A laboratory quality handbook of best practices
Based on the work of a collection of experts from the laboratory science and quality assurance fields, this book provides all of the information needed to run a successful laboratory in compliance with all relevant regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-specification responses to preparation for audits, a combination of people, instrumentation, and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance.
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Quality Assurance in the Laboratory
An Overview of Key Parameters for Evaluating
Training in the Laboratory
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acceptance accrediting bodies accuracy accuracy and precision adequate analysis analytical procedure and/or application appropriate approved assay assessment audit Automated Laboratory Practices batch calibration cGMP changes chemical compliance conducted contamination control articles corrective action data integrity determine deviation documentation Drug Administration drug product electronic equipment established evaluation failure investigation Food and Drug GALP guidance Guidelines hardware HPLC identified impurities inspection instrument integrity ISO/IEC laboratory accreditation laboratory error laboratory management Laboratory Practices Implementation LIMS Raw Data linearity maintained maintenance management shall ensure manufacturing manufacturing practice method validation nonclinical laboratory study OECD OOS investigation OOS result performed personnel pH meters pharmaceutical Practices Implementation Assistance problems qualification quality assurance quality control reagents records regulations regulatory requirements responsible retesting sample SOPs specifications Standard Operating Procedures storage study director test results test systems testing facility tion