Use of Multi-Disciplinary Validation Teams for GXP Projects White Paper

Use of Multi-Disciplinary Validation Teams for GXP Projects White Paper

Maximize efficiency and effectiveness in your validation projects by utilizing multi-disciplinary teams. The term “Validation,” as used in this white paper, will be taken to mean either or both activities of Qualifying systems and facilities as fit-for-purpose (IQ/OQ/PQ) and the Process Validation of manufacturing processes and procedures (PQ or PV).

Lean project management strategies incorporate subject matter experts (SMEs) in cross-functional teams. For example, commissioning equipment with computerized functions needs to be validated by the computer systems validation SME and the commissioning and qualification validation SME. This white paper discusses some considerations for using a multi-disciplinary team approach to sitewide or corporate Validation project planning, oversight, execution, and approval.

Table of Contents

    • Background

    • Overview of Multi-Disciplinary Validation Teams

    • Establishing Validation Teams

      • Complexity and Scope

      • Novelty

      • Criticality and Risk

    • Availability of Required Personnel

    • Organizational Experience Level

    • Time and Project Length

    • Engineering/Technical Support

    • Summary

Multi-disciplinary teams for GxP

The establishment and management of multi-disciplinary validation teams are crucial to managing changes in the modern Pharmaceutical and Biopharmaceutical industries. These teams are typically responsible for the review, planning, and approval of changes (additions of or modifications) to equipment, facilities, systems, and processes with the potential to impact product quality. Project Management can significantly impact project quality, cost, and time through the decisions and mechanisms they choose to implement. Third-party resources and service firms can help with current developments in industry practices and standards and have the potential to more than pay for themselves in terms of money and time saved.

PSC Biotech® Project Management

PSC Biotech® project management experts have a strong track record of delivering projects and offering the best solutions for all kinds of projects in the life science industry. We follow current Good Practice regulations, the Project Management Institute’s Best Practices, and ISPE’s Good Practice Guides. Our Project Life Cycle services include project initiation, planning, execution, monitoring and controlling, and closure. Throughout the Life Cycle of a project, our primary focus is on delivering our project, on time, on budget, and to specifications.

Download the Multi-Disciplinary Validation Teams for GXP Projects White Paper today!

Related Projects

Skyline at night

Validation (IQ, OQ, and PQ) of the HVAC system Reconnection

PSC Biotech provided exceptional professionalism in project planning and time management, qualification document designing, and the executive power of completing qualification tests and solving qualification deviations. 

PSC Biotech® delivered a detailed service quotation including personnel, transportation, and accommodation to our client, a global biopharmaceuticals development and manufacturing company located in Taiwan.

Volunteer, SoCal

Temperature Controlled Chamber Qualification

PSC consultants performed qualification protocol and summary generation, and qualification execution.

PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping. PSC consultants performed the calibration, ran engineering studies, wrote and executed qualification protocols, resolved deviations, and closed out reports. 

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Nonstop Growth in 52 Countries Produces Multiple Careers within PSC Biotech®

Nonstop Growth in 52 Countries Produces Multiple Careers within PSC Biotech®

PSC Biotech® has offices across North America, Europe, and Asia. PSC operates in 52 countries globally and has served thousands of clients to date. Since PSC Biotech® is a recognized name with over 25 years of experience, we have many jobs ready and upcoming on new projects. PSC® provides consulting services, software solutions, equipment rentals, and sales and manufacturing. We focus on providing quality consulting services to ensure our client’s success. PSC delivers cost-effective solutions while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We offer a range of job opportunities; here are a few areas that we frequently seek to fulfill.

Engineering

We continually have positions available for engineers. What type of engineers? All sorts! We employ Commissioning and Qualification Engineers, Manufacturing Systems Engineers, Computer Systems Engineers, Validation Engineers, Quality Engineers, and more. If you have a degree in industrial engineering, mechanical engineering, chemical engineering, or electrical engineering, we may have a job for you! If we don’t have an opportunity right now, stay tuned! As PSC Biotech® is continually expanding, we are hiring engineers. We have opportunities across the career span – ranging from interns to regional managers.

