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Quality Assurance and Quality management system are important and primary aspects of pharmaceutical industry as it constitute the tools and various systems to control and maintain the quality of a pharmaceutical formulation in aspects of its design, production, storage of raw as well finished products, in process quality checks. Validation plays an important tool for checking and maintaining the quality parameters of a pharmaceutical formulation, as if applied it monitors raw materials, equipments, instruments, manufacturing process, analytical process, as well provide the documentary evidence for the quality assessments. Nowadays quality of product is measured by the validation program design for that product. Validation and quality go hand in hand. The impact of validation is such it's been included as regulatory requirements as statutory and mandatory requirement. This review thus collectively comprehensive the validation and validation processes in pharmaceutical industry. [ABSTRACT FROM AUTHOR]

In the present study, novel Schiff bases of 2,5-disubstituted-1,3,4-thiadiazole have been synthesized. The chemical structures were confirmed by IR, 1H NMR and elemental analysis. Acute toxicity study of synthesized compounds was performed. All compounds were screened for antibacterial (Staphylococcus aureus, Staphylococcus epidermidis, Micrococcus luteus, Bacillus cereus, Escherichia coli, and Pseudomonas aeruginosa)activities and antifungal (Aspergillus niger) activities. The antioxidant activity of a series of novel 2,5-Disubstituted-1,3,4-thiadiazole was determined by DPPH radical scavenging, ferrous reducing power, Fe2+ chelating activity assay. . The minimum inhibitory concentrations (MICs) of the compounds were determined by agar streak dilution method. Among the synthesized compounds, 5-(2-Mercaptophenyl)-2-{N-(4-hydroxy-3-methoxy benzylidene)-4-aminophenyl}-1,3,4-thiadiaz-ole 8f was found to be the most potent antimicrobial activity with MICs of 0.12, 3.1, 2.9, 0.25, 0.16, 0.27 and 2.4 μg/mL against the above mentioned respective strains. The derivatives showed good antioxidant capacity in DPPH radical scavenging assay, when compared to other in vitro models and the IC50 value of most active derivative 8f was found to be 245.67μg/mL. The total phenolic content using Folinţs-Ciocalteu reagent indicated that 1mg of most active derivative 8f contains 624.5 μg with gallic acid equivalent. [ABSTRACT FROM AUTHOR]

Background: Leaf juice as well as leaves of Barleria prionitis Linn and Barleria grandiflora Dalz (Acanthaceae) is used by rural people across various regions of India in treatment of oral ailments such as dental troubles, gum ailments, pyorrhoea, dental carries and mouth ulcers. Methods: An antimicrobial activity was carried on aqueous and ethanolic extracts of both herbs and compared with standard chlorhexidine. Cell line study was carried using Human Gingival Fibroblast on ethanolic extracts of leaves of both the herbs and compared with standard marketed preparation Zyrtee. Cytotoxicity and anti gingivitis activity were evaluated using MTT assay. Results of cytokine secretion assay and cytokine measurement assay were analyzed using ANOVA followed by Dunnett multiple comparison test. P values less than 0.05 were considered as significant. Results: Results of antimicrobial activity suggest significant potency for ethanolic extracts of both the herbs. CTC50 values for ethanolic extracts was found to be 848 μg/ml and more than 1000 μg/ml respectively for Barleria prionitis and Barleria grandiflora. The cytokine secretion significantly increased by S. mutans control, whereas the cytokine level was reduced in a dose -dependent manner by ethanolic extracts in Streotococcus mutans stimulated HGF cells. The ethanolic extracts EBG and EBP showed 65.31383 ± 1.087%, 75.0425 ± 1.268% inhibition of TNF-α at tested concentration respectively. Conclusion: Thus based on findings of this study, we conclude the usefulness of Barleria prionitis and Barleria grandiflora in treatment of oral ailments such as gingivitis. [ABSTRACT FROM AUTHOR]