23-11-2012, 06:11 PM
Smilax Laboratories Limited
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INTRODUCTION TO SMILAX:
Smilax Laboratories Limited is a research driven, vertically integrated pharmaceutical manufacturing company that manufactures Active Pharmaceutical Ingredients (APIs), API Intermediates and NDDS/Pellets for the global generics market.
Smilax has incepted its journey in the world of Pharmaceuticals during the year 2005. Within three years Smilax has became a reliable supplier of its products across the globe.
Smilax has the capability of manufacturing APIs and API Intermediates in its state-of-the art manufacturing facilities located in Hyderabad and Vishakhapatnam, Andhra Pradesh, India.
Smilax is growing from strength to strength with its highly qualified and competent technical team, combining its R&D strengths, manufacturing capabilities.
Smilax is extending its foot prints in the world of pharmaceuticals day by day.
MISSION:
To become a reliable source for APIs and its Intermediates for large reputed pharmaceutical manufacturers operating in the regulated markets across the globe, with a special emphasis on contract research and contract manufacturing.
VISION:
To be a successful research driven vertically integrated API manufacturing company with core strengths in-
• R&D,
• Quality management,
• Manufacturing,
• Cost effective processes.
ETHICS AND VALUES:
A set of core values steer us through the process of transforming into a high performing and care taking organization for the customers and society, creating long-term benefits for our clients, employees, suppliers, and all others we offer our services.
• Quality,
• Customer Service,
• Leadership,
• Team work,
• Dedication and commitment,
• Business ethics and
• Social responsibility.
Smilax ensures its products and services are the "best in class". Smilax delivers excellence and strives for continuous improvement.
GLOBLE PRESENCE:
Smilax’s commitment towards quality standards in all business processes given the stand to have a established presence and supply to the emerging pharmaceutical markets such as Europe, Canada, South America, Middle East, Far East Asia etc. and exporting more than 16 Countries across the Globe.
Smilax has strong commitment to the global market place. Smilax has a strategy of pursuing a worldwide customer base.
Smilax has built a strong presence in Healthcare encompassing Active Pharmaceutical Ingredients (APIs), API Intermediates and New Drug Delivery system (NDDS)/Pellets within no time from its inception.
QUALITY CONTROL:
It describes the steps necessary to ensure the effective control of stability and trial testing programs of new and existing products.This procedure is focused on setting up of stabilityprograms, testing, reporting, general sampling procedure for stability programs, data generation and analysis, annual maintenance of stability, new product stability procedure, procedure for in house trials, reporting and interpretation of trials and conclusion of the trail program.
QUALITY ASSURANCE:
In this episode you will find procedures and practical work instructions on every aspect of Quality Assurance and Technical areas to build up a highly effective Quality Management System for your pharmaceuticals business.
In this area you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of
Quality and Master file documentation necessary for your products; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and certification procedure; rework procedures for the defective manufactured products; procedures on training for your staffs and many other procedures according to your need. All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed
separately.
UTILITIES:
The design,construction and start up phase of the clean utilities plant were managed under GMP (good manufacturing practice) allowing the project to be executed in an orderly standardized from recognized by the pharmaceutical industry. It is the most important part of the pharmaceutical industry. It is related with the production, storage and distribution of steam, brine, chilled water, etc.
1. Generation of steam:
Light diesel oil is continuously ignited in a chamber and water flows around the chamber in spiral coil path. Due to high rate of heat transfer, water is converted to steam. It is in stored in insulated chamber and supplied to plant according to need.
2. Generation of Brine and Chilled water:
Water is purified and cooled with the help of compressors and stored in insulated chamber. Similarly brine is produced by adding MEG(methyl ethyl glycol) to purified water. This water is cooled with the help of compressors and stored in insulated chambers. Temperature range of chilled water is 5-6 C and that of brine water is -25 C.
SAFETY POLICY:
It is the policy of Smilax Laboratories Limited to remain committed to manufacture active pharmaceuticals, API Intermediates in good & established practices and in strict compliance to the safety and environmental regulations.
Smilax is committed to provide, manage and maintain a work environment which is reasonably practicable, safe and in which risks to health are controlled.
In addition Smilax shall make every effort to:
• Conserve and safeguard natural resources,
• Create awareness on safety, environment and health ,
• Implement systems of work that are safe,
• To continuously upgrade technologies and processes to minimize the waste by implementing the techniques of recovery, recycle and reuse.
CONCLUSION:
1. Bulk drug industry is a growing industry. The growth and achievement of the Indian bulk drug industry has been highest among the developing countries.
2. So by doing in-plant training at bulk drug industry I come to know the various strategies and techniques used in pharmaceutical industry.
3. This session of In-plant training had given me a plenty of information about the overall factors in a pharmaceutical company.