Tag Archives: Jamnagar

Effective Quality Policies Framing Quality policies are crucial in establishing the groundwork for a thriving and enduring business. They act as a guide for organizations to attain and uphold elevated benchmarks, ensure customer contentment, and adhere to regulatory requirements. This blog will extensively examine the fundamental components of policy formulation, …

The Role of a GxP Auditor and Trainer in Quality Management Adherence to quality standards is of utmost importance in industries that are governed by Good Practice (GxP) regulations. GxP auditors and trainers have vital roles in ensuring compliance with the strict requirements established by regulatory bodies like the FDA …

A Comprehensive Guide to Navigating the Remediation of Warning Letters Receiving a Warning letter from regulatory authorities is a matter of great significance that requires prompt attention and rectification. Whether it pertains to the pharmaceutical, manufacturing, or any other regulated sector, cautionary notices signify a failure to adhere to established …

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 …

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 …