Global Inspections and Trends, PDA Dinner Meeting

pdaeventICQ Consultants will be sponsoring a table at the next PDA Dinner Meeting, “Global Inspections and Trend”.  Please join ICQ in attending this meeting held on Wednesday, November 9th at 5:30 P.M. running until 9:00 P.M.  This session will be held at the Hilton Boston / Woburn, 2 Forbes Road, Woburn, MA 01801.  Ann McGee of McGee Pharma International and Thomas Arista of FDA Invited will be speaking on the topic.  There will also be a special announcement of the NE PDA Middlesex Community College Student Chapter Scholarship winner during this dinner meeting.    Please stop by our table and say hello!facebookbanner

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Planning your next career move? Maybe it’s time to consider ICQ….

ICQ Consultants is looking to hire dedicated professionals in the NH, MA, RI, CT, NJ, PA, NC, and SC areas. ICQ is one of the largest and most sought after CQV suppliers in the Northeast and we have expanded with offices in the Southeast. We are seeking to hire mid to senior level Commissioning/Qualification/Validation, Technical Writing and Project Management staff.

The Commissioning/Qualification/Validation and Technical Writing positions have responsibilities for all aspects of planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports meeting quality and schedule expectations.

The Project Manager positions have responsibilities for all aspects of the management of small and large project’s (Tier 1, 2 and 3) demonstrating the ability to plan, coordinate, develop/manage/present budgets, schedules, and project metrics while ensuring quality and timeliness of project deliverables by the assigned team.

BENEFITS

ICQ Consultants offers extremely competitive benefits and wages in our field of business. Many of the benefit premiums are 100% funded by ICQ:

  • Tufts Health Insurance, Dental and Vision Plansbigstock-Dream-job-road-sign-37020268
  • Short Term / Long Term Disability
  • Life Insurance
  • Paid Time off for Holidays, Sick Time and Vacation
  • 401 K with a 100% match to the first 4%
  • Cloud Based and Class Room Style Internal ICQ Training
  • A supportive management and leadership structure

EDUCATION REQUIREMENTS

BS/BA degree in a Scientific/Engineering Discipline or 2 to 15 years’ related experience working in FDA-regulated industries within one of the following areas:

  • Manufacturing
  • Engineering
  • Process Development
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Commissioning, Qualification and/or Validation

EXPERIENCE REQUIREMENTS

All positions require a solid foundational understanding working in FDA-regulated industries within one of or more of the following areas of commissioning, qualification and/or Validation:

  • Process Validation
  • Sterilization Processes
  • Packaging Line Processes
  • Cleaning Processes
  • Facilities, Utilities and Process Equipment
  • Depyrogenation Processes
  • Analytical Lab Processes
  • Automation/Computer Systems (Delta V, PLCs)
  • Project Management
  • Cycle Development
  • Shake down, Start-up and Turn Over Activities
  • Decommissioning Activities
  • Environmental Monitoring

GENERAL REQUIREMENTS

  • Working knowledge of FDA and ICH requirements:
    • 21CFR Parts 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs General.
    • 21CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.
    • 21CFR Part 11, Electronic Records and Electronic Signatures
    • ICH Q7, GMP Guide for Active Pharmaceutical Ingredients
  • Working knowledge of Quality by Design (QbD) principles and approach:
    • ICH-Q9, Quality Risk Management
    • ICH-Q10, Pharmaceutical Quality System
    • ASTM E2476, Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture
    • ASTM E2500, Standard Guide for Specifications, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
  • Demonstrated ability to meet quality and schedule expectations related to the planning, coordination, development, execution and close out of commissioning, qualification and/or validation protocols/reports.
  • Demonstrated ability to customarily and regularly exercises discretionary powers and sound independent judgment.
  • Demonstrated ability to work independently or as an effective team member, leader, of project manager while completing all assign work.
  • Demonstrated ability to clearly and effectively communicate with project team members, management, clients.
  • Demonstrated ability to take ownership in obtaining, interpreting and understanding client and vendor-supplied documentation in order to meet assignment deliverables and expectations
  • Participate in internal ICQ Consultants and industry required training to ensure continued accreditation.
  • Complete all others tasks within quality and schedule expectations as assigned.
  • Travel may be required.th
  • Employee must always be compliant with the company’s Standard Operating Procedures (SOPs) and policies.
  • Strong attention to detail
  • Proficient in MS Word and MS Excel
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must
  • Demonstrated interest in continued professional development
  • Demonstrated interest to provide a high level of customer support
  • Demonstrated interest to be a representative of the company
  • Desire to help others
  • Desire to be in industry leader
  • Belief that every problem has a solution

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PDA Event – Cleanrooms and Environmental Monitoring, Where should we be Going?

