Preparing for an inspection Part I: Building an Inspection Team

Preparing for an inspection Part I: Building an Inspection Team

Site inspections are regular activities to check and verify your organization’s regulatory compliance, safety standards, and more. The FDA, EHS, and the EPA may do inspections and audits virtually or in the field. The FDA tries to inspect each licensed firm every two years or less. To successfully navigate inspections, you should have a dedicated Inspection Team. The purpose of this team is to conduct mock inspections, manage the inspection process, and ensure the readiness of the site, staff, and documents.

To address the breadth of compliance inspections, several different areas of expertise and people from various departments should participate on the Inspection Team. First, make a well-defined role and set of responsibilities for each person. Training and testing each Inspection Team member on their responsibilities reduces the risk of errors and improves confidence. 

Teamwork for inspections and audits

Members of the Inspection Team include:

    • Inspection Leader
    • Inspection Room Leader
    • Subject Matter Experts
    • Scribes
    • Hosts
    • Document Request Coordinator
    • Document Runners
    • Administrative Personnel

How to Choose Your Team

Key characteristics include performing well under pressure, ease in answering questions, and answer concisely, confidently, and intelligently. The members need to be well-versed in the Standard Operating Procedures (SOPs). This entails knowing the content, purpose, and how and when to use the SOPs. A document manager for audits, such as ACE Inspection, could improve your efficiency and success in meeting Inspector requests. The Inspection Team should comprise of representatives from:

    • Quality Assurance
    • Regulatory Affairs
    • Manufacturing
    • Quality Control
    • Material Management
    • Scientists and Technical Manufacturing Experts

The Purpose of the Inspection Team

The Inspection Team will also develop the documents and review SOPs beforehand. To prepare for an inquiry, you also need to go through a mock inspection, which the Inspection Team can perform. This simulates the stress of the actual process, assesses gaps in knowledge, prepares responses, points out inefficient methods, and builds confidence. With good preparation, you can focus on making an excellent first impression. 

Consultants

Consultants are helpful for gap analysis, identifying risks, and even prepare a readiness plan for your Inspection Team. Furthermore, consultants can help you write responses and follow-up reports after an inspection. Great consultants can work within your budget and your needs through services tailored just for you. 

PSC Biotech and PSC Software offer solutions for inspection day preparation and management. For more information on our consulting expertise, contact info@biotech.com, and for ACE Inspection software, email info@pscsoftware.com. 

The Importance of First Impressions on Inspection Day

The Importance of First Impressions on Inspection Day

What are you and your team doing to win on inspection day? Preparation for inspections is an ongoing process. You likely have a lengthy checklist of items that must go perfectly on the day of an inspection. However, many inspection readiness teams overlook the importance of first impressions. According to FDA inspectors, a positive first impression can result in quicker and smoother inspections. So, how do you prepare your team to make a great first impression?

Whether your team makes a great first impression is determined long before the inspector arrives. For instance, are the greeters well trained and prepared for inspection day? Greeters should welcome the inspector, take the inspector to your inspection room, and alert the team of the inspector’s arrival. If the inspector visited your organization in the past, a representative acquainted with the inspector should lead the opening meeting.

Greeting

During the opening meeting, the team should keep to a time-appropriate script. Give an introduction, go over the scope and schedule, provide the inspector directions to the restroom, and discuss lunch plans. Being a gracious host should be number one on your inspection day checklist. One simple thing you can do to show respect is to ask if the inspector has any dietary restrictions and go through your scripted introduction. Considerate hosts appear more experienced and prepared, which can influence the outcome of an inspection. Suppose the inspector is unfamiliar with your operations. In that case, they may request a brief tour of the facility after settling into the inspection room.

Inspectors frequently arrive unannounced, and sections of the facility may be cluttered due to everyday work activity. At the beginning of the tour, the guide should lead inspectors through the cleanest areas of the building. Inspectors often associate a clean work environment with a cGMP compliant organization. Additionally, ensure that all employees are following your written and approved gowning procedures. As they are guided through the facility, inspectors watch for inconsistencies; so, personnel attire must be consistent and by the book. Practice giving the tour to your own staff “inspectors” to ensure your team is prepared for inspection day.

Furthermore, there are several common requests that the inspector will always make at the start of an inspection. These requests are often referred to as “pre-requests”. They can include the index for SOPs, maps of the facility, product flows for the facility, SOPs on training, etc. Quickly delivering the documents that are commonly requested at the onset of an inspection will give the inspector the impression that your facility and quality management system operate in a “State of Control.”

Inspector in protective uniform with hairnet and mask taking parameters from industrial machine in a lab

Inspection readiness is crucial to the success of organizations in highly regulated industries. In many cases, a favorable first impression is merely a great start but not enough to win on inspection day. However, implementing an Inspection Management System such as AuditUtopia® or ACE Inspection® can streamline your inspection processes. PSC’s Inspection Management Systems allow your team to take scribe notes, manage requests, collaborate on requests, and report on inspection data, all within a unified and secure platform. To help prepare documents and your team for inspection day, consider our consulting services at PSC Biotech.

For a free demonstration or more information on industry-leading Inspection Management Systems, visit pscsoftware.com or contact PSC Software™ at sales@pscsoftware.com.

Effective Risk Management For Medical Devices

Effective Risk Management For Medical Devices

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.

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 

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!

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