Quality Control » Pharmaguddu

Top 10 Common Audit Findings in Pharmaceutical Manufacturing

Published on: April 30, 2025 by Naresh Bhakar

Below is a summary of the 10 most frequently observed audit findings in pharmaceutical manufacturing plants, followed by detailed descriptions, examples, preventive strategies, and relevant industry keywords. Each issue is based on industry reports and regulatory inspection data. Common Audit Finding: 1. Documentation and Record-Keeping Deficiencies: Deficiencies in documentation and records, such as missing or … Read more

Procedure for Handling of Deviations (SOP)

Last Updated on: March 23, 2024 by Pankaj Dept. Quality control

Learn About Standard Operating Procedure for Handling of Deviations in pharmaceuticals | Types of deviations | Deviation Flow chart | Devations Guidelines | Deviation Numbering | Deviation management. 1.0 OBJECTIVE: 1.1 To lay down that deviations from manufacturing instructions and quality-related procedures are recorded, investigated, and evaluated for their impact on product quality in a … Read more

Understanding Drug Product Assay and Potency

Published on: February 9, 2024 by Naresh Bhakar

In this discussion, we will delve into two very important terms associated with drug products: drug product assay and drug product potency. The aim is to clear vision on their interrelation, differences, and significance, as guided by the ICH guideline Q2 R2, which focuses on analytical method validation. Drug Product Assay Definition and Purpose A … Read more

Flow Injection Analysis (FIA) Overview

Published on: February 6, 2024 by Naresh Bhakar

The instrument being discussed in this context is known as a Flow Injection Analyzer (FIA). Its primary function is to automate several processes typically associated with conventional wet chemistry procedures. Specifically, the Flow Injection Analysis is designed to perform tasks such as automatically picking up samples, mixing them with the required reagents, and subsequently detecting … Read more

Dissolution Test Apparatus / Types of DT Apparatus Methods and Medium

Published on: January 15, 2024 by Naresh Bhakar

A Dissolution Test is used for in vitro Testing of the Tablets and Capsules. Dissolution provides the product Release info to know the drug delivery. Dissolution apparatus are used throughout the product development life cycle, from Product release to stability testing and study of the product data from product to product. Then after passing or approval from the … Read more

0.01 M Sodium Tetraphenylborate Preparation and Standardization

Published on: December 10, 2023 by Naresh Bhakar

Preparation and Standardization of 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) solution and calculating formula in Pharmaceutical labs. Name: 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) Reagents: Sodium TetraphenylborateSodium HydroxideAluminium HydroxideSodium ChlorideCetylpyridinium ChloridePotassium Chloride Method of Preparation: Method of Standardization: Calculation: The calculation formula is : Where ‘a’ is the volume of 0.005 M cetylpyridinium chloride required without potassium … Read more

0.1 M Tetrabutylammonium Hydroxide Solution Preparation and Standardization

Published on: December 8, 2023 by Naresh Bhakar

Preparation and Standardization of 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Solution in Pharmaceutical Labs. Name: 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Reagents : Preparation of 0.1 M Tetrabutylammonium Hydroxide: Method of Standardization: Storage: Store below 25°C & store in an amber-colored bottle. Protect exposure from CO2 & water. Shelf life: The shelf life of the above solution … Read more

Silica Based Column Cleaning, Regeneration and Storage

Published on: November 25, 2023 by Naresh Bhakar

Column Cleaning, Regeneration, and Storage of Silica Based Columns are necessary to prevent unnecessary problems during the Process. So when you’re using those in-line filters or guard cartridges for your HPLC columns, it’s like giving them armor against getting clogged or stuff sticking to them. But you know what? Even with these guard things, over … Read more

Degassing of HPLC Mobile Phase: Why Its Done?

Published on: November 25, 2023 by Naresh Bhakar

Why is HPAC Mobile phase Degassing done? When different liquids mix in HPLC analysis, bubbles forming can cause problems. To avoid this, we removed the bubbles by degassing the liquid used in the analysis. Unstable and Noisy Baselines Lower flow rate precision of pump due to cavitation in piston chamber or effect on check valve … Read more

0.1 N Perchloric Acid Preparation and Standardization

Published on: November 17, 2023 by Pankaj Dept. Quality control

Preparation and Standardization of 0.1 N Perchloric acid (Non-Aquos by using glacial acetic acid and crystal violet solution as indicators in Pharmaceuticals. Apparatus and Reagents Requirements: Apparatus: Conical Flask, Volumetric Flask, Reflux condenser, Measuring cylinder, Burette, Pipette and Burette Stand. Reagents: Preparation of 0.1 N Perchloric acid Standardization of 0.1 N Perchloric acid Calculation: N1V1=N2V2 … Read more

Preparation and Standardization of Potassium Permanganate

Published on: November 12, 2023 by Naresh Bhakar

Here is a detailed discussion on How to Prepare and Standardization of Potassium Permanganate (1M, 0.1M, 1N, 0.1N) solution by using different reagents in Labs. Preparation and Standardization of 1M Potassium Permanganate Potassium permanganate – M.Wt – 158 Preparation of 1M Solution of Potassium Permanganate: Principle: In volumetric analysis, many reactions involve oxidation and reduction. … Read more

0.1 M Sodium Thiosulfate Preparation and Standardization

Last Updated on: November 12, 2023 by Pankaj Dept. Quality control

Preparation and Standardization of 0.1 M Sodium Thiosulfate (Na2S2O3) solution in pharmaceutical labs. Aim: 0.1 Molar Thiosulfate (Na2S2O3) solution Preparation and Standardization Materials/Reagents: 1.0 – Sodium Thiosulfate2.0 – Sodium Carbonate3.0 – Potassium Bromate4.0 – Potassium Iodide5.0 – Hydrochloric Acid6.0 – Starch Solution Principle: Principle: This method uses a standard process called redox titration with iodometric … Read more

0.1 M KOH Solution Preparation and Standardization

Published on: November 7, 2023 by Pankaj Dept. Quality control

Preparation and Standardization of 0.1 M KOH Solution by using HCL and phenolphthalein as an indicator in Pharmaceutical Labs. Aim: To Prepare and measure 0.1 M KOH solution with HCl. Materials and Reagents Requirements: Glass: A burette, burette stand, conical flask, volumetric pipette, beaker, volumetric flask, funnel, glass rod, and a wash bottle.Chemicals: Potassium hydroxide … Read more

0.1N Silver Nitrate (AgNO3) Solution Preparation and Standardization

Published on: November 6, 2023 by Pankaj Dept. Quality control

Preparation and Standardization of 0.1N Silver Nitrate (AgNO3) Solution in pharmaceutical labs by using below steps: Steps involved in the Preparation and Standardization of 0.1N Silver Nitrate Step-1: Reagent preparationStep-2: AgNO3 solution preparationStep-3: AgNO3 solution StandardizationStep-4: Calculation Preparation of 0.1 N AgNO3 solution: Step-1: Reagent Preparation: (Pottasium Chromate solution) Step-2: AgNO3 solution preparation: Step-3: AgNO3 … Read more