Search results
Results from the WOW.Com Content Network
It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. [1]: "Decision Makers' Summary", [2] Regulatory agencies have recently begun to look at more fundamental quality metrics of manufacturers than just compliance with basic GMP regulations.
Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. [8] Probably the best known industry guidance available is the GAMP Guide, now in its fifth edition and known as GAMP5 published by ISPE (2008). [9]
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome. Quality Assurance is the planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements.
With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
Pharmacopoeial reference standards are a subset of pharmaceutical reference standards. They are established for the intended use described in pharmacopeial texts (monographs and general chapters). Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where ...
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
Healthcare quality and safety require that the right information be available at the right time to support patient care and health system management decisions. Gaining consensus on essential data content and documentation standards is a necessary prerequisite for high-quality data in the interconnected healthcare system of the future.