Uk Mhra Gmp
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITEDGLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 5866 Insp IMP 5866/21295-0018[I]
Record Details
This Uk Mhra Gmp record concerns GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED, with an inspection on November 25, 2021, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- IMP
- Inspection date
- November 25, 2021
- Issued
- February 10, 2022
- MIA number
- UK MIA(IMP) 5866
- Site address
- THIRD AVENUE, HARLOW, CM19 5AW, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Investigational Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.5 ] Biotechnology products [ 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 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.1.2 ] Terminally sterilised [ 2.2.2 ] Non-sterile products [ 2.2.3 ] Biological medicinal products [ 2.2.3.5 ] Biotechnology products [ 2.2.3.8 ] Other biological medicinal productsSynthetic Proteins [ 2.3 ] Other Importation Activities [ 2.3.4 ] OtherAuthorised for Importation of QP certified IMPs from a country on the approved country for import li
- Restrictions
- MIA GMP certification: the approval status is restricted to named patient supply to non-EU countries (no formal/commercial MIA activities undertaken on site). MIA (IMP) GMP certification: the approval status is restricted to small-scale, phase 1 manufacture. This was a focused remote inspection following a variation to add oversight process for IMP from listed countries of liquid and semisolid formulations.
View Company Profile
ID · 67453115-5fee-4156-8fc1-67e5446ca44c
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.