Back

GMP audits & inspections in the pharmaceutical industry

Valicare, a subsidiary of Bosch Packaging Technology, has supported customers in the pharmaceutical industry for many years as a specialist for GMP compliance services. Our experienced team of auditors offers comprehensive solutions for individual needs. They assist customers by preparation and implementation of third-party audits and authority inspections. They also prepare and execute GAP analyses.

 

Based on applicable standards and guidelines, our experts precisely and objectively check the GMP and/or ISO compliance of your systems and analyze the quality and GMP conformity of your products, processes, and documentation systems.

 

Main focus of our audit services:

  • Preparation, support, and execution of internal and external qualification audits, routine, and For-cause audits
  • Third-party audits, for example as part of the supplier qualification for raw materials, intermediate products, and/or active ingredients and excipients, as well as for equipment suppliers, contract manufacturers, contract laboratories, and service providers
  • Follow-up audits
  • GAP analyses for compliance check of existing GMP systems
  • Preparation and support for authority inspections
  • Carrying out mock inspections

 

The results are exactly and objectively documented in an audit or analysis report whereby verification and traceability are important aspects for us. This maximizes the benefit you will get from our analysis. CAPAs are defined if required and suggested corrective measures are checked with professional expertise. Their implementation is ensured trough Follow-up Audits.

 

 

 

 

Your benefit by choosing Valicare GMP experts is a deeper understanding of GMP compliance requirements and more calmness and sovereignty in handling audits and inspections.

 

Contact:
Mr Mohsen Masoumi
Senior Project Manager & GMP Consultant
0049 69 7909 346
mohsen.masoumi@valicare.com

2 Responses

  1. Mary Fouad says:

    we are an Egyptian company having the following production line:
    1-solid(Tablets,capsule,oral suspension)
    2- semisolid line(gel,cream,ointment)and external liquid line
    we export to many Arab and African countries and we are preparing to have the European audit to export to European community soon
    so kindly advice what type of audit and preparation service you can provide to us
    what will be the audit team experience ,the supposed audit agenda and audit time frame and the audit cost and details

    • Sandra Petrovic Sandra Petrovic says:

      Dear Mary, thank you for your comment. We forwarded your request to the responsible colleagues who will contact you.

Leave a Reply

*

Top of page