Quality Cotrol

Interview Preparation guide

Pharma Consonances guides 

How to how to manage audits in Lab

 

 

Guidelines

Stability Guideline

Method Validation Guidelines

 

Instrument
HPLC
GC
Karl Fishcher
Potentiometer
SOR

N

Guidelines

N

Interview questions and Answer

N

consultancy guidence

Instrument Section

Potentio Meter

HPLC

Karl Fischer

HPLC pump problem
Fluctuating retention times
-Unstable Pressure, check pressure section
-If mobile phase is not pre-mixed, there could be problem with the ratio been properly mixed(Inconsistent on-line mobile phase mixing)
-Unstable Column temperature
-Increasing Retention Times
-Decreasing Flow rate
-Decreasing column temperature
-Decreasing Retention Times
-Increasing flow rate
-Increasing column tempera
 
Type of impurities?
  • Organic impurities
  • Elemental impurities (inorganic)
  • Residual solvents
Type of Detector in GC
-Mass flow depend Decorator
 
-FLAME IONIZATION DETECTOR (FID):
 
-NITROGEN PHOSPHORUS DETECTOR (NPD):
 
-FLAME PHOTOMETRIC DETECTOR (FPD):
 
-Concentration type Detector
 
-ELECTRON CAPTURE DETECTOR (ECD):
 
-THERMAL CONDUCTIVITY DETECTOR (TCD):
 
-PHOTOIONIZATION DETECTOR (PID):
 
-ELECTROLYTIC CONDUCTIVITY DETECTOR (ELCD)
SST in HPLC

% RSD(Related standard deviation)/repeatability

Column efficiency / Theoretical plate
Resolution
Peak to valley ratio
Capacity factor
Signal to noise ratio (S/N ratio)
References standard check (Similarity factor or SF factor)
Retention time
type of titration

 

(1)Acid base titration (neutralization titration)
(2)Redox titration (iodometric titration)
(3)complexomatry titartion
(4)Argrntomatry titartion

 

FDA and USFDA focus in OOS investigation
1. Red flag how to handle invalid oos
2.seen your hypto how your potency
3.if you investigation of other batch which may affect on this.
4.how can you have find out root cause
why we do UV Calibration ?
Control of wave length shows
About tell us x -axis and y axis
Control of Absorption shows
How much absorb light of sample
Limit of stray light shows
unwonted light
Resolution shows
how much peak sharp and peak area and height
Why DST USE IN KF TITRATION
It is stable at 130 temp
2 mole water react with 1 mole DST means factor as defined bellows calculation
2H2O molecular weight/DST molecular weight x100
36.03056/230.08X100
15.66
Here defined range depends your instrument uncertainty

Wet Lab Section

{

Tiration

{

Normality

{

Molarity

{

PPM

{

Solubility

Fresher Interview questions and answers

Happy to Help you for Preparation

Interview Q & A

Here Give Basic Q & A for Fresher who interstate for

Interview for Pharm, chemical, pesticides company

Experience Interview questions and answers

Happy to Help you for Preparation

Interview Q & A

Here Give Basic Q & A for Fresher who interstate for

Interview for Pharm, chemical, pesticides companey

meeting

Guideline

Stability

 

ICH Q1

Validation

 

ICH Q2

Impurity

 

ICH Q3

Evaluation

 

ICH Q4

QMS(Quality Management)

alcoa++

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 be 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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pharma interview

Pharma Interview

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pharma calculator

Pharma Calculator

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ICH guideline

ICH guideline

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Sulphate Ash

Sulphate ash calculator

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Pharma Blogs

Type of Compartment of HPLC & GC ?

HPLC Going into more detail, HPLC consists of a variety of components, including a solvent delivery pump, a degassing unit, a sample injector, a column oven, a detector, and a data processor. GC GC uses an inert or unreactive carrier gas as the mobile phase, and the...

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How to Re-test defined in finish product in pharma

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Type of buffer in Hplc

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HPLC Blogs

Type of Compartment of HPLC & GC ?

HPLC Going into more detail, HPLC consists of a variety of components, including a solvent delivery pump, a degassing unit, a sample injector, a column oven, a detector, and a data processor. GC GC uses an inert or unreactive carrier gas as the mobile phase, and the...

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Type of buffer in Hplc

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HPLC Calibration As per IPC Pharmacopeia give guidance

HPLC Calibration we have perform as earlier as per protocol Company will provided Like example  Shimanzu HPLC calibration will perform as per that guidance's But now a day In 16th September 2021 As per IPC Pharmacopeia give guidance(Document ID IPC/GD/05) HPLC...

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How can read Protocol analyst

HPLC Analyst ○ Whenever supervisor give work allocation for testing any product. ○ HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ○ Then careful read specification(SOP) not missing any point which is defied in sop ○ Then Seen Which...

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Analytical method validation Blog

Different between method validation ICH & ANVISA

FORCED DEGRADATION: ICH: a2R1) VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY ANVISA: CoLLEGIATE BOARD RESOLUTION - RDC No. 53, OF DECEMBER 4, 2015 Topic: metal ion catalysed oxidation ICHNOT required ANVISARequired analysis cu 2+, Fe 3+(accelerate,...

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How can read Protocol analyst

HPLC Analyst ○ Whenever supervisor give work allocation for testing any product. ○ HPLC analyst first seen Test which is Assay by HPLC or RS By HPLC, Chiral test etc ○ Then careful read specification(SOP) not missing any point which is defied in sop ○ Then Seen Which...

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Analytical method validation (before requirements)

• the requirements of the measurement procedure• scope of experiments• RM to be used• Equipment• Statistical tools to be used• personnel for performing experiments and evaluating obtainedresults Analytical method validation

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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...

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During Job How to Control your self  Blogs

Thought of the day 2023

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Feeling in winter

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