Uk Mhra Gmp
CONCEPT LIFE SCIENCES INTEGRATED DISCOVERY AND DEVELOPMENT SERVICES LIMITEDCONCEPT LIFE SCIENCES INTEGRATED DISCOVERY AND DEVELOPMENT SERVICES LIMITED – UK MHRA GMP Certificate UK API 48975 Insp GMP 48975/19230206-0007
Record Details
This Uk Mhra Gmp record concerns CONCEPT LIFE SCIENCES INTEGRATED DISCOVERY AND DEVELOPMENT SERVICES LIMITED, with an inspection on June 22, 2021, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- June 22, 2021
- Issued
- April 17, 2023
- MIA number
- UK API 48975
- Site address
- DISCOVERY PARK HOUSE, RAMSGATE ROAD, SANDWICH, CT13 9ND, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000018046] ACTIVE SUBSTANCES FOR CLINICAL TRIALS Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES ACTIVE SUBSTANCES FOR CLINICAL TRIALS 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation, recrystallisation, filtration, salt formation 3.1.4 Other Polymorph transformation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Crystallisation, recrystallisation, polymorph transformation, filtration, drying 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing
- Restrictions
- Manufacture of APIs for use in clinical trials in B530 and B910 is certified. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Manufacture of APIs for use in clinical trials in B530 and B910 is certified.
View Company Profile
ID · 73f841e6-ddaa-4ba2-af62-547e7eb90516
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.