Search Results for Good Manufacturing Practice

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Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance By Michael Mezher - Published 18 January 2018

The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight.

Categories: News, US, FDA, Manufacturing

Tags: Compounding, Outsourcing Facilities, cGMP, Good Manufacturing Practice, Drug Quality and Security Act, DQSA

European Commission Consults on Revised GMPs for Sterile Drugs By Michael Mezher - Published 20 December 2017

The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4.

Categories: News, Europe, EC, Drugs, Manufacturing

Tags: Eudralex Volume 4, Annex 1, Sterile Drugs, Good Manufacturing Practice, GMP

FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors By Michael Mezher - Published 26 September 2017

The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May.

Categories: News, China, US, FDA, Compliance, Drugs, Manufacturing

Tags: Good Manufacturing Practice, GMP, Warning Letter

Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs By Zachary Brennan - Published 06 March 2017

The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs).

Categories: News, Asia, Canada, Europe, US, EC, FDA, Health Canada, MHRA, TGA, WHO, Crisis management, Government affairs, Manufacturing

Tags: PIC/S, good manufacturing practice for ATMP, European Commission consultation

FDA Warns Spanish API Maker for GMP Violations By Michael Mezher - Published 06 December 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May.

Categories: News, Europe, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Warning Letter, Good Manufacturing Practice, GMP

Croatian Regulator Cites Indian Manufacturer for QA, GMP Violations By Michael Mezher - Published 25 May 2016

The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on Monday issued a statement of non-compliance to Indian active pharmaceutical ingredient (API) manufacturer Dhanuka Laboratories Ltd.

Categories: News, India, Europe, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: GMP, Good manufacturing practice, HALMED, Dhanuka Laboratories

EMA Recommends Suspending Medtronic's Inductos Over GMP Issues at CMO By Michael Mezher - Published 23 October 2015

The European Medicines Agency (EMA) is calling on the European Commission to suspend the marketing authorization for Inductos, Medtronic's implant used to help new bone growth in patients with spinal disc problems and leg fractures.

Categories: News, Europe, EC, EMA, Combination products, Compliance, Drugs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement

Tags: Inductos, Medtronic, Integra LifeSciences, Good manufacturing practice, GMP

EMA to Review InductOs After US Manufacturer Cited for Contamination Issues By Michael Mezher - Published 27 July 2015

The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs, after Spanish and Dutch inspectors discovered contamination issues at a US manufacturing site which makes one of its components.

Categories: News, Europe, US, EC, EMA, Compliance, Drugs, Manufacturing, Postmarket surveillance, Quality

Tags: InductOs, Medtronic, Article 20 procedure, Good manufacturing practice, GMP, Integra LifeSciences

Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues By Michael Mezher - Published 30 June 2015

After Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products containing APIs sourced from the company.

Categories: News, Canada, Europe, EMA, Health Canada, Active pharmaceutical ingredients, Compliance, Distribution, Drugs, Manufacturing

Tags: Good manufacturing practice, GMP, EudraGMDP, Polydrug

AmpliPhi Biosciences Gets First cGMP Certification for Bacteriophage Facility By Michael Mezher - Published 04 June 2015

AmpliPhi Biosciences announced Wednesday it has received the first ever good manufacturing practices certification for its bacteriophage facility in Slovenia.

Categories: News, Europe, Biologics and biotechnology, Manufacturing, Regulatory strategy, Research and development

Tags: Phage therapy, Bacteriophage, antimicrobial resistance, Good manufacturing practice, GMP

To Boost Transparency, Canada Launches GMP Inspection Database By Michael Mezher - Published 15 April 2015

Canada's Health Minister Rona Ambrose announced the launch of a new publicly accessible database for manufacturing inspections on 13 April 2015.

Categories: News, Canada, Health Canada, Compliance, Manufacturing, Postmarket surveillance

Tags: Good Manufacturing Practice, GMP, GMP Inspections

EU Makes Major Update to Drug Manufacturing Guidelines By Michael Mezher - Published 03 April 2015

For the first time since 2001, the European Commission (EC) is updating its guidelines for pharmaceutical qualification and validation.

Categories: News, Europe, EC, EMA, ICH, Compliance, Distribution, Drugs, Manufacturing, Packaging, Quality, Regulatory strategy

Tags: Qualification and Validation, Good manufacturing practice, GMP

Health Canada to Increase GMP Inspections, Promises Greater Transparency By Michael Mezher - Published 04 March 2015

Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future.

Categories: News, Canada, FDA, Health Canada, Government affairs, Manufacturing, Postmarket surveillance

Tags: GMP, good manufacturing practice, transparency, inspections