Wrapping Up the Inspection

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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The Importance of Validation

Validation is the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process and or device can consistently deliver a quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. Creating a Validation Master Plan (VMP) is a guide for successful validation and qualification throughout a facility.

To ensure that a specific piece of equipment or process gives the output desired, the equipment used for the product must be validated. Equipment used for testing or manufacturing must be validated due to the risk it may propose to the product or end-user. Not validating equipment currently used for testing, V&V, manufacturing, and inspection purposes will likely result in a major audit finding, such as an FDA Form 483. The Validation Master Plan is the manufacturer’s roadmap for qualification throughout a facility. It clearly defines the systems which must be validated and details the program the organization sets forth to conduct validation activities.

Validation master plan

Effective process validation contributes substantially to assuring a quality product. The basic principle of quality assurance is that a product shall be made to fit its intended use. If there aren’t any controls for validated equipment, then all results and finished goods have no assurance of consistent outcomes. If something ever goes wrong with a product, it would be hard to identify the root cause of the issue if the equipment used for the process does not have proof that it is working as it should and that the outcome of its performance meets the design controls for the product.

The Function of a Validation Master Plan (VMP)

The Validation Master Plan (VMP) is beneficial for planning purposes because it identifies anticipated resource needs and provides key input into scheduling project timelines. It documents the scope of the validation effort, including impacted products, processes, procedures, facilities, equipment, and utilities.

The VMP also includes a schedule that creates specific timetables for when each validation will take place and by whom. The Quality Department, which controls validation activities, defines the impacted functional areas in the document suitably.

Like other master plans, the VMP is a tool for process control. It serves a practical function in instructing personnel on how and why validation activities should be carried out. Furthermore, it serves as a compliance function since it documents the validation program, as required by regulatory agencies for proper process control.

Additionally, the VMP enables stakeholders within the organization to unify around the details of the validation strategy. It eliminates the ambiguity in justifying validation activities, internally within teams and externally for inspectors and auditors. Beyond the frontline, it can be a vital tool for informing and educating upper managers about the importance of validation in terms of its downstream impact on product quality.

A well-crafted Validation Master Plan can be a primary resource in scoping a validation effort to determine impacted products, processes, procedures, facilities, equipment, and utility systems. PSC Biotech® offers outstanding quality assurance services that help a company be ready for an audit. Contact us now for more information about PSC Biotech® consultants for VMPs.

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ISO 17025 accreditation explained

Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO) asks you, Are you technically competent? Here we explain ISO/IEC 17025 accreditation of the general requirements for the competence of testing and calibration laboratories.

ISO 17025 provides detailed parameters for:

    • Proficiency testing
    • Metrological traceability, including the use of reference materials
    • Uncertainty measurement
    • In-house calibrations
    • Management systems operations
Calibration

Proficiency testing

An essential part of proper proficiency testing is using and maintaining a documented plan for three years of sampling activities. This document needs to include a yearly proficiency test (PT) or inter-laboratory comparison (ILC) covering the appropriate parameters, ranges, measurements, test technologies, inspections, methods, and uncertainty of measurements. You may use a PT/ILC provider if they are accredited to ISO/IEC 17043. However, if you choose to develop your own ILC, you need further approval from ANAB. Furthermore, a successful PT/ILC must be completed within 12 months of applying for ISO 17025 accreditation.

For more information and examples within a specific field and industry testing, see the ANAB administrative process rule (PR). Major fields with related parameters for testing scopes can be found in PR 2350, Preparing a Draft Scope of Accreditation for Testing Laboratories.

Metrological traceability

All testing and calibration results must be traceable whenever possible through NIST or another National Metrology Institute (NMI) to the International System of Units (SI units). This means that your metrological traceability, in order of preference, is through an NMI directly, an ISO/EIC 17025 accredited laboratory, using intrinsic standards, or from a weights and measures lab. Applicant and accredited laboratories should use ISO/IEC 17025 accredited calibration laboratory services whenever available. Acceptable ISO/IEC 17025 accredited calibration laboratories are those accredited by ANAB or another accreditation body that is a signatory of the International Laboratory Accreditation Cooperation (ILAC) MRA with the appropriate calibration services listed in the scope of accreditation. If your organization seeks to submit reference standards and equipment to a calibration provider not covered by the traceability hierarchy above, the laboratory shall use the ANAB FM 2808 and apply for the approval of that non-accredited calibration provider. To trace your metrology, use form FM 2807, the traceability and in-house calibration tracking document.

Metrological traceability using reference materials

Reference materials need to fall under:

    • Certified Reference Materials (CRMs) from a reference material producer (RMP) accredited to ISO 17034
    • Standard Reference Materials® (SRM) from NIST (called under trademark).
    • CRM from another National Metrological Institute (NMI). Use of any CIPM-active NMI may be acceptable.
    • The certified values assigned to CRMs are covered by entries in the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database.

If you cannot obtain reference materials from those sources, other authoritative sources or reference methods, or materials from internal validation may be used—document validation of the materials and methods and equipment. For information on Uncertainty Measurement, see the ANAB guidance documents.

