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The Texas Medication Algorithm Project (TMAP) [1] is a decision-tree medical algorithm, the design of which was based on the expert opinions of mental health specialists.It has provided and rolled out a set of psychiatric management guidelines for doctors treating certain mental disorders within Texas' publicly funded mental health care system, along with manuals relating to each of them The ...
Within quality management systems (QMS) and information technology (IT) systems, change control is a process—either formal or informal [1] —used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without ...
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The Texas Pharmacy Association was formed as the Texas Pharmaceutical Association (TPA) in the May 1879 in the back of a pharmacy in Dallas, Texas.The name was updated in 1994 to incorporate the idea of pharmacy as a multidisciplinary field that combines a tangible drug product with an intangible cognitive service, which has been developed to be known as Medication Therapy Management.
Pharmacy and Therapeutics (P&T) is a committee at a hospital or a health insurance plan that decides which drugs will appear on that entity's drug formulary.The committee usually consists of healthcare providers involved in prescribing, dispensing, and administering medications, as well as administrators who evaluate medication use. [1]
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.