The Enterey Blog

Top Priorities of a Successful Inspection by Mark Tucker

Posted by Tita Tavares on Fri, Mar 09, 2012 @ 08:56 AM

All companies talk about conducting successful inspections but how many have clearly defined what a successful inspection is?  In this blog, I will talk about what I feel are key attributes in order for a company to deem their inspections a success.  

Inspection 

First and foremost, a successful inspection must allow you to obtain or maintain your right to manufacture and distribute a product.  Whether this is your first pre-approval inspection or a general GMP inspection, there are significant consequences for failing to get approval or to be found “out of a state of control.”  The inability to sell and market products caused by a failed PAI GMP inspection, affects not only your bottom line but the patients that need your products. 

The second priority for a successful inspection is to avoid less severe but still damaging regulatory or market actions, which include product withdrawals, product recalls, warning letters and even seizures.  While not as severe as losing the right to operate, these actions still affect the company financially by potentially causing a loss of revenue, a loss of market share, and a loss of stock value while also damaging your company’s reputation and opening the possibility for litigation.  

The above two priorities are critical to the success of the company.  However, there are other, less critical but still important, goals for managing inspections.

Minimize the number and scope of the findings:  I believe that many companies err in making this a critical outcome for an inspection to be considered successful.  While this goal is certainly important, it is more important in my mind to look at the bigger picture.  While you definitely want to minimize the number, scope and significance of findings, in some instances, it might be better to accept a finding rather than to continuing to “discuss” the issue during the inspection.  Inspectors are human, too, and if they feel you are arguing without merit (and if the goal is zero observations, this can occur), the tone of the inspection can be negatively impacted harming your ability to influence the outcome of a more significant issue later in the inspection. 

Maintain the confidence of the health authorities: You can damage your image with health authorities by the way you handle an inspection. Regardless of the outcome of the inspection, you need the health authorities to perceive you as being open and cooperative rather than closed and secretive. You need the health authorities to feel your company is committed to quality and doing “the right thing.”

Have few or no surprises during an inspection: If you have implemented a robust inspection management system that includes regular updates to Senior Management,   no one should be surprised by the inspection findings and outcome.  However, if there are surprises, it is important to review and assess your inspection management system to understand where there are still gaps and improve the system to try and ensure there is no recurrence.

Maintain good inspection logistics: By implementing a robust inspection management system, there should be good communication between the inspection room and preparation rooms.  Documents should flow smoothly and as requested after being appropriately vetted; presenters should be well-trained and informed of the current issue under discussion before interacting with the inspectors; and the right people should be available at the right time with the right information.  If you do this really well, you can minimize the effect of the inspection on your site’s operations. 

By defining what a successful inspection is for your company, you can ensure everyone is working together to meet those goals, which in turn, will increase the probability of having a successful inspection outcome.  At Enterey, in partnership with Mark Tucker, LLC, we can help you in all aspects of inspection management to help ensure you meet your inspection outcome goals.

Comments?  Questions?  We want to hear from you.

 

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Published by Mark Tucker | Inspection Management & Auditing Expert, Enterey and Mark Tucker, LLC


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More on great Project Management


Tags: Enterey, FDA, Inspection Management, Inspection Readiness, Inspection Management Systems, Mark Tucker, Enterey News, Drug Manufacturers, Life Sciences Industry News Life Sciences News & H, Communication, Pharma, PAI, Pre-approval Inspections

4 Rules to Facility Start-up. Looking Deeper Into Rule #3

Posted by Tita Tavares on Wed, Aug 10, 2011 @ 12:25 PM

Rule #3: A deeper look into facility start-up.

