Pharma GXP - News
- Restart unannounced inspections of drug units in India, China: US Senator Posted on 08 Aug 2019
- Auditing Starting Materials - new APIC Guideline defines Standards Posted on 17 Apr 2018
- EMA bids to clarify API starting material info pharmas should provide Posted on 16 Aug 2017
- How to prepare for a Data Integrity Inspection Posted on 16 Aug 2017
- FDA Perspective on Risk Management and its Influence on Quality - Inspection Deficiencies 2015 Posted on 13 Dec 2016
- Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs - Teva Posted on 13 Dec 2016
- DC dept will give license to anybody who intends to become a drug trader in state:TN drug controller Posted on 29 Sep 2016
- New MEDDEV Document on the Clinical Evaluation of Medical Devices Posted on 29 Sep 2016
- WHO publishes Second Draft of a Global Medical Devices Regulation Posted on 29 Sep 2016
- MHRA publishes Draft Guidance on "Usability" of Medical Devices Posted on 29 Sep 2016
- Is Cost Pressure becoming the Main Reason for GMP Non-Compliance and Drug Shortages? Posted on 29 Sep 2016
- EMA recommends stopping the Supply of Medicines manufactured at U.S. Company Posted on 29 Sep 2016
- Current Considerations on Pharmaceutical Water Systems and Ozone Posted on 29 Sep 2016
- Guideline on Good Pharmacovigilance Practices (GVP) update Posted on 20 Sep 2016
- FDA's New Regulations for Drug Manufacturers Posted on 20 Sep 2016
- USFDA slaps ban on API supplied by India's Laxachem Posted on 20 Sep 2016
- STATEMENT OF NON-COMPLIANCE WITH GMP - JINAN JINDA PHARMACEUTICAL CHEMI. CO LTD, CHINA Posted on 01 Aug 2016
- Suven Life Sciences gets patent for neuro-degenerative drug Posted on 29 Jun 2016
- Annex 16: How a QP should handle unexpected Deviations Posted on 29 Jun 2016
- FDA Warning Letter to pharmaceutical manufacturer in Taiwan who owns ISO Certificates Posted on 29 Jun 2016
- FDA publishes Technical Guide on Quality Metrics Posted on 29 Jun 2016
- Agilent Technologies to acquire assets of iLab Solutions Posted on 28 Jun 2016
- Swissmedic ramps up ad hoc inspections in 2015 Posted on 28 Jun 2016
- Worried and bewildered: Brexit sparks uncertainty for Indian pharma in Europe Posted on 28 Jun 2016
- US FDA Warning to Shanghai Desano Chemical Pharmaceutical Co. China Posted on 28 Jun 2016
- USFDA Warning Letter to Chongqing Lummy Pharmaceutical Co. Ltd. China Posted on 28 Jun 2016
- Panacea Biotec launches diabetes drug 'Tenepan' Posted on 28 Jun 2016
- USFDA nods to Indian drugs up 84% in 1 year Posted on 28 Jun 2016
- 'Now is the time to include Japan' says Parexel Posted on 27 Jun 2016
- Serialisation regulations to impact all corners of pharma, says Recipharm Posted on 27 Jun 2016
- Pfizer takes axe to Hospira network, exiting 'under-utilised' Colorado plant Posted on 27 Jun 2016
- Indian pharma segment may not be impacted by Brexit Posted on 27 Jun 2016
- CDSCO renews WC certificate to API units to ease export to EU countries Posted on 27 Jun 2016
- French Authorities Call for Withdrawal of Anuh’s GMP Certificate Posted on 25 Jun 2016
- Wockhardt's India Plant Hit With Form 483 Over GMP Violations Posted on 25 Jun 2016
- India needs strict prosecution laws to fix drug regulatory system: Ranbaxy whistleblower Dinesh Posted on 25 Jun 2016
- Commissioner Califf commits to tackling staffing issues at US FDA Posted on 23 Jun 2016
- Pfizer closing Hospira plant in Colorado, 100 jobs to be lost Posted on 23 Jun 2016
- Government invites entries for NPPA logo Posted on 23 Jun 2016
- Bill to amend existing Drugs Act withdrawn Posted on 23 Jun 2016
