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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Extemporaneous Preparation with Unknown Stability

RX Note

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Metaverse or Virtual Reality? What is the Difference?

Pulses

Chandos Publishing; 2010:123-168. References Ley D, Parkes D, Walton G. 6-emerging technologies for learning. Web 20 and Libraries. Hamilton D, McKechnie J, Edgerton E, Wilson C. Immersive virtual reality as a pedagogical tool in education: a systematic literature review of quantitative learning outcomes and experimental design.

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Case Study 2 – The Journey Leading to an Approved NDA

Syner-G

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. Download a PDF of this case study. The Journey Leading to an Approved NDA.

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Extemporaneous Compounding

RX Note

A simple method is to use a small adhesive label to mark the position and thus produce a measure with just one graduation.) Furthermore, in late August 2020, the FDA approved labelling changes for hydrochlorothiazide (HCTZ) to inform clinicians and patients about the slight risk of developing non-melanoma skin cancer.

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Inhalers

RX Note

Moreover, even after the MDI delivers the number of puffs stated on their label, it may look, taste and feel like it is still working, but the dose delivered may be very low. Handling of Inhaler Devices, 2010 suggested that re-priming should be done for MDIs that are not used for more than 2 weeks. suds intact).

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10 Things To Do To Lower Your Toxic Burden

The Thyroid Pharmacist

Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises! They even have a trial package , so you can test their products out and see how they work for you! Published February 2, 2010.