Preparation and standardization of 1N NaOH as per USP
Procedure for Preparation And Standardization of 1N NaOH: Reagents used for 1N Sodium Hydroxide: 95% Alcohol Phenolphthalein Indicator Carbon Dioxide Free water Preparation of Reagent: …
Requirement for conducting stability study in pharma
What is the Requirement For Conducting Stability Study in pharma? Stability is an important study to conduct on the pharmaceutical product to determine the shelf-life …
Calibration of Bursting Strength Tester in pharma
Calibration Of Bursting Strength Tester: Bursting Strength tester is calibrated for 2 parameters. Calibration of Board Head, 2. Calibration of Paper Head Calibration of Board …
Calibration of Rotary shaker in pharma
Calibration Of Rotary Shaker There are two parameter for calibration of rotary shaker: 1. Timer calibration and 2. Verification of RPM Timer Calibration: Set the …
pH meter do’s and don’ts in pharma
PH Meter Do’s And Don’ts: pH meter do’s and don’ts are the preventive measure for the instrument to sustain the pH meter in good condition. …
Dissolution Apparatus Do’s and Don’ts in pharma
Dissolution Apparatus Do’s And Don’ts: Dissolution apparatus do’s and don’ts will help to improve the performance of the apparatus for a long period of time. …
Potentiometric Titration Do’s and Don’ts in pharma
Potentiometric Titration Do’s And Don’ts: Each instrument has its own dos’ and don’ts, today we are going to see potentiometric titration do’s and don’ts. Potentiometric …
Analytical balance possible errors in pharma
Analytical Balance Possible Errors: What are the analytical balance possible errors and what is the action plan to avoid such errors we will learn in …
How to prepare 0.1M HCl Solution in pharma
Procedure for How To Prepare 0.1M HCl Solution In the market 37% of HCl is available, on the basis of that molarity calculation has been …
Laboratory Investigation Of Aberrant Results Part-3
Laboratory Investigation Of Aberrant Results part-3 In the last 2 parts, we covered 5 points of laboratory investigation of aberrant results. Here we will cover …
Laboratory Investigation Of Aberrant Results Part-2
Laboratory Investigation Of Aberrant Results in pharmaceuticals Part-2: In the last part, we covered 2 points 1. Analyst responsibility and Awareness 2. Analytical record review. …
Laboratory Investigation Of Aberrant Results Part-1
Laboratory Investigation Of Aberrant Results in pharmaceuticals part-1: Introduction: During the daily analysis, we come across various types of aberrant results and incidences such as: …
Mechanical calibration of dissolution apparatus 1 and 2
Mechanical Calibration Of Dissolution Apparatus: “The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice” was published by the …
Is This Reasons For Peak Tailing and Fronting?
What is the reasons for peak tailing and fronting? Good separation and asymmetric peak shape are the goals of gas chromatography and high-performance liquid chromatography. …
Highest Melting Point Metal in the world?
Before knowing the highest melting point metal in the world, need to understand what is melting point? What is Melting Point? Melting point is a …
How to Perform Sulfated Ash in pharma?
What is Sulfated Ash: Sulfated ash is one of the test to perform in the pharmaceutical industry. The test is perform to measure, when the …
SOP for Calibration of pH meter in pharmaceutical
Calibration Of PH Meter in pharma/pH meter calibration sOP: Calibration of pH meter in pharmaceuticals is the requirement to get consistent results. pH meters must …
What are the Applications of pH meter?
Before proceeding to applications of ph meter, need to understand what is pH? What is definition of pH? pH stands for potential of Hydrogen ion. …
Operation and calibration of Muffle Furnace
Operation And Calibration Of Muffle Furnace in pharma: Objective: To lay down a procedure for operation and calibration of muffle furnace. Scope: The standard operating …
Operation and calibration of water bath in pharma
Operation And Calibration Of Water Bath Working/Operating Procedure of water bath: Ensure the sufficient amount of water available in the water bath. Ensure that the …
Calibration of DUSA Shaker in pharma
Dusa shaker instrument is used in the analysis of Metered Dose Inhaler (MDI). The instrument which is used in the pharmaceutical industry should be calibrated …
What are the 4 Types of Column Chromatography?
Before understanding the types of column chromatography, need to understand what is column chromatography? What is Column Chromatography? In column chromatography, the stationary phase is …
Dissolution calibration parameters and criteria
Dissolution calibration parameters and criteria in pharma: What is dissolution? Dissolution is a rate of drug dissolution in the given set of conditions in a …
What is validation in pharmaceutical industry?
