what is GLP? Which industries it requried?
- 1 Answers
- 11612 Views
- Aurobindo, AXIS Clinicals, GVK, I also Faced
- E-Mail Answers
Answer / 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 |
What is the pilot-plant in pharma sector.
Why use the Omeprazole as a reference standard to estimate the assay of esomeprazole by HPLC method
if your product is soluble in 0.1n hcl and water then which you choose as media from these 2 media?
In case of dissolution test, if there is variation within 6 individual units however the batch is complying as per S1 criteria, is it necessary to do investigation for the same? What should be the criteria for such variation?
What is the meaning of Base deactivated vials
how to selecet an exact coloumn for an new molecule development by hplc how to select exact salt as buffer for new molecule development by hplc what is the the process to select the mode of saparation of compoundes by hplc what is the use of ph of buffer what is use of buffer,ph,organic phase,ans methods how the molecules get saparated in coloumn,
why we calibrate ph meter and balance daily.....but hplc and uv requires quaterly?
As per ICH related substances stability trend limit from initial to shelf life
0 Answers Medley Pharmaceuticals, Micro Labs,
how you fix the limits of impurities?
what is optical active and non active give examples?
One Raw material failed assay test is there any chance for failing purity of that material ?
what is defferance between dipolemoment and polarity
Organic Chemistry 
