Quality
Quality isn’t just a goal; it’s a promise we keep to our customers, healthcare professionals, and patients worldwide.
“Quality is not an act; it is a habit” – Aristotle
Managing quality encompasses the organisational structure, procedures, processes and resources to ensure that the Products meet the intended specifications on quality and purity.
All quality-related activities of Chemforte are clearly defined and documented with QA being independent of Production.
Chemforte having automated Document Management System reduces the risk of non-conformance as the entire process is automated and manual errors are eliminated. As retrieval of documents is a big challenge in the manual process the retrieval becomes easy in an automated DMS
Certifications & Accreditations
Our Hallmarks of Excellence in Pharmaceutical Practice
we prioritize excellence in pharmaceutical practices, ensuring the highest standards of quality, safety, and efficacy in every product we deliver. Our commitment to pharmaceutical certification encompasses rigorous adherence to regulatory requirements and industry best practices.
Approaching Quality with Customers in Mind
We validate and continually monitor our manufacturing processes to ensure the expected performance. Each of our products is tested to confirm compliance to Chemforte quality specifications and compliance standards.
As Chemforte is vertically integrated, we supply a substantial amount of our own active pharmaceutical ingredients and this allows us to closely control product quality. We are also strict with our external suppliers, who are obliged to meet the same tough requirements that we set for ourselves.
As a result, we have an enviable record of Current Good Manufacturing Practice (cGMP) compliance which is assessed by the US Food and Drug Administration (FDA) and other Global Regulatory Organizations
Quality Control (QC)
- QC lab includes maintaining GLP practices
- Testing includes Chemical Instrumentation
- Instruments used for analysis include HPLCs, GCs, UV, FTIR, TOC, Particle analyser
- Stability studies include Accelerated long term and intermediate storage conditions
- Perform analyst qualifications as per defined procedures
- Microbial Testing includes control of Bio-burden
Quality Control Process
- Stability Studies
- Testing
- Analytical Method Validations
- Release / Rejection of RM/ PM / IP / IM / FP
- Control Samples
- Analyst Training
- GLP Compliances
- QC Instrument Calibration
- LIMS implementation in Progress
Micro Biology
The microbiology laboratory is well designed and equipped with
- Microscope
- colony counter
- Autoclaves
- BOD incubators
- pH meters weighing balance Laminar airflow
Quality Assurance
Quality Assurance holds the responsibility of maintaining the Quality Management Systems (QMS) as per ICH –Q7, GMP and 21-CFR compliances. Handling of Quality Management Systems include
- Document control & Issuance
- Change Controls
- Deviations
- Market Complaints
- Qualifications
- Validation
- Material Release
- Self-Inspection
- Training
- Vendor Evaluation
- Caliber QAMS Basic Training completed under SAT
