Tag Archives: Old Al Ghanim

Foreign Education and Why is It Important For You?

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 …

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Air Quality Near Me

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 …

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ACTIVE PHARMA INGREDIENTS/ACTIVE PHARMACEUTICAL INGREDIENTS

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 …

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Pre-dispatch inspection

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 …

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Alarm management & Alarm Challenge Test

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 …

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Total Quality Management Practices

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 …

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GxP in Pharmaceuticals: Ensuring Quality, Safety, and Compliance

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 …

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QUALIFICATION STUDY FOR VISUAL INSPECTOR

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. …

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ENVIRONMENTAL MONITORING

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 …

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QUALIFICATION PROTOCOL FOR AIR COMPRESSOR SYSTEM

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 …

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Orbital Welding

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 …

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Stainless steel and types of Stainless steel in Pharma Industries

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 …

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Change Control Quiz

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 …

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Production Quiz 03

Quiz

Production Quiz 03 Question: What is capping in the context of tablet manufacturing? Answer: Capping occurs when the upper or lower segment of a tablet separates horizontally, either partially or completely, from the main body of the tablet during ejection from the tablet press or subsequent handling. Question: What is …

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Stability (ICH Q1A) Quiz 7

Quiz

Stability (ICH) Quiz 7 Q: What are the requirements regarding the number of primary batches for formal stability studies of a drug substance? A: Formal stability studies necessitate data from at least three primary batches of the drug substance. Q: What criteria must the primary batches meet for inclusion in …

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Stability (ICH Q1A) Quiz 1

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Stability (ICH Q1A) Quiz 1 Q: What is the purpose of the revised ICH Q1A guideline mentioned in the text? A: The purpose of the revised guideline, based on the ICH Q1A guideline, is to establish the stability data package necessary for the registration application of a new drug substance …

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Production Quiz 02

Quiz

Production Quiz 02 Question: What is mottling, and what factors contribute to this defect in tablets? Answer: Mottling is a tablet defect that can be caused by colored drugs (Excipient-related), improper mixing of granular material (Process-related), dirt in the granular material, or the use of oily lubricant, leading to oil …

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Production Quiz 01

Clean Room Quiz 4

Production Quiz 01 Question: What are the challenges faced in tablet manufacturing? Answer: The challenges in tablet manufacturing include visual and functional defects, which have increased due to complexities in tablet presses and higher quality demands. Question: Why have advancements and innovations in tablet manufacture not decreased the production problems? …

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Operation cum performance qualification protocol cum report

Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to. TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description FBD Machine Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Performance Qualification Results Deficiency …

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Performance qualification protocol cum report

Performance qualification protocol cum report shall consist of minimum contents but  not be limited to TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Performance Qualification Procedure Training Date Performance Qualification Results for Run-1 Performance Qualification Results for Run -2 Performance Qualification Results for Run-2 Deficiency (if any) and …

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