Defination of Quality Assurance And its Concept BY Deepak Patil

QUALITY ASSURANCE & CONCEPTSSEMINARFORQUALITY PLANNING AND ANALYSIS SEMESTER-II PRESENTED BY MR. DEEPAK PATIL GUIDED BY: MR. SHRIKANT MORKARDEPARTMENT QUALITY ASSURANCE TECHNIQUESAISSMS COLLEGE OF PHARMACY,PUNE-01

DEFINATIONOFQUALITY ASSURANCECONCEPTSOF QUALITYASSURANCEREFERENCES

Edit the text with your own short phrases. Make it easier to change the pictures: Use the Selection Pane to temporarily hide a Picture Placeholder. (Home tab, Select, Selection Pane). Click the eye icon to hide or show an object. To change the sample images, select a picture and delete it. Now click the Pictures icon in the placeholder to insert your own image.The animation is already done for you; just copy and paste the slide into your existing presentation.

QUALITY ASSURANCE

Light Bulb Quote Horizontal(Intermediate)To reproduce the video effects on this slide, do the following:

On the Home tab, in the Slides group, click Layout, and then click Blank.On the Insert tab, in the Media group, click Video, and then click Video from File. In the left pane of the Insert Video dialog box, click the drive or library that contains the video. In the right pane of the dialog box, click the first video that you want and then click Insert.Under Video Tools on the Format tab, in the Size group, click the arrow at the bottom right corner launching the Format Video dialog box.In the Format Video dialog box, select Size in the left pane, under Size and Rotate in the right pane, set the Height to 2.5 and the Width to 3.29.Also in the Format Video dialog box, select Border Color in the left pane, under Border Color in the right pane, select Solid line, then click the arrow to the right of Color, and under Theme Colors, select Black, Text 1 (first row, second option from left).Also in the Format Video dialog box, select Border Style in the left pane, under Border Style in the right pane, set the Width to 3 pt.Close the Format Video dialog box.In the Animations tab, in the Animation group, select Play.Also on the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous.On the Home tab, in the Drawing group, click Arrange, point to Align, and then do the following:Click Align Left.Click Align Top.On the Insert tab, in the Media group, click Video, and then click Video from File. In the left pane of the Insert Video dialog box, click the drive or library that contains the video. In the right pane of the dialog box, click the second video that you want and then click Insert.Under Video Tools on the Format tab, in the Size group, click the arrow at the bottom right corner launching the Format Video dialog box.In the Format Video dialog box, select Size in the left pane, under Size and Rotate in the right pane, set the Height to 2.5 and the Width to 3.29.Also in the Format Video dialog box, select Border Color in the left pane, under Border Color in the right pane, select Solid line, then click the arrow to the right of Color, and under Theme Colors, select Black, Text 1 (first row, second option from left).Also in the Format Video dialog box, select Border Style in the left pane, under Border Style in the right pane, set the Width to 3 pt.Close the Format Video dialog box.In the Animations tab, in the Animation group, select Play.Also on the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous.On the Home tab, in the Drawing group, click Arrange, point to Align, and then do the following:Click Align Top.Click Align Center.On the Insert tab, in the Media group, click Video, and then click Video from File. In the left pane of the Insert Video dialog box, click the drive or library that contains the video. In the right pane of the dialog box, click the third video that you want and then click Insert.Under Video Tools on the Format tab, in the Size group, click the arrow at the bottom right corner launching the Format Video dialog box.In the Format Video dialog box, select Size in the left pane, under Size and Rotate in the right pane, set the Height to 2.5 and the Width to 3.29.Also in the Format Video dialog box, select Border Color in the left pane, under Border Color in the right pane, select Solid line, then click the arrow to the right of Color, and under Theme Colors, select Black, Text 1 (first row, second option from left).Also in the Format Video dialog box, select