Definitions related to Cleaning Validation: Procedure: The cleaning validation activity shall be performed in the three stages such as design, cleaning validation, and maintenance of validated state. Detailed flow chart …
Pharmaceutical concepts cover a broad range of topics related to the drug development, production, and regulation of medications. These concepts ensure that drugs are safe, effective, and accessible for patients. …
Definitions Related To Extraneous Peak: Here are some definitions related to extraneous peak; 1.Extraneous Peak: Extraneous peak is a unwanted and unexpected peak that is arise from unknown source. Any …
In chromatography many terminologies are used, some of them are defined as hare. Definitions related to chromatography: 1. Control Standard: A standard solution was prepared in duplicate and injected to …
Contamination and cross-contamination in pharmaceuticals can greatly impact drug safety, effectiveness, and general public health. Here are some important definitions related to contamination and cross-contamination. Definitions related to Contamination and …
Here are some of the definitions related to balance calibration; Definitions Related to Balance Calibration in Pharmaceuticals: 1. Calibration: A set of operations that establish, under specified conditions, the relationship …
How To Prepare 0.02N Sulfuric Acid? How To Prepare 0.02N Sulfuric Acid Also Read: Refer YT Channel: Pharmabeejpro
How to Prepare 7N Sulfuric acid? How to Prepare 7N Sulfuric acid Also Read: Refer YT Channel: Pharmabeejpro
How to Prepare 2N Sulfuric Acid? How to Prepare 2N Sulfuric Acid? Also Read: Refer YT Channel: Pharmabeejpro
How to prepare 0.1M H2So4? Sulfuric acid (H2SO4) has a molecular weight of 98 g/mol and a density of 1.84 g/ml. The following describes how to prepare 0.1M H2SO4: Preparation …
pharmaceutical contract manufacturing companies list These companies are well known as Contract Development and Manufacturing Organization (CDMO). In India, there are numerous companies that manufacture pharmaceuticals products under contract. They are …
Informed Consent in clinical trial Informed consent stands as a foundational ethical and legal principle within the realm of clinical trials and medical research. It constitutes a voluntary and informed …
What are key Principles of ICH GCP E6 guidelines? A good clinical practice (GCP) guideline for clinical studies involving human beings is called ICH E6. The International Council for Harmonization …
Principles of GCP trials: The guiding gcp principles listed below offer a flexible framework for conducting clinical trials. They are set up to offer direction throughout the clinical trial’s duration. …
Exploring Worldwide Clinical Trials: Introduction: Clinical trials are a vital aspect of medical research, offering hope for patients worldwide by driving advancements in healthcare. Conducted to evaluate the safety, efficacy, …
GCP Trials GCP stands for Good Clinical Practices in the pharmaceuticals industry. GCP Trials (Good Clinical Practices) are ethical and scientific standards for designing, recording, and reporting human research trials. …
What is an eTMF? TMF is stands for Trial Master File and eTMF stands for Electronic Trial Master File. Let’s understand What is an eTMF and TMF? Definition of Trial …
How to Prepare 0.5M Sulfuric Acid? The molecular weight of Sulfuric acid (H2SO4) is 98 g/mol and the density of H2So4 is 1.84 g/ml. Here is procedure for preparation of …
Why Water is Neutral? What could be the reason for water to be considered as a neutral? Let’s understand, The molecular formula for water is H2O, it means water has …
Clinical trial managers are essential in guiding the complex process of carrying out clinical trials in the fields of clinical research and medication development. Questions concerning their compensation for their …
Molarity of 37% HCl Solution Hydrochloric Acid is nothing but the hydrogen chloride gas aqueous solution. The molar mass of hydrochloric acid is 36.6 g/mol and the density of 37% …
21 CFR part 11: Data integrity is crucial for assuring the safety, effectiveness, and quality of products in the realm of regulated sectors. 21 CFR Part 11 is an important …
The Purpose of stability testing: The stability testing is performed in pharmaceuticals industry for the manufactured drug product to understand the drug behavior throughout the time period. “The purpose of …
Density of HCl: HCl is short form of a Hydrochloric Acid. It is an aqueous solution of Hydrogen chloride. Hydrochloric acid is classified as a strong acid. The molecular weight …
Worldwide clinical Trials Locations: Worldwide clinical trials are conducted in various locations across the globe. These trials take place in numerous countries, regions, and medical institutions to ensure a diverse …
Key role of Quality control in pharma? Key role of quality control in pharmaceutical industry include: 1. Raw Material Inspection: Ensuring that the raw materials used in the manufacturing process …
High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are both methods within chromatography employed to separate and analyze compound mixtures. Nevertheless, they contrast in their underlying principles, applications, and …
Flame Photometer Principle: Flame photometer is widely used technique to determine the concentration of alkali or alkaline earth metals, such as Sodium, Potassium, Calcium, Barium, Lithium. Flame photometry is quantitative …
Calibration of Refractometer: 1.Objective: To lay down a procedure for calibration of Refractometer. 2. Scope: This procedure is applicable to Quality control laboratory for make Anton Paar and Rudolph. 3. …
