Good Manufacturing Practice (GMP) is the testing of manufacturing products with the help of defined quality standards. By following GMP, you can prevent issues like cross-contamination, adulteration, and mislabelling. This reduces waste and losses while giving your customers the highest level of protection.
Whether you’re navigating compliance for the first time or looking to refine your processes, understanding GMP principles is critical. This guide breaks it down for you—from what GMP entails, to its key components, and the best practices to help your organization not just meet standards, but exceed them.
What is Good Manufacturing Practice?
Good manufacturing practice, short for GMP, is a total quality management system that seeks to enforce the consistent, hygienic, and safe manufacturing of products, including pharmaceuticals, foods, and cosmetics, under set quality standards. Good manufacturing practices (GMPs) contain a list of processes and procedures that should be taken in manufacturing and production stages to avoid ill effects from a product defect, contamination, mislabeling, adulteration, etc.
Generally, the purpose of GMP is to reduce the health and safety risks involved in the manufacturing of products that cannot be observed when the product has reached its final stage.
It covers all areas and components involved in a manufacturing or production stage, including materials, personnel hygiene, equipment, facility or building, machinery, premises, and so on. GMP guidelines are requirements that also extend to the storage and distribution of goods.
For utmost GMP compliance, plants, firms, and organizations should focus on the following aspect, to mention a few:
- Sanitation and hygiene (Including employees, premises, and building).
- Quality of raw materials
- Regular quality inspection and audit
- Equipment and machine functionality
- Consumer complaints
- Product documentation and record-keeping
- Validation and qualification
GMPs are basic regulations, including careful procedures and guidelines, promulgated by the US Food and Drug Administration under the jurisdiction of the Federal Food, Drug, and Cosmetic Act.
What are the 5 main components of GMP?
Following the developments of new drugs, food types, and manufactured products in general, counterfeits have propagated the market. While this occurrence is currently popular, some companies and plants don’t do well in distinguishing their products from these counterfeits due to bad quality management and control. However, different national regulations have come out to set specific quality standards to ensure good and quality products in production firms to eradicate ineffective or defective products.
When these quality standards are meticulously enforced, consumers can easily differentiate counterfeit products from original ones. As a manufacturer, good manufacturing practices are essential, especially regarding the following manufacturing components:
1. Personnel
These refer to the employees and all workers in general involved in the production cycle from manufacturing to distribution and storage. It is paramount for all personnel involved to uphold specific good manufacturing practices in an industry, firm, or organization to support the safe execution of a production process.
In light of this, GMP training could be held to assess employees’ competency, performance, and compliance with quality standards during manufacturing processes. Utmost personnel compliance with GMP guidelines will help boost product efficiency, productivity, and effectiveness.
2. Premises
The entire building or area involved or used to conduct manufacturing processes should be clean at all times. Hygiene protocols must be observed all around the premises to avoid contamination. Aside from sanitary issues, the premises should also be fit for production regarding the space, location, etc.
Check and calibrate equipment and manufacturing assets used in the premises. There should be special facility audits and building inspections to eliminate potentially dangerous and unsafe elements that could jeopardize the realization of quality and a safe manufacturing environment.
3. Processes
Processes are the different methods or steps taken while manufacturing a product. All processes or methods involved or used to facilitate manufacturing must be clear, consistent, and in compliance with set quality and safety standards. All employees should be informed of process criteria and requirements to avoid variations and deviations. Manufacturers and quality managers should endeavor to inspect processes to ensure that they consistently support the outcome of quality products.
4. Procedures
These are specific guidelines taken to ensure the success of a manufacturing process. Procedures also have to be clear, consistent, and evenly distributed to all employees so that no one deviates from the set procedures.
Procedures for various processes differ, so it’s important to properly cross-check them all to ensure that they produce effective and consistent results. If there are deviations, report them instantly for further evaluation to prevent the failure or ineffectiveness of a process or part of a process.
5. Products
Products are the final result of a manufacturing process which makes them one of the most important components that manufacturing plants should be careful about. After production, products must undergo meticulous testing, comparison, inspection before they are sent out for market distribution. Manufacturers should ensure that they follow appropriate safety and quality standards when handling, packaging, storing and distributing products.
Concerning the products, manufacturers should also endeavor to set consistent specifications for raw materials used in production to ensure that good and quality products are manufactured all the time, even if they have to take care of overall equipment performance.
Some GMP guidelines and elements to keep in mind
A manufacturing firm should follow many quality control guidelines if it wants to achieve good and effective products. To keep track of these, you can check out the pre-made GMP audit checklists that we’ve curated, for an organized process.
Below, we’ve handpicked general elements that are involved in good manufacturing practice and let you in on basic guidelines to keep in mind concerning them.
Quality management system
No progressive plant is without a good quality management system. As a manufacturer you can use the ISO 13485 to conduct consistent quality assurance tests. This is an excellent manufacturing practice that will result in less occurrence and recurrence of defective and ineffective products.
