Quality Cotrol

Interview Preparation guide

Pharma Consonances guidesĀ 

How to how to manage audits in Lab

Ā 

Ā 

Guidelines

Stability Guideline

Method Validation Guidelines

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Instrument
HPLC
GC
Karl Fishcher
Potentiometer
SOR

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Guidelines

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Interview questions and Answer

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consultancy guidence

Instrument Section

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Potentio Meter

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HPLC

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GC

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UV

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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

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Titration

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Normality

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Molarity

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PPM

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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

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ICH Q1

Validation

Ā 

ICH Q2

Impurity

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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

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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

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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.

Google play store Section

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Pharma Interview

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ICH Guidelines

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Pharma Calculator

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pharma interview

Method Validation

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Sulphate Ash

Sulphate ash calculator

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Pharma Blogs

RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES

RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES AS PER REGULATORY REQUIREMENTS 1. PROBLEM IDENTIFICATION What Happens Clearly define the deviation, OOS, OOT, complaint, breakdown, audit observation, or incident. Includes Deviation description Date & time of...

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Maximizing Efficiency in Modern Quality Control Labs

Operational excellence is demanded by modern quality control laboratories. Every single day, high testing volumes are managed by laboratory analysts. Accuracy must be maintained during complex testing procedures, including HPLC analysis and Karl Fischer titration....

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Key FDA Updates (Late Mayā€“Early June 2026)

The FDAā€™s latest updates (June 2026) include several new drug approvals, safety warnings on hidden ingredients in supplements, and upcoming regulatory decisions on therapies for COVID-19, urinary tract infections, smoking cessation, and kidney disease. These...

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Method validation pharma environment

ā€‹Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use. ā€‹Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for...

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Key Pharmacopoeia Updates 2026

These updates are quite significant because they reshape compliance expectations across different regions and therapeutic areas. Let me break down where the impact is most pronounced:šŸŒ Key Pharmacopoeia Updates- Indian Pharmacopoeia 2026    - 121 new...

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HPLC Blogs

QMS ā€“ CAPA MODULE

STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements. 2. SCOPE...

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HPLC columns classification

HPLC column HPLC columns are classified in the United States Pharmacopeia (USP) under the ā€œLā€ designation system, with each type assigned a specific USP code (e.g., L1, L3, L7). The main USP chapter that governs chromatography, including HPLC columns, is USP...

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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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Analytical method validation Blog

Method validation pharma environment

ā€‹Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use. ā€‹Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for...

read more

QMS ā€“ CAPA MODULE

STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements. 2. SCOPE...

read more

HPLC columns classification

HPLC column HPLC columns are classified in the United States Pharmacopeia (USP) under the ā€œLā€ designation system, with each type assigned a specific USP code (e.g., L1, L3, L7). The main USP chapter that governs chromatography, including HPLC columns, is USP...

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During Job How to Control your selfĀ  Blogs

How to Manage Your Diet and Mental Health in Shift Duty

Working irregular hours can take a massive toll on the human body. When the natural circadian rhythm is disrupted by rotating schedules, both physical metabolism and psychological well-being are significantly impacted. However, with the right structural changes,...

Way of success

Whenever when every morning when if you wake up first smilešŸ˜ŠšŸ˜ŠšŸ˜Š in your face. Then 15 minutes hard exercises. Then 15 minutes yoga. Then 15 minutes time spend your self. Then taken your breakfast šŸ³ā˜•šŸž(good nutrition). Then 15 minutes taken Scidual your work Afternoon...