Uk Mhra Gmp
CELADON PHARMA LIMITEDCELADON PHARMA LIMITED – UK MHRA GMP Certificate UK API 50530 Insp GMP 50530/18599281-0004
Record Details
This Uk Mhra Gmp record concerns CELADON PHARMA LIMITED, with an inspection on October 19, 2022, issued by the MHRA, covering drugs.
- Company
- CELADON PHARMA LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- October 19, 2022
- Issued
- January 13, 2023
- MIA number
- UK API 50530
- Site address
- 13 HOLFORD ESTATE, TAMESIDE DRIVE, BIRMINGHAM, B6 7AY, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [2000019058] TETRAHYDROCANNABINOLIC ACID A [1000020244] CANNABIGEROL [1000020248] TETRAHYDROCANNABIVARINIC ACID [1000020241] TETRAHYDROCANNABINOLIC ACID B [1000000540] CANNABIDIOL [1000020246] CANNABICHROMENE [1000017580] CANNABIDIVARIN [1000020243] CANNABIGEROLIC ACID [1000020247] CANNABIDIVARINIC ACID [3000020337] TETRAHYDROCANNABIVARIN [1000020245] CANNABICHROMENIC ACID [1000020242] CANNABIDIOLIC ACID [1000020249] CANNABINOL Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES TETRAHYDROCANNABINOLIC ACID A 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABIGEROL 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) TETRAHYDROCANNABIVARINIC ACID 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) TETRAHYDROCANNABINOLIC ACID B 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABIDIOL 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABICHROMENE 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABIDIVARIN 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABIGEROLIC ACID 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABIDIVARINIC ACID 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) TETRAHYDROCANNABIVARIN 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABICHROMENIC ACID 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABIDIOLIC ACID 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CANNABINOL 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Cannabis plant material will be dried, comminuted and extracted using a food-grade triglyceride oil. The resulting extract will be filtered and clarified, then adjusted with food-grade triglyceride oil or polyhydric alcohol to a standard THCA. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing)
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