This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
The Indian Pharmaceutical Alliance (IPA) questions the reliance on the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) in the Ohio State University report titled, Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events.
The 17th edition of CPHI & PMEC India, organised by Informa Markets in India opened its doors at the India Expo Centre, Greater Noida, Delhi-NCR, showcasing the robust potential of India’s pharmaceutical industry. and Rahul Deshpande, Sr. Group Director, Informa Markets in India, did the honours, amidst an august industry presence.
As environmental concerns continue to intensify, the pressure on the pharmaceutical industry to reduce its overall environmental impact, particularly in final dosage forms, is growing proportionately. In March 2024, Lonza hosted its first digital Responsible Supplier Event which brought together more than 1,100 participants.
On October 6, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy conducted Session 6 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on HVAC Systems and Qualification in pharmaceuticalmanufacturing. The session began with a keynote address by Thiru M.
Session Highlights: The event began with a keynote address by Manish Kapoor, State Drugs Controller of Himachal Pradesh, who emphasised the critical role that water systems play in maintaining pharmaceutical product quality. Express Pharma serves as the Media Partner, with Trillyum Consulting as the Knowledge Partner.
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceuticalmanufacturing site quality rating system, the Quality management maturity (QMM) programme.
While navigating changes has long been a challenge for the industry, the last two years’ events have made supply chain management significantly more difficult. The post How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?
Out of trend results What is the origin of out of specification events? In the early 1990s, the Food and Drug Administration (FDA) inspected a major generic manufacturer in the US and identified concerns with failing test results. The manufacturer challenged the FDA’s view, ending in the US District Court.
Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Regions which were once the sources of raw materials may be plagued by adverse weather events, hindering production and causing inflated costs.
The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process. Checkout sample preview s.
Pharmaceuticalmanufacturing operations typically maintain equipment varying from simple balances and scales to complex automated process control and monitoring systems. – Disintegration Testers (Critical for assessing the disintegration properties of solid dosage forms). When is equipment qualification necessary?
Table of Contents Importance of sampling in pharmaceutical industry Pharmaceutical sampling procedures are carried out during and at each major processing step during the manufacturing to ensure the highest quality is attained. What are the types of sampling plans in pharmaceutical industry?
India and the United States manufacture most finished medicines for the U.S. market This blog is part of a series on the geographic concentration of pharmaceuticalmanufacturing. This blog focuses on the manufacturing of finished dose forms. For a discussion on API manufacturing, see here.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content