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. 

Water Testing in Pharmaceuticals: Starting Clean Means Finishing Clean

Water Testing in Pharmaceuticals: Starting Clean Means Finishing Clean

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

People need their water to be clean, pure, and free from any threating microbes. This is even more imperative when it comes to pharmaceutical manufacturing, especially with injectable products.  Pharmaceutical grade waters must meet the requirements in their pharmacopoeia monograph, so how do you prove that for your Purified Water, Water for Injection, and other waters?  You have a program to regularly monitor, sample, and test the waters from your water systems.

Sampling collects samples that are uncontaminated by the sampling process from all the designated water system test points within a specific time frame. Sampling begins with getting the right containers for each test you want to perform.   

  • Pyrogen-free polystyrene tubes for Endotoxin
  • Sterile bottles for Bioburden
  • Clean tubes for Total Organic Carbon (TOC) and Conductivity
  • Sterile bottles containers including sodium thiosulfate tablets for coliforms
water testing

Generate your paperwork before collecting the water samples. Identify which outlets need to be sampled.  Prepare your sampling containers.

Label the sample containers.  Labels should contain the sample port identification, the analyst initials, the date of sampling, the time of sampling, and the type of testing that needs to be performed on the sample.

When you enter the area where the sample port is located, don the appropriate personal protective equipment (PPE) to collect the sample e.g., sterile gloves, long sleeve lab coat, safety glasses, heat resistant gloves, if needed.  Remember, Hot Water for Injection is HOT!  If you are wearing heat resistant gloves, wear a pair of sterile gloves over the heat resistant gloves to help maintain the integrity of your clean sample containers.

 

Collect your water samples according to your written, approved procedure.  Your sampling procedure shouldconsider how the water is used from that specific sample point.  For example, if the water will be used directly from the point of use without a hose, sampling must occur directly from the outlet using aseptic technique. Typically, the sample port is turned on and allowed to flush for at least one minute at full flow. Once the sample port is flushed, the samples are collected in the appropriately labeled containers. The lids should be held in a face down manner to help prevent microbial contamination and replaced on the filled sample container as soon as possible in an aseptic manner. 

Ensure the containers are labeled with the port number, time and date of collection, analyst initials, and analysis type.

Once sampling is done, the samples need to be submitted to your Quality Control laboratory and timely tested or properly stored according to USP <1231> and your written, approved procedures.  

Once you get the data, you use it to monitor your water systems.  Track and trend your data.  Analyze your data.  Verify your test results are below your Alert and Action levels.  Look for trends that predict problems with your pharmaceutical water systems. 

Alert your water users so that they are aware of the water system status, good or bad, every day.  You want your water users to know they can use your pharmaceutical grade water because you notify them that your waters meet their specifications and not guess that it is OK. 

If you have water questions, PSC® has answers and help.

PSC Biotech® has the resources and professionals available to ensure that your facility is up to cGMP standards when water testing.  It is our professional services mission and pleasure to assist your team with your water needs.  PSC® is your source for comprehensive services to keep your facility, systems, and processes in a “state of control”.  From training to validation, audit preparedness to equipment rentals and sales, PSC Biotech® has the people with the skills and tools to meet your needs.

Contact us today!

PSC’s Channel Partnership Program | Expand Your Company’s Growth

PSC’s Channel Partnership Program | Expand Your Company’s Growth

Written By: Erin Li, Channel Partnership Intern, PSC Biotech®

The PSC Channel Partnerships Program allows industry leaders to partner and accelerate the life science industry by leveraging each other’s areas of expertise.  

The PSC Channel Partners Program operates on three different partnership models.  

  • Revenue Partner:As part of a Revenue Partner, our partnership will focus on revenue generation.
  • Referral Partner: As part of a Referral Partner, our partnership will include referrals and introductions. 
  • Marketing and Education Partner: As a Marketing and Education Partner, our partnership will focus on marketing and branding efforts. 
            Channel Partnership

            We designed the PSC Channel Partnerships Program to enable partners to grow in revenue, opportunity, and brand recognition. PSC is currently seeking partners from the following industries: 

            • Value Added Resellers (VAR) for Software 
            • Construction Firms 
            • Trade Organizations 
            • Incubators 
            • Universities
            • Calibration Companies
            • Venture Capital Firms
            • Equipment Manufacturers 
            • Life Science Marketing Companies 

               

              If you want to expand your company’s growth through a partnership with PSC, contact pscbio@biotech.com. 

              Quality Assurance (QA) and Quality Control (QC) and Industry 4.0

              Quality Assurance (QA) and Quality Control (QC) and Industry 4.0

              Written By: Shauna Clizbe, Technical Operations, PSC Biotech®

              The biomanufacturing industry is currently undergoing a revolution in how it develops products. The major driving force behind this paradigm shift is known as Industry 4.0. This approach focuses on how to apply predictive modeling, data, analytics, artificial intelligence, and automation technology for the Digital Transformation of biomanufacturing manufacturing.   

