MedSpace

Important of sampling during blending: Sampling plays a great role in achieving the accurate results of analysis. Sampling must and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activities start. Samples are representative of the whole batch. So it should be handled and weight carefully because segregation may occur during weighing and transpiration. Sample quantity should not be more than the required and whole mass sample should be used in the analysis. Fig: Blending Machine Sampling for blend: Blends are tested for their homogeneity. Homogeneity of the blend is critical for the quality of the final product. The sample should be taken from at least 10 locations in the blender. The sampling location should be selected according to the difficulty of the blending. Ares of poor blending must be covered in sampling. Corners and discharged point must have sampling location.

Microbes grow resistance from disinfectants: Resistance in microbes against disinfectants for cleaning purpose is a dangerous issue in pharmaceuticals but the maximum of the pharmaceuticals operation units it is ignored. Continuous application of same disinfectants may lead to the development of resistance in the microbes. Fig: Pharmaceutical Floor Cleaning. How microbes developed resistance: Usually, we evaluate disinfectants for their efficacy using normal microbars but we do not use resistance strains. That’s why, it is important to concentrate on the development of resistance in our environment isolates against our cleaning solutions. Most of the microbes develop defense mechanism against the disinfectant solutions. Pathogenic bacteria such as: staphylococcus aureus develops some protein those helps to pump out the toxins from the cell to protect itself. Major cause of the development of resistance is use of low concentration of the disinfecta

World Health Organization     The checklist here: 1. Organogram 2. Job descriptions 3. Quality policy (e.g. quality manual) 4. Validation policy (e.g. validation master plan or programme) 5. Raw material specifications (for specific products) 6. Packaging material specifications 7. Manufacturing formula and method masters 8. Packing instructions master 9. Batch manufacturing records (verification against master documents) 10. SOP index 11. SOP: self-inspection 12. SOP: recalls 13. SOP: complaints plus records 14. SOP: batch number allocation 15. SOP: planned preventive maintenance 16. SOP and record: planned preventive maintenance of specific equipment 17. SOP: training (plus record of personnel) 18. SOP: environmental monitoring plus records 19. SOP: water sampling and testing plus records 20. Validation protocol and report for specific products