Jetpharma Quality System is in perfect compliance with:
- cGMP (ICH Q7)
- Federal Laws and Ordinances for Manufacturers of Pharmaceutical Products
- Internal SOPs
- ISO 9001
- 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.
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