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 …

QUALIFICATION PROTOCOL FOR AIR COMPRESSOR SYSTEM Air compressor system -The purpose of carrying out Qualification of Air compressor system is to establish the documented evidence that the system performance is in accordance with the predefined specifications. The scope of this protocol is to describe the procedure for different tests, acceptance criteria, Re-validation …

Orbital welding Orbital welding-The pipe or tube to be welded is held while the welding arc rotates (in “orbit”) around the workpiece. Welding parameters are set by a microprocessor, so settings can be saved and reused, ensuring a highly reproducible process. Orbital welding is the automatic or mechanized welding of …

Stainless steel and types of Stainless steel in Pharma Industries Stainless steel in pharmaceutical applications, such as food and beverage manufacturing, require structural materials to maintain structural integrity (i.e., corrosion resistance and sufficient strength to withstand the conditions of use), as well as inert surfaces (i.e., (low release of contaminants …

Change Control Quiz Question: What is change control in the pharmaceutical industry, and why is it considered a critical part of quality management? Answer: Change control in the pharmaceutical industry is a systematic approach to managing product, process, or system changes. It is considered a critical part of quality management …

Assigning Manufacturing and Expiry date to the Finished Products Objective To lay down a procedure for assigning manufacturing and expiry dates to the finished products manufactured. Scope This procedure shall apply to all products manufactured. Responsibility Executive / Officer Production shall be responsible for assigning manufacturing and expiry dates to …

Internal Audit and Self Inspection Internal Audit: An onsite verification of activity used to determine effective implementation of documented quality systems. Self-Inspection : Verification of departmental activity used to determine effective implementation of documented quality systems. Objective To lay down a procedure for periodic internal audit and self inspection, to …