What is GMP? The requirements and deployment processes of GMP
During the product manufacturing process, ensuring quality is a crucial factor. To achieve this, manufacturing businesses need to adhere to quality standards. One of the most important standards is GMP – Good Manufacturing Practice. So, what is GMP? How about the requirements and deployment processes of GMP? Let’s explore in the following article with GOL!
1. What is GMP?
GMP stands for Good Manufacturing Practices, meaning the practice of manufacturing goods adhering to high-quality standards. It is a system of principles and requirements established to ensure that products are consistently produced and quality-controlled according to recognized standards.
GMP is applied in various manufacturing industries, especially in the production of food, pharmaceuticals, cosmetics, medical devices, and more. It encompasses requirements for facilities, equipment, raw materials, production processes, and personnel, aiming to ensure that products are manufactured in a clean, safe, and procedurally correct environment, meeting specified quality standards.
GMP controls factors influencing the quality formation process, ranging from facility design, construction, processing equipment, and conditions for preparation and processing to packaging, storage, and human control of activities throughout the processing and manufacturing process.
2. Types of GMP standards
There are various types of GMP, and in some countries, there are specific standards for Good Manufacturing Practices. However, here are some of the most common GMP standards that you should be aware of.
2.1 cGMP
cGMP (Current Good Manufacturing Practice) refers to the current regulations for good manufacturing practices enforced by the FDA (Food and Drug Administration) in the United States.
The “c” stands for “Current,” reminding manufacturers to use updated technologies and systems to comply with regulations, cGMP is also known as FDA GMP. cGMP is the mandatory requirements for pharmaceutical, medical device and supplements manufacturing for the US. Additionally, Compliance with cGMP guidelines is mandatory for supplement manufacturers, guaranteeing the quality, safety, and effectiveness of their products. Covering essential aspects such as personnel qualifications, facility cleanliness, equipment maintenance, and meticulous record-keeping, cGMP sets the industry standard.
In addition to cGMP, supplement manufacturers must adhere to the standards outlined in the Food Safety Modernization Act (FSMA). Enacted in 2011, FSMA revolutionized food safety regulations, emphasizing proactive measures to prevent foodborne illnesses rather than reacting to them.
For in-depth insights into FDA rules and regulations regarding supplements, cGMP, FSMA, and compliance requirements, we invite you to contact our service. Our experts provide up-to-date guidance and tailored assistance to meet your specific needs.
2.2 WHO GMP Standard
WHO GMP, introduced in the 1960s, is applied by pharmaceutical managers and the pharmaceutical industry in hundreds of countries worldwide. It is particularly prevalent in developing nations.
The WHO GMP standard is a system to ensure that products are manufactured and controlled consistently according to the quality standards set by the World Health Organization (WHO).
2.3 EU GMP Standard
EU GMP (European Union Good Manufacturing Practice) is a guide for good manufacturing practices issued by the European Medicines Agency (EMA). It outlines the minimum standards that pharmaceutical manufacturing facilities must meet in their production processes.
The EU GMP standard encompasses a set of standards established and issued to control activities in pharmaceutical manufacturing facilities to ensure that the output products protect health, achieve high quality, and ensure safety for users. Currently, the EU GMP standard is one of the highest quality standards, challenging and costly to achieve certification.
2.4 PIC/S GMP Standard
PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme) provides GMP guidelines in pharmaceutical manufacturing. PIC/S mainly provides guidelines on aseptic pharmaceutical manufacturing.
Countries that are members of PIC/S can apply these standards. Currently, there are 46 member countries of PIC/S, mostly in Europe and America. Vietnam is also in the process of pursuing membership in this organization.
3. 5 Main Components of Good Manufacturing Practice
Regulating GMP in the workplace is crucial for the manufacturing industry to guarantee the consistent quality and safety of products. Adhering to the following 5 P’s of GMP becomes instrumental in ensuring compliance with stringent standards across the entire production process.
3.1 People
All staff members are expected to rigorously adhere to manufacturing processes and regulations. Every employee must undergo current GMP training to gain a comprehensive understanding of their roles and responsibilities. Evaluating their performance not only enhances their productivity, efficiency, and competence but also ensures compliance with organizational standards.
3.2 Products
Before reaching consumers, all products must undergo continuous testing, comparison, and quality assurance. Manufacturers must guarantee that primary materials, including raw products and other components, have clear specifications at every production phase. Standard procedures must be followed for packing, testing, and allocating sample products.
3.3 Processes
Processes should be meticulously documented, clear, consistent, and distributed to all employees. Regular evaluations are essential to verify that all employees are adhering to current processes and meeting the organization’s required standards.
3.4 Procedures
A procedure comprises a set of guidelines for executing a critical process or part of a process to achieve consistent results. It should be communicated to all employees and consistently followed. Any deviation from the standard procedure should be promptly reported and investigated.
3.5 Premises
Workspaces should consistently promote cleanliness to prevent cross-contamination, accidents, or fatalities. All equipment must be appropriately placed or stored and regularly calibrated to ensure they are suitable for producing consistent results, minimizing the risk of equipment failure.
4. 10 Principles of GMP
Below are 10 fundamental principles of GMP that we need to be aware of:
Principle 1: Design the workshop correctly from the beginning
Designing the workshop to the standard from the start is essential for manufacturing enterprises. If the workshop is designed and built with the right facilities and equipment from the beginning, it will be beneficial in assessing suitability for Good Manufacturing Practice (GMP) in the future.
Principle 2: Validation process
Validation process is a principle that businesses need to understand to control the operation of equipment and whether the workshop construction meets standards or not. That is why the validation process is an important principle.
