Uk Mhra Gmp
ALMAC PHARMA SERVICES LIMITEDALMAC PHARMA SERVICES LIMITED – UK MHRA GMP Certificate UK MIA 20782 Insp GMP/GDP/IMP 20782/15328-0018[H]
Record Details
This Uk Mhra Gmp record concerns ALMAC PHARMA SERVICES LIMITED, with an inspection on September 16, 2024, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- September 16, 2024
- Issued
- December 2, 2024
- MIA number
- UK MIA 20782
- Site address
- SEAGOE INDUSTRIAL ESTATE, PORTADOWN, CRAIGAVON, BT63 5UA, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.1 ] Capsules, hard shell [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.13 ] Tablets [ 1.2.1.17 ] Other non-sterile medicinal productsOther solid dosage forms include powders and granules. [ 1.2.2 ] Batch certification [ 1.3 ] Biological medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.4 ] Gene therapy products [ 1.3.2.5 ] Biotechnology products [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.8 ] Other solid dosage forms [ 1.5.1.13 ] Tablets [ 1.5.1.17 ] Other non-sterile medicinal productsOther solid dosage forms include powders and granules. [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.1 ] Quality control testing of imported medicinal products [ 2.1.1 ] Microbiological: sterility [ 2.1.2 ] Microbiological: non-sterility [ 2.1.3 ] Chemical/Physical [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.1.2 ] Terminally sterilised [ 2.2.2 ] Non-sterile products [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 2.3.2 ] Importation of Intermediate which undergoes further processing
- Restrictions
- MIA(IMP) packaging operations are restricted to open label, non-randomised activities. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products This GMP certificate is applicable to operations conducted in buildings 1, 1C, 2, 6, 8, 8a, 8b, 14, 14a, 15, 27b.
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