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不知道各位有没有些书籍，谢谢
来源于“http://www.askaboutvalidation.com/”
Writing & Executing a Software Validation Protocol: Plain and Simple
Author: Don Hurd
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results. While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.
An Easy to Understand Guide to Process Validation
Author: Ojingwa Ginny Gutierrez M.Sc. (Molecular Biology)
This book describes how to perform a complete process validation for a product including all steps from equipment qualification to product output. Process validation includes all of the qualification steps (DQ, IQ,OQ, and PQ) required to qualify the equipment before the process can be validated. After describing how to determine which equipment is quality relevant and the steps to equipment qualification, this book describes how process validation is carried out to satisfy regulatory requirements for multiple industries.
How To Be An Effective GMP Auditor
Author: Joginder Mittal M.Sc. (Microbiology), MBA
An audit is a methodical, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. (ISO 19011:2002, 3.1). In this book, we will share with you the best practices on how to become an effective GMP auditor. This book also serves as an ideal refresher course for anyone who needs to brush up on their current audit knowledge.
An Easy to Understand Guide to HPLC Validation
Author: Dr. David Trew BSc (Hons.), PhD, CChem MRSC
High performance liquid chromatography (HPLC) is one of the most widely used techniques in the modern analytical laboratory. The specificity, sensitivity and flexibility of the technique make it readily applicable to the determination of an enormous range of analytes in a wide range of sample matrices. This book also serves as an ideal refresher course for anyone who needs to brush up on their current HPLC knowledge.
An Easy to Understand Guide to Good Documentation Practices (GDocP)
Author: Don Hurd
GDP is an essential skill you need to have when you’re working in the life science sector. GDP is not just about initials and dates (although it does play a big part of it) it’s about doing things the right way and making everything you do transparent. Honesty is the best policy and when you’re making medicinal products its essential you follow the rules.
An Easy to Understand Guide to Equipment Qualification
Author: Joginder Mittal M.Sc. (Microbiology), MBA
This book describes how to perform the qualification assessment depending upon the impact of individual equipment on product quality. The risk based qualification assessment describes the qualification steps (RA,DQ, IQ, OQ, PQ etc.) required to qualify the equipment. This approach eliminates the duplication of effort and costly practices.
An Easy to Understand Guide to Validating Purified Water Systems
Author: Annelie H King
This quick and easy guide describes how to design, build, and validate a purified water treatment system according to current quality regulations and standards. You will find this guide especially helpful if you are in the planning phase for a new purified water treatment system, interested in upgrading your current system and new to water treatment projects.
An Easy to Understand Guide to Supplier Qualification
Author: Don Hurd
Not all suppliers are the same, for example when you buy a car or a house, time and effort is dedicated into finding the best provider with the best product in terms of quality and reliability. The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.
The Principles of a Software Validation Life Cycle
Author: Graham O'Keeffe Msc (Biochemistry), Bsc (Computer Science)
Writing a software validation test script can be a difficult task to someone who has never done it before. That’s why we felt it was about time we went back to basics and explained in simple terms the correct sequence of events. From gathering requirements to finally executing the test script, there are a number of steps in-between if followed will allow you to produce a quality test script with a minimum amount of errors.
An Easy to Understand Guide to Software Validation
Author: Don Hurd
Software validation simplified — seriously. You will be amazed and relieved to know there really is an easy way to learn about software validation. This book is for anyone working in a regulated environment that wants to learn more about software validation. Written in a clear concise manner, we can guarantee that this wonderful book will bring you up to speed very quickly.
An Easy to Understand Guide to HVAC Validation
Author: Helena Roth M.Sc (Biology)
This book will provide an insight into the complexity of HVAC systems and their designs, and how these systems can be tested and verified. HVAC’s are present in every regulated environment from Biotechnology to Pharmaceutical so it is well worth putting a little time into finding out more about how they work.
An Easy to Understand Guide to Cleaning Validation
Author: Trefor Jones B.Sc, C.Sci, C.Chem, MRSC
This book describes how to comply with equipment cleaning validation regulations and guidelines successfully for activities related to or in support of the manufacture of drug products and substances (and their associated components produced for consumption by humans and animals).
An Easy to Understand Guide to Annex 11
Author: Orlando López
The usual reaction when someone brings up the term Annex 11 is that people just gloss over it and focus on what they deem more important, which is 21 CFR Part 11. However if you work in a facility that is not manufacturing product for the US market, but for the European market then Annex 11 is the regulation you must adhere to..
An Easy to Understand Guide to 21 CFR Part 11
Author: Orlando López
The usual reaction when someone brings up the term Annex 11 is that people just gloss over it and focus on what they deem more important, which is 21 CFR Part 11. However if you work in a facility that is not manufacturing product for the US market, but for the European market then Annex 11 is the regulation you must adhere to..
The Essentials of Pharmaceutical Microbiology
Author: Joginder Mittal M.Sc. (Microbiology), MBA
Pharmaceutical microbiology encompasses those aspects of microbiology which impact directly upon the development manufacturing and use of pharmaceutical drugs. The microbiological aspects are critical to the quality of final pharmaceutical products. Regulatory agencies expect from the drugs manufacturers to measure and characterize the bioburden of their products.
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发表于 2014-7-7 09:57:43
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