United States Pharmacopeial Convention

United States, United States

United States Pharmacopeial Convention

United States, United States
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PubMed | iuvo BioScience., FDA., Health Canada., Material Needs Consulting LLC. and 10 more.
Type: | Journal: PDA journal of pharmaceutical science and technology | Year: 2016

A simulating leaching (migration) study was performed on a model container-closure system relevant to parenteral and ophthalmic drug products (PODP). This container-closure system consisted of a linear-low density polyethylene bottle (primary container), a polypropylene cap and an elastomeric cap liner (closure), an adhesive label (labeling) and a foil overpouch (secondary container). The bottles were filled with simulating solvents (aqueous salt/acid mixture at pH 2.5, aqueous buffer at pH 9.5, and 1/1(v/v) IPA/water), a label was affixed to the filled and capped bottles, the filled bottles were placed into the foil overpouch and the filled and pouched units were stored either upright or inverted for up to 6 months at 40C. After storage, the leaching solutions were tested for leached substances using multiple complementary analytical techniques to address volatile, semi-volatile, and non-volatile organic and inorganic extractables as potential leachables. The leaching data generated supported several conclusions, including that (a) the extractables (leachables) profile revealed by a simulating leaching study can qualitatively be correlated with compositional information for materials of construction, (b) the chemical nature of both the extracting medium and the individual extractables (leachables) can markedly affect the resulting profile and (c) while direct contact between a drug product and a systems material of construction may exacerbate the leaching of substances from that material by the drug product, direct contact is not a prerequisite for migration and leaching to occur.


PubMed | United States Pharmacopeial Convention, European Directorate for the Quality of Medicines & HealthCare EDQM and UK National Institute for Biological Standards and Control
Type: | Journal: Pharmeuropa bio & scientific notes | Year: 2016

An international collaborative study was organised jointly by the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC), the United States Pharmacopeia (USP) and the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe) for the establishment of harmonised replacement endotoxin standards for these 3 organisations. Thirty-five laboratories worldwide, including Official Medicines Control Laboratories (OMCLs) and manufacturers enrolled in the study. Three candidate preparations (10/178, 10/190 and 10/196) were produced with the same material and same formulation as the current reference standards with the objective of generating a new (3(rd)) International Standard (IS) with the same potency (10 000 IU/vial) as the current (2(nd)) IS, as well as new European Pharmacopoeia (Ph. Eur.). and USP standards. The suitability of the candidate preparations to act as the reference standard in assays for endotoxin performed according to compendial methods was evaluated. Their potency was calibrated against the WHO 2(nd) IS for Endotoxin (94/580). Gelation and photometric methods produced similar results for each of the candidate preparations. The overall potency estimates for the 3 batches were comparable. Given the intrinsic assay precision, the observed differences between the batches may be considered unimportant for the intended use of these materials. Overall, these results were in line with those generated for the establishment of the current preparations of reference standards. Accelerated degradation testing of vials stored at elevated temperatures supported the long-term stability of the 3 candidate preparations. It was agreed between the 3 organisations that batch 10/178 be shared between WHO and EDQM and that batches 10/190 and 10/196 be allocated to USP, with a common assigned value of 10 000 IU/vial. This value maintains the continuity of the global harmonisation of reference materials and unitage for the testing of endotoxins in parenteral pharmaceutical products. Based on the results of the collaborative study, batch 10/178 was established by the European Pharmacopoeia Commission as the Ph. Eur. Endotoxin Biological Reference Preparation (BRP) batch 5. The same batch was also established by the Expert Committee on Biological Standardisation (ECBS) of WHO as the WHO 3(rd) IS for Endotoxin. Batch 10/190 was adopted as the USP Endotoxin Reference Standard, lot H0K354 and vials from this same batch (10/190) will serve as the United States Food and Drug Administration (USFDA) Endotoxin Standard, EC-7.


Tirumalai R.,United States Pharmacopeial Convention
European Pharmaceutical Review | Year: 2016

From a microbiological perspective, pharmaceutical products fall into two categories - nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or its ingredients, but microbial bioburden control and proper sterilisation methods are critical considerations for the manufacturer throughout the product's lifecycle. This article outlines the scope and function of the United States Pharmacopeial Convention (USP) as well as the ongoing work of the Microbiology Expert Committee (Microbiology EC).


