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.

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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.

How PSC® Promotes Cross-Training, a Necessity for the Industry and the Future

How PSC® Promotes Cross-Training, a Necessity for the Industry and the Future

Written By: Christy Nguyen, CQV Engineer I -Technical Writer, PSC Biotech®

What makes a successful engineer? Moreover, what makes a successful employee? At PSC Biotech®, we train our employees to be well-versed in multiple skill sets, allowing for maximum efficiency output amongst our teams.

Times are changing in the modern world, and the life science industry is no exception. The evolving industry has caused a shift in the demand for engineers. Though engineers are still required to have a strong science and math background, there are other fundamental skills they must learn in order to achieve success. Writing, business, and communication skills for example, are still greatly needed in a well-rounded, successful engineer. Likewise, it is useful for engineers to be able to work and communicate effectively with non-technical personnel, which further enhances the engineer’s ability to work on a wider range of projects. You can call these skills cross-training skills, but the fact is that they have become a necessity for engineers to succeed in the growing industry.

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At PSC®, we do cross-training and we ensure that our employees are well attuned to both current and emergent technical and non-technical skillsets.
According to Edgepoint Learning, 6 major benefits to cross-training employees include:

• Great return on investment
• Better collaboration
• Increases employee motivation
• Increases workforce sustainability
• Improves efficiency
• Makes your company more agile

Think about a time where you were on a successful team, or a team where you were most productive. Chances are, that team had like-minded individuals who collaborated well and saw a common vision. The team was well-rounded, and they understood the process, even though they might not have had direct contact with it. In my own experience as a validation engineer specializing in technical writing, I was given the support needed from a validation engineering perspective, as well as those from a technical writing perspective. With a broadened perspective in mind, PSC Biotech® had managed to arm me with the correct skillset in order to deliver successful project for our clients.

Source: https://www.edgepointlearning.com/blog/cross-training employees/#:~:text=6%20benefits%20of%20cross-training%20employees.%201%201.%20Great,workforce%20sustainability.%205%205.%20Improves%20efficiency.%20More%20items

Regulatory Series | Part 2 | Manage your Risks with ICH Q9

Regulatory Series | Part 2 | Manage your Risks with ICH Q9

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®

An effective risk management system is part of your quality management system.

Your risk management system will identify the probability that quality issues can arise during your product life cycle. Every risk you identify is a risk you can eliminate or mitigate. Your risk management system is a proactive tool to allows you to identify the risks in real time, analyze and assess potential root causes and devise corrective and preventive actions to eliminate or mitigate the risk.

There are four phases in an ICH Q9 risk management process.

Step 1: Risk Assessment:

  • Identify the risk, the hazards related to the risk, and recognize possible after effects.
  • Analyze the qualitative and quantitative assessment of the probability of the risk occurrence and the harmful effects of the risks.
  • Evaluate the risk.

Step 2: Risk Control: You can either eliminate or reduce the risk to a minimum level or accept the risk if it is within your acceptable limits.

Step 3: Risk Communication: You need to document and communicate the risks to your Company.

Step 4: Risk Review: You need to continually monitor and review risks throughout the product lifecycle.

Figure 1: Typical Quality Risk Management Process

*Source: ICH Q9 Guideline: Quality Risk Management; https://www.ich.org/page/quality-guidelines

There are many risk management tools you can use to assess and quantify the risks.

  • Basic risk management methods like flow charts, check sheets.
  • Failure Mode Effects Analysis (FMEA).
  • Failure Mode, Effects, and Criticality Analysis (FMECA).
  • Fault Tree Analysis (FTA).
  • Hazard Analysis and Critical Control Points (HACCP).
  • Hazard Operability Analysis (HAZOP).
  • Preliminary Hazard Analysis (PHA).

You need to integrate your chosen risk management process into your quality system. Train your personnel on your risk management process.

You can access the ICH Q9 Guideline at: https://www.ich.org/page/quality-guidelines.

PSC Biotech® offers professional services, including risk assessment, risk management, gap assessment, and a variety of audit services to help your company verify your compliance status with respect to FDA, EMA, MHRA, TGA, 厚生労働省, 国家药品监督管理局, and other regulations.

Contact us if you need support with any of these services to help you accelerate your success!

Reference:

ICH Q9 Guideline: Quality Risk Management; https://www.ich.org/page/quality-guidelines

Regulatory Series | Fundamental Guideline for GMP Standards: ICH Q7 Guideline

Regulatory Series | Fundamental Guideline for GMP Standards: ICH Q7 Guideline

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®

Quality lies at the heart of every pharmaceutical process. You build quality into your product! Current Good Manufacturing Practices (cGMPs) are the minimum legal requirements to assure the quality of your pharmaceutical product.  While companies can test the final product to check for quality specifications, testing is just a check and does not substitute for quality is built into every step of the process.

You can’t test a Volkswagen into a Cadillac!  If you want to build a Cadillac you plan, design, and build a Cadillac.  You manufacture your quality pharmaceutical product by building quality into every stage of the product life cycle, from the R&D stage through the manufacturing, storage and distribution until the product reaches the end user.  When you build quality in, you get quality products out of your process.

The ICH Q7 guideline

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was founded by three Regulatory Agencies with the objective of harmonizing standards and regulations across countries and ensure consistency of the drug product and reduce duplication of efforts. Today, ICH guidelines are one of the most widely followed guidelines and accepted in many countries.

The ICH Q7 guideline focuses on how cGMP practices can be implemented for the manufacturing of Active Pharmaceutical Ingredient (API) or the active drug substance. While ICH Q7 formally applies to manufacturing of APIs, ICH Q7 can also be a good starting point for companies manufacturing any kind of product to bring cGMPs into their processes.

Key elements of ICH Q7 include:

1. Quality Management System: Companies need to establish quality units responsible for ensuring quality, developing and monitoring production activities as well as performing periodic internal audits and quality reviews.

2. Personnel: Your personnel need appropriate training, education, and experience to do their assigned jobs. You need to document personnel training.

 

ICH Q7

3. Buildings and Facilities: You need proper buildings, equipment, and utilities.  You need to validate and maintain your physical assets.

4. Process Equipment: You need to ensure that all your equipment is designed as per required specifications, that they are cleaned and maintained properly, as well as calibrated, validated, and periodically revalidated.

5. Documentation and Records: In the life-science industry “If it isn’t documented, it didn’t happen”. Good Documentation Practices (GDP) are how you prove it happened. You need to ensure all processes are documented clearly in simple language and indicate the latest practices, retain documents, and establish electronic database systems that can maintain an audit trail, track changes and deviations to aid in inspections.

6. Materials Management: You need procedures for receipt, identification of materials as well as their storage, handling, sampling, testing and rejection.

7. Production and Process Controls: You need in-process controls, acceptance criteria, contamination controls, etc.

8. Packaging and Labeling: You need procedures and controls for Packaging and Labeling materials and operations.

9. Storage and Distribution: You need procedures and controls for storage, shipping, and distribution. If you had to recall the product, does your system tell you quickly where it went?  Do you test your systems?

While this is not an exhaustive list of CGMP systems and processes you need, consult ICH Q7 Guideline at https://www.ich.org/page/quality-guidelines  as well as your local Regulatory Agency’s laws, regulations, and guidance documents.

PSC Biotech® offers professional services such as Quality Assurance and Support, Commissioning and Decommissioning services, Validation services, Regulatory Affairs support, Audit functions as well as Engineering support that can help your company implement the latest cGMPs for your processes to meet ICH and all the other regulations you have to comply with.

Contact us today if you need support with any of these services to help you accelerate your success!