Manuals & Guidelines
Good Laboratory Practices Guidelines for Pharmaceutical Quality Control Laboratories in Lebanon
Author: QAPP Program
Source: MOPH
Source: MOPH
The good laboratory practice provide advice on good practices for national pharmaceutical control laboratories involved in the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products.
These guidelines are consistent with the requirements of the WHO guidelines for good Laboratory practices and with the requirements of the International Standard ISO/IEC 17025:2005, and provide detailed guidance for laboratories performing quality control of medicines.
National pharmaceutical quality control laboratories usually encompass essentially two types of activity:
Compliance testing of APIs, pharmaceutical excipients and pharmaceutical products employing “official” methods including pharmacopoeial methods, validated analytical procedures provided by the manufacturer or validated analytical procedures developed by the laboratory;
Investigative testing of suspicious, illegal, counterfeit substances or products, submitted for examination by medicine inspectors, customs or police.
Minister Decision No.607 Date 10/4/2017
These guidelines are consistent with the requirements of the WHO guidelines for good Laboratory practices and with the requirements of the International Standard ISO/IEC 17025:2005, and provide detailed guidance for laboratories performing quality control of medicines.
National pharmaceutical quality control laboratories usually encompass essentially two types of activity:
Compliance testing of APIs, pharmaceutical excipients and pharmaceutical products employing “official” methods including pharmacopoeial methods, validated analytical procedures provided by the manufacturer or validated analytical procedures developed by the laboratory;
Investigative testing of suspicious, illegal, counterfeit substances or products, submitted for examination by medicine inspectors, customs or police.
Minister Decision No.607 Date 10/4/2017
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