957 which replaces the previous good practices for national control for pharmaceutical laboratories, 36th Report - Annex 3 of the World Health Organization Official Reports Sequences, No. 902, 2002. This guidance needs to be followed by all pharmaceutical laboratories for quality control, but excluding biologic product, because there is a different guideline called the good practices for pharmaceutical microbiology laboratories Reference QAS/09, 297 by …show more content…
It will give advice on the preliminary requirements for the labs that is accountable for quality control or studying the pharmaceutical products. It will consider the World Health Organization Good Practices for national pharmaceutical control laboratories, Official Report Sequences, No. 902 - Annex 3, 2002 guidance, in addition to the US FDA’s Good Laboratory Practice Regulations for Non-clinical Laboratory Studies delivered in the January 1999 guidance. It is uncertain right now from ICH memorandums that the ICH will consider nonclinical studies or active pharmaceutical ingredients used in drug manufacturing. ICH Guidance issued in the year 2000 for “Safety Pharmacology Studies for Human Pharmaceuticals” - S7A -2.11 describe that the quality of reliability of non-clinical safety study should be compliance with the Good Laboratory Practice (GLP) but at the same time ICH is somewhat flexible as it said that, because of the distinctive design, and practical attentions to conduct safety pharmacology studies may not be possible all the time in compliance with GLP (ICH, 2000). Studies that are not directed according to GLP, study reestablishment must confirmed through satisfactory credential of study conduct and establish the statistics and the possible influence on the assessment of the safety pharmacology endpoints need to be