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Quality Control

Megasys quality control team ensures that the entered raw materials, thru the manufacturing process until the production of final product with specified shelf life in appropriate storage conditions are specification compliant to the applicable standards. These activities are aided with the help of HPLCs and product stability monitoring apparatus; coupled with Good Laboratory Practices. The physical, chemical and pharmaceutical parameters of products are monitored in all phases of their manufacturing, until the final product is delivered.

4.0.1

Quality Control activities

The laboratory facilities are designed, equipped and maintained to suit the testing of Raw materials, Packing materials, In process and Finished products by chemical, instrumental, microbiological methods and stability testing.

Quality control laboratory has a responsibility of microbiological and chemical testing of raw materials, in-process materials, finished products, stability samples, packing components  to ensure that they conform to appropriate written specifications. Starting materials are tested according to product specifications including IP/BP/USP/JP (wherever required).Raw materials are completely tested before the use. Dissolution tests perform on routine basis. Quality failures will be recorded as OOS and appropriate measure will be taken in this regard.

  • API analysis
  • Additive analysis
  • Stability testing
  • Microbial analysis
  • Sample management
  • Batch review
  • Emission analysis

Manufacturing area monitoring is carried out by plate exposure technique and air sampling environment control as per written down procedure for ensuring the optimal quality control.

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