Quality Cotrol

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Pharma Consonances guidesĀ 

How to how to manage audits in Lab

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Guidelines

Stability Guideline

Method Validation Guidelines

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Instrument
HPLC
GC
Karl Fishcher
Potentiometer
SOR

N

Guidelines

N

Interview questions and Answer

N

consultancy guidence

Instrument Section

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Potentio Meter

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HPLC

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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
Ā 
Type of impurities?
  • Organic impurities
  • Elemental impurities (inorganic)
  • Residual solvents
Type of Detector in GC
-Mass flow depend Decorator
Ā 
-FLAME IONIZATION DETECTOR (FID):
Ā 
-NITROGEN PHOSPHORUS DETECTOR (NPD):
Ā 
-FLAME PHOTOMETRIC DETECTOR (FPD):
Ā 
-Concentration type Detector
Ā 
-ELECTRON CAPTURE DETECTOR (ECD):
Ā 
-THERMAL CONDUCTIVITY DETECTOR (TCD):
Ā 
-PHOTOIONIZATION DETECTOR (PID):
Ā 
-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

{

Titration

{

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, pesticidesĀ 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

Ā 

ICH Q1

Validation

Ā 

ICH Q2

Impurity

Ā 

ICH Q3

Evaluation

Ā 

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 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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Pharma Blogs

Before use karl fischer titration care

"Care before use" in Karl Fischer titration refers to the crucial steps and considerations taken before starting the actual titration process to ensure accurate, reliable, and safe results. Given that Karl Fischer titration is highly sensitive to moisture, these...

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Analytical method validation other concepts

Understood. "Analytical image method validation" refers to the process of ensuring that image-based methods used for quantitative or qualitative analysis consistently produce reliable, accurate, and fit-for-purpose results. This is crucial in fields like...

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Uv analysis sop in pharma

This sounds like you're looking for a Standard Operating Procedure (SOP) for Ultraviolet (UV) analysis. Here's a general outline of what a comprehensive SOP for UV analysis would typically include. Keep in mind that the specific details will vary depending on the...

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Specificity analytical method validation

According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:"Specificity is the ability to assess unequivocally the analyte in the presence of components which...

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Uv development

UV development can refer to several distinct areas, primarily revolving around ultraviolet (UV) light and its applications. To provide a comprehensive answer, let's explore these different facets:1. UV Spectroscopy Method DevelopmentThis involves creating and...

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Uv analysis in pharma

"UV analysis" most likely refers to Ultraviolet-Visible (UV-Vis) Spectroscopy. This is a widely used analytical technique that studies how substances interact with ultraviolet and visible light.Here's a breakdown of what UV-Vis analysis entails:Principle: * UV-Vis...

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Karl fischer titration

"Kal Fischer" most likely refers to Karl Fischer Titration.Karl Fischer titration is a well-established chemical method used to determine the water content of a wide variety of samples. It's a common technique in many industries, including: * Food and beverage: To...

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How to Analytical Method validation Planing

Ah, method validation planning in pharma – a cornerstone of ensuring the quality and reliability of pharmaceutical products! It's all about demonstrating that your analytical methods are fit for their intended purpose.To get started with effective method validation...

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How to measure OOT IN pharmaceuticals industry

Out-of-Trend (OOT) in Pharmaceutical StabilityIn the pharmaceutical industry, Out-of-Trend (OOT) results refer to analytical data obtained during stability studies that, while still within the established specification limits, deviate significantly from the expected...

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HPLC Blogs

HPLC PUMP TROUBLESHOOTING

HPLC (High-Performance Liquid Chromatography) pump issues can significantly impact the performance and reliability of your chromatographic analysis. Here are some common problems and potential solutions: Common Issues: Flow rate inconsistencies: Variations in flow...

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HPLC calibration compound might be use

B - naphtholCaffeineToluene Whu this use • Not harm your column • Easy mixtures like methanol water mix use the mobile phase • So not harm your column • Peak are very identical Not use any buffer so not harm in column

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HPLC calibration which substance use why ?

B - naphtholCaffeineToluene Whu this use • Not harm your column • Easy mixtures like methanol water mix use the mobile phase • So not harm your column • Peak are very identical Not use any buffer so no harm in column

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FACTOR AFFECTS ON HPLC COLUMN

1) Partial Blockage of column 2) Adsorption of sample impurities inside column surface. 3) Poorly packed stationary phase. 4) Mechanical or thermal shocks during Handling. 5) Chemical attack on the stationary phase.

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HPLC Interview Top 15 Question and answer

1. What is HPLC? Answer:HPLC stands for High-Performance Liquid Chromatography. It is a technique used for separating, identifying, and quantifying components in a mixture. It uses a liquid mobile phase under high pressure to pass through a column containing a...

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Analytical method validation Blog

Specificity analytical method validation

According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:"Specificity is the ability to assess unequivocally the analyte in the presence of components which...

read more

Uv development

UV development can refer to several distinct areas, primarily revolving around ultraviolet (UV) light and its applications. To provide a comprehensive answer, let's explore these different facets:1. UV Spectroscopy Method DevelopmentThis involves creating and...

read more

How to Analytical Method validation Planing

Ah, method validation planning in pharma – a cornerstone of ensuring the quality and reliability of pharmaceutical products! It's all about demonstrating that your analytical methods are fit for their intended purpose.To get started with effective method validation...

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Heavy metal Method -A

heavy metals in a substance. It involves reacting the substance with hydrogen sulfide (or sodium sulfide) to produce colored heavy metal sulfides, which are then compared to a standard lead solution. The test ensures that the sample does not exceed a specified heavy...

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Heavy metal analysis

measures the fluorescence emitted by atoms in a sample excited by a light source. X-ray Absorption Spectroscopy (XAS): XAS provides information about the chemical form of heavy metals in a sample. Sample Preparation:Before analysis, samples (e.g., soil, water,...

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HPLC METHOD DEVELOPMENT

HPLC (High-Performance Liquid Chromatography) method development is a critical process in analytical chemistry, involving the creation of a precise and reliable method for separating, identifying, and quantifying the components of a mixture.Here's an overview of the...

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During Job How to Control your selfĀ  Blogs

Thought of the day 2023

ā€œKeep relations, which change your situations, not ones which itself gets changed according to situations.ā€   No one is too much busy. It’s all about importance you have in their life.ā€Ā    ā€œNegative perceptionĀ and wrong judgement astray a man in...