Area Qualification

[Awad (Dr. Ahmed Mohamed Awad)]

New WHO TRS 1019 (May 2019)

WHO TRS 1019 published in May 2019 Note: the following annexes are important parts of this new WHO TRS: Annex 2: Interpretation of Guidelines on HVAC systems for non-sterile pharmaceutical products Annex 3: GMP Guidelines on Validation Introduction of Annex 2: Interpretation of Guidelines on HVAC systems: [image] Summary of Contents of Annex 3: GMP guidelines on validation: [image]

Dispensing of raw material for tablet formulation

Grade D [Screenshot_%D9%A2%D9%A0%D9%A1%D9%A9-%D9%A0%D9%A5-%D9%A1%D9%A2-%D9%A0%D9%A0-%D9%A1%D9%A3-%D9%A5%D9%A7] [Screenshot_%D9%A2%D9%A0%D9%A1%D9%A9-%D9%A0%D9%A5-%D9%A1%D9%A2-%D9%A0%D9%A0-%D9%A1%D9%A5-%D9%A1%D9%A0] https://www.who.int/medicines/areas/quality_safety/quality_assurance/GMPSterilePharmaceuticalProductsTRS961Annex6.pdf

Is it required Bioburden test for Disinfectant

Thank You Sir, For your kind information…