In-house calibrations

If you are already ISO 17025 accredited, ANAB allows you to calibrate your own equipment according to your document plan. In accordance, you will:

    • Have the appropriate environment for carrying out the calibration.
    • Appropriately trained personnel to both carry out and check the calibrations.
    • Demonstration of competency to perform the undertaken calibrations.
    • Reference standards, certified reference materials, or reference measuring instruments are traceable with appropriate measurement uncertainties.
    • Documented procedure for each type of calibration.
    • Appropriate means of recording and reporting the data and results of any calculations according to the requirements of ISO/IEC 17025.
    • Estimate, evaluate, and maintain records of uncertainties for traceability realized internally that support tests associated with the scope of accreditation.
    • Complete Form 2807, the traceability and in-house calibration tracking document.

Management systems options

As with quality assurance, your calibration and testing need to be documented, controlled, and tracked thoroughly. One option (A) is to independently meet all the specifications put forth in ISO 17025. The other option (B) is to use a management system that conforms to ISO 9001.

Industry specifics

There are different accreditation requirements set forth by the ANSI National Accreditation Board (ANAB) for:

    • Testing laboratories
    • Calibration laboratories
    • Stand-alone sampling organizations
    • Dimensional Measurement laboratories

To apply for ANAB accreditation for ISO 17025, you will need to detail the items of concern and their measurements. There are different reporting requirements for the varying fields. They are as follows:

Testing laboratories concerning:

    • Acoustics
    • Vibration
    • Biological
    • Microbiological
    • Chemical
    • Construction Material
    • Electrical, Mechanical
    • Non-Destructive
    • Optical
    • Photometric
    • Radiometric
    • Product Safety
    • Thermal
    • Subsurface Munition
    • Information Technology

Need to itemize measurements with the following information:

    • Major field
    • Specific Tests and/or properties measured
    • Specification, standard, method, or test technique
    • Items, materials, or products tested
    • Key equipment or technology

Electromagnetic Compatibility (EMC) or Radio need to itemize the test method (date/revision), test specification(s), range, and any additional comments.

Environmental laboratories need to itemize the technology, specification/standard method/test technique, and analyte.

Calibration and Dimensional Measurement laboratories need to itemize:

    • Parameter/equipment
    • Range
    • Expanded uncertainty of measurement (+/-)
    • Reference standard, method, and/or equipment

Sampling organizations need to itemize:

    • Items, materials, or products sampled
    • Component, parameter, or characteristic sampled
    • Specification, standard, method, or test technique

Follow-up

ANAB has additional, industry-specific requirements for ISO 17025 accreditation for laboratories involved in:

    • Forensics
    • Environmental
    • Food and feed testing
    • Telecom and electronics
    • Calibration
    • Aerospace
    • Cannabis testing
    • Other, non-categorized programs

How we can help

PSC Biotech® has more than 25 years of experience in calibration programs, metrology, criticality analysis, risk assessment, process validation and can provide you with calibrated, validated equipment for your metrology needs. Contact us for more information on how our metrology services can help you in ISO 17025 accreditation.

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: Metrology Survey.

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The Complete CQV: Where to Start

The Complete CQV: Where to Start

CQV engineer

Commissioning, Qualification and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of new equipment or systems into a production pipeline. In this article, we’re focusing on an over-all CQV instance, involving the launch of a new or significantly modified product is involved rather than focusing on a discrete instance of equipment qualification (IQ/OQ/PQ). In both cases, though, modern CQV practices are informed by a number of industry/regulatory guidelines including:  

    • ISPE Baseline Guide 5 “Commissioning and Qualification (Second Edition)”
    • 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”

Phase I

The first phase of a comprehensive CQV effort is to finalize the required User Requirement Specifications (URS), and Risk Assessments (RA). Quality Risk Assessments by Subject-Matter-Experts (SMEs) in the process at hand provide risk control strategies and the necessary engineering controls. Once a control strategy has been defined, the Validation Master Plan (VMP) can be developed. The VMP is a high-level document that identifies the amount and sequence of commissioning, verification, and validation activities associated with the Project.  This document captures the CQV strategy and is a living document that is revised throughout the project’s lifecycle to maintain the correct strategic approach for achieving regulatory compliance. 

Additionally, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documents are leveraged to accelerate the completion of the project, and they are based on the outcome of the risk assessment (RA). Thus, the Validation Master Plan will incorporate: 

    • Determine the extent of leveraging permissible based on risk assessment per system.
    • Alignment of construction-management inspection test plans and forms.
    • Review of completed inspection test plans.
    • Review of vendor FAT protocols.

CQV with risk in mind

A science-and-risk-based approach to CQV is a current Good Manufacturing Process (cGMP) requirement. Understanding risk assessments and associated control plans helps define your quality risk management process, which is essential for maintaining quality assurance and adhering to regulatory mandates. Risk Assessments will be critical in determining what aspects of the commissioning and verification effort represent the highest risk. Therefore, your engineers will focus the verification efforts to determine the appropriate level of commissioning and qualification testing and documentation performed for each system and equipment. 

