Effective Risk Management For Medical Devices

Effective Risk Management For Medical Devices

Jun 10, 2021 | Blog

Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk.  An effective risk management program is an essential element in the life cycle of a medical device.    

A Hazard is a potential source of harm.  A Risk is your estimated probability that a Hazard occurs for your medical device and the severity of that Hazard to patients, users, etc.  So, how do you do risk management?  You start with ISO 14971.

ISO 14971 is the International Standard that specifies terminology, principles and a process for risk management of medical devices, software as a medical device, and in-vitro diagnostic medical devices. 

The ISO 14971 process will help you identify the risks associated with your medical device, to estimate and evaluate the risks, the measures you use to control these risks, and to monitor the effectiveness of your controls.  Your risk management process applies to the full spectrum of risks including, but not limited to  biocompatibility, data and systems security, electricity, moving parts, radiation, maintenance, calibration, transport, and usability.  ISO 14971 does not specify acceptable risk levels.  You set objective criteria for risk acceptability and you set the acceptable risk levels.

medical device

Remember, an effective risk management program isn’t just a one-time exercise, it is an ongoing part of your product life cycle. Effective risk management helps you protect your patients, your products, and your reputation.

ISO has recently updated ISO 14791 with ISO/TR 24971:2020.  This technical report includes additional guidance on the principles and the process for managing risks associated with software as a medical device (SaMD) and in-vitro diagnostic (IVD) medical products.  You want to review and update your risk management process to apply the principles in ISO 14971 and technical report ISO/TR 24971 to make your risk management program optimally effective.

PSC Biotech® has experienced risk management professionals who can help you establish your program and provide risk management services tailored to your needs.  Call us today and let’s talk about effective risk management.

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How Outsourcing Professional Services Can Boost Your Company

How Outsourcing Professional Services Can Boost Your Company

Jun 3, 2021 | Blog

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Written by: Tom Kelland, Director of Southwest Operations at PSC Biotech™

Utilizing outsourced professional services can help boost your company in many different ways. This is especially true when working in a heavily regulated industry where expertise will save time and minimize costs. Outsourcing professional services provides benefits to companies of all sizes, including:

  • Gives your employees more time – Outsourcing specific professional services gives your employees more time to perform their routine activities. By not having to learn new functions that are outside the scope of their core role your employees can focus on their essential tasks.
  • Quality Assurance – Using experts provides assurance in the quality of work that is performed. This means no rework or editing work, when it is complete you can move onto other tasks.
  • Less Human Resources Requirements – Employee management can be costly and complicated! By outsourcing professional services there is no need to worry about employee management and the costs associated.
  • Availability of Expertise – Sometimes there are problems that your company will face that no one within your organization has the expertise to resolve. By outsourcing your professional services, you have expert resources at your fingertips.
  • Work Gets Done Quicker – Outsourcing leaves complicated tasks to experts who have experience executing similar work. This results in tasks getting done sooner than they would have if you kept the task for your own employees. This helps you meet tight timeframes.
  • Accelerate the Learning Curve of Your Employees – Your own employees don’t have to slowly learn the task at hand and absorb the mistakes that come with that learning. Expert professional service providers can train your employees while executing tasks to accelerate the learning curve of your employees without the risk of costly mistakes that slow your operation.
  • Have Better Control of Your Varying Workload – Your workload can vary greatly depending on initiatives and demands in the market. When you outsource professional services you don’t have to take on the risk of hiring full time employees for the times when workload is high. Outsourcing allows your business to adapt easily when a workload surge decreases so you can maintain a lower headcount.

It is clear that outsourcing professional services will help your company with time and cost savings, flexibility, subject matter expertise, and quality of work. Outsourcing lets your team focus on their core work, spend less time and avoids costly mistakes.

Contact PSC today to learn how our Outsourced Professional Services can help your business and the flexible solutions we can provide to meet your business needs.

 

Starting A New Laboratory

Starting A New Laboratory

May 27, 2021 | Blog

Written By: Matthew Greer, Technical Writer, PSC Biotech®

Introduction

Starting up a new laboratory can be a daunting task. What regulations need to be followed?  What kinds of products are you handling?  What kinds of tests will you do?

Once you know this, you need to consider the best layout for your laboratory.  You need to identify the test and laboratory safety environment.

Let’s discuss a few of the factors you want to consider in planning your new laboratory.  First, having the right team is essential, and if you need help, PSC Biotech® has the resources that you need.

Avoid the Common Mistakes

Before breaking ground, you need to consider how will you laboratory be utilized? What products will be tested in this lab? What are the methods associated with these products?

