Uk Mhra Gmp
RELIANCE LIFE SCIENCES PRIVATE LIMITED (PLANT 6)RELIANCE LIFE SCIENCES PRIVATE LIMITED (PLANT 6) – UK MHRA GMP Certificate UK GMP 41432 Insp GMP 41432/6618812-0005[H]
Record Details
This Uk Mhra Gmp record concerns RELIANCE LIFE SCIENCES PRIVATE LIMITED (PLANT 6), with an inspection on August 6, 2018, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- August 6, 2018
- Issued
- February 8, 2019
- MIA number
- UK GMP 41432
- Site address
- DHIRUBHAI AMBANI LIFE SCIENCE CENTRE (DALC), THANE, BELAPUR ROAD, RABALE, NAVI MUMBAI, IN-400701, 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) [ 1.1.1.2 ] Lyophilisates [ 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 [ 1.5 ] Packaging [ 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
- Plant 6 only is approved for the manufacture and packaging of non-sterile oncology products and sterile product manufacture is approved on Fourth Floor of Plant 6. Dispensing of API in Plant 3 and the use of the Central Store building are approved. QC testing in Plant 3, Stability chambers located in the 'South Block' building, Sterility and associated QC testing on second floor of North Block are approved. Note: The approval to manufacture products includes approval for primary packaging of the product.
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ID · 5ee32f51-9cdd-4597-82d5-3f6bb984f8ca
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