In a wider view, an organization needs to possess an excellent quality management system responsible for administrating quality practices and using quality control techniques and tools more proficiently.
There should be a solid quality risk management system that focuses on minimizing and mitigating potential risks that affect the quality of products from the initial stage of production until when it gets to the end user. This system will also need to possess a quality control procedure that will focus on sampling and testing products to keep up the consistent result of quality products.
Building or facility audit and inspection
One of the most important factors that support excellent manufacturing practice is how to fit the facility or building for manufacturing and production processes. Manufacturers have to consider the condition of their building if it is spacious and strong enough to handle a high-tech system of operations.
To validate this, inspectors need to conduct a visual inspection and run basic tests to understand the capacity of your installed equipment and facility. Doing this enables you to know when activities like remodeling, remodification, or repairing are needed.
Sanitation and hygiene
Good manufacturing practices are a prominent regulation that the Food & Drug Administration (FDA) enforces. Food items and drugs pose more risks to consumers compared to other products like cosmetics and medical devices because of possible contamination. One of the main causes of food and drug contamination is poor sanitation and hygiene. This might be either around the premises or by the workers involved.
To uphold GMP, your employees, procedures, and instruments must undergo adequate sanitary and hygiene procedures.
Material management
From the collection down to storage and inventory, every raw material used to manufacture products should be properly managed. When you have an accurate inventory of your materials and are always storing and distributing them while following necessary precautions, you’ll be better able to minimize the risk of bad customer experience on quality and effectiveness. It is one of the most important elements of GMP, and every manufacturer should keep it in mind always.
Best practices for upholding GMP standards
Some companies or industries might have it easier due to simple and straightforward production processes or light scale or work. In contrast, production plants that undergo complex manufacturing processes might have to be extra careful and astute when implementing GMPs to mitigate as many risks as possible.
Now, there are quite a bunch of principles that you need to implement to attain effective quality manufacturing results. These will help you achieve GMP compliance:
A quality team
One of the principal things to ensure that you own is a team of skilled and competent workers. The manufacturing process mostly includes multistep operations requiring various skills and expertise. It’s important that every person you’re working with knows what they’re doing and is doing it well. After you verify this, you are already in the necessary condition to implement good manufacturing practices.
As long as basic things like personal hygiene and critical factors such as proper workplace ergonomics, astuteness, and skill are in check, you are already halfway through realizing an appropriate GMP.
Documented validations
These refer to a documented record that proves that your systems, instruments, processes, and procedures are effective, consistent, and efficient. You can stay clear of lawsuits and several other consequences of bad manufacturing practices through proof of your validity with the necessary documents. These documents validate that your manufacturing process meets the required expectations according to quality and organizational standards.
Some examples are cleaning and sanitation validation, process validation, analytical method validation, and computer system validation.
Impromptu audits and inspections
The purpose of audits and inspections in production plants is to check for violations, errors, or deviations in manufacturing components such as processes, pieces of equipment, surroundings, operators, etc. Conducting surprise audits and inspections once in a while will help maintain good manufacturing practice standards and help prevent product defect or contamination, error, technical issues, mistakes, and even hazard from occurring. It will also help stricten quality and safety compliance so that effective and safe products are distributed to end users.
GMP compliance training
One of the best ways to cover all key aspects of GMPs is to train all personnel. Manufacturing can’t happen without its operators. In these sessions, workers learn how to apply GMPs and maintain standards consistently. The training will also contribute to professionalism, high effectiveness, and continuous improvements.
How do digital technologies support GMP documentation?
A GMP certification is achieved and maintained by following the principles as well as continuous and consistent documentation. The use of software tools helps to rationalize and simplify the documentation of GMP records. Supervisors and employees are supported in the daily implementation of routine GMP controls.
Lumiform is an inspection app and software that can help your company with GMP planning and documentation:
- Carry out paperless GMP controls with any mobile device
- Get notified about routine checks using automatic notifications
- Use free digital GMP checklist templates and customize them to your company
- Attach photos of any deviations directly to the controls and initiate corrective actions
- Carry out temperature controls with sensors
- Receive an automated report of all controls performed and forward it by e-mail to the responsible person for analysis.
Summary of basic GMP principles
To sum it up, any production company that wants to observe good manufacturing practices should implement the principles below:
- Stay ready at all times by creating and using Standard Operating Procedures (SOPs) proficiently.
- Endeavor to maintain systems, processes, procedures, and types of machinery to achieve consistent quality results.
- Run tests and conduct GMP audits and inspections regularly to keep the company’s safety and quality system tight.
- Maintaining cleanliness at all times to prevent the risk of contamination.
- When laying out project plans that involve production, ensure to prioritize quality and integrate it into your workflow.
- Validate that your Standard Operating Procedures (SOPs) are effective, efficient, and up-to-date in terms of processing standards. Also, make sure that your SOPs are flexible enough for a little tweak whenever needed.