Are there any safety equipment or special requirements necessary for each one? Fire extinguishers, eye wash stations?  Fume hood, Biosafety Hoods, Glove boxes? Gowning, Degowning?  Chemical and Biohazard Waste storage?  Autoclave or Dry Heat Oven?  Flammable, Acid, Base, and Oxidizer storage?  Personnel low, Sample flow, Sample Storage?  Design your laboratory on paper first.

You must understand the tests the laboratory will be asked to perform, including chemistry and microbiology tests for raw materials and in-process, final product, stability, and validation samples. 

Next you need to select the appropriate test equipment to perform the tests.  How accurate, how precise, how sensitive, etc. does the equipment have to be?  Oh yes, and remember that everything needs to calibrated.

Which type of utilities will be needed? Electricity, Gas, Air, Nitrogen, Vacuum, Water?

Do you need Purified Water, Water for Injection, Distilled Water? Make sure the correct water systems are installed for your planned testing.

Do you need to control the laboratory temperature and relative humidity?  How about vibration or light?  Do you need an ISO classified environment, such as an ISO 5 room or hood for aseptic operations?

Don’t forget the Paperwork

What about your quality management system?  Policies, procedures, forms, records, etc., are essential.  If it isn’t documented, it didn’t happen. If you need a Quality management System that is plug and go, consider ACE Essentials™, our cloud-based fully cGMP compliant system that comes with all the necessary Standard Operating Procedures (SOPs), quality event management, training management, and even more features to have your new laboratory in compliance from its very start.

These are just a few of the things that you need to consider when starting up a new laboratory.  Overwhelming?  PSC is here to help.

About PSC Biotech®

PSC Biotech® is a life science and biotechnology consulting company founded in 1996.  We can provide you a complete turnkey solution or with the specialized, qualified consultants with expertise in the areas you need, such as laboratory operations, writing documents, validating equipment, analytical methods, validation, and gap assessments.    

Let’s get your new laboratory up and running!  Contact us today!

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What is Method Transfer, and Why is it Important?

What is Method Transfer, and Why is it Important?

May 20, 2021 | Blog

Written By: Mattew Greer, Technical Writer, PSC Biotech®

When bringing new products from one facility to another or from a product development to production environment , understanding the requirements for the transfer of validated analytical methods used for testing of said products is essential. It is important to compare the initial and transfer laboratories and confirm that the latter has the capability to perform the validated method correctly and consistently. The transfer needs to check that the methods adhere to the United States Pharmacopeia (USP) and any other applicable standards as well. The goal in a successful method transfer should be to reduce the number of variables in your lab which could affect the quality of the final product. These methods need to be taken from the primary lab and transcribed into approved documents for testing at the final lab. This paper will list some of the various types of method transfer possible and how PSC Biotech® can provide assistance.

Method Transfer Types

There are typically four different types of method transfers that are based on the availability of the initial testing lab as well as the complexity of the products being tested.

Comparative Testing

Comparative Testing means to test a predetermined number of samples of the same lot by both the sending and receiving facilities and comparing the results. The transfer protocol from the initial lab will determine the acceptance criteria and procedures.

 

Co-validation

If both the initial and transfer site needs to collaborate to complete the validation, the appropriate transfer method is to co-validate. This would mean keeping lines of communication between both sites in order to confirm the reproducibility. This strategy is optimal for dealing with multiple laboratories. Similar to the comparative testing, the protocols will come from the primary site.

Revalidation

This type of testing is necessary if the initial laboratory is not available to receive the proper methods. Revalidation is the most consuming of all the method transfers but needed when the initial lab is not accessible. Usually this work involves repeating all validation testing initially performed.

Transfer Waiver

Depending on the lab’s experience and the complexity of a method, opting for a transfer waiver is a viable option for some transfers. A risk assessment would need to be taken into consideration to confirm this approach is valid.

What Can PSC™ do for you?

Method transfer can easily become a hassle, and that is where PSC Biotech® can help. We employ a team of professional consultants who are available to transition documents with ease. Our services are offered in the form of a local team who can come onsite to collaborate to make sure your facility is ready for any type of method transfer. We can take the methods provided and generate documents that are compliant with the USP guidelines. Contact us today.

About PSC ™

PSC Biotech® offers partnership opportunities for leaders looking to advance themselves throughout the Life Sciences industry through a multitude of resources and solutions. PSC™  has served the Life Sciences industry for over twenty (20) years with exemplary professionalism, quality solutions, and client-focused services. Our goal is to provide unmatched software and hardware consulting services to Life Science companies so they can perform at their highest potential.   

