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 > Inspection Report – how to write an effective response

Inspection Report – how to write an effective response

How to write an effective and well written response to an Inspection Report.

Many companies are aware of the importance of being “inspection ready” at all times and have inspection readiness programmes built into the Quality Management Systems.  A key element of an inspection readiness programme is how to respond to observations and the ability to provide well defined, systemic and holistic resolution to the observation that will be well received and satisfy the regulator.

For FDA inspections, the US FDA will issue observations on a Form 483 during the close out meeting whereas for EU inspections it is more common for a verbal list of observations to be issued during the close out meeting and an inspection report will be issued approximately 15 to 30 days after the inspection.

Before you start to write your inspection response, it is important to understand the observation fully and confirm that you are on the same page as the inspector.  Ideally this clarity is obtained from the inspector during the inspection so that any further clarification, if required, can be sought in real-time.

Each observation, whether written or verbal, should be discussed with the auditor during the close out meeting. Reiterate your understanding of the observation to eliminate any element of speculation. Do not overcommit during the inspection, it is important to spend enough time constructing a robust CAPA plan that forms part of your response. Have a scribe present during the close out meeting so that advance activities can commence in establishing CAPAs while waiting on the official inspection report.  Confirm that the observation is not a repeat finding and if yes, understand why the initial CAPA did not prevent recurrence.

The language used within the inspection response should be compelling. Write clear, factual, well-supported descriptions of events, systems, procedures and other information relevant to the observation. Keep in mind that a systemic response to any audit observations must equate to a systemic resolution of the issue within your company.

If you challenge an observation it must be backed up with factual, objective evidence. Your response must be strong enough to explain exactly why you do not concur with the observation.

Ideally the inspection response is written in three parts:

1. Cover Letter:
The cover letter should include the site address and the dates of the inspection. Thank the inspector(s) for their professionalism, providing insight or other appropriate remarks as warranted.

2. Body:
Re-state the observation and reference number and include the following for each observation:

  • Background information regarding the observation.
  • An assessment of the root cause of the problem or commitment for further investigation if additional time is needed, with target dates for completion.
  • If corrective actions have already taken place prior to issuing the response, include the dates of implementation and provide objective evidence for each action that was documented as being completed (for example training records, calibration certificates, updated SOPs, etc.).
  • Set realistic timeframes to resolve issues. Secure the resources needed to complete the plan in the committed timeframe. Do not under estimate the time it will take to close out actions, however the response will not be well received if the timeline is inappropriately long. If the action item is going to take some time to implement, state what will be done in the interim to be compliant with GMP.
  • Define how enhancements will prevent recurrence of the issue observed.
  • Explain what will be done to expand, enhance or streamline the compliance system, where applicable.
  • Describe how your company will monitor the progress and effectiveness of the corrective actions.
  • Provide objective evidence that the process is adequate to assure the safety and efficacy of the product on the market or, if not, what voluntary action will be taken to address this.

3. Attachments: 

Attachments must be easy to find, navigate, read and understand. They should be appropriately labelled and the relevant updates should be clearly highlighted / identified to facilitate ease of review.

Prior to submission of your response you should proof read, edit and re-work your response to ensure that it is as complete and compelling as possible.

Once the response is submitted you should always be prepared to answer questions and justify your actions and timelines. It is recommended that you conduct a mock audit to test the effectiveness of your CAPA’s prior to the inspector’s review of CAPA effectiveness during the next scheduled inspection.

Refer to the following link for information on how to handle inspectional observations for 483’s and Warning Letters from the FDA:  http://www.thefdagroup.com/hubfs/Downloads/The_Emergency_Guide_to_FDA_Warning_Letters_and_FDA_483.pdf

If you need additional support to successfully respond to inspection reports, PharmaLex can provide fresh, independent unbiased assessments and can support you in the accomplishment of comprehensive remediation projects. If you would like further information please connect with us to discuss +353 1 846 4742 or contactirl@pharmalex.com

Related posts
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
Points de vigilance vis-à-vis de la communication institutionnelle en France
Points de vigilance vis-à-vis de la communication institutionnelle en France
23rd November 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
  • I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

    Lorraine Henry
    Compliance Lead, Qualified Person, Amneal Ireland Limited
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