Change Management Framework

Change Management Framework

Change Management Framework is built on the foundation of facilitating change. Change is inevitable and required within organizations to stay abreast of the evolving regulatory guidelines. Company XYZ is required to change its formula due to crop shortages of a particular ingredient. Micro-parameters have been updated per regulatory guidelines. These all require changes that must be communicated and facilitated from the company to the manufacture.

Change Control is the method in how this is accomplished. There are permanent changes, temporary changes, and deviations. Permanent changes are everlasting and require a one-time change. Temporary changes may be identified as a blanket change that is set for a predetermined length of time. Deviations are changes but for a singular situation. For example, a deviation may occur when an ingredient in a formula temporarily deviated from the original recipe. The formula in question will revert to the original formula after the deviation has been completed. This one-time change is known as a deviation.

Change Management

The key points within a good Change Management Framework can be identified as follows:

  1. Communication – Communicate verbally and in writing the change needed. Communication provides the necessary action required to facilitate the change.
  2. Organize – Organization is a skill not to be taken lightly. Change Management Framework requires an organized approach to collecting information, gathering documents, outlining details, and preparing for the change.
  3. Documenting – Documenting internal records, filing paperwork, and sharing the required documentation with the parties involved.
  4. Approval – Change Management requirements involve approval at various levels depending on the complexity of the change. When the change involves sensitive information, it could take a long time to execute the change. Quality always has the final approval to sign off on all change controls in the food industry.
  5. Quality Management – Quality plays a crucial role in Change Management. Quality is the team that receives the change communications, documents the change, and helps organize and assist in executing the change through team collaboration with cross- functional teams.
  6. Closure – Closing the change control and signing off that the change has been completed.
Change controls help organizations execute customer needs, follow regulations, and pivot in an unpredictable industry. Change Control is our area of expertise! Do you need help developing a change framework, or do you have questions about the process? Let our experts know! PSC Biotech® has been doing this for over 25 years.

Authored by: Candice Harris

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Quality 101 for Cannabis Products

Quality is the driving factor that keeps our food system safe. In the United States, there is an unspoken trust put into our food system to keep it safe. How does this safety happen? There are systems and procedures that maintain the integrity of the products consumed on a regular basis. Are you interested in learning more about product quality? Learn more about product quality for small businesses inside the Quality for Small Businesses in the Food Industry white paper by filling out the form below.

We outlined some simple guidance steps that can be considered and are essential for quality when it involves cannabis products:

quality 101 for cannabis products

Quality 101 for Cannabis Products

  1. Licensing – Licensing is a must to be compliant with regulations. What type of licensing is required will be required? Types of licensing to consider are:
    • Standard cannabis licensing- adhering to all facility, city, and state regulations, etc. (high capital costs)
    • White labeling- Another manufacture produces your product. White labeling is illegal if you don’t own your Cannabis License!
    • Type-S, shared licensing- shared-use manufacturing licensing.
  2. Building Infrastructure and Building Perimeter – meeting building codes and having the proper disposal facilities, building security, and structural controls to secure the quality of the product is mandatory.
  3. Procedures – How are the documented procedures supporting the quality of the product? Are quality checks being performed hourly? Are procedures functioning to support the quality of the product? How are product samples being handled? In the industry, it is a “No-No” to give samples away. The delicate nature of the product leaves room for scrutiny at every level and can compromise the company if not handled correctly. How are batches identified/controlled?
  4. Raw Material Sourcing – finding a reputable supplier is key to maintain product quality. Is your supplier registered with METRC? How do they grow or process their CBD? Are they certified? These are some of the questions that should not only be asked but documented.
  5. Processing – Do the processing steps support the quality of the product? Has the HACCP plan been established and validated? What are the hazards during processing? How are those hazards controlled?
  6. Testing – mandatory testing is needed for every batch of product to ensure quality and safety. Testing validates THC content and ensures product safety through confirming with testing results.
  7. Packaging – Every label is required by law to have a batch number/ lot code for traceability, child-resistant packaging, cannabis standardized logo, ingredient statement, THC content level, health warning, allergens, nutrition facts panel (food products), manufacture location, etc. Packaging is constantly changing, and so are regulations! Therefore it is quality 101 to leave room for changes when it involves packaging. The package of today could be the trash of tomorrow!
  8. Storage -How does the storage support the quality of the product? Is the product being stored per regulations?
  9. Shipment – Controlled shipment is required. The transporter is required to undergo specialized training to be able to transport product to the consumer. This is a quality process to ensure the safety and quality of the product. In California, the distributor has to undergo registration and training in a system called METRC. This system is designed to track the seed to sale of cannabis. METRC is state-specific; check to see what tracking system is utilized within your region.
  10. Finances – In the Cannabis realm, there are special regulations on how money is handled on the financial level. There are limited methods in which payments can be taken and given when it involves CBD products. This is an important factor to consider for start-ups. In addition, registration is required to register and file with CDTFA.CA.GOV in California.  How do finances affect quality, you may ask? The quality of the product is directly managed from a financial background, and if your money isn’t handled properly, neither is your quality! For example, testing, how are you paying for that?

