From Critical Findings to Exemplary Status: Strategic GMP Turnaround for Pharmacies

Restoring Production Licenses and Building Sustainable Quality Systems for Compounding & Manufacturing Pharmacies in Switzerland.

Top: Glass jars filled with dried herbs on a wooden shelf near a window with sunlight; Bottom: Scientist working in a laboratory with a laminar flow hood, wearing protective gear, with laboratory equipment and illuminated signal lights.

Pharma-Grade Excellence for Compounding Pharmacies: Swiss Compliance, Redefined.

Business meeting with six people sitting around a glass conference table, with a document labeled "CAPA Plan" in the foreground, and a presentation screen displaying a bar chart in the background.

Crisis Management & Remediation

Immediate response to authority findings and developing a robust Corrective and Preventive Action (CAPA) plan.

A pyramid display with three levels labeled 'Records', 'SOPs', and 'Quality Manual' in a modern laboratory setting, with red glowing lines wrapping around the pyramid.

QMS Build-up from Scratch

Replacing outdated structures with a modern, inspection-ready QMS and fresh SOPs.

A stainless steel qualification protocol document on a clipboard with a 'Validated' seal, placed under a laboratory oven or sterilizer in a scientific laboratory.

Technical Compliance

Creation of Validation Master Plans (VMP), equipment qualification (IQ/OQ/PQ), and strategic procurement of new laboratory technology.

Success Story: Production Restart after Authority Suspension

In a recent high-stakes project, I supported a manufacturing pharmacy that had its production halted due to over 30 critical and major findings. Within just 12 months, we transformed the entire operation. The follow-up inspection resulted in an 'exemplary' rating, and the production license was fully restored.

  • A: Yes. A systematic turnaround is possible. By addressing the root causes of the findings—ranging from structural flaws to documentation gaps—we can build a remediation path that restores authority confidence and your production license.

  • A: I specialize in pragmatic "Retrofit Compliance." We analyze existing airlocks and cleanroom flows to find the most efficient way to meet current GMP standards without necessarily needing a completely new building.

  • A: The VMP is your "Shield" during an inspection. It proves to the authorities that you have a strategic grip on your equipment and processes. I provide the architecture for these plans, ensuring every new and existing device is qualified according to a risk-based approach.