Quality System

Jetpharma Quality System is in perfect compliance with:

  • cGMP (ICH Q7)
  • Federal Laws and Ordinances for Manufacturers of Pharmaceutical Products
  • Internal SOPs
  • ISO 9001:2008 Guideline
  • Health & Environment Protection Policy and Procedures.

Jetpharma Quality Assurance Unit:

  • verifies continuous compliance to cGMPs and SOPs
  • verifies that product identity, strength, quality and purity are maintained during the whole time the product is on site
  • assures continuous support to Customers, providing documents needed For Submissions
  • coordinates the Validation Activities (micronization process validation, PSD analytical method validation)
  • continuously trains employees on cGMP issues and SOPs.

Safety

Our Plant is equipped with following safety cabins CLEAN ROOM: ISO 8 (Class 100,000): qualified on a regular basis, designed to offer the best environment for handling pharmaceutical products, avoiding environmental contamination and preventing product cross-contamination. ISOLATORS: Glove Box & Half-Suite Box.

For all activities that need to be contained, JETPHARMA will ensure:

  • Complete avoidance of cross-contamination and mix-ups
  • No release of hazardous substances into the environment
  • Protection of the active ingredient, operators and surrounding area.

The capabilities of our isolators:

  • Containment level below 25 ng/m3 – 3rd party verified
  • Wide range of available handling options; packaging up to 120 litre drums
  • Fast operations and quick lead times
  • Milling flexibility provided by different types and sizes of mill
  • Choose from different activities like jet milling, sieving, pin milling, PSD analyses, dispensing, packaging under an inert environment

Jetpharma SA

Via Sottobisio 42a/c
CH-6828 Balerna
Switzerland

+41 (0)91 696 10 10

contact(at)jetpharma.com

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