- Lupin gets USFDA nod for fungal infection drug Posted on 23 Jun 2016
- Govt to re-work UPA's drug regulatory bill Posted on 23 Jun 2016
- Government to revise drugs law, draft new rules for medical devices Posted on 23 Jun 2016
- Scancell stops dosing in long-term trial of cancer vaccine SCIB1 Posted on 23 Jun 2016
- Pharmexcil starts issuing exemption to pharma cos from barcoding for exports Posted on 23 Jun 2016
- 2,839 bottles of Sun Pharma Inc being recalled in US Posted on 23 Jun 2016
- FDA Warns Medtronic Subsidiary Over Adulterated Devices Posted on 23 Jun 2016
- FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics Posted on 23 Jun 2016
- EMA and FDA Begin Collaborations on Patient Engagement Posted on 23 Jun 2016
- Three drug wholesalers have failed GDP checks according to Czech regulator Posted on 23 Jun 2016
- FDA Warns Questionable Cancer Clinic Again for CGMP Violations Posted on 23 Jun 2016
- EU issues Non-Compliance Reports for US Company Posted on 23 Jun 2016
- New Case of Counterfeits Suspected at German Company Posted on 23 Jun 2016
- German Company receives FDA Warning Letter for Data Integrity Issues Posted on 23 Jun 2016
- ECA Visual Inspection Groups works on new FAQ Document Posted on 23 Jun 2016
- Current Issues of GDP Oversight Posted on 23 Jun 2016
- GDP Non-compliance Report issued in EudraGMDP Posted on 23 Jun 2016
- Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance Posted on 15 Apr 2016
- WHO Notice of Concern (NOC) - Rabies vaccine (Lyssavac) Cadila Healthcare Limited Posted on 01 Mar 2016
- ICIG acquiring Novartis intermediates plant that was set to fold Posted on 24 Feb 2016
- Sandoz recalls more than 277,000 bottles of med made by Mylan in India Posted on 24 Feb 2016
- ICH publishes Training Modules on "ICH Q3D - Elemental Impurities" Posted on 24 Feb 2016
- Can the ventilation of GMP clean rooms be switched off overnight? Posted on 24 Feb 2016
- Zydus Cadila gets 'first' FDA approval to ship from Ahmedabad plant Posted on 23 Feb 2016
- FDA allows banned China plant to ship chemo API that is in short supply Posted on 23 Feb 2016
- Sanofi abandoning Auvi-Q after dosage problems led to total recall Posted on 23 Feb 2016
- Adverse event reporting format of MvPI put under stakeholder review for effective implementation Posted on 22 Feb 2016
- Maharashtra govt all set to adopt Clinical Establishment Act after 5 years Posted on 22 Feb 2016
- Prices of essential drugs to be cut by 3% from April Posted on 22 Feb 2016
- China research highlights country's excess use of antibiotics Posted on 22 Feb 2016
- Big Pharma's Delicate Dance on Drug Prices Posted on 22 Feb 2016
- Sandoz Inc, Macleods Pharma recall two drugs made in India Posted on 22 Feb 2016
- MHRA concerned about pharma's preparedness for excipient risk assessments Posted on 22 Feb 2016
- Divis Lab gains on successful USFDA inspection of its Unit-2 facility at Visakhapatnam Posted on 22 Feb 2016
- Pharma cos like Aurobindo Pharma, Lupin see uptick in US business Posted on 22 Feb 2016
- South Korea's SK Group moving ahead on biopharmaceutical M&A Posted on 22 Feb 2016
- India's Lupin offloading 2 generic drugs to close Gavis deal Posted on 22 Feb 2016
- Japan's MHLW to review 3 drugs, 2 devices for Sakigake list Posted on 22 Feb 2016
- Statement of Non-Compliance with GMP, Chengdu Okay Pharmaceutical Co. Ltd., China Posted on 22 Feb 2016
- CDSCO relaxes norms on NOC for pharma exports to developed countries Posted on 18 Jan 2016
- IDMA urges inclusion of clause xiii in rule 96 of D&C Rules 1945 with more clarity Posted on 16 Dec 2015
