GxP Auditor and Trainer

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 (Food and Drug Administration). This … Read more

Remediation of Warning Letters

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 standards and practices. In this … Read more

Premises & HVAC system design

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, and containment. Infiltration of outside … Read more

Processor: The Soul of computing

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 of the future. Historical development … Read more

FDA Grants Marketing Authorization of First Test for Chlamydia and Gonorrhea with at-home Sample Collection

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 collection to be granted marketing … Read more

FDA Approves New Medication for Chronic Weight Management

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 of 27 kg/m2 or greater) … Read more

WHO – Frequently asked questions

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 the highest level of health … Read more

FDA – Warning Letter – October 20, 2023

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 211 (21 CFR parts 210 … Read more

Clean Room Quiz 6

Quiz

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 methods used for performing the … Read more