GMP, Good Distribution Practice & 21 Cfr Part 11 For Pharmacy & Health
Good Manufacturing Practice (GMP)
A 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. 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.
Good distribution practice (GDP)
Good distribution pratice deals with the guidelines for the proper distribution of medicinal products for human use. Good Distribution Practice also found in Testo is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.
Testo products have Good Distribution Practice which regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
21 CFR Part 11 regulation
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records
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