Uk Mhra Gmp
PIRAMAL HEALTHCARE UK LIMITEDPIRAMAL HEALTHCARE UK LIMITED – UK MHRA GMP Certificate UK API 29595 Insp GMP/GDP/IMP 29595/18244-0044
Record Details
This Uk Mhra Gmp record concerns PIRAMAL HEALTHCARE UK LIMITED, with an inspection on December 23, 2024, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 23, 2024
- Issued
- December 23, 2024
- MIA number
- UK API 29595
- Site address
- WHALTON ROAD, MORPETH, NE61 3YA, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000009436] SPIRONOLACTONE [4000014458] MISOPROSTOL:HYPROMELLOSE 1:100 DISPERSION [4000007373] CANRENOATE POTASSIUM [2000005830] PARECOXIB SODIUM [1000009076] MISOPROSTOL [4000014629] FERRIC TRIMALTOL [1000018194] FOSTEMSAVIR Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES SPIRONOLACTONE 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 3.5 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 3.6.2 Microbiological testing (excluding sterility testing) MISOPROSTOL:HYPROMELLOSE 1:100 DISPERSION 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) .HPLC column purification (of misoprostol) 3.5 General Finishing Steps 3.5.1 Physical Processing Steps .Dispersing of Misoprostol pure with Hypromellose, milling. 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) CANRENOATE POTASSIUM 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 .Drying 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) PARECOXIB SODIUM 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 optional recrystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, sieving 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) MISOPROSTOL 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) .HPLC column purification 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) FERRIC TRIMALTOL 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Milled 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) FOSTEMSAVIR 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates Other : Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. 3.1.2 Manufacture Of Crude Active Substance Other : Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation Other : Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Milling Other : Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility and manufacturing controls have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. 3.5.2 Primary Packaging Other : Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility, manufacturing controls and packaging have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. 3.5.3 Secondary Packaging Other : Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility, manufacturing controls and packaging have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring. 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing Other : Fostemsavir is not a B-Lactam Antibiotic, however degradation products containing a B-Lactam ring structure have the potential to form in the solid state in the presence of light during manufacture and storage of the final intermediate, Phosphoester and the API Fostemsavir. Facility, manufacturing controls, packaging and QC testing facilities have been designed to mitigate the risk of potential formation and cross-contamination of photo-degradation products containing a B-Lactam ring.
- 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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