Uk Mhra Gmp
CATALENT ARGENTINA SAICCATALENT ARGENTINA SAIC – UK MHRA GMP Certificate UK GMP 27463 Insp GMP 27463/1379941-0010[H]
Record Details
This Uk Mhra Gmp record concerns CATALENT ARGENTINA SAIC, with an inspection on June 15, 2015, issued by the MHRA, covering drugs.
- Company
- CATALENT ARGENTINA SAIC
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- June 15, 2015
- Issued
- September 21, 2018
- MIA number
- UK GMP 27463
- Site address
- AVENIDA MARQUEZ 691, VILLA LOMA HERMOSA, AR-B1657CSA, ARGENTINA
- Country
- ARGENTINA
- 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) [ 1.2.1.2 ] Capsules, soft shell [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
- Restrictions
- 21/09/2018: In accordance with the Compilation of Community Procedures (EMA/572454/2014 Rev 17), following a risk-based review of GMP compliance information, the MHRA as the issuing authority confirm that this certificate based on the inspection conducted 2015-06-15 remains valid and can be utilized to support regulatory submissions until a subsequent inspection has been conducted.
View Company Profile
ID · 62f53bc9-79d0-4f15-b62a-9bc954fa662f
Other documents for CATALENT ARGENTINA SAIC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.