Hernandez-Cardoso A.,United States Pharmacopeial Convention
Pharmacopeial Forum | Year: 2014

Impurity measurements and control processes continue to evolve significantly as a result of scientific and technological innovations. These innovations, in combination with advancements in the field of toxicology, have contributed to the evolution of compendial standards for control of impurities in drug substances and drug products. As part of an ongoing monograph modernization initiative, U.S. Pharmacopeial Convention (USP) is updating general chapter Impurities in Drug Substances and Drug Products 〈1086〉 as it relates to the organic impurities tests for monographs in United States Pharmacopeia-National Formulary (USP-NF). In this issue of Pharmacopeial Forum, USP also proposes a new general chapter, Organic Impurities in Drug Substances and Drug Products 〈476〉. In late 2011, USP established the Impurities in Drug Products Expert Panel, with oversight from the Physical Analysis Expert Committee, to evaluate the current content of USP's impurities general chapters, 〈1086〉 and Ordinary Impurities 〈466〉, and General Notices and Requirements 5.60, Impurities and Foreign Substances. The Expert Panel was charged with making recommendations on updating the general chapters to align them with current standards and to help ensure the appropriate control of organic impurities in drug substances and drug products. The proposals of the Expert Panel are published in this same issue of Pharmacopeial Forum for public comments. The purpose of this Stimuli article is to (1) provide the rationale behind the revision of general chapter 〈1086〉 as it relates to organic impurities, (2) provide the rationale for the creation of general chapter 〈476〉, and (3) describe the scope of revision and the strategy for implementation.


Koch W.F.,United States Pharmacopeial Convention | Ma B.,United States Pharmacopeial Convention
Accreditation and Quality Assurance | Year: 2011

The United States Pharmacopeial Convention (USP) is an official public standards-setting authority for prescription and over-the-counter medicines and other healthcare products manufactured or sold in the United States. USP's standards are recognized and used in more than 130 countries around the globe. Over the last decade, USP has worked to advance measurement science for food and drug articles of commerce. Adoption of modern metrologic principles helps ensure that a measurement of one or more property values (attributes) of a food or drug article is acceptable without regard to when (time), where (space), or how (technology) the measurement was taken. The vision of USP is to achieve the international recognition, harmonization, and official acceptance for all USP reference standards based on sound scientific metrological principles. Current hot topics at USP, such as elemental impurities, adulteration, and contamination, as well as counterfeit drugs, are also discussed in this article. © 2010 Springer-Verlag.


Usp

Trademark
United States Pharmacopeial Convention | Date: 2012-12-18

Chemical compounds and biological cell cultures for laboratory testing use with monographs containing standards for drugs, dietary supplements and pharmaceutical excipients.


Trademark
United States Pharmacopeial Convention | Date: 2013-05-03

Chemical compounds and biological cell cultures for laboratory testing use with monographs containing standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients. Newsletters and books containing scientific research information on standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients. Providing online scientific research information on standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients.


Usp

Trademark
United States Pharmacopeial Convention | Date: 2013-05-03

Chemical compounds and biological cell cultures for laboratory testing use with monographs containing standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients. Newsletters and books containing scientific research information on standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients. Providing online scientific research information on standards for drugs, pharmaceutical excipients, dietary supplements and food ingredients.


PubMed | United States Pharmacopeial Convention
Type: Journal Article | Journal: Drug testing and analysis | Year: 2016

The United States Food and Drug Administration (FDA) issued the dietary supplement (DS) current good manufacturing practice (GMP) regulations in compliance with the mandate from the Dietary Supplements Health and Education Act (DSHEA), with the intention of protecting public health by ensuring the quality of DS. The GMP regulations require manufacturers to establish their own quality specifications for identity, purity, strength, composition, and absence of contaminants. Numerous FDA-conducted GMP inspections found that the private specifications set by these manufacturers are often insufficient to ensure adequate quality of dietary ingredients and DS. Wider use of the public standards developed by the United States Pharmacopeial Convention (USP), in conjunction with GMP compliance, can help ensure quality and consistency of DS as they do for medicines. Public health protection could be enhanced by strengthening the GMP provisions to require conformance with relevant United States Pharmacopeia-National Formulary (USP-NF) standards, or in the absence of USP standards, other public compendial standards. Another serious concern is the presence of synthetic drugs and drug analogues in products marketed as DS. Use of the new USP General Chapter Adulteration of Dietary Supplements with Drugs and Drug Analogs <2251> may reduce the exposure of consumers to dangerous drugs disguised as DS. Copyright 2016 John Wiley & Sons, Ltd.


Trademark
United States Pharmacopeial Convention | Date: 2012-11-28

Newsletters and books concerning information on drug use and drug standards.

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