| In this book, the author initially rehearses philosophical concepts
and attributes of good laboratory practice. These are all useful in the
general quality of laboratory output, although some may not be relevant
in qualifying for good laboratory practice recognition. This second edition
reveals the origin of the 2004 guidelines by the EU Committee for Proprietary
Medicinal Products on sample contamination.
The “four pillars” of GLP are totally committed management,
independent internal assurance of analytical processes, absolute control
for the trial’s study director and compliance with national monitoring.
There is a salutary example of the positive value of an audit trail in
satisfactorily resolving an otherwise trial-threatening aberrant observation.
One minor, but persistent, irritation is the frequent use of the phrase “precision
and reproducibility” without apparently recognising that, in international
statistical usage, the former subsumes the latter.
The second part of the book provides comprehensive guidance and working
details: definitions, responsibilities, facilities, standard operating
procedures, reporting and archiving. The final two parts of the book
address implementation, with helpful examples, and how compliance may
be maintained.
This book has relatively few charts, and no graphics or illustrations
to lighten the text. The literary style may strike some readers as wordy,
didactic even, but it repays closer study.
The book delivers a comprehensive examination of the critically important
regimen of GLP. For laboratory managers it is a “must” for
initiating or enhancing laboratory contribution to clinical and environmental
studies.
This book is not, and does not intend to be, a vade mecum for laboratory
accreditation and deals neither with proficiency testing nor analytical
quality assurance. Nevertheless, it does distinguish those equally important
areas and contrasts them with the protocol and procedures required for
national GLP
compliance.
Geoffrey Phillips (a pharmaceutical consultant, honorary secretary of the
Joint
Pharmaceutical Analysis Group and a freelance writer)
|
The
Pharmaceutical Journal