How HPLC works in Pharma? High-Performance Liquid Chromatography (HPLC) is an analytical method used for separating, identifying, and quantifying components within a mixture. This technique relies on chromatography principles, involving …
How to prepare pH buffer solutions: The reagent required for buffer solution preparation are; Preparation of Reagents: Potassium Tetraborate 0.05M (pH 1.68 at 25°C): Dissolve 3.1525 g of potassium tetraborate …
How to prepare 0.5M Acetic Acid? The molecular mass of acetic acid is 60 g/mol and density is 1.05 g/mol. According to the formula required volume of 1M acetic acid …
How to prepare 2M acetic acid? The molecular weight of Acetic acid is 60 g/mol and density is 1.05 g/mol. The required volume for 1M acetic acid is = 60 …
SOP for Authorization of Designee: 1.Objective: To lay down the procedure for Authorization of designee. 2.Scope: The procedure is applicable to all unit operation of company. 3. Responsibilities: Role Responsibility …
Why Quartz cuvette is used in UV spectroscopy? There are different cuvettes are used for different purposes in UV spectroscopy. A quartz cuvette is one of the cuvettes used in …
How to Prepare 1M Acetic Acid? The molecular formula for Acetic Acid is CH3COOH and the molecular mass/weight of acetic acid is 60 g/mol. The density of Acetic Acid is …
How to prepare 0.5M HCl Solution? For HCl, the molecular mass and equivalent mass both are equal due to the availability of only one hydrogen ion. Most HCl present in …
How to prepare 0.1N Silver Nitrate? The Molecular mass of the Silver Nitrate (AgNO3) is 169.87 g/mol. Also Read: Refer YT Channel: Pharmabeejpro FAQ’s on Silver Nitrate: 1.What is Chemical …
How to prepare 0.025N Silver Nitrate? To prepare 0.025N Silver Nitrate, need to know molecular mass of Silver Nitrate. The molecular mass of Silver Nitrate is 169.87 gm/mol. Calculation Formula …
How to prepare 1N Silver Nitrate? The chemical formula for Silver Nitrate is AgNO3 and the Molecular weight of the Silver Nitrate is 169.87. Silver Nitrate Wikipedia Also Read: Refer …
Operation of Refractometer: 1.Objective: To lay down the procedure for Operation of Refractometer. 2. Scope: This SOP is applicable to Quality Control Lab . 3. Responsibilities: Role Responsibilities Department Analyst …
What are the top 10 pharmaceutical companies in the world? Here is the list of the top 10 pharmaceutical companies in the world. Let’s understand the revenue of all the …
What is molality in pharmaceuticals? Molality is nothing but the ratio of moles of solute to the kilogram of solvent. or molality (m) is a unit of concentration that measures …
What is Molarity in pharmaceuticals? Molarity is moles of solute to the volume of solution in litre. or In chemistry, molarity (M) is a unit of concentration that measures the …
What is Normality? The number of gram equivalent weight of a solute into one litre of a solution is called as Normality. This solution is also called as equivalent concentration. …
Clinical Trial Interview Questions and Answers: Answer: I have a strong background in conducting clinical trials. I have worked as a clinical research coordinator for three years, managing multiple trials …
Interview questions and answers on manufacturing in pharmaceuticals: Here are suggested some interview questions and answers on manufacturing in the pharmaceutical industry: 1. Can you explain the manufacturing process in …
What are the Exhibit Testing Interview Questions and Answers in Pharma? Certainly! Here are some Exhibit Testing Interview Questions and Answers in pharmaceuticals: Question 1: How do you ensure that …
What are the Important definitions related to safety? Here we will understand what are the important terminologies are in the safety and their meaning. Flash Point: Lowest temperature at which …
Data, records and their properties: Raw Data: Raw data (Source data) is the original record (Data) which can be described as the first captured of information, whether recorded on paper …
How to prepare 0.01 N Hcl Solution: Here is the calculation for the required quantity of HCl for the preparation of 0.01N hydrochloric acid. Weight of HCl (In gm) = …
Raw Material Interview Questions and Answers: Here are the top 15+ raw material interview questions and answers for freshers as well as experienced candidates. Q: What are the most commonly …
Finished Product Interview Question and Answers in Pharma: Q1: What is a finished product in the pharmaceutical industry? A: A finished product in the pharmaceutical industry refers to a drug …
The stability of the drug product is an analytical technique to define the drug product’s shelf life. Here are some stability interview questions and answers. Stability Interview Question and Answers …
What is the Molecular Formula of Potassium Hydroxide? The molecular/chemical formula for potassium hydroxide is KOH. What is the molecular weight of Potassium Hydroxide? The molecular weight of sodium hydroxide …
What is Molecular Formula of Hydrogen Chloride? Molecular/chemical formula for Hydrogen Chloride is HCl. What is Molecular Weight of hydrogen chloride? Molecular weight of hydrogen chloride is 36.461 g/mol, Where, …
What is Molecular Formula of sodium hydroxide? Molecular/chemical formula for sodium hydroxide is NaOH. What is Molecular Weight of sodium hydroxide? Molecular weight of sodium hydroxide is 39.997 g/mol Where, …
