For my part, whatever anguish of spirit it may cost, I am willing to know the whole truth; to know the worst and to provide for it Patrick Henry Primary Guidance This article primarily relates to legislation and approaches that are EU centric. However there are a range of GMP standards (EU, FDA, ICH etc) …
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Introductory Principles of the Pharmaceutical Quality System
Quality is never an accident. It is always the result of intelligent effort. John Ruskin Primary Guidance This article primarily relates to legislation and approaches that are EU centric. However there are a range of quality system standards (EU, FDA, ICH etc) and the level of detail worldwide devoted to the definition of an appropriate …
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Introduction to the handling of unexpected deviations.
Theory is knowledge that doesn’t work. Practice is when everything works and you don’t know why Hermann Hesse Deviations should really be the opposite of this definition of practice. If it didn’t work, you should know and know why. Primary Guidance This article primarily relates to legislation and approaches that are EU centric. However there …
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Validation
To Validate; verb check or prove the validity or accuracy of Within Good Manufacturing Practice Validation is a means of assuring the quality of a process or a product. Companies need to demonstrate that they can make the product they have proposed to market in a consistent manner with a level of quality that is …
Qualified People and the Qualified Person
A key requirement of ensuring that a product is made correctly is ensuring that everyone who contributes to the production of that project is correctly trained. An example that’s easy to understand is an operative that cleans the room or location that manufacturing takes place in. That operative must know the limits of their responsibility …
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Necessity, Born of Tragedy
Good Manufacturing Practice is a series of regulations, practices and philosophies that simultaneously constrain and enable the manufacturing of pharmaceuticals and medicines that are subject to widespread marketing. They exist primarily to protect the public from the consequences of unconstrained or unregulated medicinal manufacturing. Many examples exist from history of tragedies, widespread and local, were …
My First Blog Post
Be yourself; Everyone else is already taken. — Oscar Wilde. This is the first post on my new blog. I’m just getting this new blog going, so stay tuned for more. Subscribe below to get notified when I post new updates.
Introduce Yourself (Example Post)
This is an example post, originally published as part of Blogging University. Enroll in one of our ten programs, and start your blog right. You’re going to publish a post today. Don’t worry about how your blog looks. Don’t worry if you haven’t given it a name yet, or you’re feeling overwhelmed. Just click the …
The Qualified Person's Notebook 