Validation is the most important activity in the pharmaceutical industry. There are multiple types of validation in the pharmaceutical, such as Analytical Method Validation, Process …
HPLC Calibration Parameters in pharma
HPLC Calibration Parameters: There are a total 9 parameters for calibration, these are as follows; Flow Rate Accuracy Injector Precision Injector Linearity Wavelength accuracy of …
Good Documentation Practices Dos and Donts
Good Documentation Practices Dos and Donts (GDP): Good Documentation Practices (GDP) Do’s: Use the defined colored ball pen for document entry. Use the defined date …
SOP for Operation and Calibration of Air Flow Meter
SOP for Operation and Calibration of Air Flow Meter: 1.Objective: To lay down a procedure for operation and calibration of Air Flow meter. 2.Scope: This …
Top 6 impressive Clinical Data Management Interview Questions and Answers
Clinical Data Management Interview Questions and Answers: Q1: What are the role of the Clinical Data Manager (CDM)? A: It is the responsibility of a …
Karl Fischer Titration Methods in pharma
Karl Fischer Titration Methods: Karl Fischer titrations use volumetric or coulometric titrations to assess the amount of water in a sample by oxidizing sulfur dioxide …
Applications of Karl Fischer Titration in industry
Applications of Karl Fischer Titration: There are multiple applications of Karl Fischer titration. An accurate manner of determining water content is to perform KF titration …
Clinical Trials In Human Medicines as per EU
Clinical Trials In Human Medicines as per EU: For its opinions on the approval of medicines, the European Medicines Agency (EMA) relies on the results …
Procedure for Loss on Drying USP Test
Procedure for Loss On Drying USP test: Take a dry LOD bottle as specified as per standard operating procedure (SOP). Place the empty LOD bottle …
What are the 4 types of tablets in pharma?
The term “pharmaceutical tablet” refers to both molded and pressed unit dosage forms of medications that contain one or more active medicinal ingredients. Typically, a …
Operation procedure for Ice Maker | SOP for Ice Maker in pharma
SOP For Operation procedure for Ice Maker: Objective: To lay down the procedure for the operation of ice maker. Scope: This standard operating procedure covers …
What is Clinical trial process flow as per FDA?
Before starting the clinical trial process flow, we will understand, What is a definition of a clinical trial? what is a clinical trial is in …
What is a Deviation in pharmaceuticals?
What is a Deviation in pharmaceuticals? Managing deviations is one of the most important aspects of pharmaceutical manufacturing. Defining deviation as a departure from written …
25+ Interview Questions on Polarimeter?
Polarimetric methods are reliable and simple methods for determining and analyzing the structure of expensive and nonreplicable samples in macro, semi-micro, and microanalysis. Pharmaceutical, chemical, …
2 Types of Titrimetric Methods for Water Determination
Titrimetric methods are widely used in the pharmaceutical industry to determine water content or traces present in the sample. Based on the …
What are 7 Types of USP Dissolution Apparatus?
What is Dissolution? Dissolution is the time required for the tablet to dissolve into a specified medium under a given set of conditions. What is …
Calibration of Disintegration Test Apparatus in pharma
Calibration of Disintegration Test Apparatus: The disintegration test is one of the test parameters to measure the time of tablet to disintegrate in a defined …
Definition of ALCOA Plus
Definition of ALCOA Plus: 1. A-Attributable: Attributable means recording who performed an action and when. And, if a record is changed, who did that and …
SOP for Disaster management for Chromatographic Software Data System in pharma
SOP for Disaster management for Chromatographic Software Data System Purpose: This procedure establishes a disaster management plan for handling any natural disaster or a human-made …
What are GAMP 5 Software Categories?
What are GAMP 5 software categories? There are 5 software categories as per the International Society for Pharmaceutical Engineering (ISPE). In GAMP 4 there were …
What are the 5 components of HPLC in pharma?
What are the components of HPLC? As HPLC chromatography is a widely used technique for the separation of components from the mixtures but to separate …
What is difference between ALCOA and ALCOA Plus?
What is the difference between ALCOA and ALCOA Plus? What is ALCOA? In the early 90’s, regulatory agencies defined the concept of Data Integrity by …
What is the Difference between KF and LOD in pharma?
What Is The Difference Between KF And LOD In pharmaceutical quality control, there are different methods to determine the water content or moisture content of …
Difference between Humidity and Relative Humidity?