Patient safety in clinical trials in pharma: Patient safety is a top priority in clinical trials. Clinical trials are subject to strict ethical guidelines and are closely monitored to ensure …
Advantages and disadvantages of clinical Trials: Clinical trials are research studies that involve people and are conducted to evaluate the effectiveness and safety of new medical treatments, such as drugs, …
Preparation and standardization of 0.05M Disodium Edetate VS: Reagent Used: Sodium Hydroxide TS: Dissolve 4.0 g of sodium hydroxide in water to make 100 ml. Dilute Hydrochloric Acid: Prepare by …
Preparation and Standardization of 0.1M Disodium Edetate VS: Reagent Used: Preparation of 0.1M Disodium Edetate: Dissolve 37.22 gm of Disodium edetate in water to make 1000 ml. For lower strength …
Preparation of 0.1M Lead Nitrate: Preparation of 0.05M Lead Nitrate: Preparation of 0.01M Lead Nitrate: Also Read: Refer YT Channel: Pharmabeejpro
What is the Principle of Loss On Ignition (LOI)? The Loss on Ignition test is a procedure to determine the processing of the material that is volatilized and driven off …
Content Uniformity Acceptance Limit: Content Uniformity is one of the test to measure that drug content is uniformly available in each tablet or capsule. While the blending stage the drug …
Phase 2 Clinical Trial: In phase 2 clinical trials evaluate the safety and effectiveness of new drugs or combination therapies. As part of a phase 1 trial, healthy volunteers are …
Q3 ICH Guidelines for Impurities: Q3A (R2): Impurities in New Drug Substances: First recommended for adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step …
Q2 Analytical Validation: The guideline Q2 analytical validation identifies validation parameters that are needed for various analytical methods. Here are two revisions of the Q2 analytical validation guideline; Q2(R1): Validation …
ICH stability Guidelines Q1A to Q1F: This Guidelines have been developed by the appropriate ICH Expert Working Group and have been subject to consultation by the regulatory parties, in accordance …
Operation and performance verification of Barcode Scanner: Operating Procedure of Barcode Scanner: Performance Verification of Barcode Scanner: 1 D Barcode: Activity 1: Scan 5 numbers for similar barcodes of one …
Before understanding the purpose for the revision of stability ICH guidelines need to understand what ICH stands for. What is ICH Full form? ICH stands for “International Council for Harmonization …
Stability Chamber Manufacturer: Many stability chamber manufacturers and suppliers are available in the market, some major manufacturers are listed below: Also Read: Refer YT Channel: Pharmabeejpro
types of Stability Chambers: The stability chambers are designed to conduct a stability study on the drug product. The study can define the shelf life of drug products. There are …
What is Accelerated Testing? Accelerated stability testing in stability study is designed to increase the rate of chemical degradation or physical change of drug substance or drug product by changing …
Principle of Limit test for Iron: The Limit test for Iron is based on the reaction of iron in ammoniacal solution with thioglycolic acid in the presence of citric acid …
Iodine Volumetric Solution Preparation and Standardization (0.1 N) as per USP: Preparation of Reagent: Starch TS: Mix 1 gm of soluble starch with 10 mg of red mercuric iodide and …
Zydus Receives Final Approval for Sildenafil from USFDA: Zydus Lifesciences got final approval to market the product for Sildenafil for Oral Suspension from US Food and Drug Administration. The product …
Ryaltris approved by Health Canada for Seasonal Allergic Rhinitis: Ryaltris provides relief from seasonal allergic Rhinitis. Ryaltris is a combination of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray. Health Canada …
Preparation of 1N Ethanolic Potassium Hydroxide: Reagent: Phenolphthalein Solution: Dissolve 1 gm of phenolphthalein in 100ml of alcohol (95%). 95% Alcohol: Mix 95 ml absolute alcohol with 5ml of water. …
According to different pharmacopeia, procedures to perform the limit test for arsenic are different. Here is only the limit test for arsenic as per USP. But first, need to understand …
difference between viscosity and specific gravity: Viscocity: Viscosity is a characteristic property of liquid, it determines the stickiness of the fluid. The highest-thickness liquid is a highly viscous liquid. What …
0.1M Sodium Nitrate Preparation and Standardization of volumetric solution as per USP: Preparation of 0.1M Sodium Nitrate: Standardization of 0.1M Sodium Nitrate: 17.22mg of sulfanilamide is equivalent to 1ml of …
Preparation and Standardization of 1N Ethanolic KOH: Preparation of 1N Ethanolic KOH: For lower strengths preparation follow below table: Quantity of Potassium hydroxide ( in g) Addition of Water (in …
Before launching any drug product into the market, the drug passes through various phases of clinical trials. Phase 1 clinical trial is one of the phase for the drug. Phase …
How to do UV Calibration As Per USP In Pharma? Almost every laboratory in the world uses ultraviolet-visible (UV-Vis) spectroscopy as a core analytical technique due to its simplicity and …
Phase 0 Clinical trial in pharma: Phase 0 clinical trial is the initial stage of the clinical trial. The development of a drug for a specific disease condition involves several …
What Happened When You Take Expired Medicine? According to the Drug and Cosmetic act 1940 and the Rule 1945, the medicines must have an expiry date. This is to know …
