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The Commissioning/Qualification and Validation Engineer position has 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.

EXPERIENCE REQUIREMENTS

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

• Process Validation
• Clean Utilities
• Sterilization and Decontamination Processes
• Packaging Line Processes
• Cleaning Processes
• Facilities, Utilities and Process Equipment
• Depyrogenation Processes
• Analytical Lab Processes
• Automation/Computer Systems (Delta V, Honeywell, Siemens, Snyder, Johnson Controls, 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.
• 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

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

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On a previous project, I was tasked with facilitating the technology transfer of a commercial process from a customer site to the CMO manufacturing plant. The scope of the project was for the successful implementation of the upstream process into a three (3) train, 5000L working volume production suite.

Prior to undertaking the project, the site had a string of tube sealer failures while performing aseptic connections throughout the cell expansion and fermentation stages. Measures were put in place to ensure that manufacturing personnel performed additional test welds, and subsequently, multiple welds prior to disconnecting spinner flasks, media bags, etc. This turned out be a cumbersome and lengthy process, especially when dealing with time sensitive operations.

 I viewed this tech transfer as an opportune time to introduce single-use, disposable technology into the facility. The idea of disposable technology was not a welcome one as it was “out-of-the-norm”. I had to start small – aseptic connectors. Flip some tabs, click a few pieces together, pull a tab, and voila, a sterile connection. No more time spent on warm up times, test welds or cuts and less risk to the process.

 After reviewing the process from out-of-freeze to concentration of product, I realized that there would be a number or feeds connected to the bioreactors throughout the process, with the added impetus that all were time sensitive and deemed critical.

Introducing a single-use-technology into this process (and subsequently the entire facility) would provide ease-of-use to the manufacturing associates and also allow them to remain within the established processing parameters, avoiding unnecessary deviations, or much worse, the loss of a batch. This was enough rationale to quiet the concerns of MS&T personnel and to proceed with securing vendor samples. I found the parts I needed and ensured all information was in place (BOM, ingress studies, leachable/extractable memos, delivery timelines, etc.) for a successful kickoff to the manufacturing campaign.

As the out-of-freeze date inched closer and the vendor delivery timeline grew more and more distant, I realized that our campaign would need some fine tuning in order to meet the customers’ expectations. Luckily, we had the foresight to build into our batch records the option to weld connections, avoiding the need for planned deviations for each run. Sooner or later it became evident that the parts I ordered were not going to arrive in time. I had to communicate this to the senior leadership team and face the fact that my idea would not work.

So what did I learn?

• Always dual source suppliers whenever possible. The more options, the better.
• Use suppliers with local support and/or presence. Proximity iskey when it comes to deliverables.
• Get the entire cross-functional team involved early. This was my major oversight. I had my lead times in place, but waited too long to involve my supply chain group.
• Big name companies are not necessarily the best. I had the option to go with a smaller vendor but chose the big name as I perceived they would be more reliable.
• Ensure training is in place. Although the parts didn’t arrive in time for the run, training was crucial to ensure our personnel were aware of what would be arriving.

Written By: Gregory Fischer, Consultant I

ICQ Consultants

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According to 21CFR, 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 methods 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.

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)

3. 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).

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!

ICQ Consultants, Corp.

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