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Process Validation Stages process design two

Posted on July 12, 2014 By Frndzzz

In Process validation the first stage that is Process design stage have some points which are taken into account. Some of them which are taken into consideration are as follows: Process control should address variability such as: During the process design the control to reduce the input variation and the control to adjust for input…

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Process Validation Stages process design one

Posted on July 12, 2014 By Frndzzz

In Process Validation as we know that first stage is process design, Some of the points which are discussed during the process design are as follows , so let us check it out one by one. Use Design of experiment (DOE) to develop the process by different factors such as : By Revealing relationship between…

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Process Validation Stages process design

Posted on July 12, 2014 By Frndzzz

In Process Validation the first stage out of three stages is Process Design. Following are some of the points which are taken into consideration during process design. So let us check it out one by one: To design process follow good manufacturing practices. Uses scientific principles as well as scientific methods. Conduct the internal review…

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Process Validation Stages

Posted on July 12, 2014 By Frndzzz

Process Validation is divided into three stages, So let us check it out one by one. Following are the three stages. Stage I – Process Design: With the knowledge of Scale up studies and the prior knowledge which is gained through development, The commercial manufacturing process is defined during this stage of process design. Stage…

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Process Validation

Posted on July 12, 2014 By Frndzzz

Process validation: It can be defined as the documented evidence which provides a high degree of assurance that the process which is going to be performed will consistently produce a product , meeting its pre determined specifications and all the quality attributes. Process Validation is classified into four types which are as follows: Prospective Validation…

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Line Clearance

Posted on July 6, 2014 By Frndzzz

Line clearance is the permission taken from the authorized QA person before starting actual production (Manufacturing, Filling and Packaging).  The line clearance includes: Manufacturing Area Filling Area Dispensing or packaging Area Purpose and Importance In line clearance the procedures have been established to prevent mix – up of containers, products, labels and mistakes in documents….

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Full form of MBA – Master of Business Administration

Posted on July 5, 2014 By Frndzzz

Full form – MBA is the post graduate degree in the business administration. MBA stands for Master of Business Administration. Finance, Banking, Marketing, Information technology, Human resources, Accounting are some of the subjects which are studied in MBA.

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Tablet coating: “Orange Peel Defect”

Posted on July 3, 2014 By Frndzzz

During tablet coating Orange peel defect is observed due to inadequate spraying or spreading of the coating solution. Before the drying this coating solution causes bumpy or orange peel effect on the coating. It is caused due to high spray rate and high pressure. This defect can be prevented by thinning of the polymer solution…

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Tablet Coating: color variation Defects

Posted on July 3, 2014 By Frndzzz

During Tablet coating , color variation defect is observed sometimes.  This defect is caused by improper mixing on the tablets, or by insufficient coating and also caused by uneven spray pattern on tablets.  After coating the migration of soluble dyes or any additives during drying may give tablet a spotted and mottled apperation. Due to…

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What are “Tablet Coating – Defects”?

Posted on July 3, 2014 By Frndzzz

List of  some tablet coating defects which may affect the tablet formulation and bioavailability of drug are as follows. (1) Picking and Sticking, (2) Color variation, (3) Orange peel effect, (4) Twinning, (5) Capping and lamination, (6) Mottled color, (7) Roughness, (8) Hazing or Dull film (9) Bridging, (10) Erosion, (11) Filling, (12) Chipping, (13)…

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