PPM is an abbreviation of “Parts Per Million“. In the pharmaceutical industry, PPM is a widely used term. What Is The Definition Of PPM In Pharmaceuticals? Parts Per Million is …
FITR is one of the instrument used in pharmaceuticals for the identification of the material. Here is the procedure for Calibration of FTIR spectrophotometer in pharmaceuticals. Calibration Of FTIR Spectrophotometer: …
Here is a procedure for the preparation and standardization of 1N HCl by using Tromethamine and Bromocresol as an indicator. Preparation of 1N Hcl: Dilute 85 ml of hydrochloric acid …
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 any organization. There are many …
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 markets. GMP protects the consumer …
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, machinery, material or both or …
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 understand the definitions of all …
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 calibration, there are 11 parameters …
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 root cause analysis (RCA) This …
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 the root cause of the …
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 in pharmaceuticals? How 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 these terms defined? Out-Of-Specification (OOS)Results: …
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 or sample solutions. There are …
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 is done by adding the …
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 data has been lost. Data …
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: 95% V/V Alcohol: Mix 95 …
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 compared to HPLC. Let’s understand …
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 the principle of UPLC and …
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 being conducted. Titrating methods are …
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 Quality Assurance in pharmaceutical industry? …
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 massage displayed as a ” …
Preparation and standardization of 0.1N perchloric acid VS as per USP: Multiple volumetric solutions are used in the pharmaceutical industry, here is the manual and potentiometric method of preparation and …
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 and need to understand all …
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 used to design, develop, or …
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 by referring to the below …
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 that, the firms have written …
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 proper root cause, here some …
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 contamination. To stop such problem …
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, the stability study is performed …
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 0.0 PSI. Place the filed …
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 publication of 21 CFR Part …
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 to measure on display and …
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 osmol/kg or Osm/kg. or It …
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/ IT Position: Operator/Executive/Technician/Asst. Manager/Manager Experience: …
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 yrs Qualification: B.Sc/M.Sc/D.Pharma/B.Pharma/M.pharma/ITI/Diploma Kindly share …
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. For IPQA: Department: IPQA Position: …
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 tests. Q1: What is the …
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 at the neck/walls of the …
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 marks the first full year …
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 table is widely used in …
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, containers and closures, in-process materials, …
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: Inorganic impurity usually results from …
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 make-up possible errors in pharma? …
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 less diluent may cause for …
Procedure for Preparation And Standardization of 1N NaOH: Reagents used for 1N Sodium Hydroxide: Preparation of Reagent: 95% Alcohol: Mix 95% of absolute alcohol with 5ml of water. Phenolphthalein Indicator: …
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 of the product. The requirement …
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 Head: Perform the calibration in …
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 timer for 10 mins. Press …
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. pH Meter Do’s: Before measure, …
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. Dissolution Do’s: Before using the …
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 Titration Do’s: Ensure that the …
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 this article. Let’s understand first …
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 done as follows; Dilute 370ml …
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 the remaining 4 points such, …
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. In this part, we will …
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: System Suitability Failure Out of …
Mechanical Calibration Of Dissolution Apparatus: “The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice” was published by the FDA in October 2007 as …
