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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 of clinical trials carried out by pharmaceutical companies. …

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 …

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 …

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 …

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? Managing deviations is one of the most important aspects of pharmaceutical manufacturing. Defining deviation as a departure from written …

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: The disintegration test is one of the test parameters to measure the time of tablet to disintegrate in a defined …

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 Purpose: This procedure establishes a disaster management plan for handling any natural disaster or a human-made …

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 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 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 …

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 …

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 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 It is good to use a guard column for column long life, but sometimes it increases …

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 …

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 …

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 …

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 …

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 …

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 There are several types of reverse phases columns available in the market such as C8, C18, C4, C1, C-phenyl, …

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 …

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 …

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 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 …

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 …

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 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 …

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 …

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. …

Macleods Pharmaceuticals Ltd Research Scientist hiring Macleods Pharmaceuticals Ltd Research Scientist hiring for its API unit. A job opportunity for a Research Scientist in HPLC/AMD …