Engineers

Project Management

PSC Biotech® assigns a Project Manager to each project. The Project Manager utilizes our exclusively developed Project Tracker (PT) software to maintain an accurate and up-to-date deliverable document status. PSC Biotech® provides project management training to its employees. Managers are needed across the board – in our metrology lab, purchasing, business development, and more.

Life Sciences

Quality assurance consultants come from various backgrounds, including the life sciences. For example, microbiologists are needed for environmental monitoring in pharmaceutical manufacturing. Biochemistry and molecular biology graduates are needed to do testing in laboratories and provide support for standard operating procedure development.

Supporting Staff

With talent acquisition specialists, we continue to hire new employees. For efficient and effective consulting, we need support staff such as maintenance specialists, writers, administrators, coordinators, and more.

 

Why join PSC Biotech®

Upward mobility, flexible hours, training opportunities, a benefits package, and good pay are hard to turn down. PSC Biotech® is a great company to start as a consultant with a supportive environment for young and experienced consultants. Offering a full suite of benefits, PSC Biotech® is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance to enjoy your work and have the time and resources to live happily and healthy! We offer medical, vision, dental, and supplemental insurance options. Additional benefits include pet insurance discounts, education assistance, gym discount rate, and 401K options. Plus, we give generous PTO!

Find out more today!

 

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Quality Risk Management for Commissioning and Qualification

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Engineering is the backbone of successful design, installation, and maintenance of manufacturing. Commissioning, Qualification, and Validation (CQV) in pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. CQV engineers are necessary to launch a new or significantly modified project, as well as discrete instances of equipment qualification through installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ). In a large, highly-regulated industry operation, CQV can be a daunting task. The FDA has shifted its focus to emphasize risk-based approaches to meet regulatory standards. PSC Biotech® CQV engineers with over 20 years of experience have put together this series of blogs to prioritize risk management in CQV operations.

flow mapping

CQV: Where to Start

In this article, we focus on an overall CQV instance involving the launch of a new or significantly modified product rather than focusing on a discrete instance of equipment qualification (IQ/OQ/PQ). We outline the chief regulatory guidelines in the pharmaceutical and medical device industries and the assessments you need at hand to develop the Validation Master Plan. 

Applying Quality Risk Management (QRM) to C&Q Planning

How do you apply risk management to the commissioning and qualification of quality systems at a manufacturing site? This blog offers the steps you need to take for each system involved with the change and how to tackle a multi-system project.

 

C&Q in Process Validation
CQV engineer

Risk Assessment Methods – One Size Does Not Fit All

Risk assessment is a crucial competency for modern pharmaceutical and biomedical manufacturing organizations. The objective of any risk assessment is to identify, analyze and evaluate potential risk. The ICH Q9 “Quality Risk Management” guideline defines the risk assessment principle as, “The evaluation of the risk to quality should be based on scientific knowledge and ultimately linked to the protection of the patient”. This PSC Biotech® post lists the standard formal risk assessment methods and their appropriate use. 

Critical Aspects of Pharmaceutical Facilities and Equipment – Identification and Verification

This blog article discusses the identification and verification of “Critical Aspects” (as referred to by ASTM E2500) of pharmaceutical and biopharmaceutical manufacturing systems and facilities. What are critical aspects? How are the critical aspects of manufacturing systems identified? This blog answers these questions and outlines the design, verification, and validation of critical aspects of pharmaceutical facilities and equipment.

FDA
C&Q in Process Validation

C&Q in Process Validation – Where Does It Fit In?

The FDA 2011 Guidance for Industry – Process Validation: General Principles and Practices established a three-stage “lifecycle” approach to achieving and maintaining a validated state. Specification, design, delivery, and installation are part of the lifecycle, as is verification, or Commissioning and Qualification (C&Q). What is the order of CQV that you need to follow? This blog discusses where C&Q fits into the validation lifecycle and what that means for quality risk management.

Applications for Quality Risk Management in Facility Operations

In the final installment of this series, we detail how to apply these principles and best practices on the floor and at the bench. This White Paper applies QRM principles to facility operations in the pharmaceutical industry. Update your Commissioning, Qualification and Validation principles to a science- and risk-based management. Download this whitepaper today!

