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The Practices with Data Integrity Risk (DI Risk)

What are the practices with data integrity risk? Data integrity (DI) issues and data integrity risks related to those issues are very serious problems for …

GMP in pharma help use to achieve: GMP in pharmaceuticals, prevents any substandard, adulterated and unsafe products from being introduced into both national and international …

What is an Incident? An Incident is an unplanned and unexpected event which which may result in an injury or damage to the plant, equipment, …

Correction-corrective action and preventive action in pharma: Correction-corrective action and preventive action are the 3 key definitions used in the pharmaceutical industry while investigating. Let’s …

Dissolution Apparatus Calibration procedure: There are 2 types of dissolution calibration performed in the pharmaceutical industry, 1. Physical calibration and 2. Chemical calibration. In physical …

There are different types of root cause analysis (RCA) on the basis of what kind of problem root cause you want to find. Types of …

Not only in pharmaceuticals but many industries are using Root Cause Analysis (RCA) tool. Root Cause Analysis (RCA) is a technique used to find out …

In the pharmaceutical industry, stability chambers are designed to store the drug product or material in different storage conditions. Let’s understand What are stability chambers …

Difference between OOS-OOT-OOC-OOE: When it comes to handling deviations in analysis results, the terms OOS, OOT, OOC and OOE always come up. But how are …

Types of pH meter in pharma: Ph meter is one of the instrument used in the pharmaceutical industry to measure the pH of the water …

Principle, Types And Application Of Acid-Base Titration: In laboratories, titration is used to determine the concentration of a specific analyte through quantitative chemical analysis. It …

Pharmaceutical companies tout the safety of their new drugs. However, when FDA inspectors visit the production facility, the work is immediately halted; vital quality control …

Preparation and standardization of potassium Hydroxide: Here we will understand how to do preparation and standardization of potassium hydroxide (KOH) as per USP. Reagents required: …

UPLC Advantages Over HPLC: Even though the working principle of UPLC and HPLC are the same but UPLC is a more advanced separation technique as …

UPLC Principle: It is a technique used to separate any sample into its constituent parts via liquid chromatography. There is no real fundamental difference in …

4 Different Types Of Titration In Pharma: Different types of titrations can be classified according to the substance being evaluated or the type of analysis …

QA Interview question and answers: The following are sample for QA interview questions and answers from the perspective of the Quality Assurance. Q1: What is …

IR Do’s And Don’ts In Pharmaceuticals: Do’s of IR: Whenever any error massage is displayed on the monitors, immediately inform to instrumentation engineer. Example: error …

Preparation and standardization of 0.1N perchloric acid VS as per USP: Multiple volumetric solution are used in pharmaceutical industry, here is the manual and potentiometric …

Definition Of Performed By Reviewed By Approved By And Verified By: These are the terms used in pharmaceuticals which are having different role and responsibility …

What is Computer system validation? Food and Drug Administration (FDA) guidelines for software validation outlines general validation principles applicable to medical device software or software …

Preparation Of 2 N Sulfuric Acid: Preparation of 1 N Sulfuric acid: Preparation of 1 N sulfuric acid and lower concentration solutions can be prepared …

What are the Factors Of Cleaning Validation In Pharma? Cleaning validation is an integral part of the pharmaceutical industry and has high importance. FDA expects …

What is the definition of terminologies used in oOS investigation? For investigation of Out Of Specification (OOS) results multiple terminologies are used to get a …

visitor entry and exit procedure in pharmaceuticals

Visitor Entry And Exit Procedure In Pharma: As we aware that pharmaceuticals produces a life saving drugs and involves high risk of contamination or cross …

Storage Conditions As Per USP And EU: There are multiple storage conditions in pharmaceutical which is used for storage of drug product. In the pharmaceuticals, …

Operation Of Diaphragm Pressure Gauge: Press the “Select” button to switch ON/OFF the inner pressure test gauge. Ensure the display of inner pressure gauge shows …

What should be the accelerated stability testing and shelf-life calculation is explained in the 21 CFR part 211.137- Expiration dating. As a result of the …

Calibration Of Osmometer: 3 point calibration of Osmometer: Turn on the main power supply and then switch on the instrument by using “on/off” switch. Go …

What is Definition of Osmolality? Osmolality is defined as the number of osmoles of solute per kilogram of solvent. t is expressed in terms of …

Swiss Garnier multiple openings: Phone call Interview for QC/ QA/ Production/ Packing/ Maintenance/ PPIC/ IT departments. Location: Sikkim Departments: QC/ QA/ Production/ Packing/ Maintenance/ PPIC/ …

Endo India Par Formulations Openings for Multiple departments: Endo India Par Formulation Opening for manufacturing/QA/QC/Warehouse/Stability/Packing Job Location: Chennai Department: Manufacturing/QA/QC/Warehouse/Stability/Packing Position: Analyst/Sr.Analyst/Associate/Sr.Associate/Technical Assistant Experience: 02-12 …

Gland Pharma Ltd-Walk-Ins for Production, Micro and IPQA For Production: Department: Production Position: Chemist/Compounding/Autoclave operators Experience: 2-5 yrs Qualification: B.Sc./B.Pharma/M.Sc/M.pharma Sterile injectable experience is mandatory. …

Thin Layer Chromatography Interview Questions and answers: Thin-layer chromatography is a separation technique used in the pharmaceutical industry for identification tests or for related substance …

Weighing of Material Possible Errors in pharma

Weighing Of Material Possible Errors: Weighing Possible errors: Wet volumetric flask used (After weighing and transferring the material, added diluent lately) Sticking of the material …

Danger Sign And Symbols Of Chemicals: In the early 1800s, rudimentary drawings were used to indicate poison. Today, we have advanced much beyond that. 2016 …

Modern periodic table of elements

Periodic Table Of Elements: The periodic table, also known as the periodic table of chemical elements, represents the chemical elements in tabular form. The periodic …

What are the Checkpoints Of OOS Investigation? A laboratory test, which is required by CGMP regulations (§§211.160 and 211.165), is required to ensure that components, …

Impurities In Drug Substances: Impurities fall into one or more of the following categories: Inorganic Impurities Organic Impurities Residual solvent Inorganic Impurities in drug substances: …

Diluent And Make-Up Possible Errors: While the addition of diluent and make-up the solution there are chances of errors. Here, what are such diluent and …

Sonicator’s Possible Errors and action plans in Pharma: Sonicator’s Possible errors: Addition of more diluent may cause for improper mixing of the solution. Addition of …

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: Bursting Strength tester is calibrated for 2 parameters. Calibration of Board Head, 2. Calibration of Paper Head Calibration of Board …

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: 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: 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: 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: What are the analytical balance possible errors and what is the action plan to avoid such errors we will learn in …

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 In the last 2 parts, we covered 5 points of laboratory investigation of aberrant results. Here we will cover …

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 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: “The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice” was published by the …

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. …

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 …

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 …

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 …

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 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 Working/Operating Procedure of water bath: Ensure the sufficient amount of water available in the water bath. Ensure that the …

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 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: 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 does and donts 1

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: 1.Objective: To lay down a procedure for operation and calibration of Air Flow meter. 2.Scope: This …

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: 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: 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: For its opinions on the approval of medicines, the European Medicines Agency (EMA) relies on the results …

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 and development (R&D) to separate mixtures of components. HPLC is …

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 …