- Gujarat may get India's first medical device park Posted on 16 Dec 2015
- Bristol's drug pricing under fire as UK agency rejects Opdivo Posted on 16 Dec 2015
- Insulated from Mylan notice, there will be no financial impact: Drug maker Strides Shasun Posted on 16 Dec 2015
- Govt looking into suggestions to strengthen bulk drugs sector Posted on 16 Dec 2015
- Govt plans to boost production of active pharma ingredients Posted on 16 Dec 2015
- Indian pharma market crosses Rs 1,00,000 crore mark: IMS Health Posted on 16 Dec 2015
- More systems training needed to help inspectors spot data falsification say PIC/S experts Posted on 16 Dec 2015
- Identification of Medicinal Products Standards will apply in six Months Posted on 09 Dec 2015
- FDA Guide for Microbial Vectors used for Gene Therapy Posted on 09 Dec 2015
- Statistics and Process Validation: current Findings of the FDA Posted on 09 Dec 2015
- Cipla reshuffles its senior management team again Posted on 07 Dec 2015
- Centre to amend D&C Rules to bring all notified medical devices under Schedule M III Posted on 07 Dec 2015
- Commerce ministry to consider issue related to policy circular no 9 soon Posted on 07 Dec 2015
- US FDA training held for Indian regulatory staff may force cos to adopt new technologies in plants Posted on 07 Dec 2015
- AstraZeneca to down shutters of Bengaluru API unit Posted on 07 Dec 2015
- FDA to Release Major Generic Drug Labeling Rule in July 2016 Posted on 03 Dec 2015
- Natco Pharma suspends work at Chennai plant due to flood Posted on 03 Dec 2015
- FDA suspends clinical development of obesity drug after second US trial death Posted on 03 Dec 2015
- Wockhardt's Chikalthana plant gets GMP certificate from UKMHRA Posted on 03 Dec 2015
- AstraZeneca Pharma India to close Bengaluru API unit Posted on 03 Dec 2015
- TAKE Solutions launches PVIndia to address pharmacovigilance challenges faced by Indian pharma units Posted on 03 Dec 2015
- NPPA's Pharma Jan Samadhan scheme gets good response, gets 295 complaints since launch in March Posted on 03 Dec 2015
- FDA Warns California Ophthalmologist Again Over Clinical Trial Violations Posted on 03 Dec 2015
- GAMP: Your Administrator and Administrators for Instruments Posted on 03 Dec 2015
- Italian Medicines Agency calls out IASON ITALIA SRL over Non-Compliant Manufacturing Operations Posted on 01 Dec 2015
- Revised USP Chapter <1790> on Visual Inspection published Posted on 25 Nov 2015
- Draft Annex 17: Real Time Release Testing, Revision 1 Posted on 25 Nov 2015
- New USP Chapter on Package Integrity become official Posted on 25 Nov 2015
- FDA extends comments for "established conditions" guidance Posted on 18 Nov 2015
- ECA establishes new Interest Group on Pharmaceutical IT Compliance Posted on 18 Nov 2015
- India eases testing norms for new drugs Posted on 11 Nov 2015
- USP revises Chapter <1231> on Pharmaceutical Water Posted on 11 Nov 2015
- Draft of new Ph. Eur. Chapter "Co-Processed Excipients" published Posted on 11 Nov 2015
- Court orders Dr. Reddy's to temporarily halt sales of its purple Nexium copy Posted on 11 Nov 2015
- CEO says Sanofi will 'reshape' manufacturing but is short on specifics Posted on 11 Nov 2015
- Pfizer recalls 21,000 bottles of Xanax that may be too weak Posted on 11 Nov 2015
- Sun's U.S. sales crater as plant issues cut deeply Posted on 11 Nov 2015
- FDA Form 483s From India: A Deep Dive Into the Problems Posted on 09 Nov 2015
- FDA Warns Three Companies Over DTC Genetic Tests Posted on 09 Nov 2015
- Dr Reddy's gets FDA warning letter for three drug plants Posted on 06 Nov 2015
