Uk Mhra Gmp
ELANCO SPEKE OPERATIONSELANCO SPEKE OPERATIONS – UK MHRA GMP Certificate UK ManA 50813 Insp GMP 50813/16842-0018[V]
Record Details
This Uk Mhra Gmp record concerns ELANCO SPEKE OPERATIONS, with an inspection on June 12, 2018, issued by the MHRA, covering veterinary.
- Company
- ELANCO SPEKE OPERATIONS
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- June 12, 2018
- Issued
- May 21, 2019
- MIA number
- UK ManA 50813
- Site address
- FLEMING ROAD, SPEKE, LIVERPOOL, L24 9LN, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Veterinary 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) [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.16 ] Veterinary premixes [ 1.2.2 ] Batch certification [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.3 ] OtherManufacturing of pegbovigrastim ( PEG-bGCSF ) API and importation of pegbovigrastim ( PEG-bGCSF ) grpegbovigrastim ( PEG-bGCSF ) API. [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical [ 1.6.4 ] Biological 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.1 ] Quality control testing of imported medicinal products [ 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 [ 2.2.3 ] Biological medicinal products [ 2.2.3.2 ] Immunological products [ 2.2.3.8 ] Other biological medicinal productsVaccines [ 2.3 ] Other Importation Activities [ 2.3.4 ] OtherManufacturing of pegbovigrastim ( PEG-bGCSF ) API and importation of pegbovigrastim ( PEG-bGCSF ) gr
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ID · 1ba8aab4-c491-41d8-bf4f-31044c06f8b1
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