Ephedrines Project

FACILITY   QUALITY  QUALITY PHILOSOPHY Q.C. LABORATORIES cGMP   Experience in Fine Chemicals manufacturing and the opportunities in the sunrise biotechnology industry prompted Avon to enter into biotechnology by setting up a greenfield venture in Solapur. The passion of the entrepreneurs and the expertise of the team involved is evident in the state-of-the-art facility designed as per the cGMP guidelines and executed in a record time. The young and aggressive team managing this business has one motto - to be the best in the world.

FACILITY

A few hundreds of kilometers away from both Hyderabad - India's Bulk Drugs Capital   and Mumbai - India's Commercial Capital, 80,000 square metres of prime land at   Sholapur saw the setting up of a highly specialized plant with the state-of-the-art   equipment offering an installed capacity of 150 MT of Ephedrine HCL. The strategic location of the plant in a sugarcane-growing region provides easy access to the raw   material, namely Molasses. Full-fledged manufacture commenced in March 2001 of active pharmaceutical ingredients - salt of ephedrine and pseudoephedrine, both having a wide spectrum of applications. The cGMP guidelines for the production facility and the USFDA requirement have strictly been adhered to ensuring an exceedingly high level of quality, thus appealing to the US markets as well. An ISO 9000:2001 certification is well on the cards.

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QUALITY

Right from the drawing board the plant has been conceived keeping in mind   international requirements of the highest order, in terms of facility and cGMP   requirements. Minute attention has been paid to every engineering detail in the API unit, with a view   to protecting the product from environmental factors, right from raw material to the finished product.

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QUALITY PHILOSOPHY

To achieve and sustain market leadership for the products in national and international markets by providing quality products to meet the requirements of customers. This is achieved through the following quality objectives. Development of approved vendors and procurement of raw material from approved sources. Continuous R&D efforts to improve the process and Quality. Strict and systematic quality control procedures in establishing the quality of the product. Education and training of employees to improve the Quality. Adherence to cGMP norms as an integral part of the total quality management system. Assessment of changing requirements of customer's expectations and meeting them. Develop environmental awareness among employees and adherence to pollution control norms.

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QUALITY CONTROL LABORATORIES

In-process Quality control Lab works - 24 x 365 days - sufficient for all process testing requirements of the plant. Microbiology Lab of class 10,000 is used for  innoculum preparation and all Microbial testing. Wet lab is used for testing of Finished products Raw Materials and Water Instrumentation Lab - is well equiped with                                      HPLC                                      GC                                      Digital polarimeter                                      electronic analytical balance                                      UV Visual spectrophotometer                                      melting point apparatus, etc. The lab is used for conducting Stability studies and Product development studies

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cGMP

The various aspects of cGMP which are addressed by our Quality Assurance Team are SOPs, Validation protocols, QC Test methods, Starting material, In-process, Packaging, Material finished product specifications, Forms, Registers. The cGMP activities undertaken at the plant are listed below: Qualifications (i) Facility Qualifications                                      Microbiology Lab Qualification                                      DM Water System Qualification                                      Pharma Zone Qualification (ii) Equipment Qualifications                                      Critical Production and                                      Quality Control Lab Equipment (iii) Utility Qualifications                                      Steam Qualification                                      Air Qualification Validations (i) Concurrent validations (ii) Prospective validations (iii) Retrospective validations as applicable (iv) QC Analytical method validations Calibrations Training Internal Audits Change controls and deviation handling Document controls and SOPs for all stages The cGMP activities strictly adhere to the latest ICH guidelines and ensure that the process of manufacturing is validated to produce the product consistently meeting the best quality standards and customer requirements.                                                                                                                                                                                                                                                                                                                                                      Back