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 > Top Tips – Building your ISO Quality Management System

Top Tips – Building your ISO Quality Management System

Top tips for building your ISO Quality Management System for Pharmaceutical Companies

A Quality Management System (QMS) is key for pharma companies and should encourage organisations to comply with ICH Q10 and ISO guidance. Pharmaceutical QMS must also accommodate unique industry requirements to achieve core quality principles and other requirements by providing all the features necessary to comply with cGMP, maintain global quality control, and achieve continuous improvement. These include:

Customer Focus

Determined to exceed customer expectations should be the primary focus of a quality management system. Organizations achieve success when they earn customer confidence and use customer interaction. Start-ups in the pharmaceutical industry often have an advantage when it comes to establishing a customer focused culture. This desire to help patients should be fundamental to pharmaceutical QMS. An effective PQS should encourage pharma companies to make decisions to improve the quality of products and the speed of delivery.

Continuous Improvement

For pharma companies, constant improvement is likely vital to survival. The pharmaceutical industry is under intense pressure to meet strict regulatory requirements and pricing pressures while evolving to meet changing customer expectations.

Process-Centered Approach

According to ISO, “consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes. A process-centered approach involves the development of clear SOPs for every role and responsibility in the organization, but it also requires pharma organizations to shift their focus to the entire product lifecycle. Historically, pharma manufacturers were able to place the responsibility for quality on partnerships in the supply chain.

Process-centered Quality Management Systems are crucial for regulatory compliance in pharma, particularly at organisations that rely on entirely outsourced manufacturing partnerships. Pharma organisations should consider whether their QMS supports process-centered best practices, including:

  • Conducting supplier risk assessments
  • Performing supplier audits
  • Monitoring, documenting, and reviewing supplier performance
  • Establishing written quality guidelines and SOPs for suppliers

Total Employee Involvement

Every employee at a pharma organization has an impact on the company’s ability to deliver a quality product. Quality isn’t a checklist, a goal of the management team, or the responsibility of the quality unit. It’s a core component of the culture which should be owned by every member of the organization. To involve employees in improvement, a pharma QMS should create an empowered and knowledgeable workforce through practical training, collaboration tools, and clear channels for communicating opportunities.

Integrated Systems

Quality Management Systems consist of a framework for the governance of interrelated processes. An organization can only optimize products and performance by understanding how a system produces results. Transparency of information can be supported by a comprehensive QMS software which complies with cGMP and ICH Q10.

Key elements for an integrated pharmaceutical QMS include:

  • Quality policy
  • Personnel
  • Development and implementation
  • Production
  • Documents
  • Facilities and equipment
  • Self-inspection
  • Management responsibilities
  • Evaluation of suppliers and purchasing
  • Supplier production and analysis
  • Risk analysis
  • Monitoring and control
  • Complaints and recalls (CAPA)
  • Measurement, analysis, and improvement

 

Fact-based Decision Making

“Evidence-based decision making” is among the core principles of ISO, who writes “decisions based on the analysis and evaluation of data and information are more likely to produce desired results.” Pharmaceutical executives are now required to make decisions based on data throughout the product lifecycle. A QMS must provide the comprehensive picture and analysis capabilities to avoid the risks of assumptions. Data can help leadership decide where change makes sense and when immediate changes are necessary to protect product quality.

Communications

To support relationships in a quality-driven organization, ISO advises companies to “pool and share information, expertise, and resources with relevant interested parties,” provide success metrics and channels for feedback, and refine methods for collaboration.  Communications should be easily monitored and simple to distribute based on role. A QMS should offer ease-of-use for end users with simple search features and mobile access to real-time collaboration.

The above points can be found in detail by visiting the below link: https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/pub100080.pdf

The below link to guideline ICH 10 Pharmaceutical Quality system describes a model for an effective quality management system for the pharmaceutical industry.

https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf

PharmaLex can support your organisation in many ways by developing your company’s Quality Management system, highlighting new system designs, or the provision of any support your company may require in relation to QMS. To discuss the range of services that we offer, please connect with us on +353 1 846 4742 or email us at contactirl@pharmalex.com

Related posts
Why collaboration and an Integrated Product Development program are key to successful drug development
Why collaboration and an Integrated Product Development program are key to successful drug development
14th June 2022
Key Takeaways from the PDA Europe Annex 1 Workshop
Key Takeaways from the PDA Europe Annex 1 Workshop
7th June 2022
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
Search
Upcoming Webinars

June 28th, 2022

eCTD in Australia: key steps to start a successful submission

08:30 am CET / 4:30 pm AEST

June 28th, 2022

An Introduction to Bayesian adaptive methods in clinical trials

04:00 PM CET

June 30th, 2022

Transforming the drug development process with an integrated strategy

03:00 PM CET

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·
24 Jun

Milena Shuytsova-Mircheva and Lisa Pascoe latest blog here https://www.pharmalex.com/sponsors-gear-up-for-a-smoother-process-with-ctis-but-must-first-overcome-key-hurdles/ discusses the benefit of the Clinical Trial Information System (CTIS).

💡 Interested in CTIS? Take the Phlexglobal survey to evaluate your preparation https://www.phlexglobal.com/ctis-survey

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected

    Small US Biopharmaceutical Company
    Sr Director Regulatory Affairs CMC
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