Title: Pharmaceutical Modern Quality Systems
Table of Contents
- Introduction: Assignment Brief…………………………………..3
- Pharmaceutical Modern Quality Systems…………………………4
- Cost Of Quality……………………………………………………4.1
- Pharmaceutical Quality Systems………………………………….6
- ICH Q8 Pharmaceutical Quality Systems…………………………7
- ICH Q9 Quality Risk Management Process……………………….8
- ICH Q10 Pharmaceutical Quality Systems……………………….10
- ICH Q10 Life Stage Cycle………………………………………..11
- Benefits of Q10 Pharmaceutical Quality System…………………12
It is said that pharmaceutical industry in the past has been lagging behind other sectors like semiconductors, & medical devices for efficiency & quality.
These could be reasons why? Pharmaceutical industry in the past has been slow to change to keep up efficiency with other sectors. Because they hate change and this can affect their licences and approval they already have. So lots of new validations on new changes made or change control to prevent difference. Like paper to electronic batch records, machinery electronics printout results of results parameters, personnel training. Another reason can be that it takes between ten to fifteen years for the product to be released and this can cause lot problems through the course of the time it is been produced. The product has to go through steps called steps of drug development. This is when the drug is discovered and designed. Then it is preclinical tested.
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The Pharmaceutical Industry is a highly regulated industry, but this wasn’t the case all the time. It’s only really since the mid to late 1900’s that pharmaceutical quality regulation where introduced. Before then there were no pharmaceutical quality systems in place.
Evidence shows that Pharmaceutical modern quality systems is so vital and crucial in the Pharmaceutical industry. In the past there was no Pharmaceutical Quality Systems put in place. There was so many accidents and people dyeing something at to be done to stop this from happening in the future. The Pharmaceutical Quality Regulation where put in place in the late 19 century and the 20th century to try and increase the safety of the pharmaceutical product, but there was still some problem with quality of the product. Most Pharmaceutical Quality System where developed in the 1990’s and 2000’s in implementing their quality systems to the right standards. The ICH Q8, Q9, & Q10. Where developed to help with product quality.
Pharmaceutical Modern Quality System
The Pharmaceutical sector is highly regulated industry which have to be implemented by government law. It hasn’t been always like this. Back in the mid-1900’s there was no regulations in place. Standards for drugs were not around then. Anything could be sold on the market. No testing was done on the product to see if they were ok to release on the market. In the early 2000 century the products where regulated in America. Pharmaceutical Quality Systems are the most important regulatory documentation in the Pharmaceutical sector.
The reasons why we have drug regulations is to make sure the quality of product is safe for the people that are using it.
The things we need to have in medicines quality.
- Identity: Active ingredient.
- Purity: No contaminants.
- Potency: The correct Strength.
- Uniformity: Consistent, Colour, Shape, Size.
- Stability: Ensures medicines activity for required period.
QA & QC play important role in ensuring medicines are desired quality. (1) (Donovan 2018)
Quality Assurance: Ensures that the process that is worked on will meet all requirements. It is to prevent by using good quality procedures. Quality needs to be implemented in the pharmaceutical product.
It tries to stop mistakes from happening in the manufacturing process and failures in the end product by planning and watching these processes and procedures.
Quality Assurance department take measurements and compare the results to the standard they should be at. If there is any problems with the results there has to be corrective action taken.
Quality Assurance focuses on areas such as inspection of raw materials, monitoring assemblies, inspection of processes and of production measures.
The main aim of Quality Assurance is to have in place the level of manufacturing processes and procedures that allows same result within the manufacturing process, and satisfactory finished product that meets all industry standards. (2) (Getreskilled 2018)
Quality Assurance is everything we do to try and ensure the quality of the product that we are manufacturing is to the right standard. It all so takes into account GMP and lot of other factors like documentation, Change control, Management, CAPA, Validation and Auditing. Quality Assurance is all preventing defects by using a good quality procedures. i.e. (Prevention).