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. The most common method development …
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 temperature at which solid state …
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 substance is ignited at certain …
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 be calibrated before each measurement …
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. pH refers to the concentration …
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 procedure covers the operation and …
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 instrument is properly connected to …
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 to get proper and consistent …
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 solid, and the mobile phase …
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 specified medium. Or It is …
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 Validation, Cleaning Validation, Equipment Validation, …
HPLC Calibration Parameters: There are a total 9 parameters for HPLC calibration, these are as follows; These are all calibration parameters performed while calibration. HPLC Calibration Parameters Acceptance Criteria: The …
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 and time format. Make document …
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 SOP covers the operation and …
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 clinical data manager to collect …
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 with iodine in a buffer …
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 on a substance. Likewise, this …
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 …
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 in the oven at a …
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 tablet consists of a combination …
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 the operation procedure for ice …
Before starting the clinical trial process flow, we will understand, What is a definition of a clinical trial? what is a clinical trial in pharma? What is a Clinical trial? …
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 instructions, if there are no …
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, essential oil, flavor, and food …
Titrimetric methods are widely used in the pharmaceutical industry to determine water content or traces present in the sample. Based on the iodine providing principle method can …
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 USP Dissolution Apparatus? There are …
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 medium. There are 5 parameters …
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 why. 2. L-Legible: Legible means …
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 disaster that destroys hardware, software, …
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 5 software categories but in …
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 those components from the mixture …
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 using ALCOA, which is an …
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 the sample. i.e. 1. Karl …
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 things. The amount of water …
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 sufficient number and types of …
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 trends. APQR is also known …
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 solution. there are multiple types …
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 what is a need for …
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 light that passes through a …
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 can give good results. Here …
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 in the drug product considered …
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 control department. There are some …
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 back-pressure, changes in retention times, …
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 practices are followed by the …
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 the backpressure also. When back-pressure …
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 standard without or with very …
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 and answers are a must. …
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 is bind to go through …
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 intercept the UV-Visible spectra. The …
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 times. Here is a guide …
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 the process by which various …
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 this we will understand here. …
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, C-Cyclohexyl, Cyano, and C-adamanthyl (C-12). …
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 ability to produce reliable analytical …
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 this article we will understand …
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 System In 2008, ICH Q10 …
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 asked in interviews by the …
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 process is unique for every …
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? A solution is a homogeneous …
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. These 7 QC tools are …
