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FDA / GMP

Good Manufacturing Practices (GMP)are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
Good manufacturing practices, along with good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United States, Canada, Europe, China, in addition to other countries.

Other good-practice systems, along the same lines as GMP, exist:

  • Good Laboratory Practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharma cology studies in animals)
  • Good Clinical Practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans
  • Good Regulatory Practice (GRP), for the management of regulatory commitments, procedures and documentation.
  • Good Distribution Practice (GDP), deals with the guidelines for the proper distribution of medicinal products for human use.
  • Good Transportation Practice (GTP), deals with the guidelines for the proper domestic and international transportation of medicinal products for human use.

Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. (Other examples include good agriculture practices, good guidance practices, and good tissue practices). In the U.S., medical device manufacturers must follow what are called "quality system regulations" which are deliberately harmonized with ISO requirements, not cGMPs.

Training on GMP Qualitas run on site and classroom training on GMP, validation and documentation writing. We also develop and provide training modules on topics such as Good Documentation Practices, cGMP Basics and cGMP Advance that you can use for your ongoing training needs. We also provide shop floor and practical training to workmen/operators/supervisory staff. Class room training is also provided to Officers/Executives/Managerial staff (Production/Warehouse/QA/QC/Marketing) followed by evaluation. We can provide Shop floor demos, practical training and certificates to fresher’s for immediate placement in their field of interest. Qualitas offers tailored on site training to the Pharmaceutical, Biotech industries, and Food industries. Training team together allows them to consider real life issues during the session. It also helps change management as everyone has the same understanding of what is …