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USP Introduces Useful Guidelines on Sterilization and Contamination Control

USP Introduces Useful Guidelines on Sterilization and Contamination Control

May 15 | Articles

A product recall is problematic for any manufacturer. In the last year alone, recalls of pharmaceutical and health-related products have included baby lotions, parenteral nutrition products, nasal decongestant sprays and alcohol swabs used in preparation for patient injections—all resulting from microbial contamination.

Dr. Janet Woodcock of FDA on OTC Drug Quality

Dr. Janet Woodcock of FDA on OTC Drug Quality

Sep 15 2011 | Video

The FDA's Dr. Janet Woodcock talks about the joint efforts by FDA, USP, and manufacturers to improve and secure the quality of these consumer products.

FDA Commissioner Hamburg On The FDA-USP Partnership

FDA Commissioner Hamburg On The FDA-USP Partnership

Oct 21 2010 | Video

FDA Commissioner Dr. Margaret Hamburg discusses the role that quality standards play in helping to secure the drug and food supplies; the globalization of these industries; and the FDA-USP partnership.

Standards Evolve to Meet Needs of Pharmaceutical Industry, Advance Public Health

Standards Evolve to Meet Needs of Pharmaceutical Industry, Advance Public Health

Oct 20 2010 | Articles

The quality and safety of the U.S. (and international) drug supply has garnered much attention over the past year. Whether it is quality control problems in popular medications, heists resulting in stolen pharmaceuticals, substandard, adulterated, or counterfeit drugs being sold in developing countries (and even in developed nations), the industry has faced a barrage of negative headlines.

USP's CEO Talks About Quality Standards

USP's CEO Talks About Quality Standards

Oct 19 2010 | Video

Dr. Roger L. Williams, USP chief executive officer, offers his thoughts on why public standards for medicines and foods are so critical; USP's process for developing standards; USP's close cooperative relationship with FDA; and the future of standards.

USP Advisory Panel Recommends Standardizing Prescription Container Labeling

May 11 2010 | News

To promote the establishment of universal standards for prescription medication labels -- and to address the widespread problem of patient misinterpretation of medication instructions -- an advisory panel formed by the U.S. Pharmacopeial Convention (USP) recently issued a set of recommendations to bring consistency to labeling on dispensed prescription packaging.

USP-WHO Study One-Third of Antimalarial Medicines Sampled in Three African Nations Found to be Substandard

Feb 8 2010 | News

The first results from a large-scale study of key antimalarial medicines in ten Sub-Saharan African countries reveal that a high percentage of medicines circulating on national markets are of substandard quality

Teva Animal Health, Inc. Expands a Voluntary Nationwide Recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL Vials

Dec 22 2009 | News

Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level.

Lilly Announces the First 300-unit Vial of Insulin

Dec 8 2009 | News

Eli Lilly and Company today announced the availability of a smaller insulin vial, the first in the United States containing 3 mL (300 units) of insulin, for people with diabetes being treated in a hospital.

USP Clarifies Proposed Revised Standard for Labeling of Injectable Drug Vials

Nov 24 2009 | News

To help prevent medication errors that can occur in busy clinical settings, the U.S. Pharmacopeial Convention (USP) is posting a proposed revised standard for what should—and what should not—appear on the ferrules and cap overseals of medications vials.

Blogs

The Tale of Two Deviations

The Tale of Two Deviations

Apr 23 | The QA Pharm

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Apr 16 | Girish Malhotra, PE, President, EPCOT International

The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.

Multimedia

Lung Cancer Drug Treats Rare Lymphoma Tumors

Lung Cancer Drug Treats Rare Lymphoma Tumors

May 17 | Video

A new study found Xalkori effective in treating anaplastic lymphoma among children, an encouraging development for gene-targeted therapy.

Merck - 2012 Facility of the Year Award - Facility Integration

Merck - 2012 Facility of the Year Award - Facility Integration

May 14 | Video

Brian Morrissey, Senior Project Engineer, Merck Manufacturing Division, talks to Pharmaceutical Processing's Editor In Chief Mike Auerbach during INTERPHEX 2012 about the company's Vaccine Bulk Manufacturing Facility Program of Projects. The facility has won the Facility Integration award in the 2012 Facility of the Year Award competition sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine.

Medicine from a Vending Machine?

Medicine from a Vending Machine?

May 3 | Video

A Chinese company is pushing for acceptance of traditional Chinese medicine with a machine that can dispense herbs.

Taking Precautions to Prevent Contagion

Taking Precautions to Prevent Contagion

Apr 29 | Video

With the recent outbreak of viruses such as SARS, bird flu and swine flu, officials and travelers are being extra careful about preventing the illnesses from being transmitted.

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