Maintenance/ Calibration Program Assessment – Compliance Risks & Operation Improvements

The Challenge

A major pharmaceutical manufacturer in northern Texas requested PCI assess their maintenance and calibration programs. The assessment targeted the processes for equipment induction into the plant and change management program while focusing on the front end work request and close out process.  The result was a well-defined program enabling plant operations to move towards a paperless process.

The Solution

A detailed gap analysis of their business processes for maintenance and calibration programs were performed.  The analysis included the areas of equipment criticality classification, identification of critical spare parts inventories associated with PM activities, equipment hierarchies within the CMMS systems, preventive and corrective maintenance procedures, overall maintenance program compliance, and best in class requirements improvements were identified.

The solution included the following programs and processes:

  • A standard Measurement Data Template was established for all equipment/ instruments in Blue Mountain Regulatory Asset Manager (RAM).
  • Changes to “out of tolerance” and reverse traceability processes.
  • Implemented a new process for managing 3rd party vendors and associated documentation.
  • Developed reports to print PMs with parent/ child hierarchies for any selected parent.
  • Configured e-signatures within RAM software for equipment/instrument induction.
  • Developed and implemented validated reports within RAM.
  • Identification and creation of critical spares associated with equipment/ instruments in RAM.
  • Implementation of an end-to-end paperless process for maintenance and calibration activites.

The Result

  • Calibration vendors are pre-qualified through consistent audits.
  • Reduced cost of implementation through the use of PCI’s quality approach.
  • Training directly implemented calibration workflows.
  • Compliant calibration and maintenance programs that clearly display evidence of control in FDA and client audits.

The Benefits

Benefits to the client include:

  • Calibration program policies and executable calibration procedures are shared across sites.
  • Calibration vendors are pre-qualified through consistent audits, and the audit findings are shared across sites.
  • Compliance Risk were identified and eliminated or significantly reduced.
  • Operational efficiencies were gained by moving into paperless environment.

 

For additional information, contact:
Consultant Services Team
919.781.7787

www.pci-llc.com

Pharmaceutical Analytical Laboratories – Equipment Relocation Success Story

The Challenge

A major pharmaceutical manufacture in Michigan built and commissioned new analytical chemistry laboratories used for quality control testing of multiple products.  The existing laboratories were old and ready for demolition.  All instruments and systems needed to be relocated from the existing laboratories to the new laboratories with minimum impact on QC testing of products.  The goal was zero testing downtime for the analytical testing.

The Solution

A pilot project was conducted to identify implementation issues and verify that program goals could be achieved.  The pilot project showed that instrument owners had similar functional instrument requirements but had not standardized the types of instruments purchased leaving many different makes of instruments from lab to lab.  Several labs were serviced by multiple manufacturers (OEMs).  Some labs have hybrid units where the system pumps, detector and injectors further complicating the service issue.   Each lab had setup different serviced requirements, tests, and pass/fail criteria. The pilot also showed there were discrepancies between calibration of instruments and qualification results.

On completion of the pilot program, a PCI team was developed to support qualification in the various laboratories.  As new laboratories were added to the project scope, PCI assisted in qualification protocol review and upgrade/ harmonization where possible.  Once updated qualification protocols were in place and training complete, the PCI onsite teams performed qualifications for that laboratory.

High emphasis was placed on close coordination with the instrument owner and the responsible maintenance shops to minimize operational impact on the owner and lost equipment availability.  The existing maintenance management program for the site was used to schedule qualification activities.

The Result

  • PCI executed over 200 HPLC qualifications for this client with an average time to complete a qualification reduced to less than one half the time of the previous approach.
  • Qualification protocols were reviewed and updated where applicable resulting in improved qualification harmonization between areas.
  • A reduction of calibration failures was recognized through better harmonization of qualification and calibration test requirements.

The Benefits

Benefits to the client include:

  • Release of over 2000 labor hours of client research scientist/ quality analyst in 2004 by outsourcing HPLC qualification testing to PCI. Thus, allowing those resources to be applied toward assay test and other quality control responsibilities.
  • A significant improvement in the availability of analytical laboratory instruments.
  • An overall hard cost savings in analytical laboratory instrument maintenance.
  • A dramatic improvement in the control and therefore compliance of laboratory instruments.

