"I was the new employee and needed some information," says our GMP Agent-in-Place. "Our company makes 300 products, and some products use common ingredients. We had to make a change in one commonly used ingredient and wanted to be sure that we had evaluated the effects for all the necessary products. Because I was new, I didn't know how to figure this out except by looking at all the , and I voiced this frustration to my boss. She told me to use the 'Gazinta Report.'

"So I asked several people for this report, and was given a six-inch thick computer printout. But when I looked at the title, it didn't say Gazinta, and I thought I had the wrong data. When I asked my boss again, she laughed and told me to read the name fast. Apparently, the original request for what is commonly known as 'where used' data was requested as 'what the ingredient goes into,' and the printout was titled 'Goes Into Report.'"

If a process is out of control, an FDA inspector will find it, eventually. Companies that emerge as winners will be those that embrace compliance as a core business practice. Systems models provide strategic competitive advantage.

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Six months into its initiative to update manufacturing regulations, FDA announces a raft of changes covering warning letters, inspections, and comparability — plus a fresh start o­n Part 11.

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With the biotechnology industry in the early phases of commercialization, many bioprocess companies are just beginning to build and operate commercial-scale production facilities.

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The right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.The purpose of this article is to propose a role called "quality coach," an independent expert dedicated to system and project quality, as a member of teams implementing software applications to support clinical data management activities. The article presents the issues unique to the regulated environment in which the software project resides, and explains the advantages the quality coach role brings to the team and the accomplishment of its goals. The concept of a quality coach is new and unproven.

The essential tool for maintaining 21 CFRPart 11 compliance. Since its introduction in 1997, Title 21 of the U.S. Code of Federal Regulations (CFR) Part 11 has had a resounding impact o­n the biotechnology and pharmaceutical industries. In the strictest sense, 21 CFR Part 11 is applied to any pharmaceutical manufacturing process using automated controls to generate data that can be maintained in an electronic format. The aim of this regulation is to ensure the authenticity and integrity of electronic records and associated electronic signatures.

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FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

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An extended survey was conducted o­n the topic of clinical quality assurance (CQA) benchmarking in pharmaceutical companies to gather new data.


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In a regulated laboratory, both instruments and methods must be validated to be suitable for their intended purposes. It is equally important, however, that personnel are properly trained and qualified for the task at hand. But in spite of this requirement, FDA still frequently cites firms for a lack of trained personnel. This month’s “Validation Viewpoint” examines how instrument vendors can ease the burden of training for GMP compliance.


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