Table of Contents

    • Introduction
    • QRM: Beyond Qualification and Validation
    • Applicability of QRM Concepts to a Site PQS
    • Evaluating the Quality Impact of Legacy Systems/Functions
    • Identification of Critical Aspects
    • Change Control According to Quality Impact
    • Calibration of Instruments
    • Preventative Maintenance
    • Periodic Review and Requalification of Legacy Systems
    • Summary
    • About the Author
    • CQV Outsourcing
FDA

PSC Biotech® provides engineering support and CQV services. 

PSC Biotech® is one of the largest providers for Commissioning, Qualification, and Validation services for the life science industry, with emphasis on Quality Risk Management. Our team consists of seasoned experts in the validation of facilities, utilities, equipment, computer systems, processes, cleaning, and test methods. We provide end to end solutions with expertise in Project Planning, CQV Master Planning, Requirement Specifications, Risk Assessments, Commissioning, Decommissioning, FATs, SATs, Installation Qualifications, Operational Qualifications, Performance Qualifications, Summary Reports, Traceability Matrixes, Calibration, Temperature/Humidity Mapping Services and more.

We look forward to hearing about your needs in Quality Risk Management and whether we can be of service. Please get started by emailing us at info@biotech.com or using our contact form online.

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CQV | Qualification of AQUATHERM SWS sterilizer

Our team of engineers efficiently completed the tasks of performing qualifications for the AQUATHERM SWS sterilizer (Syntegon). These tasks included writing and executing a Cycle Development Plan, an Installation and Operation Qualification (IOQ), and a Performance Qualification (PQ). PSC Biotech® continues to remain engaged with the client for continued support, as well as any future equipment qualifications to establish GMP regulations throughout the entire manufacturing facility.

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Engineering | Facilities, Utilities & Process Equipment

PSC® has been providing engineering and validation services at the San Dimas facility since 2014. When the La Verne facility startup projects began, PSC® has been providing validation support to keep the facility operational. PSC® covers all aspects of facilities, utilities and process equipment qualification and validation across the entire facility.

Past Projects

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The Importance of First Impressions on Inspection Day

Did you know that the first impression significantly impacts the audit inspector? The Inspector uses first impressions to gauge the confidence and “state of control” of your company. Find out how to make a good impression by reading this blog. Also, learn about what to do when the Inspector visits unannounced.

 

Greeting
Teamwork for inspections and audits

Building an Inspection Team

Inspections of a pharmaceutical or medical device manufacturing company may have more than one Inspector. There is usually a team of company employees managing the requests of each Inspector. Who should be on your inspection team?

This blog outlines who should be on the team and what the team should be doing before inspection day.

Inspection Day: Who to Call 

Although the Quality Assurance Department leads the inspection day, Subject Matter Experts (SMEs) will be asked questions by the FDA inspectors. How to choose which SME to use? Read this blog to find out.

Practice Audits

The internal inspection team should be running audits to practice for surprise inspector visits. Practicing audits provides your Quality Assurance Department with information on gaps in readiness. Plus, practicing audits improves your confidence and gives the inspector assurance that you are in a state of control. Read about internal audits and how to improve your company one department at a time in this blog.

Inspection Management Software

The Inspector will request a multitude of documents. How can you keep track of the requests? On inspection day, you need to monitor who is filling the request, whether Quality Assurance has approved the document, whether the Inspector has received the record, etc. Using a combination of chat, email, excel sheets, etc., is time-consuming. The longer you take to fulfill a request, the more chaotic and not in a state of control you seem. Using an all-in-one inspection management software such as AuditUtopia® or ACE® Inspection can speed up your request fulfillment. Learn more about inspection management software in this blog.

Inspection Management Software PSC
Inspection

Fulfilling Requests on The Inspection Day

This blog covers paper requests, electronic requests, and interview requests. This series of articles was written in collaboration with a former FDA inspector. Don’t miss our top tips! Find out the best practices for fulfilling requests.

Wrapping Up the Inspection

 How you handle the end of an inspection? An audit might last several days. You may have some bad news. Read our blog on how to meet challenges and address concerns.

 

PSC Biotech® and PSC Software® provide support for inspections and audits.