For additional information, contact:
Consultant Services Team
919781.7787
www.pci-llc.com

PCI’s Todd McCulloch Memorial Golf Invitational Raises $10,780 for ECU’s Heart Institute

IMG_20171005_173542544CLAYTON, NC:  Over 70 golfers teed off on Thursday, October 5, at the 15th Annual Todd McCulloch Memorial Golf Invitational to benefit the ECU Heart Institute.  Held at The Neuse Golf Club in Clayton, NC, the generous support of the golfers helped raise $10,780 for education, research, treatment and prevention of cardiovascular diseases.

Jacob McCulloch opened the tournament with a reminder of his late father, Todd McCulloch, and two of his father’s characteristics that he holds dear, fellowship and leadership.  Todd was a friend to all and his leadership had a huge influence on PCI.  “We sincerely thank you for your continued support in helping us honor and remember our dear friend and colleague Todd McCulloch,” said Andy Ferrell, PCI President.

Tournament participants enjoyed a variety of competitions in addition to the 18 holes of Captain’s Choice on The Neuse’s newly renovated greens.  Activities included Accurate Drive, Wicked Six Challenge, where participants used their #6 iron for the entire hole, and a Hole in One challenge where $10,000 was up for grabs.  Participants challenged PCI’s President, Andy Ferrell, in “Beat the President,” raising $600 for the ECU Heart Institute.

This year’s tournament closed with an Awards Dinner.  All enjoyed a BBQ dinner as awards were given out.  This year’s winning team joined us from Novo Nordisk, second place from Biogen and the Integrity Award given to one of the ECU Heart Institute teams.

The East Carolina Heart Institute is the first in North Carolina devoted exclusively to education, research treatment and prevention of cardiovascular diseases.  PCI partners with them to help improve health status and bring awareness of cardiovascular health in memory of our dear friend Todd McCulloch.

PCI provides calibration, commissioning and consulting solutions for the life sciences industry nationwide and has been a steady influence in the North Carolina life science community for over 20 years.  Find out more at www.pci-llc.com.

IMG_20171005_173439000

IMG_191011IMG_20171005_170526955_HDR

PCI Expands Commissioning Capabilities

PCI_EncovaPCI is pleased to announce that Encova Consulting, Inc. has joined the FCX and PCI Family.

Last week, Encova, a Cary, North Carolina firm, became an FCX Performance Company. Led by Rick Mineo, Encova is a licensed professional engineering company providing specialized project start-up and commissioning and validation services for customers in the life sciences industry. "This acquisition allows us to provide our clients with the trusted single source provider they are looking for from start-up of their equipment on new projects, to maintaining optimal plant performance," said FCX CEO Tom Cox.

Encova complements PCI's 3-C's (Calibration, Commissioning and Consulting) integrated approach to providing personalized service, technical expertise and a commitment to our client's success. "Strategically, this is a perfect match for PCI and Encova. Merging together we add critical mass to our Commissioning Services and provides our customers with an unmatched range of services. We are excited to work with Rick Mineo and his team," said Andy Ferrell, President of PCI.

PCI Opens Office in Boulder, CO

co office3

PCI expanded it's current footprint in Colorado with the opening of a new office in Boulder last quarter.  The new space is located at 5660 Airport Blvd., Suite 104, Boulder, CO. This new location will increase PCI's ability to provide compliance services to the life science industry for current and future clients.
"The decision to expand our presence in the Boulder area was a logical step in our business growth strategy" said, Andy Ferrell, PCI President.  "We have been providing service in Colorado for years, but we do not open offices in new locations until we know the area is a good fit for PCI. We are thankful to the Boulder area for welcoming us as their compliance service provider."
The opening of our Boulder office demonstrates our commitment to provide exceptional value to our clients through personalized service, technical expertise and a commitment to their success.  

 

Industry Leaders Discuss Data Integrity

Industry Leaders Discuss Data Integrity

download (5)

On March 29, 2017, the annual Calibration Discussion Group was held at the RTP Foundation on Davis Dr. This one-day event brings together the biopharmaceutical professionals from the industry to share common approaches, issues, and solutions. Industry associates from over twenty operating companies attended this year’s event.