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 list seven types of 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 dissolution rate in the defined …
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 TLC. How to develop iodine …
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 this through this article. What …
Gas chromatography interview questions and answers are somewhere that kept us on the backfoot while interviewing. In this article, we will try to cover such Gas chromatography interview questions. Gas …
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 are defined for every test …
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, what is Molar Solution? What …
Lupin Labs Ltd Walk-In-Interview for Dabhasa API unit at Indore Dabhasa Lupin hiring for production and Quality control department. LOCATION: DABHASA (Vadodara) Production department Position: Officer/ Jr. Officer Qualification: Diploma …
Optimus Drugs Pvt Ltd-Opening For QC/QA And AR&D Location: Dothigudem Department: Quality Control Positions: Trainee Qualification: M.Sc.(Org.Chem) & M.Sc. (Micro) Experience: Freshers 2019,2020 pass out Department Quality Assurance Positions: Chemist …
Glenmark Pharma Ltd-Opening For Production / QC Glenmark pharma hiring for Quality control and Production Location: Aurangabad Position: Assistant manager for Quality Control Qualification: B. Pharma / M. Pharma / …
Micro Labs Ltd Walk-In-Interview for Production and stores department. Micro labs Location: Bangalore Position: Officer/Executive/Sr.Executive/Asst. manager for Production Qualification: B.Pharma / M. Pharma/ M.sc /B.Sc Experience: 2-8 yrs Position: Technical …
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 are. Type of closure Dimensions …
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 pharmaceutical. Description Dimentions Weight of …
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 PVC/PVDC film test …
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 adhesive label for packing material …
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 laboratory equipment list or instrument …
Indoco Remedies Ltd-Walk-In-Interview at GOA For Production and Packing department. Location: Goa Position: For Production Officer/Sr. Officer with B.Pharma / M.Pharma and 2-8 yrs experience Associate with D.Pharma/ B.Sc/ DEE// …
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 in the units are in …
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 authorized representative. Also Read: What …
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 the quality of the drug …
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 test and approve the drug …
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 a titrimetric determination of water …
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 procedure or practice or process, …
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 title of electronic code of …
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 of the manufacturing products. Here, …
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 trail not performed? Who can …
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. The operation of Karl Fischer …
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 a widely used technique for …
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 various type of reasons to …
The interview is a challenge for the newbies as well as experienced candidates also, but here I am going to make you relax with respect to interview questions for quality …
Disintegration test interview Questions and answers: In this article we will understand the disintegration test interview questions and answers. Quality control having multiple instruments and equipment’s, today we will understand …
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 the region. The world has …
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 preparation and standardization of sodium …
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 analysis that provides a complete …
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 systems that used to store …
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 …
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 dosage forms like Solid oral, …
How to face interviews is quite a difficult problem for newbies. In this article, I tried to cover top interview questions and answers on dissolution. Most common interview questions and …
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.
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 (USA, Europe, and Japan) as …
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 Principles of Quality Control instruments …
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 to market in the United …
Particle size analysis is an analytical technique to measure and report the distribution of particle size of solid or liquid material. Particle size analysis Disturbance of particle size can …
Current Good Manufacturing Practices: 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 results …
Contamination, crosscontamination and mix-ups is big challenge for pharmaceutical industry. To avoid contamination and mix-ups precautions need to take.
In the world, every matter has physical properties and chemical properties. Without physical property, there will not be any matter on the earth. …
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 in day-to-day life we all …
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 in the 21st century and …
Data integrity and Alcoa plus 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. In the early …