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Please join ICQ in attending the next NEPDA Dinner Meeting on May 18th.  The event titled “Clean-rooms and Environmental Monitoring – Where Should We Be Going?” and “Contamination Control Case Studies” will be held Wednesday, May 18th from 5:30 – 9:00 P.M. at the Marriott Burlington, One Burlington Mall Road, Burlington, MA 01803.  The event will be hosted by Elisabeth Piquet and Rusty Morrison with talks by Jeanne Moldenhauer and Brian Hubka.  Please look for our sponsor table and say hello!

Register Here

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Method Validation

According to 21CFR21-CFR-Part-11-FDA-Regulations, 601.2, as cited in the Guidance for Industry Document, Analytical Procedures and Methods Validation of Drugs and Biologics (July 2015)1,2, biologics license applications (BLAs) must include a full description of the manufacturing process, including analytical procedures that demonstrate the product meets prescribed standards of identity, quality, safety, purity and potency. The purpose of analytical method validation is to ensure that the methods used for assessing the quality of the product being manufactured complies with the established specifications and yield accurate, reliable, and reproducible results.2

Analytical Make-compendial-standards-universal-and-compulsory-to-improve-consistency-quality-of-supplements-says-USP-paper_strict_xxlmethods require validation, verification or re-validation in the following cases: 1) before initial use in routine testing, 2) when transferred to another laboratory and 3) if the conditions or parameters of the validated method have changed.3 Laboratories are expected to utilize compendial methods for testing, however a full validation is not required. A verification is done to ensure the laboratory can achieve the performance characteristics of the method and it is suitable for the intended analytical applications. Laboratories that require developing in-house methods, modifying compendial methods or using them beyond their intended use, should carry out full validation of the methods. A full validation includes establishing specifications and performance characteristic of the method and confirming it is suitable for the intended analytical applications.

An Analytical Method Validation Master Plan (AMVMP ) is prepared, when a project includes a range of different analytical validation activities. Although not all of the validation characteristics are applicable for all types of tests, typical validation characteristics are: specificity, linearity, accuracy, precision (repeat-ability, intermediate precision, and reproducibility), range, quantitation limit and detection limit. 2   Documentation is essential during a method validation, and includes a protocol, report and summary.  Once a method is validated, its performance is monitored and evaluated by trend analysis to determine if the method requires additional optimization, redevelopment and re-validation.Revalidation-logo

Written By: Jessica Bruno,  Consultant II

ICQ Consultants, Corp.

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  1. Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics, July 2015. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386366.pdf (accessed on 22-Dec+2015)
  2. Food and Drugs, 21C.F.R. § 601.2 (2015) Available from http://www.ecfr.gov/cgi-bin/text idx?SID=136435444f0996cfa2ae3bbc2a232cc4&mc=true&node=se21.7.601_12&rgn=div8 (accessed on 22-Dec+2015)
  1. Ajay, S. and Rohit, S., Validation of Analytical Procedures: A Comparison of ICH, Vs Pharmacopeia (USP) Vs FDA, International Research Journal of Pharmacy (IRJP) 2012, 3(6).

Thank you for visiting with ICQ!

20160309_171213Everyone at ICQ would like to thank you 20160309_171239for visiting with us at the PDA Dinner “Evaluating Contract Manufacturing” on March 9th.  This event had a great turnout and was quite the success.  Thank you everyone for taking the time to attend and to all of those who dropped by and spoke with us.

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PDA Event “Evaluating Contract Manufacturing”

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Please join ICQ in attending the PDA’s event this evening.  “Evaluating Contract Manufacturing” will feature talks by Amnon Eylath and Andre Merza with the presentations concentrating on evaluating contract manufacturing for Biotech and Cell and Gene Therapy and Risk Analysis of Non-Conformances in Research Model Production.  This event will be located at the Boston/Woburn Hilton, 2 Forbes Rd. Woburn, MA 01801.  Registrations, cocktails and networking will begin at 5:30 and the event will continue until 9:00 P.M.  ICQ will be sponsoring this event and would please like you to drop by and say hello!

