Over the last several years, life sciences industry have failed not due to innovative product or technology being developed but due to improper laboratory management. QMICS Solutions in partnership with Soma Life Science Solutions aims to provide the highest quality training and con-sulting to life science professionals and industries.
As the global leader in quality life sciences industry, we offer range of consulting options for professional development in pharmaceutical, medical device, biotech disciplines. We also provide customized training and consulting by conveying content relevant to the needs of life science professional as well as life science organizations.
MANUFACTURING MANAGEMENT :
Every manufacturing facility must be in compliant with regulations to man-ufacture pharmaceutical, biologic, medical device, food, beverage or cos-metics. To be in compliant, manufacturing facility must refer to both, a standard and a guideline:
a standard sums up the requirements to a quality management system
a standard sums up the requirements to a quality management system
GOOD MANUFACTURING PRACTICES (GMP) :
Good manufacturing practices (GMP) are the practices required to conform to the guidelines set by regulatory agencies that provide minimum requirements for a manufacturer to assure that their products are consistently high in quality, from batch to batch, for their intended use. Guidelines regulate the manufacturing of phar-maceutical products, medical devices, biologics, dietary supple-ments, cosmetics and food. GMP rules may be mandated different-ly for each industry to ensure the quality of the product and pre-vent harm to the end user. Main purpose of GMP practices is to en-sure that end product is free from contamination, lot to lot variabil-ity is absent or low, process is well documented, personnel are well trained, and facility is built in compliance with regulations. Effective quality management system (QMS) is used to ensure that product is being manufactured in compliance to GMP guidelines.
