Quality
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 VNAI are clearly defined and documented with QA being independent of Production.
VNAI 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
Producing Quality Products that Improve Lives
Our uncompromising commitment to quality and compliance begins with the research and development, covering each stage of the drug development, commercialization process, procurement of raw materials, approval of our product submissions by regulatory authorities around the world and commercial distribution.
Our quality and compliance professionals are a key part of the manufacturing process. They play a crucial role in meeting our quality commitments to customers as well as to the regulatory agencies that approve our medicines.
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 VNAI’s quality specifications and compliance standards.
As VNAI 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 analyzer
- 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
Major tests are carried out in the Microbial monitoring environment subjecting water supplies and the final products to microbial tests. There is a dedicated Change Room at the entrance of the Microbiology laboratory which helps in avoiding contaminations. The laboratory is controlled by maintaining Differential Pressure across various rooms.
Quality Assurance (QA)
Quality Assurance holds the responsibility of maintaining the Quality Management Systems (QMS) as per ICH –Q7, EU 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
- Caliber LMS Basic training completed under Configuration.
- Centralized document storage followed by Compactor for archival of documents
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