Contract Services to the Pharmaceutical, Medical Device and Healthcare Industry in Ireland

By: Q.a. Resources  05/12/2011
Keywords: Medical Device, Healthcare Industry, contract services

 

  • Set up quality systems compliant to applicable standards for the Pharmaceutical and Medical Device industries
  • Review existing systems versus GMP by audit and risk assessment
  • Provide gap analysis report to highlight areas for improvement of your existing systems
  • Update quality system and related documentation to reflect industry and regulatory agency requirements with your input and tailored to your needs
  • Train your site personnel in revised systems
  • Initiate continuous improvement programmes to ensure ongoing focus on improved compliance at your site
  • Provide a resource for periodic system review
  • Provide on-site resources to implement quality systems on a contract basis to suit your company requirements
  • All auditors are trained Lead Assessors
  • Quality audits of your facility to IMB, FDA, EU, ISO 9000, ISO13485, PS9000 etc. requirements and also to your internal site procedures
  • Area and system specific GMP audits focusing on specific areas of concern to you. Audits may be carried out to address deficiencies in a particular area, as a basis for a quality improvement project or as part of your internal audit schedule.
  • Pre-regulatory inspections and reviews provide invaluable experience to site personnel in handling inspections efficiently and confidently.
  • Audit team training of site personnel
  • Audit follow-up, including preparation of improvement plans
  • Implementation of CAPA systems
  • Implementation of corrective and preventive actions following the audit
  • Devise and implement vendor assurance programs:
    We prepare the required procedures and suitable vendor questionnaires for a compliant system with your input. We devise appropriate measuring tools and vendor classification for ongoing assessment of your critical vendors, leading to enhanced supplier relationships and improved service.
  • Set up appropriate audit schedules:
    We can assist you in devising appropriate audit schedules for key vendors based on risk assessment.
  • Carry out vendor audits:
    Vendor audits are an integral part of building successful relationships with key vendors, ensuring that they understand and can provide you with the level of service you require. Our experienced auditors review vendor facilities and services on behalf of our clients. This may involve participation by your site personnel if desired.
  • Audit follow-up service:
    The service provided includes preparation of the audit report and subsequent follow-up by liaising with vendors to ensure completion of appropriate corrective actions.
  • Devise rationale for reduced testing at incoming inspection:
    Implementation of a compliant reduced testing programme allows you to maintain confidence in your vendors while at the same time freeing up valuable QC resources.
  • Design and / or update your batch processing records to allow ease of use for your personnel while ensuring compliance with appropriate standards
  • Documentation control on project basis:
    We provide personnel to support documentation control activities on your site on a temporary basis e.g. during start-up projects or to alleviate backlogs etc.
  • Review and correction of completed batch records:
    We provide this service on a contract basis, including tracking of recurring errors, feedback to production and quality personnel, to facilitate documentation completion improvement and reduce batch review times.
  • Preparation and analysis of your documentation Right First Time data:
    This service is used to measure accuracy of documentation completion, to highlight department performance improvements and feed into KPI systems.
  • All programmes are specific to your company
  • Site wide general GMP training focused on delegates requirements
  • GMP refresher training for all your personnel
  • Individual personnel coaching (e.g. for new personnel or where retraining has been identified as a CAPA)
  • Preparation of personnel for regulatory inspections
  • Area specific GMP Training
  • Quality System Module training including:
  • – Auditing and GMP Inspections
    – Vendor Assurance
    – Deviation Investigation
    – Change Control
    – Documentation Control
    – Customer Complaints
    – Validation
  • Provision of comprehensive validation support to our clients in the following areas:
  • –  Process validation
    –  Cleaning validation
    –  Method validation
  • Compilation of Validation Master Plans for specific projects or facilities
  • Preparation of protocols and reports
  • Execution of validation exercises and co-ordination of validation activities with associated departments, ensuring adherence to your pre-determined timelines
  • Review your existing validation data and files versus current standards and requirements, and where appropriate provide you with a gap analysis report
  • Preparation of relevant procedures and documents supporting your validation system and / or the facility / process / method being validated
  • Preparation and update of your Site Master File
  • Preparation and update of your Quality Manual
  • Preparation of Technical Agreements between contract givers and contract acceptors for critical vendors and sister sites
  • Review and update associated procedures
  • Preparation of Product Quality Reviews / Annual Quality Reviews for your products

Keywords: Continuous Improvement Programmes, contract services, Documentation Control, Healthcare Industry, Implement Quality Systems, Medical Device