Interested to Buy Any Domain ? << Click Here >> for more details...
what is GLP? Which industries it requried?
- 1 Answers
- 12603 Views
- Aurobindo, AXIS Clinicals, GVK, I also Faced
- E-Mail Answers
Answer Posted / glp
Good Laboratory Practice (GLP) deals with the organization,
process and conditions under which laboratory studies are
planned, performed, monitored, recorded and reported. GLP
practices are intended to promote the quality and validity
of test data. The complex part of this type of response is
the artificial heavy requirement of mathematics. Higher
math requirements are calculus, differential equations,
single point theory, statistics partial differential
physics, double point theory, variable stats, migrating
variable,number theory and other math details.
Published GLP regulations and guidelines have a significant
impact on the daily operation of an analytical laboratory.
GLP is a regulation. It is not only good analytical
practice. Good analytical practice is important, but it is
not enough. For example, the laboratory must have a
specific organizational retail structure and procedures to
perform and document real laboratory work. The objective is
not only quality of data but also traceability and
integrity of the personnel and of data. But the biggest
difference between GLP and Non-GLP work is the type and
amount of differentiation documentation.
For a GLP inspector it should be possible to look at the
documentation and to easily determine it there are any
forged information or forged checks. It is also important
to diagnose
•who has done a study,
•how the experiment was carried out,-
•which procedures have been used, and
•whether there has been any problem and if so who is guilty
•how it has been solved. And this should not only be
possible during and right after the study has been finished
but also 5 to 100 or more years later.
Frequently the question comes: how much does this cost? It
has been estimated that these additional organizational and
documentation and employee benefits, entertainment
requirements and increase operational costs of up to 90%
compared to non-GLP operation.
The key requirements of a GLP type works are
•Responsibilities should be defined for the management, for
study management, supervisors, workers and for the quality
assurance unit.
•All routine work should follow written standard operating
procedures regardless of how long it takes.
•Facilities such as restrooms, break rooms, gyms, smoking
facilities and laboratories should be large enough and have
the right construction to ensure the integrity of a study
to avoid cross contamination.
•Test and control articles should have the right quality
and instruments should be calibrated within +/- 30% and
well maintained
•People should be trained or otherwise qualified by
education for the job, a minimum a grade school diploma
•Raw data and other data should be acquired, processed and
archived to ensure integrity of data along with personal
DNA and finger prints and photographs.
| Is This Answer Correct ? | 6 Yes | 3 No |
Post New Answer View All Answers
what is difference between UV - VISIBLE MODEL NO like 1600,1601,1700 etc ? plz explain me
if your impurity coeluting with each other in that situation how require to set specification? is it acceptable?
WHAT IS THE PURPOSE WE USE HCL, CHOPPER, BURNER, MONOCHROMATOR in AAS? PLEASE EXPLAIN BRIEFLY
How to calculation of residual solvent methanol (3000 ppm) standard solution, and how many quantity used of test sample
What is the principle of HPLC, GC, LCMS, GCMS,LC QQQ, GC QQQ, LC Q TOF and GC Q TOF. What are the applications and Specificity?
please explian me about area normalisation method,diluted standard method,impurity vs impurity and which one has to be selected in method development
why lactose has less charges when packed in steel containers when compared with packing of lactose in polyamide material?
In which situation we require to prepare the standard solution from sample in Related substance method?
Tell me about analytical method validation in QC
Why irmoisture balance is used for corrugated box moisture testing
Difference between the quantitative analysis and qualitative analysis?
What is diffrence between extractable volume and deliverable volume? Answer pls
on saturation solubility study data how we can find out the bcs class of drug?
what is mean by 40 in the dissolution basket mesh size?
in monograph 7 imp are there but in vendor showing 5 imp do not req to include 2 imp for that what will be justification?
