gmp

FDA Embarks on Warning Letter “Rampage”

Last week the FDA released an astonishing 23 warning letters along with an import alert to a number of companies located across the globe. According to a recent article from Law360, the letters were...

FDA Issues Warning Letter to Chinese API Manufacturer After Lying to the Agency During Inspection

Late last month, FDA released a warning letter that had been sent to Xiamen Pharmaceutical Co., Ltd., outlining a number of “significant deviations from current good manufacturing practice (CGMP) for...

FDA Outlines Policies for Compounding Drug Products That Are Essentially Copies of Approved Drugs Under Section 503B of the FD&C Act

In our preceding FDA News article, we focused on the content of the first draft guidance, which addresses restrictions concerning the compounding of drug products that are essentially copies of...

FDA Addresses Extrapolating Adult Data for Pediatric Use

In 2004, the FDA issued a guidance document, entitled “Premarket Assessment of Pediatric Medical Devices.” The guidance stated that, when consistent with scientific principles, data can be...

FDA Issues Draft Guidance On Quality Attributes to Consider When Developing Chewable Tablets, Part One: Introduction & Overview

On Thursday, June 17th the FDA issued a draft guidance entitled “Quality Attribute Considerations for Chewable Tablets.” The document “describes the critical quality attributes that should be...

Whole Foods Receives Warning from FDA for Numerous Violations at Manufacturing Facility

On Wednesday, June 8th, the FDA issued a warning letter to Whole Foods Markets Inc., citing the company’s Everett, Massachusetts manufacturing facility for several GMP violations. The violations...

FDA Releases Guidance on Nonclinical Studies for Osteoporosis Drugs

On June 13, FDA released a new pharmacology/toxicology guidance providing guidance on nonclinical studies to support the approval of drugs intended for the treatment of osteoporosis. This guidance...

FDA Draft Guidance Addresses Increase in Data Integrity Violations

In mid-April 2016, the FDA published a draft guidance clarifying the role of data integrity in current good manufacturing practice (cGMP) for drug products, as required under 21 CFR parts 210, 211,...

Everything you to need to know about Audit Trails

In today’s validated lab environment, knowing the importance of an audit trail in computerized laboratory systems is just one of the integral qualification tasks that the ProPharma’s Computer System...

FDA’s CBER Announces Invitation to Participate in the Regulatory Site Visit Training Program

On February 2, 2016, the FDA’s Center for Biologics Evaluation and Research (CBER) published its annual invitation for biologics facilities to participate in the Regulatory Site Visit Training...

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