Search Results for Quality

Showing 1 – 25  of 89

MDSAP Changes Aim to Reduce Audit Times By Zachary Brennan - Published 30 October 2017

With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits.

Categories: News, Canada, Health Canada, IMDRF, Government affairs, In vitro diagnostics, Medical Devices, Quality

Tags: MDSAP, quality management system audits, medical device audits

UK Strategy for Pharmacopeial Quality Standards for Biologics: MHRA Discusses Comments By Zachary Brennan - Published 23 October 2017

Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopoeial standards for biologics, according to a report issued Monday.

Categories: News, Europe, MHRA, Biologics and biotechnology, Government affairs

Tags: quality standards for biological medicines, pharmacopeial standards

Mistake-Proofing the Workplace By Zachary Sherman, Max Sherman - Published 22 September 2017

This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors.

Categories: Features, Compliance, Manufacturing, Quality

Tags: Errors, Defects, Quality

CDRH to Launch 'Critical to Quality' Pilot Program By Zachary Brennan - Published 11 September 2017

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection.

Categories: News, US, CDRH, Medical Devices

Tags: Critical to Quality, FDA pilot program

EMA Updates Guidance on Three Post-Authorisation Activities By Michael Mezher - Published 14 July 2017

The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Quality, Submission and registration

Tags: Post-authorisation, Post-authorisation safety studies, Quality, Type II Variation

Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions By Monika Jain, PhD - Published 02 June 2017

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

Categories: Features, Japan, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, Drugs, Submission and registration

Tags: Quality Certificates, eCTD, GMP

ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer - Published 16 May 2017

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality

Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD

FDA Official Highlights Foreign Supply Chain Challenges By Michael Mezher - Published 05 May 2017

Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research.

Categories: News, US, FDA, Compliance, Drugs, Manufacturing, Submission and registration

Tags: Office of Manufacturing Quality, Foreign Inspections, Supply Chain

Thailand's Approach to Drug Quality Assurance: Creation of the Green Book By Thanita Patthamajinda, RPh - Published 27 April 2017

This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.

Categories: Features, Asia, Drugs, Quality

Tags: Thailand, Green Book, Quality Assurance

CDER Officials: Nanomaterial Submissions on the Rise By Michael Mezher - Published 27 April 2017

A team of officials from the US Food and Drug Administration's (FDA) Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research (CDER) say that submissions for drugs containing nanomaterials are on the rise.

Categories: Biologics and biotechnology, Drugs

Tags: Nanomaterials, Office of Pharmaceutical Quality, OPQ

EMA-FDA QbD Pilot Program Led to Further Harmonization By Zachary Brennan - Published 19 April 2017

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: QbD pilot, EMA-FDA joint program, quality by design

Researchers Link Target Product Profiles to Shorter Review Times By Michael Mezher - Published 17 April 2017

A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration

Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP

Industry Wants FDA to Hit the Brakes on Quality Metrics Program By Michael Mezher - Published 30 March 2017

The US Food and Drug Administration's (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Manufacturing, Quality

Tags: Quality Metrics

EMA Weighs New Guideline on Quality Requirements for Combination Products By Zachary Brennan - Published 16 February 2017

The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product.

Categories: News, Europe, EMA, Combination products, Quality

Tags: combination products, notified bodies, quality requirements

CDRH Warns Three Foreign Medical Device Manufacturers By Zachary Brennan - Published 07 February 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea.

Categories: News, US, CDRH, Compliance, Manufacturing, Medical Devices

Tags: warning letters, quality data

When Can Drugmakers Cite Quality Standards From Foreign Compendia? FDA Explains By Zachary Brennan - Published 27 January 2017

An updated Manual of Policies and Procedures (MAPP) for the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) lays out when drug sponsors and applicants can propose specifications for excipients, drug substances and drug products in their applications based on quality standards in the British Pharmacopoeia (BP), the European Pharmacopoeia (EP) or the Japanese Pharmacopoeia (JP).

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs

Tags: quality standards pharmaceuticals

European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017) By Nick Paul Taylor - Published 12 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: regulatory harmonization, ICMRA, Bayer, biologic quality standards

The Measure of Quality By Jennifer DiMarco - Published 29 November 2016

This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ.

Categories: Features, Quality

Tags: Quality assurance, Quality control, Quality management

FDA Revises Quality Metrics Guidance, Says Program Will Be Voluntary Until 2018 By Michael Mezher - Published 23 November 2016

The US Food and Drug Administration (FDA) on Wednesday released a revised version of its proposal to collect quality metrics data from drugmakers in response to protests from industry.

Categories: News, US, FDA, Drugs, Manufacturing, Quality

Tags: Quality Metrics, Revised draft guidance

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Categories: Features, ISO, Manufacturing, Medical Devices

Tags: ISO 13485:2016, Quality Management System

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Tags: ISO 13485:2016, Quality Management System

US, EU Look to Mutually Recognize GMP Inspections by January 2017 By Zachary Brennan - Published 26 October 2016

The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GMP inspections, regulatory harmonization, UDIs, quality inspections

New Report Investigates Use of Analytics to Measure Medical Device Quality By Michael Mezher - Published 12 October 2016

The Case for Quality, a public-private partnership between the US Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC), has released a new report on the feasibility and effectiveness of using analytics to measure medical device quality in healthcare decision-making.

Categories: News, US, FDA, Medical Devices, Quality

Tags: Case for Quality, MDIC, Medical Device Innovation Consortium

FDA to Hold One Advisory Committee for Each Initial Biosimilar By Zachary Brennan - Published 13 September 2016

The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each first new biosimilar for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar advisory committee, critical quality attributes

FDA to Revise Draft Guidance on Quality Metrics Data By Zachary Brennan - Published 12 September 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday offered a couple of revisions to its list of guidance documents for 2016. Most notably, a revision to the agency’s draft guidance on quality metrics is expected later this year.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs, Manufacturing, Quality

Tags: quality metrics, pharmaceutical quality, FDA quality metrics guidance, CDER draft guidance