GMPhar Consultants for the Industry
Pharmaceutical, Medical Devices
Cosmetic and Food

Noviembre

EDUCACIÓN A DISTANCIA

PRESENTACIÓN DE CURSOS ON-LINE

normas GMP&L

ver demo en www.gmphar-cursos.com.ar

 

ver más información en 

 CAPACITACIÓN

 

 

La Importancia de la Validacion

Microbiológica en los Sistemas de

Agua Purificada 

Por la Dra. Nora Rabinovich

Click Aquí

Address: Gualeguaychu 1718/20 (C1407ALL) Ciudad Autónoma de Buenos Aires - Argentina. Tel.:+54(11)4566-4968/4504-5641

-GMPhar Consultants for the Industry Microbiological Quality Control-
 

LABORATORY QUALITY CONTROL / QUALITY ASSURANCE CONTROL

  • Development of microbiological methods:
    • Sterile and no-sterile pharmaceuticals control, including medical devices.
    • LAL Test.
    • Preservative Efficacy Test.
    • Antibiotics Potency Testing.
    • Culture Media Control
    • Biological Control.

  • SOPs preparation.
  • Plan design and supervision of method validations.
  • Advising on basic equipment for Microbiological Control labs.
  • Inner audits or adviser for external/official audits.

MANUFACTURING AREA / QUALITY ASSURANCE

  • Microbiological validations of:
    • Treatment Water Systems (PWS / WFI / Drinking Water for lab animals).
    • Autoclaves sterilization (dry and steam system) in labs and in manufacturing supporting areas.
    • Radiation sterilization systems (nitrous oxide, gamma irradiation, etc.)
    • Aseptic Filling (AFV).

  • Isolators sterilization.
  • Environmental Control Program and mirobiological methods validation.
  • “Tree Decisions” design and procedures for microbiological Out Of Specifications (OOS) limits .
  • Diagnosis and prospecting measures for contamination troubles in:
    • Manufacturing area.
    • PW systems.


Español