Validation concept

If that is a valid concept, could that have anything to say about the consequence of this supersensitization having behaviorally inhibitory effects ... 

In the future, the enforcement of feedingstuffs will be more important because the MRLs established for food become partly obligatory for feed also. Validation concepts for this matrix must be developed in collaboration with laboratories obliged to control feedingstuffs, considering the approach of four matrix types for food crops mentioned in Section 4. 

Nevertheless, approximate transferability is a valid concept and in the next section a particular approach will be discussed, based on fuzzy subsystems of molecular electron densities. 

PMA s Computer Systems Validation Committee, Validation concepts for computer systems used in the manufacture of drug products, Pharm. TechnoL, 10(5), 24, 1986. 

We conclude from these results that a degenerate gas of small polarons is a valid concept. 

Dedicated to Theodore E. Byers, formerly of the U.S. Food and Drug Administration, and Heinz Sucker, Professor at the University of Berne, Switzerland, for their pioneering contributions with respect to the pharmaceutical process validation concept. We also acknowledge the past contributions of Bernard T. Loftus and Ira R. Berry toward the success of Pharmaceutical Process Validation. 

With the emergence of the pharmaceutical process validation concept, the following four additional steps have been added ... 

Unfortunately, there is still much confusion as to what process validation is and what constitutes process validation documentation. At the beginning of this introduction several different definitions for process validation were provided, which were taken from FDA guidelines and the CGMPs. Chapman calls process validation simply organized, documented common sense [6], Others have said that it is more than three good manufactured batches and should represent a lifetime commitment as long as the product is in production, which is pretty much analogous to the retrospective process validation concept. 

PMA Validation Advisory Committee. Process validation concepts for drug products. Pharm Tech 9(9) 50-56 (1985). 

One of the key issues in this guide is the question When does GMP start Although there is no simple answer that fits all cases perfectly, the guide has helped to decrease the uncertainty around this central problem. Another timely bit of progress is the inclusion of validation concepts that have been missing in the other GMP guides. 

PMA s Computer Systems Validation Commitee Pharmaceutica1 Technology May, 1986, "Validation Concepts for Computer Systems Used in the Manufacture of Drug Products". 

Chapter 2 introduces the reader to the computer systems validation concepts in the context of regulated operations. 

Union CotE (2002) Validation concepts for pesticide residues in food of animal origin 2002/657/ec... 

B. Jiilicher, P. Gowik, S. Uhlig, Assesment of detection methods in trace analysis by means of a statistically based in-house validation concept, Analyst, 123 (1998), 173-179. 

These general tools are called schemas, and the process of checking XML documents against schemas is called validation. A valid XML document is a document that conforms to some schema. It is important to note that the validity concept is not as precise as the well-formedness concept. The XML document is either well formed, and then any XML processor is able to read it, or it is not well formed, and then any XML processor is required to reject it. However, an XML document can be valid according to one schema and invalid according to another schema at the same time. 

Validation concepts, although not the terminology, are also expected for computer, control, and laboratory systems that have the potential to seriously affect Safety, Health, and Enviromnental (SHE) data protection and financial control. Pharmaceutical and healthcare companies may want to institute common ways of working across these requirements. 

PMA (1986), Validation Concepts for Computer Systems used in the Manufacture of Drug Products, In PMA Proceedings Concepts and Principles for the Validation of Computer Systems Used in the Manufacture and Control of Drug Products, Pharmaceutical Technology (May) 24-34. 

I am hugely indebted to Ellis Daw, Chris Reid, and especially Howard Garston-Smith and Christine Andreasen (CRC Press) for their proofreading of chapters in this book. They have not only helped improve my grammar but have also prompted inclusions of additional material to better explain some of the validation concepts discussed. 

Elements of the validation concept should be incorporated during each of the various stages of the product and process development continuum. These stages can be summarized as follows. 

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