Uk Mhra Gmp
WAYMADE PLCWAYMADE PLC – UK MHRA GMP Certificate UK API 12323 Insp GMP/GDP 6464/2814220-0006
Record Details
This Uk Mhra Gmp record concerns WAYMADE PLC, with an inspection on December 12, 2018, issued by the MHRA, covering drugs.
- Company
- WAYMADE PLC
- Compliance status
- GMPC
- Certificate type
- GMP/GDP
- Inspection date
- December 12, 2018
- Issued
- April 15, 2019
- MIA number
- UK API 12323
- Site address
- JOSSELIN ROAD, BURNT MILLS INDUSTRIAL ESTATE, BASILDON, SS13 1QF, UNITED KINGDOM
- Country
- UNITED KINGDOM
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000003268] IBANDRONIC ACID [1000003309] DOXEPIN [1000004171] CLOBAZAM [2000007338] HYDROCORTISONE ACETATE [3000004591] ESTRIOL [1000009701] NAPROXEN [2000006651] CHLORAL BETAINE [2000008148] GRANISETRON HYDROCHLORIDE [1000004182] CLIOQUINOL [2000007602] ERYTHROMYCIN STEARATE [4000014974] POTASSIUM CLAVULANATE - AVICEL BLEND (1:1) [1000009500] BENZYL BENZOATE [2000007339] HYDRALAZINE HYDROCHLORIDE [1000000089] METHYLDOPA [2000007430] AURANOFIN Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES IBANDRONIC ACID 3.2 Processing Activities of Active Substance from Natural Sources 3.2.7 Other r23r B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : r23r32 DOXEPIN 3.2 Processing Activities of Active Substance from Natural Sources 3.2.1 Plant Source Extraction B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : rfe CLOBAZAM 3.3 Manufacture of Active Substance using Biological Processes 3.3.3 Isolation / Purification B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 4234 HYDROCORTISONE ACETATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.4 Manufacture of sterile active substance 3.4.1 Aseptically prepared B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 423 3.4.2 Terminally sterilised B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 4234 ESTRIOL 3.2 Processing Activities of Active Substance from Natural Sources 3.2.3 Human Source Extraction B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : r34r34 3.2.5 Modification of extracted substance B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : r34r34 3.2.6 Purification of extracted substance B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : r34r34 NAPROXEN 3.3 Manufacture of Active Substance using Biological Processes 3.3.2 Cell Culture 42342 B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 4234 CHLORAL BETAINE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) freferf B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : fewfew GRANISETRON HYDROCHLORIDE 3.3 Manufacture of Active Substance using Biological Processes 3.3.5 Other 432432 B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 423 CLIOQUINOL 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.4 Other r32r23r2 B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : r32r32 ERYTHROMYCIN STEARATE 3.2 Processing Activities of Active Substance from Natural Sources 3.2.2 Animal Source Extraction B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : fef 3.2.5 Modification of extracted substance B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : fef 3.2.6 Purification of extracted substance B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : fef POTASSIUM CLAVULANATE - AVICEL BLEND (1:1) 3.3 Manufacture of Active Substance using Biological Processes 3.3.4 Modification B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 423423 BENZYL BENZOATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.2 Manufacture Of Crude Active Substance B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : fwefew 3.3 Manufacture of Active Substance using Biological Processes 3.3.1 Fermentation HYDRALAZINE HYDROCHLORIDE 3.2 Processing Activities of Active Substance from Natural Sources 3.2.4 Mineral Source Extraction B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : e23e 3.2.5 Modification of extracted substance B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : e23e 3.2.6 Purification of extracted substance B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : e23e METHYLDOPA 3.3 Manufacture of Active Substance using Biological Processes 3.3.1 Fermentation B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 423423 AURANOFIN 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 5tr4 3.4 Manufacture of sterile active substance 3.4.1 Aseptically prepared B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 54t54t 3.4.2 Terminally sterilised B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : t54t45 3.5 General Finishing Steps 3.5.1 Physical Processing Steps t54gt54g B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 45t4 3.5.2 Primary Packaging B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : t45t4 3.5.3 Secondary Packaging B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 45t45 3.5.4 Other g54g54 B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 45t45t 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 645645 3.6.2 Microbiological testing (excluding sterility testing) B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : 4646 3.6.3 Microbiological testing (including sterility testing) B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : t54t45 3.6.4 Biological Testing B-lactam Antibiotics Other highly sensitising antibiotics Live Cells Pathogenic Organisms (Biosafety Level 3 or 4) Radiopharmaceuticals Ectoparasiticides Other : t54t45
- Restrictions
- Hello Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Building Room2 None None None
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ID · 2a45980b-3d4b-46f1-91dc-c7c257c5a670
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