Pharma Production Site

(BIO-)PHARMACEUTICAL PRODUCTS

(Bio-) pharmaceutical companies face growing competitive and environmental pressure. Additionally, the regulatory requirement increases with the time. These challenges make up the day to day environment of modern (bio-) pharmaceutical companies.

PMS supports you in an efficient way and offers you compliant solutions based on risk- approach and focusing on the essential safety and quality aspects for the following aspects:

  • Accompaniment of start-up from scratch up to GMP certification
  • Trouble shooting for any technical, quality or regulatory aspect for well established (bio )pharmaceutical companies
  • Human resources issues for operational functions like qualified person, QA & RA Manager, qualification specialist

Services

  • Support for quality and regulatory aspects
  • Support in the construction and upgrade of the manufacturing facility
    - Conceptual design
    - Clean room qualification from URS (User Requirements Specifications) up to Performance Qualification (URS-DQ-IQ-OQ-PQ)
  • Representative functions such as contracted Qualified Person or Quality Manager
  • Risk assessments
  • Mock audit and third-party audit
  • Media fill design (validation of aseptic process)
  • Systems qualification
  • Computer system validation
  • Process and cleaning validation
  • Training
  • Process development using Quality by Design approach
  • Clinical Affairs