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Procedures, Policies, Protocol, … Oh My

Procedures, Policies, Protocol, … Oh My

May 13, 2021 | Blog

Written By: Mattew Greer, Technical Writer, PSC Biotech®

Your cGMP documents must comply with the applicable laws and regulations.  They don’t have to be easy to understand but they should be.  Writing compliant and easy to understand and use documents, that are “good” documents, is hard and time consuming work.

Easy to understand and use documents reduce the possibility of errors and increase understanding.  You want the best facility, equipment, and personnel.  You should want the best documents as well.  Good documents will save you time and money and will help to minimize human errors.

You can write good documents.  It just takes time and resources.  Sometime, lots of time and resources that you could make better use of doing something else.  So why PSC®?  Simply put, PSC® can do it for you and let you concentrate on running your business.

PSC Biotech® employs a team of skillful technical writers with the ability to create any documentation needed to help your operations run effectively and efficiently. If you are looking for documentation for qualification of equipment and systems, our writers can draft “good” documents for your Quality Management System that meet your goals, actual practices, and industry standards. PSC® writes whatever you need, including:

  • Easy to use templates
  • Policies
  • Standard Operation Procedures (SOPs)
  • Qualifications protocols
  • Logbooks
  • Protocols
  • Reports
  • Risk Assessments
  • Gap Analysis Documentation
  • Forms

When PSC® writes your documents, whether it is one, a few, or an entire quality management system, you also have access to PSC’s® network of Subject Matter Experts (SMEs) who know global laws, regulations, and guidance documents.  PSC® writes every document to conform to the way you operate and to ensure regulatory compliance.

PSC® can write your documents on-site or remotely.  PSC® can assign a dedicated writer or assemble a team, depending on your wishes, the volume of documents and the time frame for delivery.  Our team will work with your team to get you the compliant documents you need.

About PSC Biotech®

PSC Biotech® is a leading Life Sciences and Biotechnology consulting firm.  PSC® strives to provide you with solutions to your needs that are cost-effective and meet your quality requirements.  PSC Biotech® can provide our electronic Quality Management System (eQMS) software, ACE®, to process, control, and manage not only your documents but also integrate the training into a single system.  ACE® is flexible, so the workflow is your workflow, not a rigid, inflexible workflow that doesn’t reflect how you operate your business.

If you need technical writing, PSC Biotech® is happy to help. PSC Biotech® can help with almost all of your needs.  If you don’t see what you need, call us!  It is our pleasure to address your business needs with the utmost care and concern. Contact us today.

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Managing the Specification, Design, and Verification of Pharmaceutical Systems

Managing the Specification, Design, and Verification of Pharmaceutical Systems

May 6, 2021 | Blog

Written By: David Dolgin, Independent Pharma Quality Consultant/Validation Consulting and Training, PSC Biotech®

Imagine the following scenario: 

You are the Plant Engineering Manager for a small to mid-size pharmaceutical company. You have a staff of three or four experienced Plant Engineers who handle the routine care-and-feeding of your site’s equipment and utility systems, and generally keep things running the way they are supposed to.  

Your CEO just bought a new building that will require several new equipment systems and modifications to existing utilities and HVAC.  All the systems planned are like what you have now, but you have concerns about the “bandwidth” of your group.  Can you cover all aspects of the specify/design/install/commission/qualify project steps and still maintain all your other systems and duties? Corporate has not and will not offer your department a wheelbarrow full of cash so, What do you do?  

You need to identify the leanest, most efficient way to deliver the on or under cost, on time, and in compliance with the “validate-anything-that moves-and-DO-NOT-move-anything-that-is validated” and current Good Manufacturing Practices.   

Fortunately for you there is a more science-and-engineering based approach, focused on risk and methods of risk assessment that are, as described in the ICH Q91 guidance,  an effort for which “…the level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk”.   

Risk Management

A short list of the relevant current guidance documents includes: 

  • U.S. FDA “Process Validation: General Principles and Practices” 
  • ICH Q9 “Quality Risk Management” 
  • ASTM E 2500 “Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment”
  • ISPE Baseline Guide 5 “Commissioning and Qualification (Second Edition)”

Companies have reported 10%-20% reductions in the total–installed–cost of new systems when risk-based approaches are expertly applied. To be clear: Quality Risk Management (QRM) is NOT and should not be intended as a cost-saving measure.  

If you already use a risk-based process, great!  If not, supplement your staff’s expertise and set-up your risk based process with help from experienced Subject Matter Experts (SMEs) who have done it before. 

Contact PSC® to see how our consultants’ risk management-based Commissioning and Qualification know-how can save time and cost on your next significant manufacturing facility or system project.  Whether you use your personnel for execution of C&Q or ours, PSC® services will help you realize your project objectives, stay on or below budget and meet your timeline. 

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