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Remember Humpty Dumpty”

Now I’m sure you’re wondering what this rule has to do with facility start-ups, but before we go down that path let’s start with a simple exercise: draw Humpty Dumpty.  Go ahead, get out a sheet of paper and draw Humpty Dumpty.  It doesn’t need to be a masterpiece, just draw what you think of when you hear Humpty Dumpty…I’ll wait.   How many of you drew something that resembles an egg?  Before we go further, go ahead and read the typical version of the nursery rhyme “Humpty Dumpty”

 

Humpty Dumpty sat on a wall,
Humpty Dumpty had a great fall.
All the king's horses and all the king's men
Couldn't put Humpty together again

Facility Start-up


After reading the rhyme, I’ll ask a simple question, where does it say that Humpty Dumpty is an egg?  Obviously it doesn’t but we’ve been trained to think of Humpty Dumpty as an egg because someone drew him/her/it (I’ll use him for ease) that way many moons ago.  If you didn’t draw him as an egg; bravo!  I know I would have drawn him as an egg.  The point I’m trying to make is that it is important not to set artificial boundaries, particularly when trying to solve a problem.

 

 

During facility start-up the only thing you can count on is that things will change.  Issues will arise that are unexpected and that will require creative solutions.  When trying to come up with a solution just remember; Humpty Dumpty does not have to be an egg.  In other words, question everything and don’t set artificial boundaries for yourself.  Life sciences is already a regulated industry and you certainly don’t need to add more “artificial” regulations.

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Published by Carlo Odicino | Former Director, Client Services

 

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4th Rule of Facility Start-up

Tags: Enterey, Enterey News, Life Sciences Industry News, Facility Start-up, Life Sciences Industry News Life Sciences News & H

Where Do We Go From Here With Our Process Validation?

Posted by Tita Tavares on Fri, Apr 22, 2011 @ 01:00 PM

What are the next steps?

Having read our first 3 blogs to become familiar with the FDA’s recent Guidance for Industry Process Validation: General Principles and Practices (January 2011), you now need to start thinking about where you and your company go from here to align your organization and process validation activities with the new guidance.

Process Validation Success


Recommended
NEXT STEPS to help you: 


1. Build your knowledge base early. A successful validation program relies on information and knowledge obtained early from product and process development. This knowledge and understanding is the basis for establishing your approach to controlling the manufacturing process through continued process verification to produce products with desired quality attributes.

2. Understand the sources of your variation and the impact this variation has on your process and product. Detect the presence and degree of variation in your process. Control your variation proportionate to the risk it poses to your process and product.

3. Develop and implement a Risk Management program. Establish procedures, train personnel, and document and manage your risks in a risk management plan to reduce, eliminate, or accept process risks.

4. Use a Lifecycle Approach. Process validation activities occur over the lifecycle of the product and process from Process Design (Stage 1) to Process Qualification (Stage 2) to Continued Process Verification (Stage 3).  Science and process understanding will increase through the lifecycle.

5. Perform process monitoring to continually analyze your product and process data to ensure a state of control. This will eliminate the need for revalidation. Opportunities for process improvements can be identified, evaluated and implemented.

6. Use an integrated team approach to Process Validation. Include subject matter experts from various disciplines including process engineering, industrial pharmacy, analytical chemistry, microbiology, statistics, manufacturing, and quality assurance. Project plans with full support of senior leadership are important to success.

7. Plan and conduct all studies using sound science, appropriately documented, and approved per established procedures throughout the product and process lifecycle.

8. Develop an ongoing program to collect and analyze product and process data as required per 211.180(e). The data should include process trends and quality of incoming materials, in-process materials, and finished products, and be statistically trended and reviewed by trained personnel. A statistician or person trained in statistical process control is recommended.

9. Identify gaps in your existing process validation procedures and implement a plan to revise them appropriately to meet the expectations in the new guidance.

10. Prepare to address questions and show documented evidence to demonstrate that your manufacturing processes have been validated and are in a state of control though continued process monitoring.

Published by: Jim Anthony, Enterey| Director

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Trends Update! Social Media in Life Sciences

Tags: Enterey, FDA New Guidance for Industry, Process Validation, Quality Assurance, Risk Management, Variation, Lifecycle Approach, Process Monitoring, State of Control, Process Improvements, Manufacturing Process, Industrial Pharmacy, Program Development, Identify Gaps, Life Sciences Industry News Life Sciences News & H