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“Quality is not an act it is a habit”
Aristotle
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  • Technology Transfer Review:
    A new fill and finish site has been built in Ireland for a world leading manufacturer of sterile pharmaceutical and biotechnology products. Prior to completion of PV batches and full scale up we were asked to give a view on the Technology Transfer capability of the site. By comparing practices and procedures with similar facilities we were able to leave them with a truly global "Best in Class" facility and process.
  • Quality Organisation rightsizing:
    A global manufacturer of biopharmaceutical products developed a rationalisation strategy to consolidate packaging on a single European site. The transition itself required careful project management to ensure that quality and regulatory compliance was maintained throughout. This was achieved through the development and implementation of a risk identification and mitigation plan linked to a series of KPI's. Cost savings exceeded $20m with no compromise to product quality.
  • Lifting of NOC.
    The South African site of a global manufacturer of generic solid dose medicines was the subject of two Notices Of Concern (NOC) issued by the WHO. After devising and implementing a remediation programme, including training and validation packages, we managed the site through the follow up audit. The NOC was lifted and the site is now able to continue to supply life saving TB Medication.
  • H1N1 roll out:
    Project managed the extended quality requirements of a major vaccines manufacturer to support the delivery of 27m doses of H1N1 swine flu vaccine from start up to delivery in less than six months.
    • Overseeing auditing and validation of additional material suppliers and third parties
    • Ensuring that QC departments are resourced and equipped to deliver additional volumes
    • Project managed the development and validation of rapid test methods for identifying micro biological and mycoplasma in finished product. (15 days reduced to 5)
  • Remediation:
    Following an FDA warning letter and a series of unacceptable audit reports at a worldwide manufacturer of sterile products, we project managed the remediation activity across four sites, in different countries to restore compliance in key areas.
    • Sterility Assurance
    • Management of Deviations
    • Validation standards
    • Training requirements
  • Global Integration
    Following the acquisition of a vaccines manufacturing business. We were engaged to elevate the new organisation up to the global quality standards expected by a large multinational organisation. Based on audit history key projects were identified and global best practices were generated and implemented on all four sites. By a series of gap analyses, site compliance with global Quality Standards was acknowledged and remediation was completed.
  • Medical Device supply.
    Collaborated with a UK importer to develop and launch medical devices used for the correction of gait problems. Devices were manufactured in China.
  • Medical skin care products.
    Used extensive network of manufacturing facilities to source a range of medicated skin care products for a global brand.

 

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