What is GMP | Good Manufacturing Practices | SafetyCulture

What is the difference between GMP and cGMP?

Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) are, in most cases, interchangeable. GMP meaning the basic regulation promulgated by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act to ensure that manufacturers are taking proactive steps to guarantee their products are safe and effective. cGMP, on the other hand, was implemented by the FDA to ensure continuous improvement in the approach of manufacturers to product quality. It implies a constant commitment to the highest available quality standards through the use of up-to-date systems and technologies.

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What are the 5 Main Components of Good Manufacturing Practice?

It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure consistent quality and safety of products. The five main components of GMP, commonly referred to as the 5P’s, help organizations comply with strict standards throughout the entire production process.

1. People – All employees are expected to strictly adhere to manufacturing processes and regulations. A current GMP training must be undertaken by all employees to fully understand their roles and responsibilities. Assessing their performance helps boost their productivity, efficiency, and competency.
2. Products –  All products must undergo constant testing, comparison, and quality assurance before distributing to consumers. Manufacturers should ensure that primary materials including raw products and other components have clear specifications at every phase of production. The standard method must be observed for packing, testing, and allocating sample products.
3. Processes – Processes should be properly documented, clear, consistent, and distributed to all employees. Regular evaluation should be conducted to ensure all employees are complying with the current processes and are meeting the required standards of the organization.
4. Procedures – A procedure is a set of guidelines for undertaking a critical process or part of a process to achieve a consistent result. It must be laid out to all employees and followed consistently. Any deviation from the standard procedure should be reported immediately and investigated.
5. Premises – Premises should promote cleanliness at all times to avoid cross-contamination, accidents, or even fatalities. All equipment should be placed or stored properly and calibrated regularly to ensure they are fit for the purpose of producing consistent results to prevent the risk of equipment failure.

What are the 10 Principles of GMP?

1. Create Standard Operating Procedures (SOPs)
2. Enforce / Implement SOPs and work instructions
3. Document procedures and processes
4. Validate the effectiveness of SOPs
5. Design and use working systems
6. Maintain systems, facilities, and equipment
7. Develop job competence of workers
8. Prevent contamination through cleanliness
9. Prioritize quality and integrate into workflow
10. Conduct GMP audits regularly

Further information can be found at this PDF Guide to GMP: Good Manufacturing Practices.

GMP Regulations

GMP regulations are mandated by manufacturers’ respective national governments to regulate the production, verification, and validation of manufactured products and ensure that they are effective and safe for market distribution.

For example, in the United States, GMP is enforced by the US FDA through Current Good Manufacturing Practices (CGMP) which cover a broader range of industries such as cosmetics, food, medical devices, and prescription drugs. The FDA conducts facility inspections to assess if a manufacturing company complies with CGMP regulations. If any serious violations are found during the inspection, FDA recalls all products, which is problematic for manufacturers in terms of both profit and business operations.

The quality of manufactured products is highly regulated as it can pose negative health risks to consumers and even the environment. Poor hygiene, temperature-control, cross-contamination, and adulteration in any step of the manufacturing process are some examples of how a manufactured product that doesn’t follow GMP regulations can bring fatal consequences to consumers. See GMP regulation and preamble sources by country here.

GMP Standards

GMP standards are developed to enhance the safety of manufactured products, especially pharmaceutical goods, and to ensure consumers get the highest quality possible. Adherence to GMP standards not only positively impacts the reputation of manufacturing companies but also reduces batch recalls and negative reports from consumers. Below are 4 measures you can follow to uphold GMP standards:

Quality team

Have a team of skilled workers that will focus on improving current manufacturing procedures and complying with GMP. Members will perform quality assessments on operations to identify problems and develop appropriate corrective measures. Part of the team’s responsibility will also be performing scheduled monitoring of instruments, equipment, processes, and staff skills.

Validation

Validation is the documented act of demonstrating instruments, processes, and activities that are regularly used or done. This is done to check if they function according to expectations. GMP can involve a number of things to be validated, but it’s good to focus on the following processes:

• Process validation
• Cleaning and sanitation validation
• Computer system validation
• Analytical method validation

Surprise Audits

A surprise audit every now and then can help gain a more accurate insight into what goes on in the facility. Identify real root causes of non-compliance and take action before it progresses into a larger issue. Read more about best practices in doing GMP audits.

