Uk Mhra Gmp
MAC RESEARCH LIMITED - MAC CLINICAL RESEARCHMAC RESEARCH LIMITED - MAC CLINICAL RESEARCH – UK MHRA GMP Certificate UK MIA(IMP) 48101 Insp IMP 48101/16778860-0005[I]
Record Details
This Uk Mhra Gmp record concerns MAC RESEARCH LIMITED - MAC CLINICAL RESEARCH, with an inspection on November 15, 2022, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- November 15, 2022
- Issued
- November 15, 2022
- MIA number
- UK MIA(IMP) 48101
- Site address
- MONARCH HOUSE, WAKEFIELD ROAD, LEEDS, LS10 1DP, 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 [ 1.1.1.4 ] Small volume liquids [ 1.1.1.6 ] Other aseptically prepared productsManipulation of previously formulated products e.g. cytotoxics and monoclonal antibodies, GMOs and vaccines. [ 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 [ 1.2.1.6 ] Liquids for internal use [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.17 ] Other non-sterile medicinal productsWeighing and mixing of drug substance into individual subject dose containers [ 1.2.2 ] Batch certification [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.2 ] Capsules, soft shell [ 1.5.1.5 ] Liquids for external use [ 1.5.1.6 ] Liquids for internal use [ 1.5.1.8 ] Other solid dosage forms [ 1.5.1.11 ] Semi-solids [ 1.5.1.13 ] Tablets [ 1.5.1.17 ] Other non-sterile medicinal productsWeighing and mixing of drug substance into individual subject dose containers [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.3 ] Chemical/Physical
- Restrictions
- This was a targeted remote inspection for the addition of non-sterile liquid manufacture and supplements the previous inspection in August 2021. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Testing activity limited to visual appearance and visible particles. No analytical testing conducted on site.
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ID · 8d850342-7101-4ebe-8f35-61538feec7b7
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