Pfizer Hit With Warning Letter For Serious cGMP Manufacturing Problems
More Exclusive FDA and cGMP News April 10, 2013 FDA sent a serious warning letter to an Italian Pfizer plant this week. According to the letter, Pfizer violated some very basic cGMP regulations. One of the most serious was with its testing of samples of batches of a certain diluting agent, which was for its […]
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Does My FDA eCopy Submission Meet FDA Requirements?
April 9, 2013 We continue to see a lot of mass confusion and questions about FDA’s new eCopy initiative. We hope that our Webinar on FDA eCopy April 10 and May 2 will help registrants to better understand eCopy’s complex requirements. One of the most common questions we hear about eCopy is: How do we […]
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eCTD Tips – Transitioning from Paper To Electronic Submissions
April 9, 2013 We find that the successful adoption of the eCTD format means that you need to have the proper strategic assimilation of the proper people and the proper technology. And FDA has been busy the last few years promoting the many virtues of submitting documents electronically. As of 2012, about 70% of new […]
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How to Stay Compliant with 21 CFR Part 11
April 8, 2013 We all know we need to stay in compliance with all aspects of cGMP guidelines, but few FDA compliance subjects are more asked about than 21 CFR Part 11. According to some reports, the cost of complying with this FDA regulation can range from $5 million to more than $350 million, all […]
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Kabco Pharma Consent Decree Lesson – Provide Complete Warning Letter Reponse to FDA
April 8, 2013 The hammer has fallen on Kabco Pharmaceuticals. Kabo must shut down all production of its dietary products until it can prove that its quality systems and facilities meet cGMP guidelines. The consent decree came after FDA filed the complaint against Kabco in July 2012. This was after a warning letter from 2010 […]
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15 Simple Tips for cGMP-Compliant Quality Systems
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 8, 2013 If you want to have cGMP-compliant quality systems in your pharmaceutical operation, here are some easy tips to remember: SOPS Create a flowchart or process map before you start to assemble the language of the SOP. Try to write […]
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You May Not Even Know You are on Import Alert
April 8, 2013 So your drug company has some serious cGMP guideline violations. Were you aware that FDA will not necessarily tell you if your pharmaceutical company has been placed on import alert? It happens. In some cases, an importer may have gotten the product from a third country, or from a shipper not allowed […]
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How to Ensure FDA cGMP Compliance With Employees
April 5, 2013 We frequently hear from QA managers who talk about innovative ways to keep employees focused on cGMP regulations and to help all workers to understand their vital importance in modern drug production. There is no doubt that regular cGMP training can help to keep employees well trained on FDA compliance. But most […]
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cGMP Inspection Tip – Best and Worst 483 Response Letters
More Exclusive FDA and cGMP News! April 4, 2013 So, you had a cGMP FDA inspection, and you got a 483 with some cGMP guidelines violations. What is a good and a bad response letter to that 483? First of all, remember that the 483 is just a preliminary observation report from the FDA investigator. […]
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Beware of Repeat 483 Violations
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 4, 2013 We came across this week a warning letter dated March 18, 2013, issued by FDA to Keystone Laboratories in Bozeman, Montana. This cosmetics manufacturer was cited for a number of fairly significant GMP violations. The company didn’t maintain its […]
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