PSC Biotech® experts have extensive knowledge and experience with submitting Global Regulatory Documents. We provide all highly regulated industries with pre-market and post-market activities for global life science submissions. Our teams develop and implement regulatory strategy, provide guidance on regulations and standards, review and maintain project documentation and records, participate in risk-benefit analysis for regulatory compliance, generate and manage submission files, and review and author submission documents.

PSC Software® options for inspection management include AuditUtopia® and ACE® Inspection. Read our case studies on how AuditUtopia streamlined inspection management for global pharmaceutical companies.

C&Q in Process Validation

How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®

With the cost of a failed regulatory inspection approaching hundreds of thousands of dollars, the VVS division needed a dedicated solution to manage their regulatory and client inspections. Thermo Fisher’s VVS division soon found that one software, AuditUtopia®, stood above the rest.

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Auditing – Quality Systems and Records

The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. PSC Biotech® appointed a Project Manager and a Senior Supplier Quality Auditor who successfully developed and maintained a supplier audit schedule in consultation with the client quality team.

Past Projects

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Cybersecurity | Keeping your data safe with eQMS

Cybersecurity | Keeping your data safe with eQMS

Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US government is closing ranks with energy firms to guard against attacks. How does this affect pharmaceutical and medical device manufacturing?

cybersecurity and eqms

Medical devices face additional governance from the FDA.

Secure login and device access faces further scrutiny from the FDA. The top concerns for medical devices are:

    • Privileged access
    • Identification of cybersecurity vulnerabilities and incidents
    • Prevention and mitigation of cybersecurity vulnerabilities
    • Product lifecycle challenges and opportunities

Pharmaceutical and medical device manufacturing continues to operate according to general cybersecurity best practices.

  1. Update software – new updates may have additional security measures to protect against new threats and ransomware approaches.
  2. Avoid opening suspicious emails – protect against phishing scams and data breaches.
  3. Keep hardware up to date – Software updates may work better on new machines.
  4. Protect against unauthorized access – use a secure file sharing system, use secure logins, be sure to log out, etc.
  5. Train employees – practice cybersecurity to minimize susceptibility and vulnerability.
  6. Simplify – tracking updates to multiple software platforms and tracking training through various training methods can be complicated. Prevent gaps in training and tracking by simplifying and performing routine gap analyses.

How to protect your electronic quality management system

Your electronic quality management system (eQMS) is your pipeline. The PSC Software® family of eQMS and inspection management software includes the Adaptive Compliance Engine (ACE®) platform and AuditUtopia®.

  1. Update software – ACE® and AuditUtopia® have three updates per year. Every update is ready-to-use, GxP compliant, validated, and qualified.
  2. Secure access – ACE® and AuditUtopia® has configurable options to manage accounts via Single Sign On, Active Directory, OKTA, 2FA (two-factor authentication). Plus, ACE® and AuditUtopia® have tiered administrative access and role-based permissions restrictions.
  3. Secure storage – ACE® and AuditUtopia® are cloud-hosted via Amazon Web Services (AWS). By utilizing cloud-based software from a specialized hosting platform, you benefit from the teams of people working on cybersecurity for data storage and data access. AWS is compliant with many ISO standards for pharmaceutical and medical device industries, such as ISO 9001, ISO 27001, ISO 27017, and ISO 27018. Find out more about AWS cybersecurity here.
  4. Train employees – ACE® provides a structure for internal training documentation and tracking. Reduce the headache of tracing, tracking, and performing gap analysis for training on cybersecurity protocols with ACE®.

PSC Software® Solutions

PSC Software® is a trusted, industry-leading, cloud-native provider of quality management software specializing in pharmaceutical, medical device, and other regulated industries. PSC Software® is dedicated to cybersecurity and GxP compliance with the added goal to develop software that is intuitive to use, easy to learn, and flexible to fit each company’s needs.

 

Join us for a free webinar.

Contact us to find out more!

PSC Biotech® provides quality and compliance professionals for consultation on life science manufacturing. Check out PSC Biotech® for metrology, engineering, quality assurance, CQV services, and more!

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PSC Software Solutions

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Hire Consultants

PSC Biotech Services provide fast, budget-friendly, high-level expertise.

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Quality Risk Management for Commissioning and Qualification

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