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Quality assurance. Quality assurance ( QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product (s) delivered to customer (s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer.
Good clinical practice ( GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of ...
Validation (drug manufacture) The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products ...
t. e. Current good manufacturing practices ( cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
The National Committee for Quality Assurance ( NCQA) is an independent 501 (c) (3) nonprofit organization in the United States that works to improve health care quality through the administration of evidence-based standards, measures, programs, and accreditation. The National Committee for Quality Assurance operates on a formula of measure ...
Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences.
Verification and validation. Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000.
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...