While the majority of the attendees are North Carolina based, this years event include attendees from as far away as Maryland, Illinios, and Colorado.  The keynote speakers from Biogen, Tanisha McClendon and Brian Urban, discussed the importance of quality and integrity throughout the manufacturing process and how data integrity is crucial in the pharmaceutical industry.

 

The theme of this year’s event was Data Integrity, multiple industry subject matter experts led discussion topics which included:

  • Criticality Assessments & Instrument Classifications
  • Establishing Operating Ranges, Instrument Tolerances, and Service Frequencies
  • Key elements of overall calibration & maintenance programs along with criticality of data and data use

The open forum, networking, and presentations resulted in a better understanding of industry trends and common program approaches.

 

The Calibration Discussion Group (CDG) was established in the early 1990’s in response to the lack of training courses offered for instrumentation professionals working in the pharmaceutical industry.  In 1990, local leaders from companies such as Abbott Labs in Rocky Mt, Glaxo in Zebulon, Miles Laboratories in Clayton, and Burroughs Welcome in Greenville, collaborated to form a one-day meeting for pharmaceutical instrumentation professionals.  The leadership of the Calibration Discussion Group consists of regional biopharmaceutical calibration professionals who are addressing the same issues and asking the same questions as their constituency. As a result, the learning technique applied at a Calibration Discussion Group allows attendees to return to their company with information and tools that can be directly applied at their facilities.  In recent years, the attendees have expanded to include professionals from QA, Maintenance, Engineering, and Manufacturing.

PCI Enhances the Georgia Process Service Team

Gerald Houston Named Team Manager of the Georgia Process Service Team
Gerald joins PCI with 24 years of combined experience in managing others and calibration services. GHoustonBefore PCI, Gerald was a Calibration Lab Manager at WIKA Instrument, LP. He was responsible for coordinating all aspects related to the calibration of WIKA products, development, implementation, accreditation, and support of ISO/IEC 17025:2005 and ISO 9001:2008, and the creation of SOPs, work instructions, and calibration procedures and operations in calibration labs.
Gerald is looking forward to getting back to his roots in a fast paced environment and being challenged.
"We are excited about the experience and technical leadership Gerald brings to the Southeast Region," said Rodney Perkins. "This is another key hire for PCI's vision and commitment to our clients and associates in this region."

PCI Strengthens Metrology Lab Team

PCI is pleased to announce that Frank Reagan has joined the PCI team as the Metrology Lab Manager. FReagan
Frank has over 20 years of metrology experience working across numerous industries and disciplines including metrology lab manager, lead technician and senior technician. Efficiency, customer satisfaction, and quality have been significantly improved as a result of his leadership.
Frank said he is looking forward to leveraging his unique skill set in metrology lab operations and customer service to add to the already unmatched level of professionalism and technical expertise that PCI possesses.
"We are excited about the experience and leadership Frank brings to this business unit," said Andy Ferrell.  "This is another solid move toward building stronger team and group of services for our clients."

PCI Makes a Strategic Hire for Consulting Services

Don Stuck has joined the PCI team as the Senior Director of Consulting Services.
Don brings 27 years of Pharmaceutical Industry experience in all aspects of facilities and laboratory management, automation and calibration to PCI. He understands the complexities associated with the implementation of calibration and maintenance programs forDStuck ISO, FDA, and OSHA regulated industries.  Don has experience in capital project management and program development for calibration and maintenance processes, building management, electrical distribution and process improvement. He's extensive experience with implementing, managing, consolidating, and streamlining pharmaceutical maintenance programs as well as recognizing and solving compliance issues makes Don a valuable asset to PCI's clients.
Don is looking forward to learning more about being on the service industry side while bringing his institutional and broad industry knowledge to PCI.
We are excited about the experience and leadership Don brings PCI in Global Technology Platforms, Engineering Data Strategies, and extensive experience in Calibration/LIS Enterprise Service Management " said W. Rodney Perkins. "This is a key hire for the vision of our Consulting Services and Company."