CQV engineers review all the project specifications and documentation, focusing on floor plan layouts, equipment and utility piping and instrumentation diagrams, User Requirement Specifications (URS’s), and other documents that specify requirements to be tested/or documented during commissioning.  Based on these specifications, the CQV engineers develop a conservative, risk-based approach for commissioning and qualification using the already developed System Impact Assessment (SIA) as a starting point.  

Next

Check out other blog articles in our CQV series where we will tell you more about the Validation Master Plan. Then watch for future CQV articles on Phase two of a CQV project – the execution phase performed onsite and remotely. On-site, engineers document and test equipment, facilities, utilities, computer systems, processes, and cleaning. Preparing onsite components is the core component of CQV projects, and we look forward to elucidating this process.  

CQV Engineers and Project Managers

PSC Biotech® Commissioning, Qualification, and Validation Engineers and Project Managers are available to:

    • Develop the Validation Master Plan.
    • Complete Gap and Risk Assessments.
    • Perform Pre-Startup Safety Reviews.
    • Generate, perform, and document the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
    • Execute a System Impact Assessment (SIA).
    • Provide Installation and operational qualifications (IQ/OQ) for Building Management System (BMS) Systems and Environmental Monitoring Systems Development and assessments for maintenance programs.
    • Detailed Operational Qualifications Process Validation (PV).
    • SOP development and preventative maintenance implementation.
    • Turnover documentation package preparation.
    • Compile the CQV Issues Log.
    • Finalize the project with a CQV Summary Report (CQVSR).

Furthermore, unless otherwise requested, PSC Biotech assigns a Project Manager to each CQV project. The Project Manager utilizes our exclusively developed Project Tracker (PT) software to maintain an accurate and up-to-date deliverable document status. With years of expertise and regulatory awareness, our engineers execute CQV projects in a highly efficient manner to get your product started as soon as possible. See our project success pages for examples. Contact us for a bespoke assessment and cost estimate.

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Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

Inspection Room - Fulfilling the Investigator requests

In this blog article series on regulatory affairs inspections, we talked about the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting together a preparedness inspection management team. Also, we went over basic and advanced options for inspection management software to stay organized and expedite the inspection process. In the last inspection series installment, we initiated the discussion on who to have available during an inspection. In this blog, we’re taking it one step further and into the crux of the matter – fulfilling the inspector or investigator’s requests.

Inspection Day

You’ve created a room for the inspector to do their work, the audit room. With the inspector are the host and at least one scribe. The scribe is writing down everything the inspector says, and these notes are relayed to the backroom. The backroom can contain several people, as many as needed to expedite the process.

The goal is to fulfill an inspector’s request in 15 minutes or less.

Inspector Requests

The three main request types are paper records, electronic records, and asking to speak to someone. Keep a record of all documents, files, drawings, etc., that are being provided.

Paper requests

Requests for paper documents or records are relatively simple –

    • Make sure the document is complete and doesn’t have any yellow stickies on it.
    • Figure out who is the best person to talk about the record, if so needed.
    • Bring the document to whoever is going to present it to the inspector.
    • Give it to the inspector, and then they will give it back when they’re done.

Electronic requests

An electronic record request is similar in structure to the paper record, but simpler. These kinds of requests are fast and easy with inspection management software. The primary components for electronic record and document requests are:

    • Review the electronic record or document in the backroom.
    • Send it to the investigator.

Interview requests

The final type of request is a bit more involved. The regulatory affairs inspector or investigator might request to talk to someone in the company. For example, they might want to interview someone from quality control specializing in chemistry or microbiology. Have your Subject Matter Expert (SME) come into the room with the inspector. Then the SME will undergo a series of questioning as if they are on the stand in a courtroom. The SME should:

    1. Listen to the investigator and what they want carefully. Every time the investigator asks a question with two components, the SME should clarify first with, ‘which question do you want me to answer?’, and then wait for the answer.
    2. Answer the question as if in a court of law because this is, more or less, the same thing.
    3. Only respond with ‘yes’ or ‘no’ or the most concise and brief answer to the question – without elaborating or going off-topic.
    4. Then immediately discontinue speaking and wait patiently.

Summary

There’s nothing better than practice. Practice inspections, practice retrieving and presenting, practice showing documents virtually, have the SMEs practice by grilling them and giving feedback. PSC Biotech® provides experienced professionals to help you prepare for and practice inspections. Contact us for more information!

Remember – be polite, listen to the question, and think before responding.

We have several more tips for you in our subsequent installments of the inspection series – frequently asked questions, how to wrap up an inspection, and our recommendations for your receptionist’s red book. Follow our blog by email or social media for more insights from our former FDA inspectors, engineers, and exceptionally experienced professionals! 

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A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

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The Importance of Validation

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ISO 17025 accreditation explained

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Are you a laboratory? Do you perform any sampling, calibrations, or testing? Then, the International Organization for Standardization (ISO) asks you, Are you technically competent? Here we explain ISO/IEC 17025 accreditation of the general requirements for the...

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