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Uk Mhra Gmp
•PIRAMAL HEALTHCARE UK LIMITED•December 23, 2024

PIRAMAL HEALTHCARE UK LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 29595 Insp GMP/GDP/IMP 29595/18244-0044[I]

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.

Company
PIRAMAL HEALTHCARE UK LIMITED
Compliance status
GMPC
Certificate type
GMP
Inspection date
December 23, 2024
Issued
December 23, 2024
MIA number
UK MIA(IMP) 29595
Site address
WHALTON ROAD, MORPETH, NE61 3YA, UNITED KINGDOM
Country
UNITED KINGDOM
Products
Human Investigational Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 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 [ 1.2.1.13 ] TabletsRange of hormonal property tablets [ 1.2.1.17 ] Other non-sterile medicinal productsTablet/ medical device combination. Over encapsulation of a rangedosage forms [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.5 ] Biotechnology products [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.13 ] Tablets [ 1.5.1.17 ] Other non-sterile medicinal productsPackaging of a range of over encapsulated range of products. Packaging of tablet/ medical device combination [ 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 [ 2.1.2 ] 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 [ 2.2.3.5 ] 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 ] OtherBatch Certification of products imported into EU but not to the Piramal Morpeth site
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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ID · 16f53c74-f1e0-440b-9d16-9d00c7415f24

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