Clean Room Quiz 2 Question: What is the objective of the air pressure difference test.? Answer: The objective of the air pressure difference test is to confirm the effectiveness of the cleanroom’s air movement system in maintaining the designated pressure differential between the cleanroom and its surrounding environment. Question: When …

Clean Room Quiz 1 -Question & answers on Clean Room Question: What is the definition of an “airborne particle”? Answer: An airborne particle is described as a solid or liquid object suspended in the air, whether viable or non-viable, falling within a size range spanning from 1 nanometer (nm) to …

FDA News FDA Roundup: November 17, 2023   Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, to mark the 15th anniversary of the FDA foreign offices, the FDA published an interview with Susan Winckler, who was FDA chief of staff …

FDA News – FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus For Immediate Release:  November 09, 2023 Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure …

FDA News – FDA Clears First COVID-19 Home Antigen Test For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the …

FDA News – Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature Products For Immediate Release:  November 16, 2023 Yesterday, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court …

FDA NEWS – Federal Court Enters Consent Decree Against Arizona-based Company for Distribution of Unapproved Contraceptive Drugs For Immediate Release:  November 15, 2023 Today, the U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women’s Choice, Inc., an Arizona-based company, and Jennifer …

Indian eyedrop maker issues recall of various eye drops in US for potential safety reasons. Kilitch Healthcare India Limited recalled 27 variants of eye drops being sold in the United States due to potential safety concerns after FDA investigators found insanitary conditions. The Food and Drug Administration warned consumers last month not to purchase or …

Newsd- Explore the fast-changing pharmaceutical news environment. The pharmaceutical industry is a dynamic and growing sector that plays an important role in global health. As medical advances continue to push boundaries, the landscape of the pharmaceutical industry is constantly changing, making it important for stakeholders to stay on top of the …

Hydroxyzine drugs Hydroxyzine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can cause itching and hives on the skin. Hydroxyzine can be used to treat allergic skin reactions such as hives and contact dermatitis. Hydroxyzine also reduces the activity of the central …

Foreign Education and Why Is It Important For You? Are you planning to become a teacher or are you interested in pursuing a degree in education? If so, then globalization, the rise of international schools, and the mobility of students and teachers around the world. It is important to know …

Deepawali The five-day Diwali, starting November 10, includes Dhanteras, Choti Diwali, Diwali, Govardhan Puja, and Bhai Dooj. Here’s everything you need to know. Diwali, also known as Deepavali, the biggest Hindu festival, is just around the corner and people are already busy with preparations. It falls on the 15th day …

Air Quality Near Me Air Quality Near Me – Exposure to air pollution can affect everyone’s health. When we inhale air pollutants, they enter the bloodstream, causing coughing and itchy eyes, and can cause or worsen many respiratory and pulmonary diseases, leading to hospitalization, cancer, and even premature death. Air …

ACTIVE PHARMA INGREDIENTS An active pharma ingredients /pharmaceutical ingredient (APIs), also commonly known as a drug substance, is the active ingredient of a biologically active drug or pesticide. The similar term “pharmaceutical active ingredient” is used in medicine, and the term “active substance” can be used to refer to natural …

What is Pre-dispatch inspection? Pre-dispatch inspection is a step taken by manufacturers to inspect finished products before dispatch of the finished product for sale and distribution in the market for the supply of medicine to user points. The purpose of Pre-dispatch inspection is: Check the quantity and quality of the …

Alarm management Alarm management is the understanding, design, implementation, and use of effective alarm capabilities for plant operators. It is designed to notify the operator of situations or events that require the operator’s attention. Explicitly within a reasonable time frame. Designer of production process control systems. These systems are traditionally …

Total Quality Management Practices Total Quality Management Practices (TQMS) the first thing that comes to mind when you think of the word “quality”? The word “quality” has many definitions. Quality can be defined as a characteristic or characteristic, as in the following statement: “They are honest people, and that is a …

GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance To lay down a procedure for good documentation practices requirements for the compliant, consistent and accurate completion of GxP Documentation. GxP in Pharmaceuticals This Procedure applies to all cGxP documents (electronic and handwritten) used in the manufacturing, packaging, labelling, testing, storage and …

QUALIFICATION STUDY FOR VISUAL INSPECTOR To establish documented evidence that Visual Qualification Protocol is capable to qualify the visual inspector, within the specified quality attributes thereby establishing the Visual Inspectors qualification procedure. Detect and remove units of drug product with predefined defects in a reproducible manner in a controlled process. …

ENVIRONMENTAL MONITOR To ensures clean and sterile conditions for compounding and preparing pharmaceutical products. Sterile compounding pharmacy environments and other cleanrooms can demonstrate compliance standards for monitoring and controlling airborne particles. ACPH. Manufacturing & storage rooms require at least 20 air changes per hour (ACPH) nonsterile area. Buffer rooms and …