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.

How we can perform Linearity study for validation by HPLC with very low conc of sample

1 Answers  

---

why we use sodium salicylate in uv light calibration at TLC chamber

1 Answers   Aurobindo, Lee Pharma,

---

why water, methanol, ethanol ets solvents are used in UV SPECTRIPHOTOMETER for blank reading ?

7 Answers  

---

What are the six USP melting point reference standards?

1 Answers  

---

Which type of material analysis in GC using Theramal conditivity detector ?

7 Answers  

---

How we will choose pH of a mobile phase if analyte pKa value is 4

2 Answers   Celon Labs, Laurus,

---

what is assay in hplc

3 Answers  

---

inhouse product is in capsule form in combination and RLD is in tablet form then can we proceed for multimedia CDP? in inhouse capsule product disso is paddle with sinker in release media is there then RLD product in tablet form then with same as paddle with sinker we can proceed n.a.?

0 Answers  

---

What is post run in hplc?

1 Answers   Cipla,

---

Please do not join if u got offer in oncotherapies ltd (STRIDESARCOLAB)especially Mr.Mahesh Bhatt team because job is not secure his team and doesn't have confidence on him becareful this offer?

1 Answers   Strides Arcolab,

---

If i performing one analysis on C8column then the same analysis done on C18 column then what will happen about Rt;Resulution;Peak shape Explain ?

1 Answers  

---

why 0.02% solution toluene &noHexane using in uv calibration?

1 Answers   Graviti Pharmaceuticals, Orbit Pharma, Ranbaxy, Vimta Labs,

---