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Home » Topics » Pharmaceuticals » GMPs

GMPs
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Poor Quality Factor in Stratus, Sonar Shut Down by Federal Judge

July 3, 2017
A federal district judge shut down drugmaker Stratus Pharmaceuticals in Florida and distributor Sonar Products of New Jersey with a permanent injunction Thursday. Read More

Manufacturing, Safety Concerns Sparks Phillips Recall

July 3, 2017
Phillips Co. is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed after an FDA inspection found significant manufacturing practices that call into question “the safety, identity, strength, quality and purity” of unexpired drug products made at the firm in the past three years. Read More

OPQ Emerging Tech Program Aims to Improve Quality

July 3, 2017
The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep pace with industry innovation. Read More

CFDA Conducted Fewer Foreign Inspections in 2016

July 3, 2017
China’s Food and Drug Administration only carried out a fraction of the dozens of planned GMP inspections of foreign sites last year. Read More

FDA Relaxes Medical Gas GMP Compliance Guidance

July 3, 2017
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More

Hospira Quality Problems Lead to Recall, Creates Ripple Effect

July 3, 2017
Quality issues and violations of FDA current good manufacturing practices are plaguing Hospira, triggering a series of recalls, contributing to a drug shortage and costing the drugmaker’s parent company a biosimilar license for a second time. Read More

Hospira’s Epoetin Biosimilar Delayed Following CRL Over GMP Violations

June 30, 2017
Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning. Read More

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

June 30, 2017
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More

Compounder Warned for Long List of GMP Violations

June 30, 2017
Empower failed to establish and follow written procedures for microbiological contamination. Read More

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

June 30, 2017
The previous version, issued in 2003, required that each container bear an expiration date, based on related storage conditions. Read More

Compounder Warned for Long List of GMP Violations

June 29, 2017
A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Read More

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

June 28, 2017
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More
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