              Companies are investing in improved analytics, process control, and more of the elements of Industry 4.0.  Examples include using data and analytics from raw materials and bioproduction operations to improve the process with the goals of improving efficiency, lowering costs, and getting products to market faster. 

              Quality Assurance (QA) and Quality Control (QC) are of utmost importance in the production of API’s, pharmaceuticals, and biopharmaceutical products, not just to meet Good Manufacturing Practices (cGMP) standards and regulatory requirements, but as a major tool in the Digital Transformation.  Processes and controls must be effective and enforced throughout your facility and process, from clean room operations to calibration of instruments and preventative maintenance in utilities systems. 

               

              Industry 4.0

              While investing in better automation and analytics, biopharma manufacturers can take advantage of modular, pre-validated, and pre-tested single-use equipment, bioreactors, and chromatography systems that include built in electronic batch record (EBR) and manufacturing execution system (MES) functionality.  Integration of these complex systems with a QC and QA team can be a complex and sometimes difficult task.  Quality Control and Quality Assurance play inter-related and essential roles.  Creating successful QC and QA programs within the organizations can be streamlined by following some best practices;

               

              • Train your staff 
              • Documentation is key, especially in the age of Industry 4.0; 
              • Perform at least an annual review of SOPs, policies, and programs; 
              • QA and QC must enable your efforts, not disable them; 
              • Bindependent of the rest of the organization; 

              Creating QC and QA programs in any regulated industry is essential for success; contact PSC Biotech to learn about our Quality Services and Programs today 

              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.
              How PSC® Brings Value to Incubators

              How PSC® Brings Value to Incubators

              Written By: Erin Li, Channel Partnership Intern, PSC Biotech®

              PSC Biotech® (“PSC®”) is a global life sciences software solutions and consulting company. There are now over 1,400 incubators in the United States, bringing great value to the life science industry startups with laboratory spaces, seed funding, mentorship, education, and investor opportunities. PSC® partners with life science incubators and startups to accelerate the realization of the startup’s products and to help bring life changing products into the life sciences industry. This is the PSC Incubator Program to get startups’ innovative products and services to market quickly, effectively, and efficiently using PSC’s® professional expertise and regulatory knowledge. With over 25 years of experience in the life sciences industry, PSC® can provide startups with top-tier expertise in each and very stage of a project, from generating thorough, comprehensive project plans to reaching extensive production operations.

              How did the PSC Incubator Program start? Biotechnology Innovation Organization’s (BIO), the largest trade organization that represents the biotechnology industry, chose PSC® as its preferred partner for professional consulting services and electronic quality management software (EQMS) products. PSC’s® is a proud partner in the BIO BBS Program which allows start-up companies to leverage PSC’s® expertise.

              Startups can get discounts through the PSC Incubator Program discounts on PSC Software® products that have provided systematic cloud-based and downloadable software solutions for life science companies around the globe for over 10 years. PSC’s Software® products include AuditUtopia®, ACE®, and ACE Essentials™.

              • ACE Essentials™: ACE Essentials™ allows startups to have a fully compliant quality management system from day one. ACE Essentials™ is a fully IOPQ validated system for any stage, preclinical, stage 1, and stage 2 company that comes equipped with 35+ Standard Operating Procedures (SOPs), 10 Preconfigured workflows, and 80+ document types.

              • ACE®: ACE® is the enterprise version of ACE Essentials™ that allows your company to configure everything to fit the way your company wants to work. ACE® can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities.

              Startups can get discounts through the PSC Incubator Program discounts on PSC’s® professional services, including Computer Systems Validation (CSV), Commissioning, Qualification, and Validation (CQV), Quality Assurance, Technical Writing, Regulatory Affairs, Metrology, Engineering, and Project Management.

              Startups can get discounts through the PSC Incubator Program discounts on educational webinars and seminars such as Regulatory Expectations from a Startup Company, Why Gap Assessments are Important to Accelerate Success, Data Integrity, Thermal Mapping is NOT a one-time occurrence, The Importance of Evaluating Old Validation Plan, and more.

              Startups can gain access to PSC’s® vast network of life science subject matter experts and investors.

              The PSC Incubator Program allows incubators and startups to partner and accelerate the life science industry by leveraging PSC’s® expertise, software, and professional services. When you become a part of the PSC Incubator Program, you gain access to PSC’s® Professional Services, PSC Software®, PSC’s Educational Webinars and Seminars, PSC’s® vast network of Subject Matter Experts and Investors, and much more. Call us today.