bela-pharm GmbH & Co. KG possesses a production permit for the commercial production of pharmaceuticals in accordance with German Pharmaceutical Law. The review of this permit generally occurs every two years through the competent inspector and also encompasses the review of abidance to GMP (Good Manufacturing Practice) rules.
bela-pharm GmbH & Co. KG is entitled to produce medicines and veterinary medicines in the following pharmaceutical forms:
1. Powder
2. Solutions
3. Emulsions
4. Suspensions
5. Ointments
The pharmaceutical forms 1 to 4 may also be produced for parenteral application.
For this purpose, the different types of agents are processed in accordance with procedures for workplace safety and environmental protection:
• Antibiotics
• Chemotherapeuticals
• Local anaesthetics
• Analgesics
• Hormones
• Vitamins
• Minerals and electrolytes
• Homeopathics
The modern production facilities, manufacturing processes and control mechanisms, which come into effect, ensure adherence to the required quality specifications:
• Filling through micro processor controlled units
• Automated bottle capping, sealing, boxing and final packing
• Final sterilisation of sterile products in water irrigated autoclaves
Thereby, the following filling quantities are produced:
• Injectables - 1 ml ti 250 ml
• Infusion solutions - 250 ml to 10 L
• Oral solutions - 10 ml to 10 L
• Pre-mixed medicines and powder - 1 g to 25 kg |
