GLP Quality Audit Manual

GLP Quality Audit Manual
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.

Glp Quality Audit Manual

Glp Quality Audit Manual
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.

Good Laboratory Practice Standards Inspection Manual

Good Laboratory Practice Standards Inspection Manual
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

Guidelines for Laboratory Quality Auditing

Guidelines for Laboratory Quality Auditing
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.

The Laboratory Quality Assurance System

The Laboratory Quality Assurance System
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.

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)

GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 1 - With Checklists and Software Package)
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

Guide to Preparing the Corporate Quality Manual

Guide to Preparing the Corporate Quality Manual
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.