The purpose of study is to formulate and process validation is to create a robust formulation and to validate all the critical parameters challenged in manufacturing process like dry mixing, blending, lubrication, compression, coating and packing. By comparing the results of above challenged parameters, it shown that all the results of three batch’s had met the pre determine specification and FDA requirement. Finally by seeing the results we can say that the process followed was correct and are as per c GMP requirements.

In present study five drug samples viz Zingiber officinalis, Boerhaavia diffusa, Glycerrhiza glabara, Terminalia arjuna, Terminalia chebula were analysed for microbial load(Total bacterial count & total yeast and mould count) and for specific pathogenic bacteria (E.coli, Salmonella spp, Staphylococcus aureus, Pseudomonas aeruginosa) as per WHO norms(Anonymous 1998). Total bacterial load is higher in four samples of herbal drugs (Zingiber officinalis, Boerhaavia diffusa, Glycerrhiza glabara, Terminalia chebula). The total Yeast and mould count in all five samples is beyond the prescribed limits of WHO while Specific pathogenic bacteria are absent in all five sample of herbal drugs.