Material Analysis
All raw and packaging materials are reviewed and tested before moving forward to ensure that only approved materials are used for production stage
Our Story
Everything About Our QC & QA System
At 9M India, quality control & quality assurance are prioritised at every stage of the manufacturing process. Our in-house quality check-in systems are designed to monitor the entire process, maintain consistency across each batch and ensure that every product displays our dedication to provide world class quality pharmaceutical solutions across diverse healthcare sectors.
By implementing essential testing protocols, we are able to uphold the highest standards of safety and efficacy in our products. This commitment not only enhances customer trust but also positions us as a leader in the pharmaceutical industry.
Our Capabilities
Precision-Driven Quality Assurance
9M India is raising quality standards in the pharmaceutical industry through disciplined check-ins and uncompromised consistency
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In-house Quality Control System
In-house strict quality check-in to ensure complete control, accuracy, and reliability at every step
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Consistent Output Across Batches
Each batch is closely monitored to ensure that the quality, performance, and consistency stay the same
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Quality Check-ins at All Stages
Several checkpoints throughout the process to ensure everything stays aligned with strict quality standards
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Documentation Ready for Compliance
All processes and batches are well-documented, which makes compliance and audits easy and hassle-free
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Controlled Manufacturing Environment
Production takes place in a controlled and monitored setting to ensure the quality and integrity of the product
The Process
How Our QC & QA Process Works
From raw materials to final batch dispatch, at 9M India we track, test and maintain consistent quality standards for every product.
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Process Monitoring
During the manufacturing process, structured check-in are carried out to track parameters and maintain consistency
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Product Testing
Finished batches are made to undergo final testing to verify quality, compliance and their performance before dispatch
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Stability
ProgrammeFinal products are evaluated against defined specifications and subject to ICH Q1A-aligned stability studies under Zone II, Zone III/IVa and accelerated conditions
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Final Product Release
Only after meeting the essential required standards and documentation check-ins, final products are released
Our Laboratory Systems
What Powers Our Laboratory Systems
At 9M India, our analytical laboratory operates as an extremely important part of the manufacturing process. Everything is handled in-house, reducing the chances of dependency on any separate or external procedures. Every Certificate of Analysis issued under 9M India is generated using our verified and highly trusted instruments, validated methods, and qualified analysts. This ensures complete accountability across the entire testing process, with no reliance on any third-party or external laboratory, no delays in turnaround, no unexpected costs or limitations and no gaps between manufacturing and documentation.
Our Key USPs
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HPLC Systems
For assay, related substances, and dissolution studies, using validated methods (validated ICH guideline)
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LAL Endotoxin Testing
Bacterial endotoxin testing to sterile products using gel-clot and turbidimetric techniques
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Particle Size Analysis
Laser-based analysis for micronised APIs and suspension-based formulations
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Microbiology Lab Setup
Supports sterility testing, microbial limit, preservative efficacy testing (PET), and environmental monitoring
We Keep Answer Short
Frequently Asked Questions
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Do 9M India's QC and QA systems match with international standards?
9M India provides structured quality control (QC) and quality assurance (QA) systems that follow ICH guidelines ensuring consistency across all products.
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Is testing conducted in-house or through third-party laboratories?
We manage all critical pharma solution testing in our in-house laboratory systems with no external dependencies ensuring full accountability.
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Do you provide stability data for regulatory submissions?
Yes, we conduct stability studies under the conditions defined by ICH, along with full reports to help with product registration, tenders, and export requirements.
Our Commitment
Our Commitment to Ensure Long-Term Product Life
Unlike most pharmaceutical companies who state nothing about their stability programmes when questioned by institutional, export and CDMO buyers, 9M India acknowledges that the role of shelf-life establishment is just as crucial.
Here at 9M India, we provide an established and structured stability data that is generated under defined ICH conditions, covering multiple zones and study types to support regulatory and market requirements.
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Real-Time Studies — Zone II (25°C / 60% RH)
Conducted for long-term stability studies for regulated markets including European and US based countries. Minimum 12 months of data is analyzed for lifecycle management.
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Accelerated Studies (40°C / 75% RH)
This study shows product stability, helping us analyze temporary claims about its shelf life.
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Tropical Real-Time Studies — Zone III/IVa (30°C / 65% RH)
The study is designed for India and other tropical markets and regions in Asia, Africa, and the Middle East to analyse the actual storage conditions.
Our Infrastructure
Advanced Manufacturing
Infrastructure
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