- Qualified Person: Very important person in the roll of quality assurance. Qualified persons are either qualified chemist, pharmacist, biologist, or a person with another qualification. This roll was only brought in the mid 1970’s and it only applies with the European Union. They are to ensure and certify and check each batch product complies with the laws that are in forced and the marketing authorisation. QP is responsible for the releasing of each batch to the market. If anything goes wrong with the batch when it is released the qualified person is responsible for the batch.
- Quality Control: Main concern is with detection. Sampling, specification, and testing the drug products to make sure that it 100% safe.
It is concerned with the quality throughout the process.
It checks for what raw materials and API’S are used to produce the product.
When the raw materials come into the plant they are all checked to make sure that they are the right raw materials they ordered, and then they are tested to see there is no problems with the raw materials.
Quality control may have to check and release all different packaging. The components with physical contact with the drug product, i.e. vials, caps, syringes, and bottles. QC will do in-process sampling and also on finished product samples.
Records will always be kept on batch records in case something goes wrong when the batch is released to the market. (3) (WhatIs.com, 1999)
Cost of Quality
- Prevention: Find the problem at very early stage, see if something has happened and try and prevented it from happening. It may cost you money but it will cost lot less if it did not get picked up and there was failure and the product was on the market. We can do daily audits, Process control, Make sure people are attending training, machines and test equipment are always checked and maintained.
- Estimate cost activities: Inspecting the tools machines and the drug product.
Test the product when it is finished to see if it is ok and go to the next stage of the process.
Monitoring: keeping an eye on each step of the process stages.
Auditing: all the software and hardware process.
3 Internal failure cost: Can cost the company lot time and money by been away from manufacturing or development by spending too much time into finding out why there is problems with the product. Investigating why this went wrong. Can cost the company money from scrapping product to have to do rework on the tools and machines. Cost money for analysing the failure of the product.
4 External failure cost: When the product has left the plant and is delivered or shipped to the customer. There could be major problems if this happens, like court case, warranty cost, getting licences been cancelled or orders, or even plants been closed down for a period of time until they do investigating why this happened and stop it from happening again.
ICH Pharmaceutical Quality Systems
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Pharmaceutical Quality Systems have high rates of failure. They also have long cycle time. They had no desire to change things in the past unless they had to change there was also a lack of innovation in the pharmaceutical sector. It is said that the pharmaceutical sector could be classified as reaction sector rather than looking for ways to make changes, and opportunities to make new technology was missed. Continues improvement would not have been on top of the list, and quality cost was very high. For example semiconductor sector like Intel have all ways been looking to change to improving the quality and efficiency of the product. They have lean, six sigma, quick and easy Kaizen. Also QEF which is quality efficient, good catches, and improvement trackers. Pharmaceutical industry yield is very low and very high defects in comparison to the semiconductor and medical devices sectors.
ICH Quality System were developed in the 1990s and 2000s. There is 3 Quality Systems that integrated with each other and are also standalone they are ICH Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems. Evidence shows that they provide great product assurance of quality and for better effective quality system.
Reason we need Pharmaceutical Quality System.
- Good Business Practice.
- The Global Economy.
- Massive changes in the external business environment.
- Big focus on efficiency, Lean process.
- Greater competition and lower cost sources.
ICH Q8 Pharmaceutical Development
ICH Q8 Design a better quality drug product and the Manufacturing Process to always deliver the best performance of the product that is been produced.
QBD product quality they do multiple experiments. Not just looking at one factor at a time like temperature density mixing speed pressure. They are looking at things together and how they might impact on one another, and effect one might have on the other. Try to design the best process based on data and knowledge that they generated. What they do is enough experiments at certain level to give enough information to set up what is called the design space which means your specifications you do all the time will be in the design space, but if something changes that they normally manufacture, we allow our self’s through experiments the scope to make some changes like flexibility to changes things, if you remain in the design space down the line if you want to make changes. This is not seen as a change because this is already implemented into the product development this is highly recommend by the regulatory bodies.
Traditional Approach: Does product testing to document quality. It never looks too far ahead. It is not designing experiments to show us that one thing can impact on another. This is an old fashion way of designing product. There still has to be validation done. It is not as efficient, it doesn’t give you near the same degree product and process knowledge understanding and doesn’t over flexibility when your manufacturing. They are not keen to move away from this approach to the QBD approach which is the ICH Q8.
QBD Approach: It is about improvement proficiency driven, Science and risk based, The ICH Q8 traditional approach is still acceptable. But the QBD provides better assurance of product quality and manufacturing efficiency and flexibility. (5)(Donovan 2018)
Q9 Quality Risk Management Process
ICH Q9 has been around for a long time in most sectors. Now it is a regulatory expectation in the pharmaceutical sector. It is relevant at each stage of your product life cycle.
Quality Risk Management Process Diagram
Risk Assessment: It identifies defects and it analysis the dangers associated with exposure to those defects.
What we will check for in the risk assessment
- Can anything go wrong
- What is the possibility it will go wrong?
- What are the outcomes?
Risk Identification: They use statistics to check for dangerous or potential risks. They call this the risk question. They will keep records.
The question Risk Identification is asking is what might go wrong with the process. Trying to identifying the possible problems. This shows we need further movement in the quality risk management process.
Risk Analysis: To find out the risks associated and identified the dangers. The process and chance of something happening and what harm it could cause.
Risk evaluation: Works to stop a dangers event happening, it also works to minimise the risk or control it to a level that is required. Have to make sure the risk is acceptable and no risk reduction or detection controls are required. (7) (Donovan 2018)
Risk Control: About making decision to minimize or accept the risks that could happen. The aim is to control the risk and to minimize the risk to acceptable level.
Risk control will focus on.
- Is the risk to high?
- What can we do to minimize or stop the risks?
- Are new risks introduced as a result of the identified risks being controlled? (8) (Ich.org, 2005)
Risk Reduction: When actions will be taken to narrow down the chance of event of some harm been done, also the seriousness of the harm that has been done. Corrective Action and Preventive Action are used.
Risk Acceptance: When the decision of the risk or risks is accepted. Even the most excellent quality risk management practice might not be able to remove the risks. In a case like this it might be agreed that the quality risk management has been applied and the quality risk is minimized to an acceptable standard.
Risk Review: Senior managers need to be involved in the quality management process. This is where they review or monitor the output results of the risk management process, deciding if the suitable and new information and experience about the risk. They have to check nothing has changed to affect the QRM outputs and conclusion.
ICH Q10 Pharmaceutical Quality Systems
Q10 explains the type for successful quality management system. This applies to the development and manufacture of the pharmaceutical drug substance and drug product.
ICH Q10 was issued in 2008. It aims to further progress from separate GMP compliance procedures at each step of the product life cycle to a quality systems approach over the life cycle of the product.
ICH Q10 interact with different quality systems like the ISO, GMP, Q8 and Q9. Q8, Q9 & Q10 can also be standalone. Q10 is the model for PQS that can be planned throughout the different process of a product lifecycle. Most of the information of ICH Q10 to manufacturing companies is currently identified by GMP requirements. ICH Q10 don’t intended to make any new changes beyond current regulatory requirements. (9)(Ich.org, 2008)
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ICH Q10 Life Stage Cycle
Pharmaceutical Development: API Development and Drug substance Development. What excipients go into the API, looking for new excipients and will they work well with the API. New formulation Development, and were it is needed. How you formulate your drug product. What closure system will be best for this product? Delivery System is it injectable, parental, transdermal. Analytical testing.
Technology Transfer: New product is transferred from development process to manufacturing process. Transfer between manufacturing and testing sites for market drug product.
Manufacturing: Provide the facilities, utilities, and all the equipment for the manufacturing. Set up the production facilities including the packaging and labelling area. Quality control and assurance set up and managed. Storage of the product when finished. Distribution of the product.
