Big Changes for Ayurvedic Medicine Manufacturers in Schedule T | GSR 140 E by Ministry of AYUSH

Major changes in upcoming Schedule T. Announced 14 Feb 2025 vide GSR 140(E)

https://pharmadocx.com/downloads

1 Aluminium partition in Mfg Area not allowed. Flush partition to be done. It can be Puff Panel / Brick Wall/ Gypsum Wall
2 Open pipe fitting like water pipe/ air pipe/ electric pipe not allowed. They need to be conceived under wall or drop directly on machines.
3 Open beton/ plastic pipe carrying electric wire not alllowed
4 Material Receiving & Dispatch bay shall be separate.
5 Raw Material shall be purchased from GMP certified companies only.
6 Process Validation, Water System Validation, Analytical method validation shall be done.
7 Expiry date can be given after performing Stability studies.
8 Separate man and material flow shall be there
9 Air Lock, Cross Over Bench needed before entry to Mfg Area
10 Equipment Qualification like DQ IQ OQ PQ shall be done.
11 Base material composition shall be be mentioned in label
12Ancillary area shall be provided
13 Microbiologist shall be appointed

Pharmadocx Consultants
Phone: 9996859227
Email: [email protected]
Address: Opposite Dewan Mill, Old D.C. Road, Sonipat, Haryana (131001)
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