Pharma-GMP-News

Pharma GMP News of the Week: 15-May-2022 Period: May 8, 2022 to May 14, 2022 EMA updated “Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO)” EMA/INS/GCP/155794/2022 Date of update: May 05, 2022 Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iv-procedure-conducting-gcp-inspections-requested-chmp-sponsor-contract-research-organisations_en.pdf  Medical Device Coordination Group Document guidance provides clarity on permitted changes …

Pharma GMP News of the Week May 15, 2022 Read More »

Pharma GMP News of the Week: 8-May-2022 Period: May 1, 2022 to May 7, 2022 EC proposed European Health Data Space to enable research opportunities Date of news: May 3, 2022 The European Commission launched the EHDS (European Health Data Space). It will help the European Union to support the way healthcare is provided to …

Pharma GMP News of the Week May 8, 2022 Read More »

Pharma GMP News of the Week: 1-May-2022 Period: April 24, 2022 to April 30, 2022 FDA Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research issued guidance on “Providing Submissions in Electronic Format — Postmarketing Safety Reports” Date of issue: April 27, 2022 The objective of the guideline is to assist …

Pharma GMP News of the Week May 1, 2022 Read More »

Pharma GMP News of the Week: 24-April-2022 Period: April 17, 2022 to April 23, 2022 The HAD (Healthcare Distribution Alliance) issued guideline to support pharma industry for placement of bar code labels on their products to meet the Drug Supply Chain Security Act (DSCSA) Date of issue: April 18, 2022 Source: https://www.hda.org/resources/2022-guidelines-for-bar-coding-in-the-pharmaceutical-supply-chain FDA published final …

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

Pharma GMP News of the Week: 17-April-2022 Period: April 10, 2022 to April 16, 2022 FDA published Guidance on “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs” Date of release: April 11, 2022 The objective of the guidance is to provide requirements of submission of …

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

Pharma GMP News of the Week: 10-April-2022 Period: April 03, 2022 to April 09, 2022 MHRA update: “Medicines: reclassify your product – Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification” Date of Update: April 4, 2022 Update: Updated Approved reclassifications to Mar 31, 2022 Source: …

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

Pharma GMP News of the Week: 3-April-2022 Period: March 27, 2022 to April 02, 2022 News from ICH: The draft of ICH Q2(R2) and Q14 reaches at Step 2 process Date of News: March 31, 2022 Revision of ICH Q2(R2) and Q14 reached to Step 2 of the process on March 24, 2022. At this …

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

Pharma GMP News of the Week: 27-March-2022 Period: March 20, 2022 to March 26, 2022 News from EDQM, “Metals and alloys used in food contact materials and articles: updated technical guide released for consultation” Date of news: March 21, 2022 EDQM open the text for 2nd edition, for consultation by all concerned parties viz. business …

Pharma GMP News of the Week Mar 27, 2022 Read More »

Pharma GMP News of the Week: 20-March-2022 Period: March 13, 2022 to March 19, 2022 European Pharmacopoeia (Ph. Eur.) invites experts to join the Ph. Eur. network. Date of news: March 14, 2022 Ph. Eur. is inviting independent experts to join Ph. Eur. groups and working parties. This includes experts from authorities such as official medicines control …

Pharma GMP News of the Week Mar 20, 2022 Read More »

Pharma GMP News of the Week: 13-March-2022 Period: March 6, 2022 to March 12, 2022 EDQM published batch release guideline on Pandemic COVID-19 vaccine (Recombinant Spike Protein) Date of news: March 8, 2022 Source:  https://www.edqm.eu/sites/default/files/medias/fichiers/COVID-19/guideline_for_pandemic_covid-19_vaccine_recombinant_spike_protein080322.doc FDA released draft guidance on “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs” Date of …

Pharma GMP News of the Week Mar 13, 2022 Read More »

Scroll to Top