The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.
Report indicates persistent challenges and concerns with FDA foreign inspections.
The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical devices life cycle. What is new?
The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).
A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.
From inadequate cleaning to poor laboratory controls of quality and purity - a manufacturer of homeopathics in the U.S. received a Warning Letter from the FDA.
European Warning Letters? Is there such a thing? Basically, no. Warning Letters are issued by the US-American FDA. However, there is something "comparable" namely the "Non-Compliance Reports" published in the Eudra GMDP database. Now, one may question what the authorites has complained about in the last 3 months.
Water systems are one of the most important systems in the pharmaceutical industry. What are the GMP requirements for the qualification and running of these systems? The US GMP regulations (21 Code of Federal Regulation (CFR) 210/211) do not provide much concrete information on this. There is still a Guide to Inspection for FDA inspectors from the early 90s. So, what does the FDA expect today? A current Warning Letter provides a few answers.