LIMS for Lab Quality Control
LIMS (Laboratory Information Management System) is becoming more and more crucial to ensure quality control and assurance in laboratories, because most analytical activities within a modern lab work to...
View ArticleLean Biomanufacturing: Keeping Your Eye on the Quality Goal
By Nigel J Smart PhD, Smart Consulting Group To some, Lean Manufacturing is a meaningless concept when one is considering medical therapies or medical products. Often there is confusion in common...
View ArticleWhat You Should Know About Your cGMP Inspection
By government mandate, the FDA is required to conduct regular cGMP inspections every year, at different manufacturing establishments that have association with FDA regulated companies. Because...
View ArticleBuilding an Optimal Quality System
… management to develop such a system that not only demonstrates commitment to develop and maintain their system, but also takes responsibility for their success or failure. Regardless of how much a...
View ArticleGMP Guidelines/Regulations in Stem Cell Research
Good manufacturing practice or (GMP) is a common term for the control, management and manufacturing of quality control practices, applied to the pharmaceutical industry. These common practice...
View ArticleThe Lean Laboratory of the 21st Century
… These fears stem from a concern that a Lean manufacturing approach will cut down on the quality control of a product, resulting in lower quality products, which may result in lawsuits or non FDA...
View Article5 Important Factors to Measure in Your Lean Process Strategy
Lean process procedures are a companywide initiative, with the goal to achieve operational excellence. It is a kind of systematic approach that facilitates improvement on every level, while putting...
View ArticleKey Factors in Third Party Testing on Combination Products
Proper and unbiased testing is an integral part of any manufacturing process. And this is especially vital in the pharmaceutical industry. Because of the pharmaceutical industry’s inherent need for...
View ArticleWhat You Need to Know About Vendor Audits
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and...
View ArticleLean Manufacturing and PAT – The Next Level For Pharma
… analysis, process control, and continuous improvement. With these tools, pharmaceutical manufacturers can move toward the common goals of reduced cycle times, fewer rejects, increased automation, and...
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