Compliance Training

Providing compliance training to staff is the best way to ensure compliance with GMP standards. Help staff gain a better understanding of GMP and continually improve operations or systems in place to ensure standards are GMP-compliant. All employees should receive training on recordkeeping, sanitation, proper equipment handling, and labeling, and SOPs to minimize errors and maintain compliance.

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How to Comply with Guidelines

GMP guidelines and regulations address different issues that can influence the safety and quality of a product. Meeting GMP or cGMP standards helps the organization comply with legislative orders, increase the quality of their products, improve customer satisfaction, increase sales, and earn a profitable return on investment.

A GMP audit helps improve the overall performance of different systems including the following:

• Building and facilities
• Materials management
• Quality control systems
• Manufacturing
• Packaging and identification labeling
• Quality management systems
• Personnel and GMP training
• Purchasing
• Customer service

Ensure Compliance with Manufacturing Regulations

Simplify internal audits, capture site observations, and address gaps in compliance to meet regulatory requirements.

GMP Training

We’ve curated a list of GMP training courses that will guide your employees in following GMP standards so they can be proactive in minimizing risks in all aspects of manufacturing products such as food, cosmetics, and pharmaceutical goods. These courses cover topics such as good manufacturing practices, quality control, risk management, and many more.

Customer Story

1. Protect Data integrity and compliance 

Pharmaceutical companies are subject to strict regulations and standards and must also carefully protect the integrity of their data. Finding an efficient, reliable way to do so can help these companies to boost their productivity and product quality.

Switching to electronic data recording, for instance, can increase efficiency and reliability in quality control. Initial results become available during the production process, and reports and compliance documentation are ready as soon as a batch is finished. With paper-based data recording, this information takes much longer to process.

Electronic, automatic data recording also reduces the likelihood of errors when recording production data. If a recorded value is outside of the expected range, quality management will receive an automatic alert. Also, when data is stored on a cloud-based system, all employees have access to the most up-to-date data, regardless of which internet-connected device they’re using.

With zenon, you can also alter your processes without revalidation, which saves you significant amounts of time and money. zenon also provides full, out-of-the-box compliance as standard. Equipment, processes or operations do not need to be altered in spite of the conversion. zenon’s solutions meet regulations such as FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines. The platform also meets the requirements of Good Automated Manufacturing Practice (GAMP) 5 Software Category 4. These features enable you to meet compliance requirements more easily and efficiently.

2. Reduce paper and simplify operation workflows

Few industries have quality requirements as strict as those of the pharmaceutical industry. Every part of the process, from making the products themselves to package labeling to sanitizing the equipment used, must be tightly controlled.

In the pharmaceutical industry, the batch process, in which products are made in batches rather than continuously, is common. While this comes with benefits, it also means that one small mistake can ruin a whole batch. A bad batch means a significant amount of wasted money, time and raw materials.

If the manufacturer doesn’t catch the bad batch, the damage can be even worse, leading to serious bodily injuries, resulting in fines and lawsuits, as well as a huge damage to the reputation.

To avoid these and other negative scenarios, effective batch control is essential. zenon's Batch Control feature, for example, enables you to easily control the process and optimize production with user-friendly interfaces, hardware-agnostic implementation and seamless integration.

The data that pharmaceutical manufacturers collect about their processes is crucial to ensuring product quality. Many companies, however, still rely on paper documentation, which leaves data collection and management prone to errors.

Using automation with mobile devices can help reduce the likelihood of these errors and make data collection more efficient. zenon’s Paper on Glass application allows you to digitize and automate your data-related processes. The process itself doesn’t change, however, so it’s also efficient for validation. With Paper on Glass, the user gets detailed instructions for each task, such as safety instructions or prescribed user actions, which help to prevent errors.

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zenon collects data from many different sources, standardizes it and analyzes it. It produces easy-to-read reports, which help with quality assurance, available immediately after a batch is completed. With paper-based data collection, completing these reports is often a much longer and more expensive process.

3. Maximize efficiency and flexibility

Efficiency refers to how much input, including time, money and materials, it takes a business to produce a given amount of output. So, efficiency is closely linked to productivity.

Using zenon, for instance, lets you collect information from across your entire facility, enabling you to get a clear picture of your operations' efficiency. You can use the data and reports you obtain to uncover areas where you can improve your processes and facility.

zenon also enables you to automate various parts of your processes. Automation can allow you to get the same amount of work done with less manual input, time and resources. For example, with automated alarms, operators receive immediate notification of problems and can correct them quickly.

