Uk Mhra Gmp
EUROFINS SELCIA LIMITEDEUROFINS SELCIA LIMITED – UK MHRA GMP Certificate UK API 27830 Insp GMP 27830/119738-0012
Record Details
This Uk Mhra Gmp record concerns EUROFINS SELCIA LIMITED, with an inspection on November 22, 2021, issued by the MHRA, covering drugs.
- Company
- EUROFINS SELCIA LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 22, 2021
- Issued
- January 17, 2022
- MIA number
- UK API 27830
- Site address
- FYFIELD BUSINESS AND RESEARCH PARK, FYFIELD ROAD, ONGAR, CM5 0GS, 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) Small scale crystallisation 3.1.4 Other Carbon-14 labelling of APIs for Clinical Trials 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 4 Other Activities Carbon-14 labelling of APIs for Clinical Trials Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Manufacture in GMP suite (Rooms 131/132, 133, 134), QC Testing Room 013 Preparation and 14C labelling of APIs for Clinical trials
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ID · 0ce4feb4-6930-4174-8761-d762234e3559
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