1.2.3.7. Quality by Design
As PharmaKonic Ltd utilises Quality by Design for the process development and scale up studies executed in the previous Upstream Process to maintain process continuity, this concept will be integrated into the production of the Quality Strategy and Quality Maintenance System.
Quality by Design focuses on a risk based approach to ensuring process and product quality through an in depth understanding of product attributes and the overall process and product performance. This concept will be achieved by defining the product to be produced and through the identification of Critical Quality Attributes (CQA) and their potential impact upon the process and the final product. The Quality by Design System will be shown in the following diagram:
Figure 1.1: Quality by Design System adapted from (Huynh-Ba, 2009)
The Quality by Design concept is created based on process stages which are included as follows:
• Product designed based on requirements of consumers
• Process design consistently meets product Critical Quality Attributes (CQA)
• Quality system used to integrate process and product knowledge gathered during development
• Full understanding of potential impact of formulation components and process parameters on the quality of the product
• Evaluating and controlling causes of process variability
• Ensuring reliable and consistent quality throughout the process lifecycle by monitoring and integrating process improvement.
1.3. Quality Risk Management
Quality Risk Management has been considered a valuable element of an efficient quality system and once executed plays a crucial role in the assessment and control of the potential risks to drug quality throughout the entire manufacturing proce...
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... backbone, within this framework there is one O-linked carbohydrate which plays no significant role in maintaining bioactivity, three N-glycans attached show great influence over the stability, immunogenicity and overall solubility.(Li and d’Anjou, 2009) The amino acid sequence will be analysed for the correct structure through use of HPLC to differentiate between the 165 amino acids present within Epoetin omicron.
3. Isoelectric point
Epoetin omicron has been determined to have an isoelectric point of 3.5 to 5 and will be analysed to ensure this result by use of an isoelectric focusing gel. This will establish whether the in process sample analyzed shows any potential for protein modification such as glycosylation or phosphorylation and following this run will be measured for the correct isoelectric point by use of 2D gel electrophoresis. (LifeTechnologies, 2014)
The analysis is therefore one of the most effective methods of ensuring that each drug being prescribed to patients is safe. It also ensures that all drug components are understood in terms of their structure and chemical behavior. This understanding is very important in the manufacture of drugs and other pharmaceutical products.
...nagement practices which result in measurable continous quality improvement. It is this ongoing procceess of quality improvement. It is this ongoing process of quality improvement which contribute to changes in production.
Most proteins have a primary, secondary and tertiary structure, but some of them, like hemoglobin, also have a quaternary structure. The primary structure of a protein is represented by the ordered succession of its amino acids held together by covalent bonds. While in nature amino acids may possess either the D or L configuration, amino acids within proteins almost exclusively possess the latter, as this allows proteins to have binding sites with three-dimensional properties matching those of their ligands. From an evolutionary standpoint, the existence of D-amino acids in certain proteins and peptides is highly beneficial since many D-amino acid-containing peptides participate in defense roles. This group includes antibiotic activities of secreted peptides against neighboring bacteria as well as toxic effects of psycho-active peptides on larger predators. The mode of action for these peptides involves their insertion into another organism that often possesses defense mechanisms based on stereo-specific recognition, like in the case of proteolytic enzymes and antibodies. The presence of D-amino acids prevents the host’s defense system from recognizing and degrading the peptide (Kesssel,A. and Ben-Tal N. (2011) Introduction to Proteins: Structure, Function and Motion, London: CRC Press).
Methods for quality improvement offer numerous benefits and there are many models to use for quality improvement. These models and features have traits in the up to date version of total quality management practise models and are of numerous benefits, with the likes of six sigma and kaizen model using these traits (Royal Charter, 2011)
The book outlines the important steps that make up the Quality Improvement (QI) processes. First you must identify the needs that are most important. Second a multidisciplinary team must be put together to review the needs that have been identified. Third data must be collected to assess the current situation being evaluated. The fourth step should be to create goals and quality indicators that can be assessed and evaluated. The fifth step is where you develop and place into practice the plan to achieve the desired outcome/ goals. Lastly data must be collected to assess the effectiveness in the change of practice, and to see of all goals have been met.
