The shrub, Clerodenrum viscosum Vent. is traditionally used in the treatment of a number of diseases, including oxidative stress, inflammation, gastritis, burns, wounds, headaches, fever, jaundice, organ damage and so on. Oxidative stress and inflammatory events trigger cardiovascular diseases (CVD), which are one of the major consequences in health problems. The aim of the present study was to evaluate the possible clotlysis activity of C. viscosum leaf (MECVL). The hot MECVL was evaluated for anti-radical (DPPH: 1,1-diphenyl-2-picrylhydrazyl radical), egg albumin protection and inhibition of hemolysis of human erythrocytes (HRBCs), and clotlysis analysis, with ascorbic acid, acetyl salicylic acid and streptokinase as standards, respectively. Additionally, a preliminary phytochemical study was also conducted, which indicated the presence of alkaloids, glycosides, flavonoids, reducing sugars, and gums in MECVL. The MECVL concentration dependently scavenged the DPPH, inhibited protein denaturation, protected HRBCs and caused clotlysis. In the DPPH assay, MECVL at 100 μg/mL scavenged DPPH radical by 47.1 ± 0.8%. The highest activity was observed at the highest concentration of the MECVL (500 μg/mL), at which it inhibited protein denaturation, protected HRBCs and caused clotlysis by 81.5 ± 0.1, 89.4 ± 0.1 and 81.9 ± 4.8%, respectively. Although, in all cases, the standards exhibited better activities, but the effects of MECVL should be considered significant (p <0.05) in comparison to the negative control. The extract exhibited an anti-atherothrombosis capacity possibly via antioxidant, anti-inflammatory and membrane stabilization pathways, recommending C. viscosum as a promising phytotherapeutic tool.

To ensure that the pharmaceutical product is being produced with its consistent quality standard, process validation is a very effective tool. It establishes documented evidence to ensure a high degree of assurance that specific process will consistently produce a product meeting its predetermined specifications and quality requirements. Process validation is a cGMP requirement for finished products and to standardize the method used in establishing process validation studies, a process validation protocol is developed.Based on the protocol, once the process validation is done, a complete process validation report will be prepared which will aid in preparing a complete BMR and BPR for manufacturing and packaging of pharmaceutical products. Process (Prospective) validation aims to gain full understanding of the manufacturing process on the production equipment expected to be routinely used. This is achieved by establishing parameters to be used to operate within a state of control. Once the validation of process is completed, a Batch Manufacturing Record (BMR) to be finalized to use in routine manufacturing. Any variation mode to this BMR should be made in accordance with change control procedure [1][2][3][4][5].