How Outsourcing Professional Services Can Boost Your Company

How Outsourcing Professional Services Can Boost Your Company

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

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!

Managing the Specification, Design, and Verification of Pharmaceutical Systems

Managing the Specification, Design, and Verification of Pharmaceutical Systems

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

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 totalinstalledcost 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. 

Innovation as Enabler for Success and Quality Improvement

Innovation as Enabler for Success and Quality Improvement

Written By: Jorge Sugranes, Technical Operations Director LATAM, PSC Biotech®
We are in a global era in which creative thinking, technological innovation, and doing things differently are necessary to compete in the international market. High quality, rapid production, and efficiency are important, but no longer the secret weapons that bring competitive advantage to our manufacturing sector. Our competitors are doing exactly the same. Innovation, reengineering, and continuous improvement are at the forefront of bringing a sustainable competitive differentiation to our business.

Group of people looking at a screen
History has demonstrated significant evolution and transformation in the manufacturing sector, especially in the medical devices and pharmaceutical industry. These highly technological companies are under continuous threat and pressure from a competitive global market, strong regulations, and incremental financial performance expectations. Business differentiation and sustainability are the biggest challenges.

Before embracing any innovation, reengineering, or continuous improvement initiative, we must clearly understand these concepts, their implications, and their differences. Operational innovation should not be confused with operational improvement or operational excellence. Those terms refer to achieving high performance via existing modes of operation without fundamentally changing how that work is accomplished. Operational innovation means coming up with entirely new ways of doing any activity that an enterprise performs.

We can agree that process improvement is great, excellence in operations is better, but innovation is best. I strongly believe that innovation with quality in mind is the way to go to bring business differentiation and strength competitive position. I encourage you to exercise creative thinking, continue looking for innovative ideas and quality improvements.
A Penny Saved is a Penny Earned. The Importance of Staying on Track and on Project Costs on Large Complex Projects

A Penny Saved is a Penny Earned. The Importance of Staying on Track and on Project Costs on Large Complex Projects

Written by: Chandler Conley, Business Development Manager

Pharmaceutical industry projects are some of the largest and most complex many of us have ever seen. We all have a goal to supply safe and cost-effective therapies and products, which is why it is critical to stick to pre-determined budgets and schedules at all costs- pun intended!

The question is, how is a project cost determined? One way is to consider similar projects as a baseline and point of reference. Did that project stay on budget? Is the cost realistic? How are the deliverables, scope, and processes in this prior project different from the project you are planning for? The process of staying on budget starts in the initial budgeting, proposal, and planning process. Invest the time to be clear about the scope of work for all parties involved and always try to be as realistic as possible to set the team and yourself up for success. Think about what steps are contingent on other steps… will the manufacturer of a piece of equipment have the equipment and accessories delivered in time to meet your deadlines? Are you giving your quality department enough time to review any documents they should? Will any materials or documents that you need to provide the project team be ready by the project start date? Also recall how long safety and onboarding will take for any new employees hired for this project, as this is frequently overlooked in project schedules.

If you are outsourcing support to any service providers and requesting proposals, your point of contact is thinking about these things and also trying to develop a realistic proposal and schedule for you. I promise- they want to go over budget even less than you do!

A fundamental part of project costs are hourly rates. This is a double-edged sword. Having a senior/experienced person may be able to complete a task in less time, which is helpful for project schedules and will result in less labor hours charged. That being said, mixing in multiple experience levels can ensure that people with the appropriate experience level are doing the required tasks. There may be some entry level tasks associated with the project, such as document control support and administrative tasks, so these can be good areas to save some money and utilize staff that are more junior.

 

 

We find it is important to allow time for project management in a capital project, so budget should also be reserved for this. Once a project is rolling, a strong Project Manager will manage deliverables and schedules for you and can give regular updates on the project burn rate. They can also be your primary point of contact for the project. Hypothetically, if a team of 10 people are involved, you either have to communicate updates for changes to all 10 people, or you can communicate to the Project Manager who can then ensure the rest of the team gets the communication without taking up any more of your time, which is the option we recommend. 

project costs
Significance of Project Management in the Life Science Industry

Significance of Project Management in the Life Science Industry

Project Management lets you implement your project to meet your specifications, on time, and on budget. Project Management lets you optimize the triple constraints of time, cost, and quality to achieve the successful completion of any pharmaceutical or life science project. PSC Biotech is the right partner for project management!

Globalization has significantly changed how you do business.  You must consider global utility for every project.  You need Project Management with local attention to the details that make your project globally useful.

PSC’s 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 main focus is on delivering our project, on time, on budget, and to specifications.

Let’s consider key Project Management practices in the Life Science Industry.

Project Management Approach for the Pharmaceutical and Life Science Projects

Apply a project management approach that involves skills application, knowledge, tools, and techniques. This helps to achieve the project’s objectives efficiently. Each project has four essential processes:

  • Initiation
  • Planning
  • Execution
  • Control

It is vital to

identify the requirements early during the project,

set achievable targets keeping the cost, quality, scope, and time in mind,

Identify risk and mitigation strategies, and

Involve and gain approval from key stakeholders.

Use of Information Technology

IT is essential to modern Project Management.  Good IT systems enable

  • Efficient and Effective project execution and management
  • Quick decision making on the basis of recent trend/data
  • Market expansion/Increased market access
  • Improving customer service
  • Risk management

Overcoming Key Challenges in Project Management

The pharmaceutical and life sciences industry is heavily regulated across the globe, which makes it challenging to manage Pharmaceuticals and life sciences projects. Professional project management helps to ensure success and to overcome any of the following challenges:

  • Scope identification and management
  • Global project execution and management
  • Cost, timelines, and budget planning
  • Key stakeholder management including the regulatory agencies
  • Quality management
  • Risk management.

Ending Note

Your local project that is now or soon will be a global project is the new reality in the Pharmaceutical and Life Science industry.  Project success means you need to manage locally and think globally.  PSC Biotech is ready to provide you the Project Management Services to help make your project a success.  Contact PSC Biotech at www.biotech.com.

 

Stay In the Loop - Join Our Newsletter