Uk Mhra Gmp
ONYX SCIENTIFIC LIMITEDONYX SCIENTIFIC LIMITED – UK MHRA GMP Certificate UK API 21540 Insp GMP 21540/606032-0008
Record Details
This Uk Mhra Gmp record concerns ONYX SCIENTIFIC LIMITED, with an inspection on February 27, 2025, issued by the MHRA, covering drugs.
- Company
- ONYX SCIENTIFIC LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- February 27, 2025
- Issued
- February 27, 2025
- MIA number
- UK API 21540
- Site address
- UNITS 95, 96, 97, 98, BUSINESS & INNOVATION CENTRE, WEARFIELD, SUNDERLAND ENTERPRISE PARK, SUNDERLAND, SR5 2TQ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000018046] ACTIVE SUBSTANCES FOR CLINICAL TRIALS Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES ACTIVE SUBSTANCES FOR CLINICAL TRIALS 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Salt formation and purification steps 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Filtration/Drying 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing
- Restrictions
- This certificate is issued based on a desk-based assessment of GMP compliance information provided by the manufacturer. This certificate should be used in combination with the relevant authorisation/registration. A risk-based site inspection programme remains in force.
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ID · 9aec7357-7d02-4316-90b5-d4d3d3b70c6e
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