Current Good Manufacturing Practices (cGMP) are systems in place that ensure that a product is being made according to current regulations. This means that it meets quality standards, production standards, and regulatory standards. While working in quality engineering at Zimmer-Biomet, 21 CFR Part 820 of the QSR was the bible in our department. I agree with all of the parts listed in the task and they provide a good overview of the requirements as listed in the book. cGMP's are important in any step of the manufacturing process, whether its the initiation, planning, execution, closing, or monitoring phase. In the initiating and planning phase, the goal is to essentially come up with a procedure to, lets say, create a new product. A regulatory system is essential at this step because it lays out all of the regulatory requirements needed to even begin the project. In the Executing phase (manufacturing step), a product must be traceable to ensure proper creation, and to limit scrap and co-mingling of parts during the manufacturing of the product. In the monitoring and controlling phase, a quality system and security measures are essential to assess any issues with the process and ensure the proper nonconformance/CAPA process is followed to troubleshoot any errors and get they system back on track. Lastly in the closing phase, again, a quality system is necessary to provide proper assistance to any issues that arise post-production and once the product is out in the market.

According to ISPE, Good Manufacturing Regulations were created by the FDA to ensure that manufacturers take the proper steps to validate their products safety, purity and effectiveness. With these regulations the consumer is less at risk of receiving a product which is harmful or not effective. Since the GMP regulations are supported by law, the consequences of not abiding by them can be very serious. The cGMP regulations allows for more control of the PDCA cycle within project management. The planning phase/ planning processing group is where the thought process on which objectives are needed to reach the goal are determined. Being able to figure out from the beginning as to which regulations need to be followed to reach the end goal will help predict future development issues. Therefore, within the initiating processing group the steps on how to start the project can be modified to ensure that the final product abides by the cGMP regulations (regulatory). Executing Processing group is the development stages of the product. Within this stage traceability is vital because if a part has an issue then it can be traced back to its source and be fixed. I believe that the monitoring/ controlling processing group occurs throughout the entire PDCA cycle because everyone is always trying to figure errors in the device or plan in order to fix them before the deadline. Within this phase, the cGMP regulation of security will take effect. Lastly, the closing processing group is when quality regulations must be followed to make sure that the final product meets the quality assurance of the company.
Reference:
http://www.ispe.org/gmp-resources/what-is-gmp
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm

Based on my experience with GMP, it is a vital practice that ensures companies in the eyes of regulatory agencies that there products are traceable, they meet all quality standards, meet regulatory agency standards, and are safe.I know with respect the manufacturing of microneedles, each needle is hand inspected by a technician for defects, ranging from curvature of the needle to actual penetration is tested. Overall, GMP ensures that the customer receives the best quality product possible.

chris

Good manufacturing practices (GMPs) play a huge role in starting up a new project. They are absolutely meant to ensure quality and safety of the products being produced. Put another way, from my experience with GMPs, they are in place to cover all of your bases in terms of accountability as one mistake can easily cause multi-million dollar law suits. This will have the biggest effect on the Initiating and Planning phases of the PDCA cycle. For example, if there was a project set up a plant that manufactures stock solutions for chemicals. This would involve finding a suitable location, procuring the correct equipment for storage and handling, hiring the correct staff, having all the proper clearances to build, knowing all of the proper ways for disposing hazardous wastes and the list goes on. Any product being mass produced for the public or private use requires a significant amount of planning and clearance ahead of time.

When it comes to the execution phase, everything should be being done to all the correct specifications and the whole time, from the initiation phase to the execution phase is carefully monitored according to the Monitoring/Controlling phase which would probably be the most difficult part for a medical device project manager. Monitoring every aspect so that it all stays within budget, within a time frame, following all of the correct safety regulations and GMPs. In short, GMPs will dictate most of the planning phases as well as having to follow them to the letter during the doing phases.

If I apply this question to submarine technologies, I believe the answer changes from what is already outlined. In this situation, security is important at all stages and influences how you do all stages. At any of these stages, foreign nations can compromise or gain sensitive information which would be catastrophic. Security would make it a lot harder to do any of these stages so one would have to understand that those stages are going to take longer and cost more than if security wasn't a factor. In the initiation and planning stages, traceability is very important because if you don't probably trace your parts you could end up with refurbished, faulty equipment. Its imperative that quality parts are used or the product would be compromised. In the initiation and planning phase, regulatory is another huge thing because these are lots of standards that have to be met and you have to start early on to ensure that you meet all of them. During the execution, closing, and monitoring/controlling phase, a quality system has a big impact to make sure the product is assembled correctly and even after its put into service, is still meeting standards.

I believe this answer changes depending on the project and the situation.