It may feel a little overwhelming, and that is why PSC Biotech® is here to alleviate those feelings of uncertainty. Contact us today! Our team of experts understands Quality 101 and what is needed to secure the safety and vitality of your product.

Authored by: Candice Harris

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Equipment Calibration – Keeping Your Equipment in Top Working Order

Equipment Calibration – Keeping Your Equipment in Top Working Order

When thinking about the heart of the company, the equipment that produces your product must come to mind. Without good working equipment, your products may become compromised and hurt the company’s reputation for producing good quality products. Let’s say that during a manufacturing process, the scale that was used had gone out of calibration. The product has now possibly been compromised because the scale may not be working within its specifications. Keeping your equipment calibrated is very important to ensure that the products coming from your company are top quality.

Any equipment used to produce, check or inspect your product should be working correctly and within specification. Depending on your companies’ policies, your equipment should be calibrated at least once a year to ensure it is working properly. Equipment gets used and moved around several times, which can cause the equipment to become out of specification and could start to cause problems with your production.

In this example, the balance had an expired calibration and was used to weigh the material for production. Since the balance was out of calibration, the question became whether the appropriate amount of each material was added. Was there too much? Or was there not enough added? Now not only has your product possibly compromised, but you also have a deviation on your hands. Let’s look at what you as a company can do to keep your equipment working accurately.

equipment calibration

First of all, your company needs to put a Standard Operating Procedure (SOP) for the equipment, stating when and how many times a piece of equipment gets calibrated. Label each piece of equipment with the calibration due date so that operators know when it becomes overdue and not to use it. A great tool to incorporate is to have an equipment log with all your equipment and their calibration due date, that way, you can plan when to send out a piece of equipment. It is an excellent idea to have a backup for your equipment, so production is not on hold because the equipment is out for calibration. Alternatively, add a section in your batch records and forms for the equipment calibration date, which should catch if the equipment is still within its calibration.

Properly working equipment means your product is being produced at a high quality, and that’s what you want. Adding checks is one way to keep your equipment running smoothly and to ensure that no equipment is out of calibration.

How PSC Biotech® can help you calibrate

PSC Biotech® provides metrology services to calibrate and test for your laboratory equipment. We meet the requirements for yearly proficiency testing. Contact us for more information on how our metrology services can help you.

We are seeking to understand more about the metrology needs of people who visit our website. Please consider filling out our survey so that we may increase our capacities in areas of interest: here.

 

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In 2001, ISPE published “Baseline Guide 5 – Commissioning and Qualification”, which proposed a systematic mechanism called “Impact Assessment” to determine if an equipment system was GMP-relevant and had the potential to directly impact product quality. This seminal risk-management document preceded ICH Q9 publication by four years and began the “science-and-risk-based approach” to Equipment Validation and Qualification. The science-and-risk-based approach is summed by this ICH Q9 core principle: “The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk”.  Because not all facilities or systems impact product quality and not all aspects of design and function are equally critical, risk identification and prioritization are required to implement ICH Q9 QRM principles in the planning of C&Q activities.

Here we outline the steps to applying QRM in C&Q planning:

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

Initiating the C&Q process:

    1. Identify a team of Subject Matter Experts (SMEs) familiar and knowledgeable about both the equipment or facilities and their intended uses/functions and the manufacturing process to be supported.
    2. Define and document the description of the change, the scope of work, and the reason and justification for change(s). Most pharmaceutical manufacturing organizations will already have an established process for such changes, including the designation of required approvers.

For each system involved with the planned change:

    1. Perform a preliminary screening for potential quality impact using high-level tools such as a Preliminary Hazards Analysis (PHA), ISPE System Impact Assessment, or a similar documented methodology. Changes or systems that have little or no quality impact potential should not require formal Qualification.
    2. For systems with “Direct Impact,” select an appropriate risk assessment tool (e.g., FMEA) to identify specific failure modes and the necessary risk mitigations or controls.
    3. The controls and mitigations based on engineering design aspects, for example, alarms and interlocks, are the “Critical Aspects” and must be demonstrated and documented (verified) as being present and operating as designed in the installed and operational system. The Critical Aspects should be documented and approved by the Quality unit and designated SMEs.

For complicated, multi-system projects:

    1. An overarching C&Q Plan is recommended to consolidate the quality information regarding a C&Q project and answer the following questions if they do not already exist in the firm’s SOPs.
    2. Which Quality System (QS) requirements are applicable based on project definition and scope?
    3. What aspects of the new or modified facility or system require Qualification, and what is the rationale for any exclusions?
    4. Will the use of properly documented (GDP-compliant) commissioning work meet Qualification requirements in lieu of repeat testing against a pre-approved protocol?
    5. How will nonconformances be handled?
    6. What are change control rules during project execution? If they differ between “Project Change Control” and “Operational Change Control,” at what point do routine Operational Change Control rules re-apply?

