International journal of pharmaceutical compounding
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Despite the numerous industrially manufactured medicines available in the market, extemporaneously prepared drugs still have their niche among the services offered by the pharmacies. The physicians prescribe extemporaneously prepared drugs for special patient groups that require custom approach. Therefore, physicians' knowledge about extemporaneously prepared drugs and experience in prescribing them is the main precondition for satisfying patients' needs. ⋯ Otorhinolaryngologists most commonly prescribed nasal drops and semi-solid dosage forms. Pediatricians, as well as general practitioners and otorhinolaryngologists, favored nasal drops. To find out the opinion of general practitioners, dermatovenereologists, otorhinolaryngologists, and pediatricians on extemporaneously prepared drugs and the factors that hinder or facilitate their prescription, an extension of the study is planned that will include partially structured, in-depth, qualitative interviews.
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Process analytical technology was introduced by the U. S. Food and Drug Administration about 20 years ago to assist the pharmaceutical industry in making changes that should reduce batch failures, ensure performance, and enhance quality. ⋯ The purpose of this article is simply to introduce the concept of process analytical technology into compounding with the understanding that it will take a number of years for it to be evaluated and implemented, even on a small scale. It is not feasible to do it all at once; just one step at a time. Since patient safety is uppermost in compounding, this concept should be considered.
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What do you do when something goes wrong in your cleanroom? What do you do when a sterility test fails and what are the implications of such a failure? What should you do when your environmental monitoring or personnel monitoring provides results that exceed your action levels? A root cause analysis is needed in any situation where action levels are exceeded or tests are out of specification. However, should the questions be what can be done to prevent these occurrences, and how can the development be noticed before they occur? In this article, we will discuss going beyond the recommendations of United States Pharmacopeia Chapter <797> to attempt to build a program that limits the possibility of contamination through monitoring of the facility, personnel, and procedures in aseptic processing. ⋯ S. Food and Drug Administration that address monitoring of sterile compounding and aseptic processing.
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Compounders engaged in making sterile preparations need to employ a quality-assurance system of documented policies and procedures to attempt to reduce the possibility of contamination. The quality-assurance program will be monitored through the facility's quality-control system. Compounders should be aware of the requirements of each state they are licensed in as well as the inspection observations commonly noted in 483s issued by the U. ⋯ Food and Drug Administration. Part 1 of this 2-part article discussed the currently evolving regulatory environment and why sterile compounding requires planning and monitoring to deliver quality compounds to patients. Part 2 examines the United States Pharmacopeia's discussion on the principles of quality assurance and quality control in sterile compounding.
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Compounders engaged in making sterile preparations need to employ a quality assurance system of documented policies and procedures to attempt to reduce the possibility of contamination. The quality-assurance program will be monitored through the facility's quality control system. Compounders should be aware of the requirements of each state they are licensed in as well as the inspection observations commonly noted in 483s issued by the U. ⋯ Food and Drug Administration. In part 1 of this 2-part article, we discuss the currently evolving regulatory environment and why sterile compounding requires planning and monitoring to deliver quality compounds to patients. Part 2 will examine the United States Pharmacopeia's discussion on the principles of quality assurance and quality control in sterile compounding.