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The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. According to the Project Management Institute , change control is a "process whereby modifications to documents, deliverables, or baselines ...
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).
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
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 first list of approved drugs, with information on how they should be prepared, was the London Pharmacopoeia, published in 1618. The first edition of what is now known as the British Pharmacopoeia was published in 1864, and was one of the first attempts to harmonise pharmaceutical standards, through the merger of the London , Edinburgh and ...
Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. [ 1 ] [ 2 ] It is a sub-discipline of health economics . A pharmacoeconomic study evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of ...
Configuration change control is a set of processes and approval stages required to change a configuration item's attributes and to re-baseline them. Configuration status accounting is the ability to record and report on the configuration baselines associated with each configuration item at any moment of time.
Setting quality and safety standards in pharmaceutical practices and pharmaceutical care: public authorities and the pharmaceutical industry devote much of their resources to ensuring the quality, safety and efficacy of medicines. However, the best treatment outcomes are only achieved when medicines are used safely and appropriately.