Wet Granulation Film Tablet: Process Analysis

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Process Map: Wet Granulation Film Tablet Manufacturing Process

Course Module: Process Analytical Technology

Assignment Descriptor: Process map of a wet granulation, film coated tablet manufacturing process.

Process Analytical Technology (PAT)

Candidate Name: Kevin Mansfield Tel. 0894511106 Candidate Signature: Kevin Mansfield Date: 14th March 2016 Class: Level 8 Pharma Cohort 22 Waterford PAT

Table of Contents

Section 1: Introduction Page 3 of 12

Understanding what Process Analytical Technology (PAT) is.
Fundamental understanding of Critical Quality Attributes (CQA)
Fundamental understanding of Critical
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In order for us to develop and implementation an effective PTA strategy for a process, we will need to know and understand what our Critical Process Parameters (CPP) and our Critical Quality Attributes (CQA).

The FDA promotes the gathering of data from manufacturing processes and the effective analysis of this data. Data is gathered via “analyzers or process analytical chemistry tools; process and endpoint monitoring and control tools”. The intension is to promote continuous improvement via the management and utilization of empirical knowledge, the application of this knowledge in light of the data gathered over time.

In essence the aim of PAT is to develop the fine tuning and control of processes within scope such that they will consistently ensure a predefined quality of product at the end of the manufacturing process each and every
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For the purposes of validation or otherwise Critical Quality Attributes are chemical, physical, biological and microbiological attributes that can be defined or measured. CQA’s can be continually monitored to ensure that the final product outputs remain within acceptable quality limits; for example a chef may be making soup and he tastes the soup; based on the taste he decides that it needs more salt. He adds the salt and then taste the soup again, the taste tells him it requires some more salt, so more salt is added and then the soup is again tasted, this time it tastes just right. The relevant taste CQA for the soup has been achieved i.e. “the final product outputs remain within acceptable quality limits”. We can define CQA for a product or component or even a material object. The identifiable attributes are how we define the subject and how we qualify that the particular component or product. From the known CQA descriptions we can determine the quality of the product and how it emulates or concurs what were are expecting and whether it might be acceptable or

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