Uk Mhra Gmp
PAREXEL INTERNATIONAL LIMITEDPAREXEL INTERNATIONAL LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 12689 Insp IMP 12689/27547-0026[I]
Record Details
This Uk Mhra Gmp record concerns PAREXEL INTERNATIONAL LIMITED, with an inspection on October 23, 2025, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- October 23, 2025
- Issued
- November 18, 2025
- MIA number
- UK MIA(IMP) 12689
- Site address
- CLINICAL PHARMACOLOGY RESEARCH UNIT, LEVEL 7, NORTHWICK PARK HOSPITAL, WATFORD ROAD, HARROW, HA1 3UJ, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.1 ] Large volume liquids [ 1.1.1.3 ] Semi-solids [ 1.1.1.4 ] Small volume liquids [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.1 ] Capsules, hard shell [ 1.2.1.5 ] Liquids for external use [ 1.2.1.6 ] Liquids for internal use [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.5 ] Biotechnology products [ 1.4 ] Other products or manufacturing activity [ 1.4.1 ] Manufacture of: [ 1.4.1.3 ] OtherAssemble and Import closed containers of cytostatics/cytotoxics, where there will be minimal risk of exposure/ Importation of QP certified IMPs from a country on the approved country for import list [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.2 ] Capsules, soft shell [ 1.5.1.3 ] Chewing gums [ 1.5.1.5 ] Liquids for external use [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.9 ] Pressurised preparations [ 1.5.1.11 ] Semi-solids [ 1.5.1.12 ] Suppositories [ 1.5.1.13 ] Tablets [ 1.5.2 ] Secondary packaging 2. IMPORTATION OF MEDICINAL PRODUCTS [ 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 [ 2.2.3.5 ] Biotechnology products [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 2.3.2 ] Importation of Intermediate which undergoes further processing [ 2.3.4 ] OtherAssemble and Import closed containers of cytostatics/cytotoxics, where there will be minimal risk of exposure/ Importation of QP certified IMPs from a country on the approved country for import list
- 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. The most recent full scope inspection included cleanrooms on Level 7 of N block. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products The most recent full scope inspection included cleanrooms on Level 7 of N block.
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ID · c69dc29f-e6a2-4666-b7aa-cf6694c2f8d2
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