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Guideline
QMS(Quality Management)
ALCOA to ALCOA Plus for Data Integrity
The term Alcoa is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa
Plus (Alcoa +), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.
Over time, the concept of Alcoa plus has been adopted by various industries, as a framework for ensuring that data
OOS Handle
The objective of OOS investigation should beĀ to identify the root cause of the OOS result Or NSQ results and take appropriate corrective and preventative action. Investigation should include a review of Laboratory testing, review of production and sampling procedures, and will often include additional laboratory testing and Cross functional investigation along with the handling of associated samples and test data
Change Controle
The term change control is used to describe the controlled set of actions necessary to ensure a change does not negatively impact a product’s safety, efficacy, quality or compliance.
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How can read Protocol analyst
ā¢ HPLC Analyst ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen...
How can read Protocol analyst During HPLC analysis and what Is flow ?
ā¢ HPLC Analyst ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen...
USFDA found 483 in Intas Pharmaceuticals in Ahmedabad unit
The manufacturing practices of Indian drug makers have once again come under the scanner after the US Food and Drug Administration (USFDA) recently issued 11 observations to Intas Pharmaceuticals Limited over questionable practices at its manufacturing facility in...
Chromatography
Chromatography
Potentometry titration
Potentiometric titration
How do you perform a potentiometric titration?
The analyte is typically an acid or a base. The titration is performed by adding a measured volume of the standard solution to the sample solution, and then measuring the resulting change in the electrical potential (potential) of the solution. Quality control...
Guideline value- ICH Q1A for stability study
Guideline value- ICH Q1A for stability study
Interview questions and answers karl Fischer titration
Guide line935 USPType Karl Fischer titrationColoarimatry and volumetry titrationColarimatry titration because use of a electromagnetic filedVolumetric titrationThere is a manually titration (classical method like In burette fill kf reagent and conical flask fill a...
Why only Water & Sodium Tatrate Is Use For Calibration Of Karl Fischer Titrator?
DST is primary standard and it is stable up to 150 degree Centigrade. It release free water molecules easily when reacts with KF reagent.DST is easily soluble in methanol. This DST has 15.66% water molecules so we can easily calculate and standardize the KF reagent....
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HPLC Blogs
How can read Protocol analyst
ā¢ HPLC Analyst ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen...
How can read Protocol analyst During HPLC analysis and what Is flow ?
ā¢ HPLC Analyst ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen...
Chromatography
Chromatography
Why does Acetonitrile use in HPLC Method development?
it is miscible with water, has good eluotropic strength and also low viscosity alone and mixed with water. Acetonitrile high-sensitivity analysis with UV detection in the short-wavelength region. However , organic solvents which have been processed for HPLC IN...
Accuracy – Analytical method validation, hplc, pharmaceutical
Accuracy is also part of method validation different placeĀ Different terminology used for accuracy like recovery, truth value, biaus etc
Specificity -Analytical Method validation -pharmaceutical companies
Specificity -Analytical Method validation
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Analytical method validation Blog
How can read Protocol analyst
ā¢ HPLC Analyst ā Whenever supervisor give work allocation for testing any product. ā HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ā Then careful read specification(SOP) not missing any point which is defied in sop ā Then Seen...
Chromatography
Chromatography
Analytical method validation (before requirements)
ā¢ the requirements of the measurement procedureā¢ scope of experimentsā¢ RM to be usedā¢ Equipmentā¢ Statistical tools to be usedā¢ personnel for performing experiments and evaluating obtainedresults Analytical method validation
Why does Acetonitrile use in HPLC Method development?
it is miscible with water, has good eluotropic strength and also low viscosity alone and mixed with water. Acetonitrile high-sensitivity analysis with UV detection in the short-wavelength region. However , organic solvents which have been processed for HPLC IN...
Precision Type
Precision main three parts
Method validation guidelines and chapter
ā¢ Ich Q2(R1) guidelines ā¢ ā©1224āŖ TRANSFER ANALYTICAL PROCEDUR ā¢ (Transfer between laboratory to laboratory) ā¢ <1225>VALIDATION OF COMPENDIAL PROCEDURES Chromatography focus this chapter ā¢ <1226>VERIFICATION OF COMPENDIAL PROCEDURES Method suitable and time...
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During Job How to Control your selfĀ Blogs
Thought of the day 2023
āKeep relations, which change your situations, not ones which itself gets changed according to situations.ā No one is too much busy. Itās all about importance you have in their life.āĀ āNegative perceptionĀ and wrong judgement astray a man in...
Feeling in winter
Symptoms Feeling listless, sad or down most of the day, nearly every day Losing interest in activities you once enjoyed Having low energy and feeling sluggish Having problems with sleeping too much Experiencing carbohydrate cravings, overeating and weight gain Having...
How to become fearless in fight, some were
Why nerves and self-doubt are normal before a fight How responding to your fight or flight response impacts your performance in the ring Three tips on how to manage your pre-fight nerves and fight like a champ self-awareness Self-awareness is part of performance and...