What is the Difference Between Humidity And Relative Humidity? Q. What is Humidity? Answer: The term ‘Humidity’ and the term ‘Relative Humidity’ are two different …
What is GDUFA and PDUFA in pharma?
What is GDUFA and PDUFA in pharma GDUFA and PDUFA are US FDA programs that are designed to help the agency hire and retain a …
What is Annual Product Quality Review (APQR) in pharma?
In Pharmaceutical, an Annual product quality review (APQR) is of high importance to summarize the product quality for an improvement or to know the product …
What are the detectors used in high performance liquid chromatography (HPLC)?
Detectors used in high performance liquid chromatography Detector plays a very important role in High-performance liquid chromatography (HPLC) to detect the compound from the sample …
Equipment Qualification Principles and Practices in pharma
Equipment Qualification Principles And Practices Equipment qualification is an important process for any equipment or instrument used in the pharmaceutical industry. First, need to understand …
Principle of Turbidity in pharma
Principle of Turbidity in pharma Turbidity is the optical property, that causes light to be scattered and absorbed, rather than transmitted. The scattering of the …
KBr Pellet preparation and precautions for IR spectroscopy in pharma
KBr Pellet Preparation and Precautions: Generally, Identification by Infrared spectroscopy is a test where the pellet needs to prepare for scanning. A good pellet preparation …
What is a significant change in stability as per ICH?
What Is A Significant Change In Stability A significant change instability is a deviation from its trend. According to ICH guidelines, the remarkable changes observed …
UV-Visible Spectrophotometer Do’s and Don’ts in pharma
UV-Visible Spectrophotometer Do’s And Don’ts Multiple instruments are used in pharmaceuticals. The UV-Visible spectrophotometer is one of the widely used instrument in the pharmaceutical quality …
What are the steps to clean or regenerate columns?
Steps To Clean Or Regenerate Columns Depositions on the inlet frit, in the column, or on the surface of the stationary phase can cause increased …
SOP for Handling of Rejected Batches in the pharmaceutical industry
SOP for Handling Of Rejected Batches In Pharma Industry Every organization is having its own SOP on the handling of rejected batches. Let’s understand common …
What to do when column backpressure Increases in pharma?
What To Do When column backpressure Increases in pharma It is good to use a guard column for column long life, but sometimes it increases …
How to Determine the void volume in HPLC
How To Determine The Void Volume In HPLC As a rule of thumb, the void volume of a system can be determined by injecting a …
20+HPLC Interview Questions and answers in pharma
HPLC Interview Questions And Answers If the interview is conducted for quality control in the pharma or research and development department, then HPLC interview questions …
What are the 4 types of FDA inspections?
Types Of FDA Inspections If the organization is manufacturing drugs or drug devices or it is the processor of the USFDA product, then the organization …
How To Use UV-Visible Spectrophotometer Step-By-Step Guide
How To Use UV-Visible Spectrophotometer In the analytical aspect, a UV-Visible spectrophotometer is an important instrument to determine the absorbance of the solution and to …
25+ HPLC chromatographic terminologies used in pharmaceuticals
What are the chromatographic terminologies used in pharmaceuticals? Even with the numerous technical terms involved, Chromatography is challenging enough to comprehend at the best of …
What is The HPLC Principle and applications in Pharma?
Hplc principle and applications: HPLC is a very popular separation method used in pharmaceutical research to separate mixtures of components. HPLC is the process by …
What is Normal Phase Chromatography in pharma?
Normal Phase Chromatography what is it? Generally multiple times we heard about normal phase chromatography and reverse phase chromatography, but what is actually meaning of …
Difference Between C8 and C18 column in pharma
Difference Between C8 And C18 Column There are several types of reverse phases columns available in the market such as C8, C18, C4, C1, C-phenyl, …
10 Method Validation Parameters in Pharma
Method Validation Parameters in Pharma Analytical Method validation is an essential step in the development of reference methods and in the assessment of a lab’s …
What is DUNS number meaning/duns meaning in pharma?
In pharmaceutical industry there are multiple processes for registration and renew of food and drug facility. DUNS number is one of the basic requirement. In …
What is ICH Q10 in the Pharmaceutical Quality System?
In this article, we are going to learn about Scope of ICH Q10 and Objective of ICH Q10 in pharmaceutical. ICH Q10 In Pharmaceutical Quality …
CAPA Process In Pharmaceutical Quality Management System
What is the full form of CAPA? What is CAPA in pharma? what is the difference between CA and PA? Such types of questions generally …
10 Typical Interview Questions and How to Prepare
10 Typical Interview Questions And How To Prepare for them Would you like to be confident that you will do well in interviews? The interview …
The Concentration Of Solution-Volume And Weight Basis in pharma
Concentration Of Solution-Volume And Weight Basis There are two types of solution concentration. Concentration on volume basis and concentration of weight basis. What is concentration? …
What are the 7 QC tools used for process improvement?
