Uk Mhra Gmp
PFIZER HEALTHCARE INDIA PRIVATE LIMITEDPFIZER HEALTHCARE INDIA PRIVATE LIMITED – UK MHRA GMP Certificate UK API 49859 Insp GMP 49859/122060-0004
Record Details
This Uk Mhra Gmp record concerns PFIZER HEALTHCARE INDIA PRIVATE LIMITED, with an inspection on June 27, 2018, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- June 27, 2018
- Issued
- October 22, 2018
- MIA number
- UK API 49859
- Site address
- L-8 & L-9, MIDC INDUSTRIAL AREA, WALUJ, AURANGABAD, IN-431136, INDIA
- Country
- INDIA
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000002970] MEROPENEM [1000004383] CILASTATIN [1000008812] IMIPENEM Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES MEROPENEM 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) 3.6.3 Microbiological testing (including sterility testing) CILASTATIN 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) 3.6.3 Microbiological testing (including sterility testing) IMIPENEM 3.5 General Finishing Steps 3.5.2 Primary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) 3.6.3 Microbiological testing (including sterility testing) Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Areas of the facility for the manufacture of sterile APIs (Block 32) and supporting QC & storage areas were included in the scope of this inspection. Sterile APIs for EU supply: Meropenem and Imipenem/Cilastatin were covered by this inspection.
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ID · 56e93d90-d069-4506-8cd8-efa0a5405432
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