Standard

ISPE ISPE Good Practice Guide: Quality Laboratory Facilities

Sept 2012 Published

Note: This standard has a new edition: ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

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Abstract

ISPE has produced the industry's first Guidance Document to establish a baseline for the design of Quality Laboratory Facilities. The ISPE Good Practice Guide: Quality Laboratory Facilities is a comprehensive guide to defining design guidelines for Quality Laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications. It provides a step-by-step process that guides the reader through all phases of producing a quality lab and all the factors that must be considered at each phase. The Guide helps save time and money by facilitating effective communication between lab owners, engineers and builders about the function, operation and design parameters that must be met.

Document information

Standard from ISPE
Published: 1 September 2012
Edition: 1st
Version: 0
Document type: IS
ISBN:

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Version history History (45)

ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

ISPE ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems

ISPE ISPE Good Practice Guide: Validation 4.0

ISPE ISPE Good Practice Guide: Digital Validation

ISPE ISPE Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

ISPE ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems

ISPE ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) Second Edition

ISPE ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations

ISPE ISPE Good Practice Guide: Process Gases, Second Edition

ISPE ISPE Good Practice Guide: Containment for Potent Compounds

ISPE ISPE Good Practice Guide: Membrane-Based Water Injection Systems

ISPE ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

ISPE ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification Mapping and Monitoring

ISPE ISPE Good Practice Guide: Good Engineering Practice, Second Edition

ISPE ISPE Good Practice Guide: Maintenance

ISPE ISPE Good Practice Guide: Equipment Reliability

ISPE ISPE Good Practice Guide: Critical Utilities GMP Compliance

ISPE ISPE Good Practice Guide: HVAC and Process Equipment Air Filters

ISPE ISPE Good Practice Guide: Asset Management

ISPE ISPE Good Practice Guide: Process Validation

ISPE ISPE Good Practice Guide: Single-Use Technology

ISPE ISPE Good Practice Guide: Technology Transfer

ISPE ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities

ISPE ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases

ISPE ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring

ISPE ISPE Good Practice Guide: Management Engineering Standards

ISPE ISPE Good Practice Guide: Operations Management

ISPE ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems

ISPE ISPE Good Practice Guide: Technology Transfer

ISPE ISPE Good Practice Guide: Clinical Supply Systems

ISPE ISPE Good Practice Guide: Booklet Labels

ISPE ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)