Medicines and Healthcare products Regulatory Agency
CERTIFICATE NUMBER : UK API 12323 Insp GMP/GDP 6464/2814220-0006
Certificate of GMP Compliance Of A Manufacturer(1),(2)
Part 1
Issued following an inspection in accordance with :
Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)
The competent authority of United Kingdom confirms the following :
The Manufacturer :
WAYMADE PLC
Site address :
WAYMADE PLC,
JOSSELIN ROAD,
BURNT MILLS INDUSTRIAL ESTATE,
BASILDON,
SS13 1QF,
UNITED KINGDOM
Is an active substance manufacturer that has been inspected in accordance with Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916).
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 12/12/2018, it is considered that it complies with
- The principles of GMP for active substances referred to in Regulation B17 and C17 of the Human Medicines Regulations 2012 (SI 2012/1916)
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.
- (1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.
- (2) These requirements fulfil the GMP recommendations of WHO.
Part 2
Human Medicinal Products
Manufacture of active substance. Names of substances subject to inspection:
- [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
| 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 or Remarks
Hello
Any restrictions related to the scope of this certificate:
| Building | Room | Line/equipment | QC Testing | Products |
|---|---|---|---|---|
| Building | Room2 | None | None | None |
| 15/04/2019 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |