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Home » Topics » Pharmaceuticals » GMPs

GMPs
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Facility Inspections Factor in Slow Generics Reviews, Says GAO

July 3, 2017
The FDA is improving its response times for generic drug applications, but facility inspections remain a major hang-up in the process, according to a GAO report. Read More

Warning Letter Roundup: Size Doesn’t Matter

July 3, 2017
Persistent problems with quality will draw continued scrutiny and citations from the FDA, regardless of company size. Read More

Ipca Products Banned From U.S. Market After Drug Shortage Ends

July 3, 2017
The FDA broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. The drugmaker’s continued GMP violations already kept most of the company’s products out of the U.S. market, but shortages led regulators to allow a handful of Ipca’s drugs into the country. Read More

483 Roundup: Sterility, Cleanliness Common Threads in Form 483s

July 3, 2017
Companies that are not keeping up with GMP cleanliness and sterility requirements are likely to get more than just a Form 483 from the FDA—they may get multiple visits from inspectors whose additional scrutiny could result in even more quality violations. Read More

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
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