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ISPE CaSA 23rd Annual Life Sciences Technology Conference

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ICQ Consultants will be sponsoring a table at the 23rd ISPE CaSA Life Sciences Technology Conference in Raleigh, NC.  The event will take place on Thursday March 31st starting at 9:00 A.M. through 7:00 P.M. and will be held at the Raleigh Convention Center.   This event features many different speakers and will feature different companies exhibiting along with educational seminars, product demonstrations and a networking social event.  Please visit us at table number 203 and say hello!  We look forward to seeing you there.

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Five Keys to Problem Solving

WhyWhen an ICQ consultant is hired for a project, the main objective can appear fairly straight forward. Validate this system, write that protocol, etc… But in practice, helping a client achieve what they need never turns out to be that easy. Problems arise, and it’s at that moment that we need to be able to leverage both our own industry knowledge, and that of all of ICQ, to help remedy the situation. Every problem will be different, but there are some steps that will be needed regardless.

  1. Define the problem / Focus on the Root Causes (Not Symptoms)

There are many techniques for getting to the heart of a problem (flowcharts, cause and effect diagrams, root cause analysis, the 5 Why’s), but the important part is to be able to identify when a problem is a root cause or just a symptom of a deeper problem. There may be multiple root causes. Experience is key to being able to successfully define a problem. Make sure the right people are in the room, and if you feel as though something is being missed, remember that you work for a growing consulting firm that has years of collective experience. Leverage that experience.

  1. Look to turn off all Root Causes / Generate alternative Solutions

If we only look to resolve one root cause (for a problem with multiple root causes) the problem will likely resurface shortly, but perhaps appear to be a new or different problem. We want to find solutions that effectively “turn off” all the root causes. We also want more than one solution for any problem. This may be difficult for those of us with many years of experience, but showing patience in these early sets of problem solving can yield much higher dividends.

 

  1. Evaluate and Select Solutionssaas-software-solutions

Some things to consider when evaluating and selecting a solution might be:

  • What chance does a solution have to solve the problem without causing unanticipated problems? We might want to find simple solutions that affect as few contributing factors as possible. This will limit the impact to processes that are not currently experiencing a problem.
  • Will all individuals affected by the problem accept this solution? This may be a tough question to gauge, but if we have the right people in the room, we can find a solution that works for everyone.
  • Is it likely that the solution will be implemented? This goes hand in hand with the bullet above. If a solution will be difficult to implement, it’s more than likely that the problem will persist.
  • Does the solution fit within organizational constraints? Again, if a solution doesn’t work for the client, they are not going to implement it.

  1. Implement and follow up

Make sure to thoroughly plan the implementation of any solution: include goals, roll-out programs, CAPAs and plan the allocation of resources. Success will depend on getting the people affected by the problem involved in the solution. Feedback channels should be facilitated and welcomed as a way to continuously monitor the effectiveness of any change.

  1. Audit Results of Problem Solving

Once a problem has been solved within an operation, we should audit the affected process to make sure we have actually solved, not just contained, the problem. An assessment would also benefit the organization to figure out why a solution was effective or ineffective.Problem-Solved-Stamp-300x215

 

By effectively helping our clients to solve problems within their operations, we can create a good working relationship that goes beyond commissioning and qualifying systems.

Written By: Steve Graham, Consultant II

ICQ Consultants, Corp.

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Proper Calibration for Successful Qualification

Why does calibration matter? If the equipment has a current calibration certificate and calibration stickerth then we can check that off and we are on our way. Well maybe? Too often we overlook a key component for a successful qualification. Proper calibration starts with the manufacturer’s design and operation of the equipment. We purchase equipment for GMP use and fast track the qualification to meet the project deadline. The service manual usually provides a calibration method based on the design and operation of the equipment. In our expedience we sometimes neglect details that we may consider mundane and jump right to our one size fits all method of calibration for related equipment, calibrate and assume success.

 Let’s first understand that if equipment passes calibration it only proves that it maintained its calibrated state since the last calibration. It does not guarantee the next day that it is still in calibration. So, calibrating prior to qualification may be beneficial.

