TEVA Pharmaceutical Industries Limited is a global pharmaceutical company operating in over 50 countries and employing approximately 25,000 people. The company specializes in the development, production and marketing of generic and proprietary branded pharmaceuticals as well as active pharmaceutical ingredients.

TEVA UK Limited package and market one of the widest ranges of generic products in the UK. From their headquarters in Morley near Leeds, they deliver direct to their customers through wholesale partners. Since 1998, the Hampden Park facility in Eastbourne has been a Centre of Excellence for Packaging. The investment in this Centre allowed them to be the first generic supplier to convert their range into patient packs.

Mick Worsfold is the Calibration and Environmental Engineer at TEVA UK Limited, he is part of the Engineering Support Services team and responsible for the calibration needs at both the Eastbourne and Leeds facilities, ensuring these activities meet the requirements of the regulatory authority. With over twenty-seven years engineering experience in the pharmaceutical industry he has seen the needs and requirements of the business changing and evolving.

The majority of in-house calibrations are carried out using existing Beamex calibrators. The results from hand-written sheets are then typed into a QM6 database. Other calibrations are carried out by third party companies to scales, checkweighers, and laboratory equipment. Documentation from this work is stored in the department where the equipment resides. Functional checks are also performed on a daily/weekly basis by otherTEVA UK staff prior to using, or during the use of equipment or systems, and the results are stored either on paper or a database.



A number of needs were identified for improving the control and visibility of the activities associated with calibration:

  1. Calibration and systems check results needed to be integrated into one database and be available for evaluation.

  2. Results needed to be traceable, auditable and available from a validated, compliant source.

  3. Access to the calibration database needed to be networked to make it more widely available to other staff.

  4. Effective communication was required between the calibration database and our MMS (COSWIN) to enhance the control of maintenance activities.

  5. Improvements needed to be made in calibration efficiency and security by means of data transfer from calibrator to database.

  6. Manual entry of calibration and check results needed to be registered directly to a calibration database without the use of a paper system.

  7. The database needed to be validated and compliant with existing data. It also had to be expandable, flexible and user-friendly with the ability to evolve according to changing demands.
“In a heavily regulated industry our objective is to ensure that our processes comply with the relevant pharmaceutical regulations, directives and guidance requirements, and that our customers receive products of the highest quality possible at all times”, Mick Worsfold describes.

“As part of our commitment to achieve these objectives, the calibration functions we perform must reflect this; our choice of Beamex in supplying the equipment to fulfil this obligation is based on ten years of experience in using their products,” Mr Worsfold continues.

At present TEVA UK Limited is utilizing Beamex TC305 temperature and PC106 pressure calibrators, as well as QM6 as the calibration database. The system is based on a stand-alone PC in the calibration workshop.

“It was therefore not a difficult choice when the project to update and upgrade our equipment was carried out. Although we looked at a number of options from other reputable companies, none would provide the seamless transition of our current and historical calibration data,” Mr Worsfold explains.

“We already had an excellent history of working in partnership with Beamex here in the UK. From that we knew that we would be provided with the right tools for the job. One of Beamex’s strengths lies in the ability to improve their products by listening to the people that use them,” says Mick Worsfold.

TEVA UK decided to take the server-based CMX with the Pocket PC option along with the replacement of the TC305 and PC106 with the MC5 Multifunction Calibrator.


CUSTOMER PROFILE:
TEVA UK Limited, Pharmaceutical, UK

TEVA UK Limited identified a number of needs in improving and enhancing their current way of carrying out calibration and systems checks. Data from these functions needed to be integrated into the existing MMS and made available to key staff for evaluation and auditing purposes. The calibration management system needed to be flexible and expandable to allow other sites to be added as the company itself grows.
  • MC5 Multifunction Calibrators
  • CMX calibration management software - CMX for server
  • 21 CFR Part 11 compliant calibration system with full audit trail
  • Improved efficiency of the calibration process
  • Paperless calibration system possible
  • After-sales support and training


 
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