The U.S. FDA issued a warning letter to GlaxoSmithKline after determining that GSK did not take sufficient action to resolve problems after contaminated APIs were found at the drugmaker's Ireland manufacturing plant.
The contaminated ingredient, paroxetine, is used to make antidepressant drugs Paxil and Seroxat. During an October inspection, an FDA investigator reported that paroxetine was contaminated with material from the Cork plant's pharmaceutical waste tank. According to the FDA, some batches of drugs using the contaminated ingredient were later shipped and GSK failed to notify its customers about the lapse.
The most strongly worded portion of the March 18 FDA warning letter stated, "We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact. In your response to the Form FDA-483, you acknowledged that you should have informed your customers of this incident; however, you did not describe any recent or future communication with your customers regarding the incident to rectify the prior lapse."
GSK has responded by stating its plans to recall certain batches of Paxil from wholesalers.From the FDA warning letter itself [I've changed the "(b)(4)" from the letter to "[redacted]"]:
(You have to love a letter that is addressed directly to the CEO. Wow.)...Your firm discovered that the [redacted] used to manufacture [redacted] batches of [redacted] and [redacted] batches of [redacted] was contaminated with material from your pharmaceutical waste tank, which contained APIs, intermediates, and solvents. (emphasis CJ's) Examples of chemicals that are collected in the waste tank include [redacted]. Your firm became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of [redacted] manufactured using the contaminated solvents on April 19, 2013. Your firm distributed [redacted] shipments of [redacted] potentially contaminated [redacted] batches after becoming aware of this significant deviation. In contrast, [redacted] batches made with the contaminated [redacted] were rejected.Quality impact assessments were made for both [redacted] and [redacted], but we note that the approach taken in the two assessments was different. For instance, the [redacted] assessment noted that the standard release testing did not detect significant quantities of contaminants in the potentially impacted [redacted] batches, but that additional testing on [redacted] from [redacted] showed the impacted batches were exposed to significant amounts of [redacted]. The assessment states that the sample preparation used in the [redacted] sample release testing appears to be incapable of complete extraction of the potential contaminants, and it therefore relied on results obtained from the additional testing from the [redacted] of [redacted] product to demonstrate that the [redacted] batches were impacted by the pharmaceutical waste contamination event. Your firm’s assessment for [redacted] included no such additional testing and relied on the [redacted] samples’ passing test results, concluding that there was no quality impact to the [redacted] batches.......Please also describe why the quality assessments appear to assume uniform distribution of contaminants following addition of [redacted] to the waste stream and before the backflow of contaminants into the [redacted] tank. Provide a revised quality assessment for [redacted] that clearly describes all calculations used to support the conclusions, and clearly describe any altered conclusions after addressing the issues described in this letter. For each analytical method used to support your conclusions, provide method qualification information, including the limit of detection for each potential contaminant. Also, provide a quality impact assessment for your [redacted] product, which was also manufactured using [redacted] around the time of the initial contamination in the [redacted] tank. Describe any contact you have had with the customers of the potentially affected products and your plans with respect to the disposition of any potentially affected batches that remain within expiry.
The oil and gas industry has been historically volatile and marked by boom-and-bust cycles caused by fluctuating commodity prices, with company prospects often tied to hit-or-miss exploratory drilling. Not surprisingly, the industry has struggled with periodic brain drain since the 1980s as students looking for steady employment and career growth have been turned off by such uncertainty.
Technological advances such as seismic imaging, horizontal drilling and hydraulic fracturing—all developed by private companies—have removed much of this volatility and changed the nature of the industry to more of a manufacturing operation. But now another source of even greater uncertainty has been injected into the mix: political and regulatory risk. This is one energy lesson that undergraduates are hearing loud and clear from their professors.Relax, all you wildcatters, the oil and gas industry's more like making license plates* these days. Ho hum.
