Compendial Compliance

The United States Pharmacopeial Convention (USP) launched a 12-month pilot Technical Assistance Program (TAP) to provide developing countries in sub-Saharan Africa with greater capacity to test the quality of medicines.

USP helps to improve drug quality in 32 countries.

Innovations protect the quality of temperature-sensitive products.

Last week, the US Pharmacopeia published proposed standards for the content, language, format, and appearance of prescription drug labels in an effort to enhance patient understanding and safety.

John Taylor to Serve as Acting Principal Deputy Commissioner after Joshua Sharfstein's Departure, and more.

USP is working to ensure quality standards and to increase public information.

The US Pharmacopeia (USP) has announced two new collaborations.

As part of a team, you will prepare meetings of European Pharmacopoeia groups of experts, contribute to the preparation of working documents for these groups, contribute to the elaboration and revision of European Pharmacopoeia texts and follow up meetings with a view to publication of scientific texts and memoranda.

As part of the Certification team, you will evaluate dossiers submitted with requests for revision of certificates of suitability to the European Pharmacopoeia and prepare draft reports; you will ensure consistency of assessment reports for similar products and consistency of the reports with the policy of the procedure, if necessary analysing and reporting any discrepancies.

The US Pharmacopeia released a statement this week that explains in more detail last January's recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28).

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

The EDQM inspection program helps to ensure the quality of APIs on the European market.

USP to Make Pharmacopeial Forum Free Online, And More.

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

PharmTech talked to anticounterfeiting experts to discuss terrorism as a source of counterfeit products.

Changing or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don?t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.

Manufacturers and regulators on both sides of the ocean move to ensure the safety of heparin and other globally distributed drug products.

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

The US Pharmacopeia recently convened a meeting of stakeholders to set goals for its 2010–2015 cycle.

Regulatory Roundup: USP and Russia's Roszdravnadzor Sign MOU

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

Sundlof Resigns as FDA's Head of Food Safety; and More

European Parliament Approves Proposals On Falsified Medicines and Pharmacovigilance; And More.

The authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The US Pharmacopeial Convention recently held its convention in Washington, DC.

The US Pharmacopeial Convention will hold its governance meeting next week in Washington, DC.

The US Pharmacopeial Convention welcomed Minghao Zhou of China's Zhejiang Provincial Institute for Food and Drug Control.

Collaboration has been key to the pharmacopeia's achievement.

As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges.

The United States Pharmacopeial Convention is recalling USP 33?NF 28.