- Health ministry to raise validity of licences in Form 11 & Form 29 from one year to 3 years Posted on 05 Nov 2015
- Mylan receives US FTC nod for proposed acquisition of Perrigo Posted on 05 Nov 2015
- Torrent Pharma commences production from new plant in Gujarat Posted on 05 Nov 2015
- Pharma institutes sign 17 MoUs with corporates Posted on 05 Nov 2015
- Lupin appoints Thierry Volle as President of EMEA business Posted on 05 Nov 2015
- U.S. FDA Form 483 has Indian drugmakers 'spooked' Posted on 05 Nov 2015
- Faster USFDA nod won't boost margins, will lead to intense competition: Analysts Posted on 05 Nov 2015
- PMO to review the status of bulk drug imports today Posted on 05 Nov 2015
- Delhi HC blocks Reliance from launching copy of Roche's breast cancer drug Posted on 05 Nov 2015
- Health Canada Non-Compliance Report: MS Pharma Inc., Canada Posted on 05 Nov 2015
- IPC to become first WHO Collaborating Centre in SE Asia Posted on 05 Nov 2015
- Consequences of the new MHRA Guideline for Excel Posted on 05 Nov 2015
- New USP General Chapters on Extractables and Leachables: <1663>, <1664> Posted on 05 Nov 2015
- ECA publishes revised version of Good Practice Guide on Process Validation Posted on 05 Nov 2015
- Indiana aspirin maker hit with Warning due to tablet inconsistencies Posted on 05 Nov 2015
- Pfizer: No safety snags at China plant despite 'missing document' 483 Posted on 05 Nov 2015
- Data Integrity in the QC Laboratory - How to Handle Breaches by Charles M. Chee Posted on 03 Nov 2015
- Indian drug manufacturing companies need to make continuous efforts to maintain quality:Dr Vadlamudi Posted on 02 Nov 2015
- Non-Compliance with GMP to CARGILL FRANCE by French National Agency for Medicines and Health Product Posted on 01 Nov 2015
- Audit Trails Reviews for Data Integrity by Ivan Soto Posted on 31 Oct 2015
- Novartis to close one Indian manufacturing plant as FDA warning bites Posted on 30 Oct 2015
- Ph. Eur. Chapter 5.15. Functionality-related characteristics of excipients Posted on 30 Oct 2015
- What are "complex manufacturing processes"? A recent reply from the EMA Posted on 30 Oct 2015
- Annex 15 and FDA Process Validation Guideline: Similarities/differences from the FDA perspective Posted on 30 Oct 2015
- ICH announces organisational changes Posted on 30 Oct 2015
- UK's MHRA Calls Out GSK China Plant Over GMP Non-Compliance Posted on 23 Oct 2015
- FDA cites Cipla India plant after U.S. recall of asthma drug Posted on 20 Oct 2015
- Cipla gets FDA's nine observations and issues noticed memo for Indore unit Indian drug maker Cipla h Posted on 20 Oct 2015
- Recall - potential for user injury as a result of device breakage Posted on 14 Oct 2015
- Pharma companies may pay double penalty for violating norms Posted on 14 Oct 2015
- If you want new excipients, regulate them, says BASF Posted on 14 Oct 2015
- USP wants to considerably expand the Monograph for Ophthalmic Preparations <771> Posted on 14 Oct 2015
- Finally published: new Annex 16 on QP Certification and Batch Release Posted on 14 Oct 2015
- GDP certification by accredited bodies and GDP audit by QPs - dangerous misunderstandings Posted on 14 Oct 2015
- The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in Manufacture of API Posted on 14 Oct 2015
- Cipla's new U.S. plant received Form 483 just ahead of deal Posted on 14 Oct 2015
- FDA issues Form 483 to compounder AmerisourceBergen is buying for $2.6B Posted on 14 Oct 2015
- FDA Warns Indian API Manufacturer for Data Integrity Issues Posted on 14 Oct 2015