Pharma-GMP-News

Pharma GMP News of the Week: 2-October-2022 Period: September 25, 2022 to October 1, 2022 India publishes proposed regulations for registering Class A medical devices that are neither sterile or measuring Date of news: September 20, 2022 The draught revisions to the medical device rules have been made available for comment by the Indian Ministry …

Pharma GMP News of the Week October 2, 2022 Read More »

Pharma GMP News of the Week: 25-September-2022 Period: September 18, 2022 to September 24, 2022 PIC/S website published “list of PIC/S Participating Authorities”, 1 October 2022  Date of news: September 2022 Source: https://picscheme.org/docview/4753 Revised Annex 1 (Manufacture of sterile medicinal products) to guide to good manufacturing practice for medicinal products is published on PIC/S website …

Pharma GMP News of the Week September 25, 2022 Read More »

Pharma GMP News of the Week: 18-September-2022 Period: September 11, 2022 to September 17, 2022 News from EDQM – At the EDQM conference in Strasbourg, the Indian Pharmacopoeia Commission will be represented Date of news: September 12, 2022 The EDQM will host the international conference “Collaboration, Innovation, and Scientific Excellence: the European Pharmacopoeia 11th Edition” …

Pharma GMP News of the Week September 18, 2022 Read More »

Pharma GMP News of the Week: 11-September-2022 Period: September 04, 2022 to September 10, 2022 PMDA Japan published English translation of guide to remote inspection procedure Month news: August-September 2022 The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has translated its remote inspection method guide into English. The guide explains how businesses may prepare …

Pharma GMP News of the Week September 11, 2022 Read More »

Pharma GMP News of the Week: 4-September-2022 Period: August 28, 2022 to September 3, 2022 News from TGA – Update to the Manufacturing Principles for medicines, APIs & sunscreens Date of news: August 25, 2022 The Therapeutic Goods Administration (TGA) in Australia has provided information on the modifications brought about by the adoption of version …

Pharma GMP News of the Week September 04, 2022 Read More »

Pharma GMP News of the Week: 28-August-2022 Period: August 21, 2022 to August 27, 2022 FDA issued draft guideline “Charging for Investigational Drugs Under an IND: Questions and Answers” Date of news: August  23, 2022 This guidance provide information to industry,  physicians, researchers,institutional review boards (IRBs), and patients about the implementation of the FDA’s regulations …

Pharma GMP News of the Week August 28, 2022 Read More »

Pharma GMP News of the Week: 21-August-2022 Period: August 14, 2022 to August 20, 2022 FDA published Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products Date of news: August  15, 2022 The purpose of guidance is to assist in transmitting electronic individual case safety reports and …

Pharma GMP News of the Week August 21, 2022 Read More »

Pharma GMP News of the Week: 14-August-2022 Period: August 7, 2022 to August 13. 2022 News from TGA – TGA is inviting applications from professionals with adequate expertise in science, medicine, or consumer perspectives and issues. Month of news: August  2022 The chosen applicants will give independent expert advice on technical matters relating to the …

Pharma GMP News of the Week August 14, 2022 Read More »

Pharma GMP News of the Week: 7-August-2022 Period: July 31, 2022 to August 6, 2022 US FDA has published draft guideline on “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry” Date of news: August 2, 2022 The purpose of this draft guideline is to assist ANDA applicants while submitting expedited …

Pharma GMP News of the Week August 7, 2022 Read More »

Pharma GMP News of the Week: 31-July-2022 Period: July 24, 2022 to July 30, 2022 US FDA published final guidance on “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices” Date of news: July 25, 2022 The objective of …

Pharma GMP News of the Week July 31, 2022 Read More »

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