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 for Deviation Writing

Top Tips for Deviation Writing

Improving the quality of your deviation:

Investigations of discrepancies in Production record review (CFR 211.192) continues to be one of the most frequently cited observations for drug products by the FDA. Inspectorates will usually issue an FDA-483 if a company fails to demonstrate that they completed a detailed, accurate and timely deviation investigation. If, however, FDA observes a systemic failure to conduct accurate and timely investigations, it is more likely to be classified as Official Action Indicated, with appropriate compliance measures. Companies face many challenges in delivering highly consistent, effective and thorough investigation reports. Some of the challenges centre around issues such as having sufficient, knowledgeable staffing in place, handling faster paces, tighter deadlines, increased workload, increased regulatory requirements and globalisation to name but a few. Here are some key areas to focus on improving the quality of your deviation/ investigation reports 1.  The investigation/deviation report should tell a story that can be easily understood by all parties well after the event and the investigation. It must be focussed on all future potential readers and ensure that it provides evidence and a systematic approach that underpins the findings, CAPAs and overall conclusions of the report. 2.  A thorough deviation investigation should be completed in a timely manner (typically within 30 days) 3.  The deviation investigation should include the following:

  • Event summary
  • Description of the deviation: Include the who, where, what, when details in this section. Be specific, give exact and precise data. Do not attempt to give the “why” answer in this section. Detail only facts, data or observations prior to, during and/or after the event. Write all details in chronological order as much as possible. Provide information as to how the event was controlled and/or limited at the time of occurrence.
  • Materials/lots affected and rationale: This is critical as it must be very clear that any potential risk was addressed immediately and that the rationale for identification and control of the impacted material was fully documented in this section.
  • Root-cause investigation: This is the section to demonstrate that a systematic approach was taken to investigate the true root cause of the issue. Include the output of the problem solving tool that was employed. Often companies like to employ a single problem solving tool such as the 5 why process as a consistent approach is more reliable. There should be a clear description of the investigation’s path and its ultimate identification of the final or most probable root cause(s). An inspectorate will expect to see the rejected hypothesises as well as the final one to ensure the investigation was thorough.
  • Impact assessment: A clear description of the effect of the deviation event on product quality, including all lots affected or potentially affected. The assessment and resulting conclusions must be objective and scientific based.
  • Trending analysis: Set up the deviation recording system so that trending can be easily completed. An analysis of deviation events and root causes should address trends and note whether more in-depth investigations were or will be pursued. Any recurring events or root causes must be fully assessed to determine the effectiveness of the previous CAPA and/or the accuracy of the root-cause determination.
  • CAPA: Identification of appropriate corrective and preventative actions should be completed based on the root cause investigation section and should address all root causes identified. A plan for assessing the effectiveness of actions taken should be developed and implemented.
  • CAPA Effectiveness: It is reasonable to assume that if a problem is worth solving, it is also worth verifying that the solution worked.

4.  When arriving at root causes, dig a little deeper. Often root causes will arrive at the usual suspects such as equipment failure/ availability/design or human error. While these are valid intermediate root causes, they need further analysis to arrive at truly effective CAPAs. At this point it is important to add another layer to the root cause investigation. This can be done, for example by applying the 5-whys technique again starting with the intermediate root cause. 5.   Close the loop: Management with executive responsibility must be aware of and review CAPA results. Organisations must take prompt action when violative products or situations are discovered. Remember a surveillance system is only as good as the information it receives, it is key to rapidly pick up on important signals. Follow-up is crucial. Close the loop by providing input into design control/R&D requirements/study design. If you are interested in exploring how we can help you, please get in touch to discuss how PharmaLex can assist your organisation, contact us at +353 1 846 47 42 or contactirl@pharmalex.com

Related posts
Resilience of Pharma Supply Chains and the Impact of Covid-19 Pandemic
Resilience of Pharma Supply Chains and the Impact of Covid-19 Pandemic
17th May 2021
Contamination Control
Contamination Control
8th April 2021
Rules on Ownership of Medicinal Product stock distributed in Great Britain
Rules on Ownership of Medicinal Product stock distributed in Great Britain
7th April 2021
GET SMART: reliable analytical results & continuous regulatory compliance!
GET SMART: reliable analytical results & continuous regulatory compliance!
30th March 2021
Challenges of Advanced Therapy Medicinal Products (ATMPs)
Challenges of Advanced Therapy Medicinal Products (ATMPs)
16th March 2021
Supporting M&A in the pharmaceutical / biopharmaceutical industry
Supporting M&A in the pharmaceutical / biopharmaceutical industry
11th February 2021
Search
Upcoming Webinars

May 10th, 2022

Using Real World Evidence to Transform Drug Development and Evaluation: Opportunities and Challenges

04:00 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·
4 May

Francesco Lanucara’s latest article discusses how important it is to provide clear information and keep up with regulatory guidelines.

Read the article here: https://lnkd.in/dFt4KBVy

For this and more articles subscribe to our newsletter.
#cellandgene #lifescience #cmc #ilap

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Hard working and there when you need them

    Europe based large biotech
    Regulatory Manager
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