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.
Since GMP basically looks out for the quality of manufacturing processes and systems, 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. It ensures that all activities and elements involved in manufacturing consumable goods and usable goods do not pose risks to consumers and clients. GMP guidelines are requirements that also extend to the storage and distribution of goods. Good manufacturing practices can help prevent catastrophic events that result from negative product impact. 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. This act was established to ensure that manufacturers meet all quality standards during the production, distribution, and storage of foods, drugs, and cosmetics to avoid product error and ineffectiveness. Recommendations on meeting up with good manufacturing practices include implementing more sanitary and safe systems and using up-to-date technological systems.
Table of contents
- What Is Good Manufacturing Practice?
- What Are The 5 Main Components of GMP?
- Some GMP Guidelines Elements and Respective Guidelines To Keep In Mind?
- Some Measures You can Use To Uphold GMP Standards
- A quality team
- Basic GMP Principles
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:
- Personnel: These refer to the employees and all workers in general involved in the production cycle of production 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.
- 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. Equipment and manufacturing assets used in the premises should be checked and calibrated, and 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.
- Processes: Processes are regarded as 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.
- 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 they are all properly cross-checked to ensure that they produce effective and consistent results. If there are deviations, they should be instantly reported for further evaluation to prevent the failure or ineffectiveness of a process or part of a process.
- 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 Elements and Respective Guidelines To Keep In Mind?
A manufacturing firm should follow many quality control guideline if it wants to achieve good and effective products. These guidelines cut across many areas of manufacturing processes, from the different stages of production to the elements utilized, such as equipment, space, materials, procedures, etc. It might be burdensome to have you read a lengthy detailed description of every guideline in manufacturing.
Also, it would be out of the question to do so because there are varieties of plants for various types of products that we can’t begin to count. However, we’ll handpick 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 observe consistent quality assurance tests should be done regularly on products as it is an excellent manufacturing practice that will result in less occurrence and recurrence of defective and ineffective products. In a wider view, an organization or a manufacturing firm needs to possess an excellent quality management system responsible for administrating quality practices and utilizing 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. These are all elements of good manufacturing practices that will prevent consumers from harm.
Building/Facility Audit & 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. It is one of the most fundamental good manufacturing practices to keep in mind as a manufacturer or quality manager.
Sanitation & Hygiene
Good manufacturing practices are one of the very prominent regulations that the Food & Drug Administration (FDA) strictly demands from production companies. Food items and drugs mostly threaten consumer health compared to other products like cosmetics and medical devices because of the dangers of contamination. And one of the main causes of food and drug contamination is poor sanitation and hygiene either around the premises or by the workers involved. To uphold GMP in your firms and companies, endeavor that all your employees, procedures, and instruments undergo adequate sanitary and hygiene procedures.
From the collection down to storage and inventory, every raw material used to manufacture products should be properly managed because proper stock management has a huge role to play in actualizing quality produce. When you have an accurate inventory of your materials and are always storing and distributing them while following necessary precautions, you’ll be above to minimize the risk of bad customer experience on quality and effectiveness. It is one of the most important elements of GMP and a good manufacturing practice that every manufacturer should keep in mind always.
Some Measures You can Use To Uphold GMP Standards
Without regular and meticulous evaluation, it might be a little hard to realize the ideal standard of the good manufacturing practice. The result of inappropriate GMPs is still evident today and will most likely continue to be evident as long as we remain the imperfect humans that we are. However, we can still tremendously mitigate manufacturing risks if we consider upholding good manufacturing practices and standards.
Some companies or industries might have it easy 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 effectively and quality manufacturing results. Whether you’re running a large plant or working in a firm with a diverse system of operation, once you complete the following measures, you’ll most likely neet up with an acceptable standard of the good manufacturing practice.
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, so 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 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.
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 as long as you have proof of your validity with the necessary documents. These documents validate that your manufacturing process and what you’re using to facilitate them meet the required expectations according to quality and organizational standards.
Examples of some of the validations you need to attain to be on a good gmp standard 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. Therefore 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 few ways you can generally cover all of the major aspects of good manufacturing practices is to engage all personnel and workers in GMP compliance training. Manufacturing can’t take place without its operators, so, in this training, all workers undergo training sessions that enable them to undertake GMPs more and learn how to maintain its standards consistently. The training will also contribute to professionalism, high effectiveness, and continuous improvements.
Basic GMP Principles
Any production company or firm that wants to actualize a manufacturing atmosphere where all good manufacturing practices are observed should remember to implement the following principles below. These principles basically cover the specific acts and prerequisites expected from a company aiming to achieve good manufacturing practices.
- 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.