Subscribe
  
IPQ Inside the global regulatory dialogue

Your Search Results

IPQ Monthly Update, July/August 2013

The IPQ Monthly Update for July/August 2013 is now available....

FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....

FMD Implementation in Europe Drives Better API Sourcing Knowledge and Interagency Communications

Implementation of Europe’s Falsified Medicines Directive (FMD) has shed important light on what the active pharmaceutical ingredient (API) part of the global pharmaceutical supply chain actually looks like and has led to enhanced communication between the countries that participate in it....

Analyses of Defect Reports by Ireland’s IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area

Analyses by the Irish Medicines Board (IMB) and FDA of their data on deviation reporting over the past few years indicate the prominence of packaging and labeling as a problem area in the pharmaceutical manufacturing arena....

Compounder Recalls, 483s and Warning Letters Continue in Wake of FDA Inspection Blitz

The wave of recalls of contaminated preparations and FDA-483s is continuing as FDA’s extensive inspection blitz of compounding pharmacies across the US hits the four-month mark....

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

Pharmacy compounding will remain center stage as FDA’s focus on drug quality continues to intensify, FDA Commissioner Margaret Hamburg told attendees at the 2013 Food and Drug Law Institute (FDLI) Annual Conference in late April in Washington, D.C....

FDA Inspection Blitz Reveals Weakness in Sterile Practices at Large Compounders

A review of the initial results from an inspection blitz of about 30 high-volume sterile pharmacy compounding operations nationwide launched by FDA in late February shows a clear pattern of weakness in their sterile practices including environmental monitoring, gowning, personnel practices and sterility/endotoxin testing....

Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

An early February letter from CDER Director Janet Woodcock to hospital infusion/admixture supplier PharMEDium Services puts compounders and the hospitals they serve on notice that the agency will expect compounded preparations to be linkable to the specific patient using them....

CDER Officials Shed Light on Forces Impacting Generic Injectable GMP Compliance and Drug Shortages

FDA’s current engagement with the GMP compliance problems in the generic injectable arena illustrates the tightrope the agency is walking in trying to protect patients against substandard, high-risk products, while at the same time trying to assure that they have access to the critical medicines they need...

Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility – focusing more heavily on identifying and monitoring critical process steps than on reviewing batch records....
Pages: Prev 1 2 3 4 5 6 7 8 9 10 Next

Subscription Benefits

SUBSCRIBE TODAY and get 24/7 access to the IPQ family of publications:

.
● “In the News” — breaking stories on our website

● “News Alerts” — sent via email

● “Monthly Updates” — the key CMC and GMP developments in the US, Europe and internationally

● “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern

Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

.

 

CLICK HERE  for the IPQ Monthly Update – July 2021 in Review


IPQ takes its readers from:

● the headlines to the forces driving them

● regulations and policies to their underlying intent

● the pieces of the puzzle to their interconnection

● requirements to implementation pathways

● random data to critical trends

● the sidelines to helping shape the outcome

● compliance problems to proactive quality tools

● information to intelligence

.

©2021 IPQ Publications