VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of products purporting to be sterile, sterilization, aseptic filling, and closing operations must be adequately validated (§ 211.113). The goal of even the most effective sterilization processes can fail to achieve their objective if the sterilized …

Air Filtration – High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or at various points on the filter media. Thereafter, leak tests …

Air Filtration by Membrane AS PER USFDA GUIDELINE Air Filtration by Membrane – A compressed gas should pass for purity test to ensure it is free from oil and meets the required standards for microbiological and particle quality after filter. The quality of the compressed gas should be at least …

Alcoa++ In a world where data plays a crucial role in decision-making and technological advancements shape various industries, the significance of data integrity cannot be emphasized enough. Alcoa, a company renowned for its commitment to excellence, extends the principles of Alcoa Plus Plus beyond aluminum production to prioritize data integrity …

CIP -Cleaning In Place  CIP, also known as Cleaning In Place, is a methodical and automated technique used to clean the inner surfaces of manufacturing equipment, including tanks, pipes, and vessels, without the need for disassembly. This approach is extensively utilized in the pharmaceutical sector to remove any remnants of …

Intervention during Media fill Media fill is a simulation exercise conducted in aseptic processing areas to evaluate the capability of operators and the manufacturing environment to maintain sterility. The process involves filling sterile growth media into containers using the same equipment and procedures employed in the actual drug manufacturing. It …

GLP-GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS General Requirements OF GLP :- The laboratory or the organization it belongs to must have legal authorization to operate and be held accountable under the law. The management is responsible for ensuring that the laboratory conducts its testing, calibration, validation, and other technical …

Methods of sterilization Sterilization is necessary for the complete destruction or removal of all microorganisms (including spore-forming and non-spore forming bacteria, viruses, fungi, and protozoa) that could contaminate pharmaceuticals or other materials and thereby constitute a health hazard. Since the achievement of the absolute state of sterility cannot be demonstrated, …

Introduction of New Product in Facility The implementation of a novel product in a pharmaceutical industries necessitates a Carefully planned & organized sequence of actions to guarantee a seamless and adheres to regulations and guidelines. Below is an exhaustive compilation of activities that should be taken into account: New Product Project …

Emulsion & Role of Emulsifying Agents Emulsion refers to a colloidal dispersion where two liquids that do not mix are blended uniformly. It comprises small droplets of one liquid dispersed in another liquid. The stability of emulsions is of utmost importance in various industries such as food, pharmaceuticals, and cosmetics. …

Premises & HVAC system design Both the architectural design of the building and the HVAC system design should be carefully considered to achieve the objectives of preventing contamination and cross-contamination and ensuring a suitable environment for pharmaceutical production and control. It is crucial to maintain the required environmental conditions, cleanliness, …

Processor: The Soul of computing Processor -The ongoing pursuit of more powerful and efficient processors faces challenges ranging from the physical limitations of semiconductor technology to the growing demand for sustainable computing solutions. Researchers are exploring alternative materials, architectures, and computing paradigms to overcome these challenges and shape the processors …

FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection For Immediate Release: November 15, 2023 Today, the U.S. Food and Drug Administration granted marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample …

FDA Approves New Medication for Chronic Weight Management For Immediate Release: November 08, 2023 Today, the U.S. Food and Drug Administration(FDA) approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/ m2) or greater) or overweight (body mass index …

What is the World Health Organization (WHO)? Founded in 1948, the World Health Organization (WHO) is the United Nations agency dedicated to global health and safety. The Organization connects nations, partners and communities to promote health and serve the vulnerable. World Health Organization works with its Member States to achieve …

Warning Letter – October 20, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, from February 20 to March 2, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and …

Clean Room Quiz 6 Question: What is the purpose of an airflow direction test and visualization? Answer: The purpose of an airflow direction test and visualization is to demonstrate that the airflow direction and its uniformity of velocity conform to the design and performance specifications. Question: What are the four …

Clean Room Quiz 5 Question: What is recommended for measuring the supply air volume flow rate in cases where there is local airflow turbulence and jet velocities issuing from an outlet? Answer: It is recommended to use an airflow capture hood that captures all of the air issuing from each …

Clean Room Quiz 4 Question: What is the purpose of the airflow test? Answer: The purpose of the airflow test is to measure airflow velocity, uniformity, and supply air volume flow rate in cleanrooms and clean zones. This includes measuring velocity distribution in unidirectional airflow areas and supply air volume …

Clean Room Quiz 3 Question: When need to plan for testing and verification testing should be conducted according to the ISO 14644? Answer: Testing should be carried out at minimum during the following instances: a) In connection with classification according to ISO 14644-1; b) At verification during start-up; c) At …