Product Discontinuation: Keeping records on data documentation. Documentation for how long and how you are going to do it. Retain some samples. Continue product assessment and reporting has long as there is product out on the market (11)(Ich.org, 2008)
GMP: Is relevant and applies in the involment of the product life cycle and for the investigation that are tested in the clinical trials.
Management Responsibilities: Is involved in all the steps of the product life cycle. The senior managers are essential to commitment to quality, and for the performance of the quality system. Senior management is responsible to ensure that there is effective PQS in place.
PQS Elements: Process performance and product quality monitoring system to make sure that the state of control is sustained, provide assurance of permanent capability of process controls to produce a product of the desired quality.
(CAPA) Corrective Action/Preventative Action system. This system should result in product and process improvements. (12) (Donovan 2018)
Change management system to implement changes and have change control. Change is good because it allows the company to change to improve, but has to make sure there is no intend harm in making the changes.
Management Review is when the all the senior managers meet up every couple weeks to talk about the product quality review. Mangers need to be working together to identify areas for improvement.
Enablers: (1) Knowledge Management: Product and process knowledge should be managed and developed through the commercial life of the product and up to discontinuation.
(2)Quality Risk Management: it is all about the risks that are found, and don’t wait for something to happen. It’s about been proactive. It is used in the investigation and the product defects to identify root causes. (13) (Fda.gov, 2009)
Benefits of Q10 Pharmaceutical Quality System
The Pharmaceutical sector and regulatory bodies are dedicated to ICH Q10 to make sure the consistent availability of drug product around the global.
It shows benefits from ICH Q10 instructions for sector and regulators bodies.
All the pharmaceutical companies are encourage to improve their manufacturing processes and reduce unwanted changes, this will lead to more reliable drug product quality and also improve process conditions and more efficiency.
New ideas or better solutions and continues change in every part of the process product life cycle.
Produces the relationship between development and manufacturing to create systems that are in place for management.
It helps the people that are involved in making the big decisions and gives them confidence that the right decisions are made.
The senior management have strong management leadership and commitment to quality and efficiency.
Supports risk based approach to quality decisions.
It encourages CAPA culture, this is to make sure actions are taken before any problems happen or could happen.
Advance quality monitoring and analysis (e.g. records, statistical process control and process capability measurements), this structures the starting point for better product understanding, and regular improvement of processes.
Providing better assurance.
Improved factory process performance, proper training for all sector in the company
The cost for all different failures are reduces i.e. internal failures (rejects, reworks, scrap, and investigations) so this can drive quality improvement.
(14) (I Thrussell, MHRA 2008)
In my research in finding out about Pharmaceutical Sector there is evidence to say that it has been lagging behind other sectors like semiconductors and medical devices for quality and efficiency for a long time, and still is to a certain extent but is improving all the time. There was lot of incidents where people were killed or sick from the quality of product not been made to the right standard, and with this happening there at to be change. For a long time the Pharmaceutical sector have been afraid to bring in changes, where the semiconductors and medical devices seem to be changing, and bring in new ideas and new product all the time. But since the Pharmaceutical Quality Systems and ICH Q8, Q9, and Q10 were introduced in the 2000’s there has been more aim towards the quality and efficiency in the sector. There is also benefits to the ICH Q systems for quality and efficiency. ICH Quality Systems like Q8, Q9, Q10 with been integrated together gives a stronger improvement for quality process and procedures to the pharmaceutical sector. They provide great product assurance of quality and for better effective quality system. They are also stand-alone quality systems.
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I do believe from my research that the Pharmaceutical Sector has improved a lot in the last fifth teen years or so since it has brought in the ICH Quality systems. But I still feel they are still behind the likes off the semiconductor and medical device sectors in different areas of quality like still not keen to make changes, quality cost seems to be more expensive and happens more in the pharmaceutical sector.
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