7 QC tools are used to identify the and fix the problem with respect to product quality. It is systematic and scientific problem solving approach. …
Classification of dissolution apparatus in pharma
Classification Of Dissolution Apparatus As per USP General chapter No. <711> there are seven types of dissolution apparatus in the pharmaceutical industry. Here is a …
What are S1 S2 and S3 stages in Dissolution?
What Are S1 S2 And S3 stages In Dissolution in pharmaceutical? In the pharmaceutical industry, it is a very important test to know the drug …
Procedure for How to Develop Iodine chamber for TLC in pharma
Development of iodine chamber is a technique for getting a good results for Thin Layer Chromatography (TLC). Lets understand how to develop iodine chamber for …
What is form 482-483 and 484 in pharma?
Generally, this question comes to mind of every pharma person working in the industry. So, what is the exact meaning of these forms lets understand …
Top 31 Gas chromatography interview questions and answers
Gas chromatography interview questions and answers are somewhere kept us on backfoot while interview. In this article we will try to cover such Gas chromatography …
What is the Definition of OOS in pharma?
What Is The Definition Of OOS in pharmaceutical OOS is a short form of Out of Specification in the pharmaceutical industry. In pharma, certain limits …
How to prepare 0.1M NaOH Solution (0.1 M Sodium Hydroxide) in pharmaceutical
How To Prepare 0.1M NaOH Solution or 0.1 M Sodium Hydroxide Before starting how to prepare 0.1M NaOH solution, first of all need to understand, …
List of tests for ribbed smooth plastic cap with pulp liners-packing material
List Of Tests For Ribbed Smooth Plastic Cap With Pulp Liners-packing material The tests to be performed for Ribbed Smooth Plastic Cap With Pulp Liners …
List of test for Silica gel pillow pouch/Bag-Packing material in pharma
List Of Test For Silica Gel Pillow Pouch/Bag-packing material The tests need to be performed for the silica gel pillow pouch/bag for packing material in …
List of test for PVC/PVDC film-packing material in pharma
List Of Test For PVC/PVDC Film-Packing Material What are the test need to perform for PVC/PVDC film for packing material in pharmaceutical. Here is the …
List of test for printed and plain self adhesive label-packing material
List Of Test For Printed And plain Self Adhesive Label for packing material What are the test to be performed for printed and plain self …
50 Pharmaceutical laboratory equipment list / Instrument list
Pharmaceutical Laboratory Equipment List In pharmaceutical laboratories what are the equipment or instrument are used that helps to generates the results. Here is the pharmaceutical …
How many and What are the types of validation?
How Many And What Are The Types Of Validation Validation is an important part in pharmaceuticals. Validation provides evidences and assured that the drug manufactured …
What is the Definition of change Control?
Definition Of Change Control Change control is a formal process to implement the new change in the existing system in a justified way by an …
What is the Definition of Quality Assurance in pharmaceuticals?
What Is The Definition Of Quality Assurance In Pharmaceuticals? Quality Assurance is one of the department in the pharmaceutical manufacturing industry. Quality Assurance is assuring …
What Is The Definition Of Quality Control In Pharmaceuticals?
What Is The Definition Of Quality Control In Pharmaceuticals? Quality Control is a testing unit in the pharmaceutical. Once a drug product manufactured need to …
What is the principle of KF Autotitrator?
What Is The Principle Of KF Autotitrator? Water content test is performed to determine the amount of water present in the drug product. It is …
What is Change Control process in pharma?
What Is Change Control process In Pharma? Change control is one of the change management processes in pharmaceuticals. Whenever it needs to change in the …
50 Electronic Codes of Federal Regulation (e-CFR) in pharma
As per FDA there are 50 title of Electronic Codes Of Federal Regulation (E-CFR) In Pharmaceutical. In this article we will see the all 50 …
Frequently asked questions on FDA data integrity
Data integrity and compliance are nowadays the top priorities of all pharmaceutical companies. Data integrity and compliance in the pharma industry assures, quality and reliability …
What is an audit trail in pharma?
What is an audit trail in pharma? Why audit trail is required? Does audit trail in pharma is a regulatory requirement? What if the audit …
What is the procedure for the Operation of karl fischer apparatus?
