Pharma-GMP-News

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 »

Pharma GMP News of the Week: 24-July-2022 Period: July 17, 2022 to July 23, 2022 US FDA published draft guidance – Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding” Date of news: July 21, 2022 The objective of this guideline is to support applicants …

Pharma GMP News of the Week July 24, 2022 Read More »

Pharma GMP News of the Week: 17-July-2022 Period: July 10, 2022 to July 16, 2022 CDSCO, India has published three draft guidelines on performance evaluation, postmarket surveillance and stability studies to reshape the manufacturer’s approach for vitro diagnostics (IVDs) Date of guidances: July 7, 2022 To read the guidance, click to the following links. Performance …

Pharma GMP News of the Week July 17, 2022 Read More »

Pharma GMP News of the Week: 10-July-2022 Period: July 3, 2022 to July 9, 2022 FDA published draft guideline “Identifying Trading Partners Under the Drug Supply Chain Security Act” Document published on: July 5, 2022 The FDA has issued the guideline to assist industry and stakeholders in understanding how to categorize the entities in the …

Pharma GMP News of the Week July 10, 2022 Read More »

Pharma GMP News of the Week: 3-July-2022 Period: June 26, 2022 to Jul 2, 2022 MHRA Published Government response to consultation on the future regulation of medical devices in the United Kingdom Document published on: June 26, 2022 MHRA had consulted on required changes to the regulatory framework for medical devices in the UK between …

Pharma GMP News of the Week July 3, 2022 Read More »

Pharma GMP News of the Week: 26-June-2022 Period: June 19, 2022 to June 25, 2022 News from CDSCO India, Ministry of Health’s proposal to add barcodes or quick response (QR) codes on around 300 top medicines to provide authentication. It will come into force in May 2023. Government Document dated: June 14, 2022 Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODYyMA==  …

Pharma GMP News of the Week June 26, 2022 Read More »

Pharma GMP News of the Week: 18-June-2022 Period: June 12, 2022 to June 18, 2022 MDCG published Position Paper “Notice to manufacturers to ensure timely compliance with MDR requirements” Date of notice: June 13, 2022 Source: https://ec.europa.eu/health/system/files/2022-06/mdcg_2022-11_en_0.pdf  US FDA published a draft guideline “QUALITY RISK MANAGEMENT Q9(R1)” on its website that currently is under public …

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

Pharma GMP News of the Week: 12-June-2022 Period: June 5, 2022 to June 11, 2022 PIC/S releases work plan for 2022: Key highlights – onsite and desktop assessments,  Annex 1 of the GMPs for sterile products,  GMP Guide Chapter 1   Date of release: May 2022 Source: https://picscheme.org/docview/4697  U.S. FDA published guideline on “Electromagnetic Compatibility (EMC) …

Pharma GMP News of the Week June 12, 2022 Read More »

Scroll to Top