 Several years ago I was calibrating three new GMP Freezers for a client prior to qualifying them. Our calibration SOP stated to place the calibration temperature test probe in the center of the chamber or adjacent to the controlling probe of the unit, as prescribed by the manufacturer. manualThe service manual clearly stated that the unit be calibrated to the center of the chamber. It just so happened that the client had their calibration contractor performing “6 month” calibrations on the existing identical freezers in the lab. I curiously asked the technician where in the chamber he was placing the calibration temperature test probe. His answer was that they always place the test probe adjacent to the unit’s controlling probe. The controlling probe for these freezers were located in the back right hand side corner of the middle shelf. This location also happens to be the coldest point in the unit. With a quick demonstration the client was able to see that there was almost a 2° C difference in the recorded temperature in the center of the chamber versus the temperature reading with the calibration temperature test probe placed adjacent to the controlling probe. The client’s SOP stated to place the calibration temperature test probe adjacent to the controlling probe of the unit and directed that the three new units be calibrated as such due to the project time constraint and not being able to revise the calibration SOP in time. Our demonstration proved almost a 2° C difference and by calibrating to the coldest point in the unit would jeopardize the acceptance criteria temperature span on the warm side. The first two brand new freezers failed qualification and could not maintain temperature criteria. The warmest locations in the freezer were more than 10° C less than the required set-how-to-draw-a-thermometerpoint. The devastated client quickly revised their calibration SOP and re-calibrated to the center of the chamber with all three new freezers then able to pass qualification.

It is always beneficial to double-check an equipment manual when performing a calibration, even is there is an established procedure in place and you are familiar and comfortable with a certain process.  SOPs are often written based on previous practices and may not take new equipment models and locations of sensors into consideration.   Verifying the proper set of instructions insures the proper calibration the first time and in the long run will save time and frustration.

 

Written By: Jim Scearbo, Senior Consultant

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ICQ Consultants is looking to hire top talent

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ICQ Consultants is looking to hire dedicated professionals in the MA, NC, NJ and PA areas. ICQ is one of the largest and most sought after CQV suppliers in the Northeast and we have expanded with offices in the Southeast as well. We are seeking to hire mid to senior level Validation staff.

Integrated Commissioning & Qualification, supplies services in the life science industry. In addition to offering commissioning and qualification services, we also offer QA, QC, Engineering, PV, PM and technical writing staff.

We focus on the commissioning effort in alignment with qualification, which can leverage many aspects of those efforts with complying to procedures and quality systems.

Our company provides some of the most competitive benefits and wages in our segment of service provider which include the following:

  • Tufts Health Insurance, Dental and Vision Plans – Paid 100% by ICQ
  • Short Term / Long Term Disability – Paid 100% by ICQ
  • Life Insurance – Paid 100% by ICQ
  • Paid Time off for Holidays, Sick Time and Vacation
  • 401 K with a 100% match to the first 4%

GENERAL RESPONSIBILITIES AND REPORTING/EDUCATION/EXPERIENCE
REQUIREMENTS

These positions report to the assigned manager and have responsibilities for development and execution of commissioning and qualification protocols, including test functions, and sampling.  Employee must always be compliant with the company’s Standard Operating Procedures and policies. Adherence to timelines and deliverables are a must.  Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving one or more of the following:

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  • 5 to 7 years’ experience in Cleaning Validation and/or Sterilization
  • 5 to 7 years’ experience in Environmental Monitoring
  • 5 to 7 years’ experience in Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment

 

RESPONSIBILITIES:

  • Knowledge of FDA requirements, including cGMP’s, Quality System Remediation and Quality by Design, ICH-Q9, ICH-Q10, ASTM E-2500 principles.
  • BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Develop and execute commissioning/validation plans, test plans, validation protocols/reports and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader, part of commissioning/validation team, or independently to develop protocols and procedures, execute same including test functions, sampling and calibration.
  • Responsible for developing new business opportunities at assigned client sites.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.
  • Travel may be required.
  • Research and interpret client and vendor-supplied documentation in order to write documents.

OTHER DESIRED SKILLS AND EXPERIENCE

  • Process Validation
  • Sterilization / Autoclave Performance Qualification
  • Quality Systems and Remediation
  • Implementation of Quality by Design
  • Packaging Line Validation
  • Cleaning Validation
  • QC Lab Commissioning/Qualification/Validation
  • Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
  • Strong Attention to Detail
  • Proficient in MS Word and MS Excel
  • Excellent Communication Skills
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must
  • Demonstrated interest in continued professional development
  • Demonstrated interest to provide a high level of customer support
  • Primavera Scheduler
  • CQV Project Managers

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