Criteria and process performance indicators that allow for a science and risk based decision about the ability of the process to consistently produce quality products. The criteria should include descriptions of the statistical methods to be used in analysing all collected data.
Quality is an important part of any business rather from a customer’s perspective or a producer’s perspective. Quality from a customer’s perspective is they “want value and quality has become a major factor in the value of products and service” (Russell & Taylor, 2013, pg. 53). “The customer is the most important part of the production line” (Russell & Taylor, 2013, pg. 53). This can be referred to as quality of design meaning “involves designing quality characteristics into a product or service” (Russell & Taylor, 2013, pg. 54). Now let’s look at the quality from a producer’s perspective. This can be referred to a quality of conformance meaning “making sure the product or service is produced according to design” (Russell & Taylor, 2013,
The total quality management is valuable asset for Longxi providing it was an competitive edge over most of other competitors. However Longxi needs to improve the quality control system further to meet industry accept standard, i.e. ISO9002 to expand further into the overseas markets.
Use of Quality Measurements outside of Reimbursement Quality measurements, once collected, need to be used, this a reoccurring theme in the literature. One way the data is used is to help physicians meet standards and regulations and ensure quality care. The American Board of Emergency Medicine has shown great support for the development of quality measure reporting for emergency physicians (ABEM, 2015). In their article discussing the considerations for a registry for EM physicians, they are discussing such a thing because of the push for quality measurements to be linked to quality reporting, reimbursements, and their desire for continuous professional development (ABEM, 2015). They would like to use the data collected to improve their work.
In order to ensure quality, a continual quality process will be used throughout the project life cycle. This iterative process includes measuring process metrics, analyzing process data, and continuously improving the process.
We commonly view quality as a physical property of our product and therefore see our task as producing a product that meets these physical characteristics.
Cairns, D. (2008). Essentials of Pharmaceutical Chemistry. Third Edition. Pharmaceutical Press. London. Great Britain. p152 – 154
Quality is a very important thing in an organization; therefore it is not possible to improve the quality of a product or service substantially without major changes in all aspects of the organization. Because quality is so important if changes aren’t made throughout the organization the output of the product will no be very successful. Everyone in the organization plays a major role in the out come of its products.
In 1987 the Food and Drug Administration (FDA) established its expectations regarding process validation in the Guidance for Industry Process Validation. In this document the general principles and process validation components that are considered vital towards effective process validation are outlined. It also highlights the importance that these approaches be consistently and repeatedly used by all manufacturers through their manufacturing processes. The FDA also outlines the importance of the cohesion between process validation and other pharmaceutical regulatory systems such and Good Manufacturing Practice (GMP), Quality, compliance and the manufacturing lifecycle. Since 1987, the FDA has also produced revised guidance's building on the principles in its original document to maintain and modern and updated approach to the topic. In essence, this document highlights how controlled and effective process validation is required to maintain the highest standards of drug quality to allow the safe and repeatable production of pharmaceuticals intended for human use. If these principles h...
Quality is a word which has been used for a very long time, lots of books have been written about it, and many of the world scientists have defined it in many different ways. In this research paper, I will emphasis on the Quality Management System, why is it important? What is it used for? What is the importance of having a Quality Management System? Many people think implementing QMS costs a lot and all the benefit is a piece of a paper which say that your company is certified in having QMS so you can only hang this picture or certificate on the wall and tell your smart customer that you have it. In fact, no blames on them, they have not used this system yet, they do not know that this system save a lot and a lot of money for companies. They do not know that this system create a dynamic motion within the companies so everyone know what he/she is doing, everybody understands his/her role, and everyone can feel being an important part of the process then everybody can work towards a clear and unified target. However, having a lot of benefits requires a reasonable cost and in the same time it worth. There are several organization which are concerned and involved in this issue, those organizations have produced a unified standards and those standards have its requirements. The International Standardization Organization which located in Switzerland which have a contribution of 157 countries have produced a standard which is concerned about the QMS.