In today’s world of manufacturing, it is essential for a company to have regulatory laws in place. Good Manufacturing Practises (GMP's) are regulations placed to meet the company’s quality standards and production standards. More importantly, GMP's regulation sets the company standards higher and also plays a role in the market. For example, if I were to give a contract to manufacture medical parts to a company, I would look for GMPs before signing the contract. GMP's can affect each phase of manufacturing when creating a new product. In the Initiation and planning phase, it is important to create a step by step instruction on how the project will be done. In addition, project manager creates an estimated timeline of the project. Next, is the regulatory phase in which one gathers all the certification of the materials that will be used to create that product. Traceability becomes important here because FDA requires that all parts included in the manufacturing of medical parts must be able to trace it back to its original source. Lastly, is the Monitoring and Controlling phase in which security measures are placed to avoid mixing up manufacturing lots and to reduce scraps. This process is further controlled by CAPA process which controls or prevents the same mistake from happening again. Finally, a quality rep looks at the paper works and signs off before leaving the company and into the market.

I would like to share my interview experience on this post. I was interviewed for a position and the manager specifically asked me about GMP and what it meant. So in the real life examples, a company must be able to provide a chain of custody of each product or sample in their possession. I would argue that Traceability influences a project in the initiation, planning, execution, closing, and monitoring/controlling phases. Any project would require an actual product or samples for clinical trials. The Traceability will be the key component if your project faces any legal issues because the chain of the custody will be the first under review if anything or any piece of the project is unaccounted for even for a couple hours. The project team must be able to account for the samples or pieces at ALL times. In addition, if under FDA review, your traceability will be looked at in order to detect fraud of falsified documents or results. Therefore, it will influence any project the most.

Early on in the initiation and planning phases it is important to understand GMP requirements and how they relate to the project. For example, if your company is now developing a combination device and they have not before, they will be required to meet a whole additional set of standards. These quality system updates will need to be factored into the project planning. During project execution you will be making sure all of the GMP requirements are met for the project. Submissions to regulatory agencies will be required and they will be auditing the company to make sure the requirements were properly carried out. During the controlling and monitoring phase you are observing the process after project implementation to identify problems and risks. This is where a good quality system is very important. If you did a good job with the project management process, there will be quality checks set up throughout the process so those things can be identified early and quickly.

Adding to all of the definitions of GMPs mentioned above, it's also extremely helpful to have Good Manufacturing Practices as well as Good Lab Practices (GLPs) for the company's own benefit. GMPs and GLPs often lead to root cause of major problems and the company is then able to solve them accordingly. Besides improving the quality of the products, companies are therefore also able to mitigate losses caused by major product failures. Moreover, with GMP, companies can avoid facing lawsuit consequences if they are able to trace back to product development and prove their product integrity. 

Good manufacturing practices are a fundamental part of any industry for any kind of product they are producing. They were made to ensure the product are harmless for the public by making sure the premises and the equipment are controlled with quality standards. That way all the products are traceable throughout the manufacturing process. From the raw material all the way to when the finished product is shipped to the customer. At work, GMP is something we all follow strictly. We want to mitigate any kind of contamination that could happen at any point. To clean equipment, for example, they use color-coded brooms, pails, etc. Everything is labeled and reported whenever they are producing a new batch. Also, training is constantly in place to keep all the personnel up to date with the safety regulations and guidelines.  

Where I am currently employed we follow GMP/cGMP guidelines. As a QA specialist our procedures are governed by the FDA which follows strict GMP guidelines and we have quality management system in place to ensure quality in our manufacturing process. Dealing with Car-T therapy these GMP practices are enforced in the strictest matter. We want to ensure manufacturing steps are done so that the final product is safe and pure for the patient. GMP/cGMP practices is common in manufacturing and its is applicable in the project management field and the PDCA cycle. For plan and initiation establishing GMP practices to the project from the start will ensure proper regulations are followed and the project is compliant with FDA. For the execution phase this is most comparable to manufacturing so procedures need to be in place for traceability to ensure each manufacturing step is recorded and can be traced back to if an issue occurs, in my line of work this means following good documentation practices when recording data and so if an issue occur we can determine who, what, when, and how the issues happened. For the check/act phase this is where quality management systems come to play to tackle any issues that occur during he project, in my company this can be any nonconformance and or CAPA aka some of what I do at work. For closing, again this is quality systems to ensure everything is in conformance before release. 

To my knowledge the term good manufacturing practice refers to a branch of quality assurance that makes sure that any goods or products are regularly manufactured and controlled to the quality requirements suitable to their proposed use and as requested by the marketing authorization of the WHO. Good Manufacturing Practice (GMP) has several principles, and a few are already mentioned in the question itself and I want to include very few of them in the discussion. A few Good Manufacturing Practice principles (GMP) to say are:

• Enhancement of the design facility layout: to deliver the best quality product to the market, the crucial step is to have the location, design, and production environment clean and contamination free. Taking earlier precautions can eliminate the hazards or contamination of the products during manufacturing.
• Keen scrutiny of raw materials: Deep inspection of raw materials can help the organization identify the defects and illegal trades at the beginning. Usually, an inspection can include examining various samples at random or testing for surface material damage. Conducting an earlier inspection of raw materials can help in reducing the probability of damaging production accidents and even cost-involved corrective measures in the subsequent stages.
• Assigning specific role and responsibilities of stakeholders: To have well-balanced manufacturing needs clearly defined and communicated roles and responsibilities. There should not be any type of doubts about task schedules, job descriptions, and shift changeovers. It is necessary for everyone in every level of various departments to know their schedules and have to document materials.