Summary

    1. QRM must be used to accomplish C&Q and Validation Master Plan (VMP) planning to fully realize the Science-and-Risk-Based Approach advocated by U.S. FDA and many international regulatory agencies.
    2. Simple “screening” tools such as the ISPE Quality Impact System Assessment checklist can separate and identify systems with potential product quality impact from non-GMP systems such as environmental control, waste management, or non-GMP packaging equipment.
    3. Once you identify “Direct Impact” systems, standard risk assessment methodologies, such as Process Hazard Analysis, Fault Tree, and FMEA, can identify specific design and engineering- based risk controls required for each system, called “Critical Aspects” by ASTM E 2500.
    4. Critical Aspects for each system inform the design, specification, and testing. Also, Critical Aspects define the parameters for approved as Qualified for clinical or commercial use, and therefore must be included in protocols and comprehensive planning documents.

Find Experts

PSC Biotech® applies QRM to C&Q on every level. The risk-based assessment component is a cornerstone for PSC Biotech®. Our biggest asset to your C&Q process is consulting on QRM. We are more than technicians at your service by additionally bringing specific consulting for problems and complicated systems. Contact us to let us know what you need.

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Wrapping Up the Inspection

This series on inspection success has stressed the importance of making a good first impression,  preparing your inspection management team, using inspection management software, who to have available during an inspection, and how to fulfill the inspector’s requests.  We conclude the series with a discussion about what to do at the end of each day of an inspection.

You want to do a wrap-up meeting at the end of each inspection day.  The inspector usually covers what they examined today, presents what they found, and briefly describes the most critical findings found today.  The inspector or investigator will usually NOT cover all findings.  You will need to check the complete audit report.

If this is a multi-day audit, the inspector may give you a list of documents, specific items, or areas that they want to see when they return the following day.

Inspection

When the audit is over, you will have a final wrap-up meeting.  If the inspection is an FDA inspection, the inspector will present a Form 483 listing their findings listed in order from most to least important.  If it is not an FDA audit, the inspector will usually do the same thing, minus the Form 483.  Listen to the inspector.  Ask questions to clarify anything you are unsure of.  Do not argue. Be polite.  Say thank you.  The inspector may give you their preliminary conclusion if you do or do not operate in a “State of Control”. Do not argue. The inspector will tell you how the final audit report will come to you, when you can expect to receive it, and how to respond to the audit report.

Thank the inspector. Walk the inspector out and bid them a pleasant evening. Always be polite to your inspector.

When it is all over and the inspector is gone, go through the 483 or the audit report.  Your audit response will respond to absolutely everything.  Quote each finding, write down your response, and attach evidence for everything.  Cover every single point. If the inspector wants evidence for green, blue, and yellow valves, provide one attachment for each color valve. They want evidence to prove that you did what you say you did.

PSC® can help you achieve success on every audit.  Consult with our experts. We have over 25 years of experience with audits, audit preparation, mock audits, and compliance gap analysis.  Consider using PSC’s AuditUtopia® and ACE Inspection™ audit management software to automate and simplify your audit process.  PSC® is your one-stop solution for audit and inspection success.

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A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

A Deviation has Occurred - CAPA

Something went wrong during the manufacturing process; there was a piece of equipment used that was overdue. The error has now become a deviation. What is a deviation? A deviation is an action of departing from an established course or accepted standard. Processes are carefully thought out to minimize any critical errors that could compromise the product. Therefore, there must be an investigation when a product step is missed or a deviation occurs. The investigation needs to assess what happened, why it happened, and how to prevent this error from happening again. Here we give you an overview of the proper process after a deviation has occurred. 

There could be several factors that can cause a deviation to occur. For example, there might be a new hire who is not familiar with the process, or the manufacturing crew may be rushed in completing a batch. Other potential factors include: distractions in the room, the wrong material was added, or the equipment being used may have an expired calibration. Suppose a member of the manufacturing team used a piece of equipment on which the calibration was overdue. During an in-process check by a member of QA, they spotted the calibration on the equipment had expired. This is when the deviation process begins.

There are several steps when talking about the deviation process. The purpose of the deviation is to identify, investigate and close. Also, remember that the amount of time to complete a deviation from beginning to close is very important and should be specified in your deviation Standard Operating Protocol (SOP). Here are the three principles for the deviation process:

    • Identify the error – Notify the appropriate management/personnel and fill out the required form that describes what exactly happened to cause the deviation.
    • Investigate what happened – Talk to the personnel involved, review any videos in the room, review any paperwork inside the room, and look at how this piece of equipment’s calibration was missed. This part of the process is basically to understand why this deviation occurred.
    • Closing of a deviation – Occurs is when the investigation is complete. We now know exactly what happened. Closing of the deviation consists of correcting the error. In this example case, get the equipment checked out to make sure that it is within specification. The other part is putting in place a check to ensure that this doesn’t continue to occur. Once these items are in place, the deviation can be closed.

The entire company needs to be on the lookout for anything that may cause a deviation. You must have checks and double-checks because we are all capable of missing something. What it all comes down to is deviations will happen, but how you handle them and learn from them is what matters to make your company the best it can be.

For more information in the field of Corrective and Preventative Actions (CAPAs), see our blog on CAPAs for Equipment.

PSC Biotech® has engineers and professionals to help you through the deviation process and establishing CAPA procedures. Contact us now to find out more!

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