(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
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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