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Sara Pharmaceuticals - Certifications
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WHO GMP - World Health Organisation Good Manufacturing Practice |
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Many countries follow the guidelines provide by WHO. Food and Drugs Control Authority India follows WHO guidelines. WHO GMP certification is a requirement and well accepted in most of the countries across Asia, Africa, CIS and Latin America
WHO Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
WHO GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP.
for more details about WHO GMP look here
http://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/index.html
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ISO - International Organisation for Standardization |
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ISO standards contribute to making the development, manufacturing and supply of products and services more efficient, safer and cleaner. They make trade between countries easier and fairer. They provide governments with a technical base for health, safety and environmental legislation.
They aid in transferring technology to developing countries. ISO standards also serve to safeguard consumers, and users in general, of products and services - as well as to make their lives simpler.
for more details about ISO look here
http://www.iso.org/iso/en/aboutiso/introduction/index.html
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IDMA - Indian Drugs Manufacturers Association |
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IDMA plays a vital role in the growth and development of the Indian Pharmaceutical Industry. This is a private certification for Quality Excellence. IDMA announces Quality Excellence award for the pharmaceutical manufacturer in India.
Sara Pharmaceuticals has participated in this award and has also won the Quality excellance certificate.
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