New Solid dosage forms plant

REPHINE SPEECH MARKS OPEN GXPCONSULTANCY

The development of a project for a new
pharmaceutical manufacturing plant with our
consultants will allow you having a plant with an
appropriate design to fulfill GMP requirements and
minimise risks of contamination as well as meeting
the current qualification and validation standards.

REPHINE SPEECH MARKS CLOSE GXPCONSULTANCY

About this Case Study

An international pharmaceutical company in Portugal expanded its operations with a new solid dosage form plant to serve the EU and US markets. The project involved establishing a Validation Master Plan, reviewing GMP compliance, and implementing qualification protocols for equipment, utilities, and cleaning methods. The facility was designed to minimise contamination risks and ensure GMP compliance, meeting both local and international regulatory standards.

Discover how our consultants helped streamline the process and ensure seamless project delivery—read more to see how we supported the client in achieving their goals.

Download the full case study now.

Download the Case Study

View other our other resources and company news

GMP Design Review Guide header image CSV

REMS Program Audits: Ensuring Safety and Compliance

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
AI CSV Jan 2025 blog Blog

Considerations for the Use of Artificial Intelligence in Regulatory Decision-Making for Drugs and Biological Products

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.
Read More
AIQSV guide header image CSV

Streamlining Analytical Instrument Qualification & System Validation (AIQSV) Guide

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
GMP Design Review Guide header image CSV

GMP Design Review – A Comprehensive Guide to Ensuring Compliance from Concept to Completion

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
mock inspection blog header Blog

Mock Inspections: How to Prepare for FDA Compliance in the OTC Market

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.
Read More
GSPR MedTech guide header image CSV

Essential Guide to EU GSPR Compliance for Medical Devices

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Cloud systems maintenance guide header image CSV

Maintaining Cloud Systems – A Continuous Effort

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Close up of nurse holding and typing on tablet Case Study

New Solid dosage forms plant

The development of a project for a newpharmaceutical manufacturing plant with ourconsultants will allow you having a plant with anappropriate design to fulfill GMP requirements ...
Read More
Doctor Article

Maintaining Data Integrity with Digital Validation

The importance of data integrity is a widely discussed issue. There has been a rise in regulatory bodies like the FDA and WHO auditors focusing ...
Read More
Contact Us