TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > News & Events > Ireland > How to implement a robust Quality Risk Management Program

How to implement a robust Quality Risk Management Program

Quality Risk Management has been an industry hot topic for the last number of years and the recent draft Annex 1 revision has highlighted the particular focus that regulators will place on this element of the Pharmaceutical Quality System in the future.

In the pharmaceutical industry, we are still accustomed to looking for black and white guidance on how to implement controls that impact the quality of our product. However, with the rising prominence and importance of Quality Risk Management we need to implement QRM programs that will give us the information and scientific rationale for how and when we implement controls in our processes.

QRM is not a new concept in the industry, but we are still finding our feet, often resulting in unwieldy and complex risk assessments, primarily based on FMEA that have become ‘tick the box’ exercises to satisfy the regulators. When this happens, we are missing an opportunity to significantly benefit from the correct implementation of a QRM program.

QRM programs when implemented successfully reduce the workload on an organisation by focusing effort on the areas of highest criticality which also brings a knock-on positive effect on product quality and patient safety. QRM implementation does not need to involve convoluted additional processes that are resource heavy but should focus at a base level on five questions;

  1. What can go wrong?
  2. How bad will the effect be if it goes wrong and who will be impacted?
  3. What controls do I have in place to prevent things going wrong and are they robust enough?
  4. Will I detect something going wrong?
  5. Do I need to improve my control to prevent issues from happening?

The focus in all cases should be on prevention of issues and pre-emptory solutions to potential problems in a process in order to safeguard product quality and patient safety.

QRM can also be used successfully to enhance knowledge management by providing complete overviews of processes or systems, their weaknesses and the critical controls that are in place to prevent issues from occurring.

Once implementation of QRM and application of its principles has started for all critical processes, the next task is ensuring that the program is correctly integrated and communicating with all other site systems, particularly the PQS.

An example of this integration is change control, a process with which QRM should be closely linked. Typically risk assessments are generated to assess the impact of a change control but this approach alone can be short sighted. When a Change Control is proposed, the change should also be assessed against all existing relevant risk assessments to determine if the change will reduce or increase the risks that have been identified in the process, facility or system.

Likewise, the distribution of capital funding should ensure that areas of higher risk are funded before areas that may not impact product quality to the same degree.

A successfully implemented and robust QRM program should provide the glue that holds it all together, providing channels of communication, methods for documenting valuable information, a template for making decisions and a mechanism for prioritisation that ensures that product quality and patient safety is at the heart of everything we do.

If you would like support in the implementation of a QRM program or an independent review of the QRM processes you have in place, PharmaLex have subject matter experts in this area that are happy to help.

To discuss how PharmaLex can support your organisation, please connect with us on +353 1 846 4742 or email us at contactirl@pharmalex.com.

Related posts
NLS DAYS 2022
NLS DAYS 2022
September 28 - May 29th, 2022
Addressing Limitations of Sterility Testing
Addressing Limitations of Sterility Testing
9th May 2022
Are virtual audits sustainable post-pandemic?
Are virtual audits sustainable post-pandemic?
6th May 2022
Orphan Drug Designation: Securing the Significant Benefits
Orphan Drug Designation: Securing the Significant Benefits
28th March 2022
Virtual Audits: To be, or not to be, that is the question
Virtual Audits: To be, or not to be, that is the question
26th January 2022
Quality Risk Management ICH Q9 – Revision published for public comments
Quality Risk Management ICH Q9 – Revision published for public comments
5th January 2022
Search
Upcoming Events

September 28 - May 29th, 2022

NLS DAYS 2022

Visit us at booth X51

Categories
  • All News
  • Webinars
  • Events
Archive
Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
16 May

PharmaLex is proud to be a supporting sponsor at #AusMedtech2022 24 May-26 May. In keeping with our CSR, we are sponsoring reusable coffee cups at this event. Be sure to reuse your Coffee cup to support good sustainable practices and our environment.
https://www.ausmedtech.com.au/

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

    Leading European Specialist Pharma Company
    Head of Medical Writing and Publications
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.





    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for