of-the-art facilities and equipment for quality assurance and control
Advanced Laboratory
State-of-the-art testing equipment
Quality Testing
Precision analytical methods
Cleanroom Standards
ISO certified controlled environment