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In 2011 the Food and Drug Administration published a report [1] outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in Process Validation.
The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting.
p.v., PV per vaginam: vaginally q quaque: every, per q.1 h, q.1° quaque 1 hora: every 1 hour (can replace 1 with other numbers) q4PM at 4:00 pm (can replace 4 with other numbers) mistaken to mean every 4 hours q.a.d. quaque alternis die: every other day q.a.m. quaque die ante meridiem: every morning (every day before noon) q.d./q.1.d. quaque die
Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
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.
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Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.