Meeting the demanding legal regulations and expectations of the pharmaceutical market requires improvement of the quality assurance system in all areas of the company. The highest quality and safety of our production is confirmed by GMP certificates, and in some faculties also FDA. Observance of quality standards requires the staff employed to be committed, diligence and continuous improvement of qualifications.
Production and quality
The Quality Assurance System is fully adapted to the requirements of Polish pharmaceutical legislation and complies with the regulations governing the production of pharmaceutical products in force in the European Union. Activities are carried out to ensure the quality and maintenance of GMP standards and meet the requirements arising from the development of new pharmaceutical forms. As part of the Quality Management Division, the functions are performed by the Quality Assurance Department and the Quality Control Department.
The Quality Assurance Department is responsible for creating, developing, coordinating and managing the entirety of issues related to the Pharmaceutical Quality System. Quality Control is an integral part of the Pharmaceutical Quality System. This department has a modern laboratory facilities where, among other things, physicochemical, microbiological and pharmacological tests are performed, laboratories meet EU standards in the scope of performing analyzes, validation of analytical methods, quality certification, and contract analysis.
Certificates and other key documents:
- GMP CERTIFICATE issued by the Main Pharmaceutical Inspectorate for sterile forms of medicinal products (lyophilisates, liquid forms of small volume and solid forms)
- GMP CERTIFICATE issued by the Main Pharmaceutical Inspectorate for liquid and semi-solid, including aseptically produced, forms of medicinal products
- GMP CERTIFICATE issued by the Main Pharmaceutical Inspectorate for solid forms of medicinal products (tablets, capsules in a hard shell)
- GMP CERTIFICATE issued by the Main Pharmaceutical Inspectorate for liquid and semi-solid investigational medicinal products
- GMP CERTIFICATE issued by the Main Pharmaceutical Inspectorate for imported medicinal products for people
- GMP CERTIFICATE issued by the Main Pharmaceutical Inspectorate for quality control tests for medicinal products for human use
- U.S. Approval Food and Drug Administration published by the US Food and Drug Administration for sterile liquid forms and solid forms of medicinal products for the American market
- GDP CERTIFICATE distributor of active substances
- RUSSIAN GMP CERTIFICATE issued for Jelfa S.A.
- PRODUCTION OR IMPORT AUTHORIZATION for a medicinal product
- CERTIFICATE OF THE ENTRY TO THE NATIONAL REGISTER OF MANUFACTURERS, IMPORTERS AND DISTRIBUTORS active substances
- PERMIT FOR MANUFACTURE, PROCESSING AND PROCESSING psychotropic substances of II-P and IV-P and I-N narcotic drugs
Contract production:
As part of our business, we can offer professional contract manufacturing services of medicines, dietary supplements, cosmetics and medical devices.
We invite you to the contract production website that our company can provide for you, as well as other record companies in Poland included in Valeant Pharmaceuticals International .
https://bausch-contract.com/
As part of our business, we can offer professional contract manufacturing services of medicines, dietary supplements, cosmetics and medical devices.
We invite you to the contract production website that our company can provide for you, as well as other record companies in Poland included in Valeant Pharmaceuticals International .
https://bausch-contract.com/
Report a side effect:
The form should be printed, enter all information you have about the side effect, if the applicant is a doctor or pharmacist, please sign and seal.
Injury report form for the doctor
Report a patient’s adverse reaction form
The application can be sent to the postal address, by fax or e-mail:
Medical Department
Valeant Pharma Poland sp. O.o.
ul. Przemysłowa 2
35-959 Rzeszów
fax: + 48 44 789 00 36
e-mail: activities.noexposed@valeant.com
You can also report an adverse reaction by phone:
+ 48 724 182 068
Patients may also report side effects directly to the attending physician.
Information for the patient on reporting side effects
The form should be printed, enter all information you have about the side effect, if the applicant is a doctor or pharmacist, please sign and seal.
Injury report form for the doctor
Report a patient’s adverse reaction form
The application can be sent to the postal address, by fax or e-mail:
Medical Department
Valeant Pharma Poland sp. O.o.
ul. Przemysłowa 2
35-959 Rzeszów
fax: + 48 44 789 00 36
e-mail: activities.noexposed@valeant.com
You can also report an adverse reaction by phone:
+ 48 724 182 068
Patients may also report side effects directly to the attending physician.
Information for the patient on reporting side effects
Jelfa S.A. Pharmaceutical Company
Jelenia Góra
Jelenia Góra
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland
58-500 Jelenia Góra
Poland
+48 75 64 33 100
+48 75 64 33 102
+48 75 64 33 103
+48 75 64 33 102
+48 75 64 33 103