Karl Fischer titrator is one of the instrument in the quality control laboratory which is used to determine the water content/moisture content of the sample. …
Top 25 Karl Fischer titration interview questions and answer in pharma
Here in this article, we will try to understand the Karl Fischer titration interview questions and answer for quality control in pharmaceutical. Karl Fischer is …
Top 10 reason for getting Warning letter to employees
Not only in the pharmaceutical industry but all industries having a root of a treat for not following the company rules and policies. There is …
Top 31 Interview questions for quality control analyst in pharma
Interview is challenge for the newbies as well as experience candidate also, but here I am going to make you relax with respect to interview …
18 Disintegration test interview Questions and answers for Pharma QC
In this article we will understand the disintegration test interview questions and answers. Quality control having multiple instruments and equipments, today we will understand disintegration …
Stability climatic zones of the world as per ICH and it’s study
According to ICH guidelines the world is divided into four different climatic zones and the climatic zones are decided on the basis of climate of …
Preparation and standardization of Sodium Hydroxide volumetric solution as per USP
Sodium hydroxide volumetric solution is a common solution that is used in the pharmaceutical industry. It is an acid-base titration. Here we will see the …
Raman spectroscopy uses advantages and disadvantages
Identification is one of the test to identify the functional group of drug substance in the pharmaceutical industry. Raman spectroscopy is non destructive technique of …
Important Difference between 21 CFR part 11 and EU Annex 11
21 CFR part 11 and EU annex 11 both are guidance for the electronic records and electronic signature. The guidances are applied to the computerized …
Friability test: Top 18 Friability test Interview Question and Answer
A Good Interview is a first and last impression on the interviewer. More you know more you fearless while interview. It is more important to …
Best 24 Definition of Pharmaceutical Terms and dosage forms
In pharmaceutical industry multiple terminology are being used.Here we will understand definition of pharmaceutical terms and dosage forms. Pharmaceutical industry is a manufacturer of multiple …
31 most important interview questions and answers on dissolution for quality control in pharma
How to face interview is quite difficult problem for newbie.In this article I tried to cover top interview questions and answers on dissolution. Most common …
What are 3 Practical Difference between assay potency and purity in Pharmaceutical?
The difference between assay potency and purity in pharmaceutical industry. Assay can be calculated by three different ways. Such as assay on dried basis, assay on anhydrous basis and assay on as us basis.
Understand 14 ICH guidelines in the pharmaceutical in an easy way
ICH full form: International Council on Harmonisation of a technical requirement for registration of pharmaceutical for human use. ICH is a joint initiative of three different regulatory bodies …
10 Principle of Quality Control instruments in pharma lab
Principle of Quality control instruments in Pharma lab In the pharmaceutical industry, multiple instruments are used. In this article, we are going to explain the …
What is Drug Master File (DMF) and types of Drug master file in pharmaceutical
Drug Master File (DMF) is a confidential data provided by the manufacturer to the Food and Drug Administration (FDA) for review, before approving any product …
Best basic information of Particle size analysis (PSD)
Particle size analysis is an analytical technique to measure and report the distribution of particle size of solid or liquid material. Particle size analysis …
Current Good Manufacturing Practices (cGMP) 10 principle’s
Good Manufacturing Practices (GMP) is a set of guidance, regulation, and codes. GMP is also known as Current Good Manufacturing Practices (cGMP).To get consistent and quality …
Impact of Contamination, cross-contamination & mix-ups in Pharmaceutical
Contamination, crosscontamination and mix-ups is big challenge for pharmaceutical industry. To avoid contamination and mix-ups precautions need to take.
30 Physical properties and Chemical properties- Ultimate guide
In the world every matter having physical properties and chemical properties. Without physical property, there will not be any matter on the …
IR Spectroscopy principle and applications in pharmaceutical industry
IR Spectroscopy principle and Application: Here we will learn about what is Infra-Red spectroscopy? IR spectroscopy principle and Applications. IR spectroscopy technique. IR spectrometer While surviving …
Best Information of X-Ray Diffraction
X-Ray Diffraction what it is? Does X-Ray Diffraction is a good technique for the identification of material structure? X-Ray Diffraction machine Today we are …
Best practices to avoid Data integrity issues and ALCOA plus
Data integrity and Alcoa plus in pharmaceutical
Understand the Abbreviated New Drug Application in Pharmaceutical
Background: Today here we are going to discuss Abbreviated New Drug Application (ANDA) in pharmaceutical and how ANDA has arrived in the industry. …