Uk Mhra Gmp
ALMAC SCIENCES LIMITEDALMAC SCIENCES LIMITED – UK MHRA GMP Certificate UK API 31890 Insp GMP/GDP 31890/383321-0015 [H]
Record Details
This Uk Mhra Gmp record concerns ALMAC SCIENCES LIMITED, with an inspection on December 16, 2019, issued by the MHRA, covering drugs.
- Company
- ALMAC SCIENCES LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP/GDP
- Inspection date
- December 16, 2019
- Issued
- November 5, 2020
- MIA number
- UK API 31890
- Site address
- ALMAC HOUSE, 20 SEAGOE INDUSTRIAL ESTATE, CRAIGAVON, BT63 5QD, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [2000017443] URIDINE TRIACETATE [2000018682] AMIFAMPRIDINE PHOSPHATE [3000017276] SELEXIPAG [1000007809] IOBENGUANE [1000018046] ACTIVE SUBSTANCES FOR CLINICAL TRIALS Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES URIDINE TRIACETATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) crystallisation 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing AMIFAMPRIDINE PHOSPHATE 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) crystallisation 3.5 General Finishing Steps 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) SELEXIPAG 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) crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps micronisation 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing IOBENGUANE 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 3.5 General Finishing Steps 3.5.1 Physical Processing Steps sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.3 Microbiological testing (including sterility testing) ACTIVE SUBSTANCES FOR CLINICAL TRIALS 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates Radiopharmaceuticals 3.1.2 Manufacture Of Crude Active Substance Radiopharmaceuticals 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) crystallisation, distillation, chromatography or similar alternatives Radiopharmaceuticals 3.5 General Finishing Steps 3.5.1 Physical Processing Steps micronisation 3.5.2 Primary Packaging Radiopharmaceuticals 3.5.3 Secondary Packaging Radiopharmaceuticals 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing Radiopharmaceuticals Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products QC testing may also be carried out at ALMAC SCIENCES LIMITED site 16997281 - Block A, Breagh Trade Park, Breagh Drive, Portadown, Craigavon, BT63 5XA, United Kingdom, which operates within the scope of the same Quality Management System.
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ID · 79d1bc16-d083-451b-9d95-8dd71c94ba62
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