We are investing heavily in new technologies for the manufacture of our drugs under an initiative termed Advanced Manufacturing Technologies (AMT). Among these technologies the Synthetic Biochemistry team (a cross-divisional, cross-scientific function, global team) is seeking to develop industrial biotechnology and synthetic biology approaches to create new routes for manufacture of drugs. We’re also looking to enable better chemocatalytic solutions through application of smart automation and catalyst design. We are seeking people across a variety of skillsets at sites in the US (Upper Merion, PA and Research Triangle Park, NC). These new AMT roles will be embedded within the current Global API Chemistry teams at these sites with the intention of growing current capabilities or introducing new skills to the team...
...If you are interested in a career in either chemical catalysis or synthetic biochemistry, there can be few better environments in which to pursue your ambitions than GSK. The positions will involve working within a multidisciplinary environment where you will be encouraged to expand your technical knowledge through a combination of courses, conferences and on-the-job experience.Sounds pretty interesting. 5 positions, M.S./Ph.D. Having 5 people spread out over a number of sites doesn't exactly sound like the most concentrated of efforts, though.
...NuLabel is actively searching for Coating Formulation Chemist and/or Polymer Scientist with a strong background in polymer chemistry to fill a Senior Scientist role.
Key Activities:
Requirements:
Last year, I offered cash stakes ($10) for anyone who would take the over on a over/under bet for US real GDP for 2013. Well, the US Conference Board finally (today) put the magic "actual value" asterisk on Q4:If you see anything whose propriety or legality causes you to hesitate, be sure to give me a call.I just got done reading this year's report (via this article that talks about Berkshire falling behind the S&P 500 of late) and I was struck by this list of Berkshire's largest stock holdings. Sure seems like they're invested in a lot of chemists:
However, it’s very likely that if a given course of action evokes such hesitation, it’s too close to the line and should be abandoned. There’s plenty of money to be made in the center of the court. If it’s questionable whether some action is close to the line, just assume it is outside and forget it.
It is upsetting that C&EN would feature an image of a burned animal being probed by a spectroscopist as some kind of evidence for progress in health science and diagnostics (C&EN, Jan. 13, page 28). In fact, the decision to include the photo of this shaved, burned, and undoubtedly traumatized mouse, strongly suggests that the magazine is out of touch when it comes to matters of taste and blind with regard to ethical considerations that should surround decisions involving animal research.The debate around animals in medical research is a heated one to be sure; interesting to see there is disagreement on the subject amongst chemists as well.
I would prefer that the researchers on this team shave and burn their own skin before anesthetizing and probing each other. I am serious. Not only would it be a better story, with more gripping photos, but it might also give such researchers pause as they consider the harm and suffering they inflict on their unfortunate lab animals.
Is it any wonder that much of our citizenry continues to regard animal-based scientific studies with revulsion? I hope that C&EN will adopt changes in its editorial review that considers and rejects coverage (and implied approval) of research invoking such obvious cruelty to animals.
David Cordes
Forest Grove, Ore.
Online Access To ACS Publications Is Restored After Some Customers Were Unintentionally Blocked
On Wednesday, a blog published information about a security feature that the American Chemical Society uses to protect the stability of its website and prevent unlicensed wide-scale downloading of its content. Curious readers who then clicked on the link provided in the post ended up disabling their institutions’ access to ACS publications, which include more than 40 journals as well as C&EN. The society has already restored access for the sites of approximately 200 affected customers.
Known as a “spider trap,” the security feature is designed to be triggered not by individual users but by automated website crawling and data extraction.
The spider trap information was posted by University of Cambridge chemist Peter Murray-Rust after he was told about it by an unnamed source, whom he dubbed Pandora. Murray-Rust reported that Pandora found the link associated with an online ACS journal article and clicked on it thinking it would lead her to another journal paper. She then received an automated message saying her institution’s access to ACS publications had been blocked.
Those who have clicked on the link and have unresolved issues can e-mail support@services.acs.org with their institution name, and ACS will work to reinstate access as quickly as possible.The original blog post by Peter Murray-Rust is pretty interesting -- read the comments to see all the people who were clicking the Spider Trap Link of Doom, and then finding out that they had accidentally cut off their institution from access. (Onion headline: "Fog in Channel, ACS cut off")
