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
This addition aids in controlling the reproducibility and retention. Separation of the mixture via RP-HPLC can be done using continuous gradient or stepwise to move out the sample components. For every separation, the ideal gradient and volume must be
Overall, Spun did an amazing job portraying methamphetamine and its effects. I found that the content related to methamphetamine was very accurate. First, the movie accurately portrayed most the many methods of taking methamphetamine. According to the How Is Methamphetamine Abused (2013), methamphetamine can be taken orally, snorted, injected, and smoked. Spun showed that methamphetamine can be taken orally.
Characterization. Or in simpler terms, a description of the distinctive nature or features of someone or something. Many times in the war, Jews were faced with characterization, inside, and outside of the camps. Examples of this being the act of painfully needling numbers onto prisoners, and the act of tagging Jewish residents like cattle. This characterization allowed for discrimination to be very likely, since anyone could see a Jew’s ethnicity, just by looking at the yellow star on their clothes.
Also understanding the criteria’s in which a
3. To purify and identify the product, recrystallization is used in order to purify the product, then melting point and TLC techniques are used to identify the product. Theory 4.
Process and tools Target Corporation uses tolls and process for product safety and quality assurance. The company assesses a program for risk –based product safety and quality at every stage in the product life cycle, from development through the life of brand product. Target global team implement a program across 36 countries and 2228 factories producing target product, during the process will require independent third-party testing to validate safety and quality before the guests purchase product. the vendor in the company are expected to employ best practices, including clearly defined and well-documented manufacturing and quality processes including staff training , and record keeping. What does the TC required to do the job?
A set of characteristics by which something is familiar is an identity. People are able to recognize a chair by its flat surface and the legs that support it, however, humans adapt to this identity. For instance, there may be only one leg, but that does not stop it from being identified as a chair. When talking about humans the basic idea of identity tends to become perplexing. This does not stop oneself from identifying various people.
The relationship between critical thinking and ethics Critical thinking is a way of thinking it is the process of analyzing, applying, and evaluating information with problem solving abilities. Critical thinking greatly improves a person’s thinking. This is the process that will determine whether the outcome of a problem is right or wrong. The critical thinking process is the mindset to make effective decisions based upon verified and truthful information. The steps to critical thinking are remembering, understanding, applying, analyzing, evaluating and creating.
It is a requirement that should be followed without paying much attention to profit acquisition. Quality products must reflect health standards and guidelines. With such aspects observed, authorities are not going to investigate the organization for any fraudulent dealings. The health and perception of customers in the market are essential.
Goldratt believes that physical restraints are easier to identify. If the time constraint is overcome by company, another constraint will appear in store. Often appear market restrictions (when there is insufficient demand for any product), this situation sometimes makes managers think that the constraint is out of their control as they are only the provider of other’s products to the direct customer. On many other occasions, the constraint is self-created by the same management through the definition of internal policies. Goldratt, "hardly find a company with a real market restriction, as all are with ruinous policies marketing restrictions” (Oglethorpe and Heron, 2013).
Technology Development PTCL is working on latest technologies which make it able to perform effectively and satisfy their customers. By the use of ERP (enterprise resource planning),
The best companies in the world are discovering a powerful new source of competitive advantage. It's called supply chain management and includes all onboard activities that bring products to market and satisfied customers. The Supply Chain Management program covers topics from manufacturing operations, transportation, purchasing and physical distribution for a single program. Coordinated the successful management of the supply chain and all these activities integrated in a continuous process.
This deals with a customers’ perception that a product or service they are buying provides them with a higher value than a competitor. Superior quality can be broken down into two kinds of attributes: quality as excellence and quality as reliability. A customers’ perspective of quality as excellence would be that they want a product or service that provides features and a level of service that has no comparison. With regard to quality as excellence, if customers perceive that the products design, features, and functions are better than everyone else, then they would be more likely to buy their product. Higher quality products allow for a higher sense of value provided to the customer.