Quality on Austere

Austere Pharma facility at UK, started its commercial production from 2005. The plant is in accordance with the guidelines of various international regulatory bodies like US-FDA, TGA, MHRA, MCC, WHO, ANVISA etc, which is the true testimony of Megasys’s commitment towards quality and safety. Such standards helped Austere to attain strong footholds in the global market.

It has been serving customers promptly at an affordable cost. The facility is WHO & GMP certified. No toxic or hazardous products are being manufactured in this facility.

Quality Assurance

The well-structured Quality Assurance system help Megasys to deliver their primary objective consistently – that is to create and deliver safe, effective yet affordable pharmaceutical preparations that can succeed in this competitive market place. The metrics integrated monitoring system with dedicated staff at all relevant levels empowers their Quality Assurance team to excel in their objectives. The well-defined Quality Assurance protocol ensures that all products meets the prescribed quality standards of safety and efficacy.

Quality Assurance Functions

• Adherence to GMP, GLP and GDP
• Controlled operations
• Specified roles and responsibilities
• Packaging standards
• In-process quality control
• Equipment calibration
• Finished product quality control
• Marketing authorization
• Storage and shelf-life quality
• Quality audits
• Product registrations

Quality Control

Austere 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.

Quality Control activities

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.