Border Style in the left pane, under Border Style in the right pane, set the Width to 3 pt.Close the Format Video dialog box.In the Animations tab, in the Animation group, select Play.Also on the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous.On the Home tab, in the Drawing group, click Arrange, point to Align, and then do the following:Click Align Right.Click Align Top.On the Insert tab, in the Media group, click Video, and then click Video from File. In the left pane of the Insert Video dialog box, click the drive or library that contains the video. In the right pane of the dialog box, click the fourth video that you want and then click Insert.Under Video Tools on the Format tab, in the Size group, click the arrow at the bottom right corner launching the Format Video dialog box.In the Format Video dialog box, select Size in the left pane, under Size and Rotate in the right pane, set the Height to 2.5 and the Width to 3.29.Also in the Format Video dialog box, select Border Color in the left pane, under Border Color in the right pane, select Solid line, then click the arrow to the right of Color, and under Theme Colors, select Black, Text 1 (first row, second option from left).Also in the Format Video dialog box, select Border Style in the left pane, under Border Style in the right pane, set the Width to 3 pt.Close the Format Video dialog box.In the Animations tab, in the Animation group, select Play.Also on the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous.On the Home tab, in the Drawing group, click Arrange, point to Align, and then do the following:Click Align Left.Click Align Bottom.On the Insert tab, in the Media group, click Video, and then click Video from File. In the left pane of the Insert Video dialog box, click the drive or library that contains the video. In the right pane of the dialog box, click the fifth video that you want and then click Insert.Under Video Tools on the Format tab, in the Size group, click the arrow at the bottom right corner launching the Format Video dialog box.In the Format Video dialog box, select Size in the left pane, under Size and Rotate in the right pane, set the Height to 2.5 and the Width to 3.29.Also in the Format Video dialog box, select Border Color in the left pane, under Border Color in the right pane, select Solid line, then click the arrow to the right of Color, and under Theme Colors, select Black, Text 1 (first row, second option from left).Also in the Format Video dialog box, select Border Style in the left pane, under Border Style in the right pane, set the Width to 3 pt.Close the Format Video dialog box.In the Animations tab, in the Animation group, select Play.Also on the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous.On the Home tab, in the Drawing group, click Arrange, point to Align, and then do the following:Click Align Bottom.Click Align Center.On the Insert tab, in the Media group, click Video, and then click Video from File. In the left pane of the Insert Video dialog box, click the drive or library that contains the video. In the right pane of the dialog box, click the sixth video that you want and then click Insert.Under Video Tools on the Format tab, in the Size group, click the arrow at the bottom right corner launching the Format Video dialog box.In the Format Video dialog box, select Size in the left pane, under Size and Rotate in the right pane, set the Height to 2.5 and the Width to 3.29.Also in the Format Video dialog box, select Border Color in the left pane, under Border Color in the right pane, select Solid line, then click the arrow to the right of Color, and under Theme Colors, select Black, Text 1 (first row, second option from left).Also in the Format Video dialog box, select Border Style in the left pane, under Border Style in the right pane, set the Width to 3 pt.Close the Format Video dialog box.In the Animations tab, in the Animation group, select Play.Also on the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous.On the Home tab, in the Drawing group, click Arrange, point to Align, and then do the following:Click Align Right.Click Align Bottom.Press and hold CTRL and select all three bottom videos. On the Home tab, in the Drawing group, click Arrange, point to Align, and then click Distribute Horizontally.To reproduce the text effects on this slide, do the following:

On the Insert tab, in the Text group, click Text Box, and then on the slide drag to draw a text box.Type the following in the text box: We now know a thousand ways not to build a light bulb. Select the text. On the Home tab in the Font group, select Garamond from the Font list, and then select 44 pt from the Font Size list, then click the Bold icon.Under Drawing Tools, on the Format tab, in the Size group enter the Height of the text box to be 1.58 and the Width to be 10.Under Drawing Tools, on the Format tab in the WordArt Styles group click the arrow at the bottom right corner launching the Format Text Effects dialog box.In the Format Text Effects dialog box, select Text Fill in the left pane, then under Text Fill in the right pane, select Solid fill. Click the arrow to the right of Color and under Theme Colors select, White, Background 1 (first row, first option from left).Also in the Format Text Effects dialog box, select Text Outline in the left pane, then under Text Outline in the right pane, select Solid line. Click the arrow to the right of Color and select more colors, and then under the Custom tab do the following:In the Red box, enter 255.In the Green box, enter 255.In the Blue box, enter 204. Click OK to close the Colors dialog box.Also in the Format Text Effects dialog box, select Outline Style in the left pane, then under Outline Style in the right pane, set the Width to 0.75 pt.Also in the Format Text Effects dialog box, select Glow and Soft Edges in the left pane, then under Glow and Soft Edges in the right pane, under Glow in the right pane, click the arrow to the right of Color and under Theme Colors select Orange, Accent 6, Lighter 60% (third row, tenth option from left).Also under Glow in the right pane, set the Size to 8pt.Also under Glow in the right pane, set the Transparency to 80%.Also in the Format Text Effects dialog box, select 3-D Format in the left pane, under 3-D Format in the right pane, click the arrow to the right of Top, under Bevel select Circle (first row, first option from left), and then do the following:To the right of Top, in the Width box, enter 3 pt.To the right of Top, in the Height box, enter 2 pt.Under Depth, In the Depth box, enter 4.5 pt.Under Contour, click arrow to right of Color and under Theme Colors, select Tan, Background 2 (first row, third option from left).Under Surface, click the arrow to the right of Material and under Standard, select Metal (first row, fourth option from left), and then click the arrow to the right of Lighting and under Neutral, select Balance (first row, second option from left).In the Angle box, enter 35 degrees.Close the Format Text Effects dialog box.On the Home tab in the Paragraph group, click Center Text, and then click the arrow to the right of Align Text and select Bottom.Select the text box. On the Home tab, in the Drawing group, click Arrange, point to Align, and then click Align Middle. On the Insert tab, in the Text group, click Text Box, and then on the slide drag to draw a text box.Type text, Thomas Alva Edison, in the text box and then select the text. On the Home tab in the Font group, select Garamond (body) from the Theme Fonts section, and then select 18 pt from the Font Size list, then click the Bold and Italic icon.Select text box. Under Drawing Tools, on the Format tab, in the Size group, click the arrow at the bottom right corner launching the Format Shape dialog box.Select Size in the left pane, and under Size and rotate in the right pane enter the Height as 0.4 and the Width as 2.45.Also in the Format Shape dialog box, select Position on the left pane, then under Position in the right pane set the Horizontal to 7.5 and the Vertical to 4.5.Close the Format Shape dialog box.Under Drawing Tools, on the Format tab in the WordArt Styles group click the arrow at the bottom right corner launching the Format Text Effects dialog box.In the Format Text Effects dialog box, select Text Fill in the left pane, then under Text Fill in the right pane, select Solid fill. Click the arrow to the right of Color and under Theme Colors select, White, Background 1 (first row, first option from left).Also in the Format Text Effects dialog box, select Text Outline in the left pane, then under Text Outline in the right pane, select Solid line. Click the arrow to the right of Color and select more colors, and then under the Custom tab do the following:In the Red box, enter 255.In the Green box, enter 255.In the Blue box, enter 204. Click OK to close the Colors dialog box.Close the Format Text Effects dialog box.Select the text box and under Drawing Tools on the Format tab, in the Shape Styles group, click the arrow at the bottom right corner launching the Format Shape dialog box.In the Format Shape dialog box, select Position in the left pane, under Position on Slide and set Horizontal to 7.5 and Vertical to 4.5.Close the Format Shape dialog box. To reproduce the background effects on this slide, do the following:

On the Design tab, in the bottom right corner of the Background group, click the arrow at the bottom right launching the Format Background dialog box. In the Format Background dialog box, select Fill in the left pane, under Fill in the right pane select Solid fill, and then click the arrow to the right of Color and under Theme Colors, select Black, Text 1 (first row, second option).3

DEFINATION :-Quality Assurance is a wide ranging concept covering all matters that individually or collectively influence the quality of the product.

Make it easier to change the pictures: use the Selection Pane to temporarily hide a Picture Placeholder. (Home tab, Select, Selection Pane). Click the eye icon to hide or show an object. To change a sample image, select the picture and delete it. Now click the Pictures icon in the placeholder to insert your own image. If you dont see the Pictures icon, click the Reset button (Home tab, Slides, Reset).The animation is already done for you; just copy and paste the slide into your existing presentation. Sample pictures courtesy of Bill Staples.

It is the activity of providing evidence to establish confidence that quality requirements will be met.

Quality Assurance is sometime the name of department concerned with many quality management activity such as quality planning, quality control, quality improvement, quality audit and reliability.

Quality Assurance measures apply to the laboratory analytical work overall, which includes; Identifying the person having the overall responsibility for quality.

Having laboratory equipment calibrated to recognised standards.

Using reference materials.

Joining proficiency testing schemes with other laboratories doing similar tests.

CONCEPTS

Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP).

Product and control operations are clearly specified in a written form and GMP requirements are adopted.

Managerial responsibilities are clearly specified in job description.

Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.

All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.

Deviation are reported, investigated and recorded.

There is a system for approving changes that may have an impact on product quality.

Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.

REFERENCES

Juran J.M., Godfrey A.B., Jurans Quality Planning and analysis for Enterprise Quality, Mc Graw Hills Publication, New Delhi, Fifth Edition, 2007; Pg. No. 519-534.

Manohar A. Potdar , Pharmaceutical facility design and layout, Nirali prakashan , pune page no.5.5 5.9 .

Thank you

Relax at the Lake Video Template(Basic)To reproduce the effects on this slide, do the following:On the Home tab, in the Slides group, click Layout, and then click Blank.On the Insert tab, in the Media group, click Video, and then click Video from file. In the left pane of the Insert Video dialog box, click the drive or library that contains the video. In the right pane of the dialog box, click the video that you want and then click Insert.Under Video Tools, on the Format tab, in the bottom right corner of the Video Styles group, click the arrow opening the Format Video dialog box. In the Format Video dialog box, click Size in the left pane, and under Scale in the right pane uncheck Lock Aspect Ratio.Then under Size and Rotate in the right pane set the Height to 7.5 and Width the 10.Select the video. On the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous.With the video selected, under Video Tools, on the Playback tab, in the Video Options group, select Loop until Stopped.

To reproduce the text effects on this slide, do the following:On the Insert tab, in the Text group, click Text Box, and then on the slide drag to draw your text box.Select the text. On the Home tab, in the Font group, do the following:Select Verdana in the font list.Click the Bold icon.In the Font Size box, enter 88 pt.Also on the Home tab, in the Paragraph group, select the Center Text icon.With the text selected, under Drawing Tools, on the Format tab, in the Size group, click the arrow at the bottom right corner to open the Format Shape dialog box.In the Format Shape dialog, click Position in the left pane, under Position and Size in the right pane set Horizontal to .0 and Vertical to 2.27.With the text still selected, under Drawing Tools, on the Format tab, in the WordArt Styles group click the arrow at the bottom right to open the Format Text Effects dialog box.In the Format Text Effects dialog, click Text Fill in the left pane, under Text Fill in the right pane, select Solid Fill. Then under Fill Color click the arrow to the right of Color and select More Colors.In the Colors dialog box, click the Custom tab and do the following:Color Model: RGBRed: 0Green: 176Blue: 240Click OK to close the Colors dialog box.Still in the Format Text Effects dialog, Text Fill right pane, under Fill Color set the Transparency to 40%.Also in the Format Text Effects dialog box, select Reflection in the left pane, and in the Reflection right pane do the following:Transparency : 20%Size: 50%Distance: 0.3 ptBlur: 4 ptIn the Format Text Effects dialog box, select 3-D Format in the left pane, under 3-D Format in the right pane do the following:Under Bevel, click the arrow to the right of Top and select Slope (second row, fourth option from left), and then enter Width as 5 pt and Height as 5 pt.Under Depth, set the Depth to 5 pt.Under Contour, click the arrow to the right of Color and under Theme Colors, select Dark Blue, Text 2 (first row, fourth option from left), and then enter Size as 0.5 pt.Under Surface, click the arrow to the right of Material and under Translucent select Powder (first option from left), and then click the arrow to the right of Lighting and under Neutral select Three Point (first option from left)In the Format Text Effects dialog box, select 3-D Rotation in the left pane, under 3-D Rotation in the right pane, click the arrow to the right of Presets and under Perspective select Perspective Front (first option from left).Close the Format Text Effects dialog box.

To reproduce the animation effects on this slide, do the following:Select text box, on the Animations tab, in the Animation group, select Float In (under Entrance, first row, fourth option from left).Also on the Animations tab, in the Timing group, click the arrow to the right of Start and select With Previous, and set the Duration to 4.00 and the Delay to 1.00.

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