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Uk Mhra Gmp
•MW ENCAP LIMITED•February 3, 2025

MW ENCAP LIMITED – UK MHRA GMP Certificate UK MIA 13485 Insp GMP 13485/85964-0014[H]

Record Details

This Uk Mhra Gmp record concerns MW ENCAP LIMITED, with an inspection on February 3, 2025, issued by the MHRA, covering drugs.

Company
MW ENCAP LIMITED
Compliance status
GMPC
Certificate type
GMP
Inspection date
February 3, 2025
Issued
February 3, 2025
MIA number
UK MIA 13485
Site address
UNITS 1-8, OAKBANK PARK WAY, OAKBANK INDUSTRIAL ESTATE, MID CALDER, LIVINGSTON, EH53 0TH, UNITED KINGDOM
Country
UNITED KINGDOM
Products
Human Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 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 [ 1.2.1.17 ] Other non-sterile medicinal productsLarger scale manufacture of Cytotoxics in dedicated high containment facilities. Initial dispensing of drug substance is carried out in an isolation cabinet. Packaging: Strip and/or blister packing [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.6 ] Human or animal extracted products [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.17 ] Other non-sterile medicinal productsCytotoxics [ 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 [ 2.1.3 ] Chemical/Physical [ 2.2 ] Batch certification of imported medicinal products [ 2.2.2 ] Non-sterile products [ 2.3 ] Other Importation Activities [ 2.3.2 ] Importation of Intermediate which undergoes further processing
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 · 73653ced-3250-449d-9384-8137b78fe161

Other documents for MW ENCAP LIMITED
  • 483 - 2018-12-14December 14, 2018

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