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Replacing An Existing Paper-Based GMP Record System And Manual Process With...
Goals To replace an existing paper-based GMP record system and manual process with an electronic monitoring system Challenges A significant amount of time is spent each day manually reviewing...
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What Role Should Your Suppliers Play In Single-Use Equipment Validation?
In the ongoing battle to cut costs while delivering quality and technically sound product, the biotech industry has spent the past two decades gradually moving toward single-use pre-sterilized...
View ArticleLights, Camera, Validation! — Preparing For FDA Prime Time
This article is the fourth in a five-part series examining vital relationships in each stage of medical device development. Read parts one, two, and three here. You have proven your concept, fully...
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Navigating The Ethics Of Product Validation
Medical device development is a complex and costly process affecting many stakeholders, including the human factors consultants tasked with assessing a product’s safety and usability. Competing...
View ArticlePinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation
Shipping and its validation are too often underappreciated in pharmaceutical quality systems (PQS), which can hide risk and uncertainty in the supply chain. A line-of-sight (LOS) approach to shipping...
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Improving Process Validation for Dry Granulation, Solid Dosage Form Unit...
Effective process validation contributes significantly to assuring drug quality. The FDA defines process validation “as the collection and evaluation of data, from the process design stage through...
View ArticleProcess Validation: Do We Need Brainwashing?
Michel Crevoisier is retired senior quality assurance expert, ChemOps, at Novartis Pharmaceuticals In its 2011 Guidance for Industry on Principles and Practice of Process Validation (1), FDA...
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Cleaning of Dedicated Equipment: Why Validation is Needed
Thinkstock Images/Getty Images Cleaning of pharmaceutical equipment is essential to reduce the risk of product contamination and, as stated in relevant guidelines and as recognized by the...
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Best Practices for Cleaning Validation Swab Recovery Studies
Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach. ZenShui/Odilon Dimier/Getty...
View ArticleValidation Of Visual Inspection As An Analytical Method For Cleaning Validation
Part of the Cleaning Validation for the 21st Century series U.S. Regulation 21 CFR 211.67 (b) (6) has required the “inspection of manufacturing equipment immediately before use” since 1979. In...
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Molding Process Validation for Medical Devices: Five Things to Know
Plastics are used in many of today’s medical devices because of the wide range of materials and properties available to match the device requirements. In addition to being lightweight, plastics can be...
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Quality Risk Management 101: Risks Associated With Medicinal Products
To establish a quality risk management program and ensure that the appropriate types of risks remain at the forefront of subsequent QRM efforts, it is necessary for QRM practitioners to understand the...
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Cleaning Validation for APIs
FoapAB/Shutterstock.com At home, when washing the dishes, do we ever consider what meal they will be used for next? When plates and cutlery are taken out of the cupboard to set the table, do we ever...
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Reducing Cleanroom Complexities and Cost
Why shouldn’t biopharmaceutical manufacturers be able to leverage standardized construction practices to improve time to market? For pharmaceutical and biopharmaceutical manufacturers today, a key...
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What You Should Know About Pharmaceutical Cleaning Validation
Cleaning validation is a necessary and time consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost of validation can be lowered if the cleaner supplier can...
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Process Validation in Biologics Development
Strategies for successful process validation in the wake of faster approval timelines Process validation is an important step for potential therapies that have had early success in the clinic and are...
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FDA Announces Draft Guidance for Bioanalytical Method Validation
The FDA announced the availability of a draft guidance for industry, “M10 Bioanalytical Method Validation,” in a June 28, 2019 press release. The draft guidance, developed by the International Council...
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FDA Announces Draft Guidance for Bioanalytical Method Validation
FDA announced the availability of a draft guidance for industry, “M10 Bioanalytical Method Validation,” in a June 28, 2019 press release. The draft guidance, developed by the International Council for...
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Want to Go “Lean”? First, Understand What It Means
Lean is more than a buzzword. Because the common understanding of lean is incomplete, it’s been unjustly dismissed and criticized. Lean systems are widely misunderstood. Although the term was...
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“Validation” Or “Qualification”– What’s The Difference?
What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. For those studying, manufacturing, or experimenting with...
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