% RSD(Related standard deviation)/repeatability
Happy to Help you for Preparation
Interview Q & A
Here Give Basic Q & A for Fresher who interstate for
Interview for Pharm, chemical, pesticides company
Happy to Help you for Preparation
Interview Q & A
Here Give Basic Q & A for Fresher who interstate for
Interview for Pharm, chemical, pesticides companey
The term Alcoa is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. Alcoa was then expanded to Alcoa
Plus (Alcoa +), by the addition of a few more concepts which are; Complete, Consistent, Enduring and Available.
Over time, the concept of Alcoa plus has been adopted by various industries, as a framework for ensuring that data
The objective of OOS investigation should be to identify the root cause of the OOS result Or NSQ results and take appropriate corrective and preventative action. Investigation should include a review of Laboratory testing, review of production and sampling procedures, and will often include additional laboratory testing and Cross functional investigation along with the handling of associated samples and test data
The term change control is used to describe the controlled set of actions necessary to ensure a change does not negatively impact a product’s safety, efficacy, quality or compliance.
Download app store
Download app store(google)
Download app store
Download app store
Download app store
RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES AS PER REGULATORY REQUIREMENTS 1. PROBLEM IDENTIFICATION What Happens Clearly define the deviation, OOS, OOT, complaint, breakdown, audit observation, or incident. Includes Deviation description Date & time of...
* Nitrosamines are trace chemical impurities. * They are classified as probable human carcinogens. * Global agencies require a strict 3-step risk assessment framework. * Manufacturers must evaluate, test, and fix any impurity risks.1. The Global CPCA SystemAgencies...
Specificity This concept is essential in scientific analysis. When you create a method to measure something (like a drug or a chemical), you must prove that the method only measures that specific substance and isn't being 'fooled' by other things in the mixture. Case...
If you run high-performance liquid chromatography (HPLC) assay, you know that consistency is everything. In a validated method, your retention time (RT) should remain rock-steady from injection to injection. But every chromatographer eventually faces that frustrating...
Operational excellence is demanded by modern quality control laboratories. Every single day, high testing volumes are managed by laboratory analysts. Accuracy must be maintained during complex testing procedures, including HPLC analysis and Karl Fischer titration....
🇺🇸 FDA Updates CAVHANZA (nilotinib) approved (June 2, 2026) for Ph+ chronic myeloid leukemia with improved formulation allowing use alongside PPIs/H2 blockers without restrictions. Ensitrelvir (Xocova) approved (May 29, 2026) as the first oral option for COVID-19...
The FDA’s latest updates (June 2026) include several new drug approvals, safety warnings on hidden ingredients in supplements, and upcoming regulatory decisions on therapies for COVID-19, urinary tract infections, smoking cessation, and kidney disease. These...
Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use. Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for...
These updates are quite significant because they reshape compliance expectations across different regions and therapeutic areas. Let me break down where the impact is most pronounced:🌍 Key Pharmacopoeia Updates- Indian Pharmacopoeia 2026 - 121 new...
If you run high-performance liquid chromatography (HPLC) assay, you know that consistency is everything. In a validated method, your retention time (RT) should remain rock-steady from injection to injection. But every chromatographer eventually faces that frustrating...
STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements. 2. SCOPE...
In the competitive landscape of modern pharmaceutical companies, ensuring precise product quality isn't just a regulatory requirement—it is the foundation of patient safety. At the heart of this quality assurance is HPLC analysis (High-Performance Liquid...
HPLC column HPLC columns are classified in the United States Pharmacopeia (USP) under the “L” designation system, with each type assigned a specific USP code (e.g., L1, L3, L7). The main USP chapter that governs chromatography, including HPLC columns, is USP...
HPLC (High-Performance Liquid Chromatography) pump issues can significantly impact the performance and reliability of your chromatographic analysis. Here are some common problems and potential solutions: Common Issues: Flow rate inconsistencies: Variations in flow...
Using compounds like B-naphthol, Caffeine, and Toluene for HPLC (High-Performance Liquid Chromatography) calibration is a standard practice because they are "well-behaved" molecules. They help ensure your system is accurate without the risk of damaging expensive...
Specificity This concept is essential in scientific analysis. When you create a method to measure something (like a drug or a chemical), you must prove that the method only measures that specific substance and isn't being 'fooled' by other things in the mixture. Case...
Goal of Validation: Analytical validation proves that a testing method works correctly for its intended use. Why it Matters: Accurate testing ensures that medicines are safe, effective, and of high quality. Because of this, regulators have required validation for...
STEP-BY-STEP PROCEDURE 1. PURPOSE To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements. 2. SCOPE...
The pharmaceutical and biotechnology sectors in New South Wales are experiencing an incredible boom. From the bustling research hubs in Macquarie Park and Westmead to the clinical trials happening across Randwick, local innovators are developing next-generation...
FTIR METHOD DEVLOPMENT Fourier Transform Infrared Spectroscopy (FTIR) is widely used in analytical method development because it provides rapid, sensitive, and eco‑friendly characterization of pharmaceutical substances, excipients, and formulations. It is especially...
HPLC column HPLC columns are classified in the United States Pharmacopeia (USP) under the “L” designation system, with each type assigned a specific USP code (e.g., L1, L3, L7). The main USP chapter that governs chromatography, including HPLC columns, is USP...
Working irregular hours can take a massive toll on the human body. When the natural circadian rhythm is disrupted by rotating schedules, both physical metabolism and psychological well-being are significantly impacted. However, with the right structural changes,...
Finding pharmaceutical jobs outside of India requires looking at specific global platforms that specialize in life sciences. Since you have experience in Quality Control (QC), you can find many opportunities in manufacturing hubs like the USA, Europe (Germany,...
Whenever when every morning when if you wake up first smile😊😊😊 in your face. Then 15 minutes hard exercises. Then 15 minutes yoga. Then 15 minutes time spend your self. Then taken your breakfast 🍳☕🍞(good nutrition). Then 15 minutes taken Scidual your work Afternoon...