Uk Mhra Gmp
STERIL GENE LIFE SCIENCES PRIVATE LIMITEDSTERIL GENE LIFE SCIENCES PRIVATE LIMITED – UK MHRA GMP Certificate UK GMP 44621 Insp GMP 44621/35425718-0003[H]
Record Details
This Uk Mhra Gmp record concerns STERIL GENE LIFE SCIENCES PRIVATE LIMITED, with an inspection on February 5, 2024, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- February 5, 2024
- Issued
- August 14, 2024
- MIA number
- UK GMP 44621
- Site address
- NO. 45, MAIN ROAD, MANGALAM VILLAGE, VILLIANUR COMMUNE, PUDUCHERRY, IN-605110, INDIA
- Country
- INDIA
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.4 ] Small volume liquids [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.3 ] Small volume liquids [ 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 [ 1.2.1.13 ] Tablets [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.2 ] Dry heat [ 1.4.2.3 ] Moist heat [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.13 ] Tablets [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
- Restrictions
- Activities covered by this GMP certificate are limited to: Block C (for manufacturing of small volume sterile products aseptically prepared and terminally sterilised); Block D (ground floor for non potent non sterile products, first floor for microbiology laboratory, and second floor for potent non sterile products); Block J (third floor for quality control analytical/physical testing); Block A (for manufacturing of capsules); and Block B (first floor for manufacturing of hormone non sterile products).
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ID · 3212a23b-27d5-4292-a983-7dbc6b2d4e5e
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