Validation is a crucial part of the pharmaceutical manufacturing process because of the regulations and standards the industry must adhere to. zenon can help increase efficiency in this area, as well. It offers full compliance as standard and allows you to change or improve your processes without revalidation, which can save you a significant amount of time and resources.

zenon also helps you to streamline the packaging portion of your production process. Like during the batch production process, during packaging, zenon can control, monitor and visualize your process, making it easier for you to identify ways to improve it. You can also access data remotely, so you can monitor and work on your process from anywhere. This mobility, along with user administration and access rights, also help you ensure each employee gets precisely the information they need, which can help to speed up the process.

One influential factor in these areas is the convergence of information technology (IT) and operational technology (OT), which prompts manufacturers to take advantage of Industrial Internet of Things (IIoT) technology.

Efficient IT/OT communication means the efficient sharing of data between the production and business levels. For example, it lets you use the data collected from your manufacturing process to inform business decisions that can improve efficiency. zenon helps to create seamless communication between these two levels by providing a common structure for information flow.

4. Improve the life of production assets

Another way that companies in the pharmaceutical manufacturing business can increase their efficiency is by improving the life and uptime of their machinery.

When equipment breaks down and needs replacement, companies lose money, both to purchasing or repairing their equipment and to lost production time. If equipment underperforms, a company may not be able unleash its full potential because of the slow or defective machines. Faulty equipment could also cause damage to batches of products, which means wasted time and resources.

Investing in high-quality equipment can help companies avoid these equipment issues. Having an effective maintenance program in place is also essential.

One way to improve your maintenance program is to switch from a fixed maintenance schedule or reactive maintenance program to a predictive maintenance program. This kind of program involves forecasting when machines need maintenance work so that you can determine the optimal frequencies and times to conduct maintenance. This helps you to avoid doing unnecessary maintenance work, which can increase costs, as well as missing signs of future failures, which can result in downtime and high repair costs.

To inform your predictions, you can use data from sensors affixed to your equipment. If your system detects abnormalities in how your system runs, you will receive an alert that maintenance work is needed. Using zenon and other external applications, you can create maintenance schedules easily and efficiently due to the automation these systems provide.

By investing in quality equipment and creating an efficient maintenance program, pharmaceutical businesses can avoid downtime and errors in production, thereby increasing productivity.

5. Integrate all technology 

Pharmaceutical manufacturing processes are complex, and the facilities contain a wide range of equipment and systems. The production process on its own is complex, but you also have to consider the auxiliary equipment and the building systems. The production process for pharmaceuticals requires a tightly controlled environment, so even heating and cooling systems must be kept in mind.

Integrating these systems can make it easier to control the production process and environment and ensure it’s optimized to increase productivity.

A comprehensive platform like zenon can be helpful in this area, as you can use it to monitor, control and optimize production equipment as well as other systems. It allows you to keep track of your entire system and see how the different parts interact. This enhanced visibility can help you find ways to improve efficiency and productivity.

The native drivers and industry protocols within zenon help to make integration easy, even if you have many different kinds of equipment from different manufacturers and generations. zenon Historian, for example, can use native drivers to connect to any system, whether that’s an enterprise resource planning (ERP) system, manufacturing execution system (MES) or another type of system, without any changes to the third-party system.

You can also integrate all areas, including clean rooms, into a single monitoring system. zenon includes chronological event lists, alarms, test logs, archiving and more, all in one platform. This provides you with improved analysis and data presentation, which helps you to gain better insights into your systems and how to improve them.

6. Improve industrial security

Cyberattacks and other security threats can bring production to a halt. These threats can also cause pharmaceutical companies to hesitate to adopt new technologies that could boost their productivity. New technologies, such as IIoT devices, can provide many benefits but can also introduce potential new threats that must be protected against.

Because these technologies can provide productivity improvements and many companies hesitate to adopt them, finding a way to implement them while protecting against security threats can offer a substantial competitive advantage.

All pharmaceutical companies need to have a robust cybersecurity system in place. These systems play a crucial role in enabling companies to adopt innovative, new technologies. Companies also need to choose to use technologies that have excellent cybersecurity features built into them.

Looking for providers that have earned certifications can help with this. COPA-DATA has received a certificate of conformity to the ISA/IEC -4-1: security standard from TÜV SÜD, which is part of the German Association for Technical Inspection. This certificate demonstrates that our processes meet the requirements of current industrial IT security guidelines.

zenon includes security features such as encryption, authentication, file signature, secure interfaces and secure user administration, which protect against data loss and other threats. These features make it easy to integrate zenon into your existing security strategy.

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