Glp Quality Audit Manual
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Author | : Milton A. Anderson |
Publisher | : Interpharm CRC |
Total Pages | : 408 |
Release | : 1992-01-01 |
Genre | : Chemical laboratories |
ISBN | : 9780935184334 |
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents discussions of and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section Ill comprises the full texts of the relevant standards and regulations along with the Priniciples of Good Laboratory Practice.
Author | : Milton A. Anderson |
Publisher | : Informa Healthcare |
Total Pages | : 424 |
Release | : 2000-07-01 |
Genre | : Business & Economics |
ISBN | : 9781574911060 |
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.
Author | : Milton A. Anderson |
Publisher | : |
Total Pages | : 121 |
Release | : 1987 |
Genre | : Chemical laboratories |
ISBN | : 9780935184075 |
Author | : U.S. Environmental Protection Agency |
Publisher | : Government Inst |
Total Pages | : 116 |
Release | : 1994-01-01 |
Genre | : Science |
ISBN | : 9780865873933 |
Includes detailed questions EPA will ask when conducting inspections, techniques, recordkeeping, GLP Compliance review, audit procedures, post-inspection activities, and more
Author | : Singer |
Publisher | : CRC Press |
Total Pages | : 434 |
Release | : 1992-11-23 |
Genre | : Technology & Engineering |
ISBN | : 9780824787844 |
This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.
Author | : Thomas A. Ratliff |
Publisher | : John Wiley & Sons |
Total Pages | : 246 |
Release | : 2005-03-11 |
Genre | : Technology & Engineering |
ISBN | : 0471721662 |
Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual: -Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories. -Provides blank forms used in preparing a quality manual. -Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.
Author | : P. M. Henschell |
Publisher | : |
Total Pages | : 0 |
Release | : 1994 |
Genre | : |
ISBN | : |
Author | : James E. Sayre |
Publisher | : Interpharm CRC |
Total Pages | : 151 |
Release | : 1994-02 |
Genre | : Clinical trials |
ISBN | : 9780935184563 |
Author | : Leonard Steinborn |
Publisher | : CRC Press |
Total Pages | : 633 |
Release | : 2019-04-23 |
Genre | : Medical |
ISBN | : 0429525826 |
Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these
Author | : Bernard Froman |
Publisher | : CRC Press |
Total Pages | : 252 |
Release | : 2020-11-26 |
Genre | : Business & Economics |
ISBN | : 1000145964 |
Utilizes advanced concepts, guidelines and requirements from the latest ISO 9000 and 10000 series of standards, as well as other models, including TQM (Total Quality Managment). The text shows how to define a policy and explain it clearly. It offers procedures for developing a quality manual, to be used by personnel performing quality-related functions and for external auditors and customers.