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 Active Pharmaceutical Ingredients - Quality Management
MSN is committed to deliver highest Quality products by implementing and complying to various Quality Systems through our Quality Assurance and Quality Control Organizations.
Quality Systems / Compliance
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Established Quality Systems (as per ICH Q 7, US FDA – 21 CFR and Schedule-M) |
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Our Quality Systems got Audited by several Regulatory Authorities and got approval |
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Full fledged Regulatory Affairs Team |
Regulatory Approvals / GMP Certifications / Quality Certifications
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COS Granted for Terbinafine HCl & Alfuzosin HCl |
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MSN facilities have received ISO 9001:2000 Certifications |
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MSN facilities have received the WHO GMP Certifications |
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EU-GMP Certification from NIP Hungary for MSN Laboratories Ltd & MSN Pharmachem Pvt Ltd |
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USFDA approval for MSN Laboratories |
QA / QC
Quality Control Facility
MSN Quality Control is equipped with state of the art quality testing equipments which are handled by well qualified and trained personals to ensure the Quality & Specifications of the Products are met as per customer requirements.
Quality Control department facility is available to perform various activities like
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Testing of samples to meet customer specifications |
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Control of all Raw Materials, Intermediates and final API |
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Chemical Analysis (Wet Laboratories), Instrumental Analysis, Particle Size Analysis |
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Control Samples Storage |
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Develop, Validate and Operate Robust Analytical Procedures and provide Analytical Support |
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Various Analytical Techniques are employed to meet Customer Specifications |
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Quality Assurance Department
Quality assurance department is mainly responsible for the site specific maintenance, Compliance and realization and the further development of internal quality management system. The Quality Assurance guarantees that pharmaceutical ingredients and other products comply with the respective requirements and are developed, produced, tested and released according to cGMP-demands.
The Quality Control supports the Quality Assurance in the accomplishment of the cGMP-demands, mainly in the field of release analytics.
Major activities handled by Quality Assurance are
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Document Control |
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Review of all Validation of all critical processes and procedures |
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Change Control & Deviations |
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On-going internal auditing, customer auditing, and review |
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Complaints |
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GMP Training |
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Product Release |
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Annual Product Reviews,...etc., |
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