Principle 3: Write down procedures and follow the written procedures
Regardless of the size, every business needs to establish procedures and adhere to those procedures. Especially in the pharmaceutical, food, or medical equipment industries, there is a focus on good practices in the workplace.
Businesses can hire professionals with expertise and good capabilities to write clear, logical, understandable, and applicable procedures for them. In addition, businesses also need an independent department to review and improve the procedures to make them more suitable.
Principle 4: Determine who does what?
Every employee in the organization needs to understand the duties of each individual. What tasks are assigned to them.
Principle 5: Keep good records
Keeping good records is one of the 10 basic principles of GMP that we need to remember. Keeping records will help businesses track all activities carried out in the production process.
Principle 6: Training and development of employees
For optimal operation, businesses should establish a specific training program for all employees in production or quality control as well as activities related to product quality. And we all know that personnel are an important factor in any organization.
Principle 7: Practice good hygiene
Businesses need to have an environmental hygiene program to minimize the risk of product contamination at a minimum level. In addition, companies should develop a program that can meet the necessary cleanliness requirements for products.
Requirements for each individual employee always maintain cleanliness such as washing hands after going to the bathroom to prevent contamination.
Principle 8: Maintenance of workshop and equipment
Maintaining the workshop and equipment is one of the 10 basic principles of GMP that businesses need to pay attention to. To prevent the sudden breakdown of equipment affecting the production process, it is necessary to maintain the equipment regularly.
Maintaining equipment is also a way to reduce the risk of product contamination and maintain the “validated state” of the facility or equipment. Sometimes an unexpected incident can affect workshops, equipment, and in such cases, businesses need to repair immediately.
Principle 9: Design quality based on the entire product life cycle
Building product life cycle quality is an extremely important factor because the health and safety of customers depend heavily on product quality.
Principle 10: Regular inspections
Businesses, organizations should also conduct self-inspections several times a year to ensure that production processes comply with GMP. In addition, businesses can also conduct inspections by focusing on different areas of the production area or different departments for more effective control.
Read more: What is a critical control point (CCP)? 4 types CCP decision trees
5. The requirements of GMP
The workshop and processing facilities are designed and constructed in accordance with the sequence of processing technology, divided into safe zones such as material gathering, processing, packaging, storage, etc. This process helps ensure no cross-contamination between raw materials, semi-finished products, finished products; between food and packaging materials, cleaning chemicals, or waste;
- Control of the processing process: Manufacturers have measures to control quality with raw materials, the processing process; monitor hygiene activities; implement prevention of potentially contaminated products; test microbiological, chemical, and impurity indicators at necessary stages to determine the risk of contamination;
- Workshop hygiene control: Meaning that the workshop, equipment, tools, and other physical means always meet the permissible hygiene standards. In addition, sanitation equipment, water supply – drainage systems, surfaces in contact with products, accessories, waste, storage containers, and personal items must always meet hygiene standards and operate effectively;
- Control of preservation and distribution stages in transportation, product preservation, ensuring prevention of contamination by physical, chemical, microbial agents that do not degrade the product;
- Health requirements for workers: Manufacturers have a regular health examination regime for workers to detect, treat, and isolate those with infectious diseases, preventing spread. Those who have direct contact with the product must strictly follow hygiene regulations
6. Scope and objects of GMP
GMP is applied at all stages of the manufacturing process, from receiving raw materials and materials to the final product dispatch. The scope of GMP includes:
- Facilities: Manufacturing facilities need to be designed, constructed, and maintained under clean, safe conditions that comply with production requirements.
- Equipment: Manufacturing equipment needs to be designed, installed, and maintained under conditions suitable for production requirements.
- Raw materials: Production raw materials need to ensure quality, safety, and compliance with production requirements.
- Production processes: Production processes need to be established and implemented scientifically, ensuring that products are produced to specifications and meet quality requirements.
- Employees: Production employees need to be trained in the knowledge and skills necessary to ensure the production of quality products.
- Quality control: Quality control activities need to be carried out regularly and continuously to ensure that products meet quality requirements.
- Record management: Production records need to be stored fully and accurately to facilitate inspection and traceability of product origins.
Objects of GMP
- GMP applies to all manufacturing enterprises, including:
- Food, pharmaceutical, cosmetic, and medical equipment manufacturing businesses.
- Businesses produce products that affect the health and safety of consumers.
- Depending on the manufacturing industry, GMP requirements may be supplemented or adjusted to fit specific needs.
7. The benefits of GMP standards
Pharmaceutical and medical device manufacturers all adhere to GMP rules and procedures, while some manufacturers have created their own guidelines in accordance with their laws.
7.1 Benefits for Manufacturers
- Timely identification of manufacturers and management issues,
- Compliance with important laws and guidelines,
- Enhancement of brand reputation,
- Reduced safety and quality risks of products,
- Increased consumer trust in the products.
- Helps reduce operating costs due to rework and penalties for non-compliance,
- Promotes export opportunities,
- Reduces duplicate inspections,
- Cost savings.
One of the key benefits is a significantly improved quality system and quality compliance at the manufacturing site. We have seen these improvements in the months leading up to GMP certification and continuing in the years immediately following GMP certification.
7.2 Benefits for Consumers
Customers often reduce their skepticism towards manufacturers that have obtained GMP certification. Consumers know that to be certified, manufacturers must have systems in place and provide evidence that non-compliance and customer-notified changes are handled appropriately.
This assurance is often not achieved through a one-day supplier audit that pharmaceutical companies conduct; instead, it is obtained as a result of thorough, multi-day assessments for manufacturers as part of the certification assessment program.
In conclusion, understanding and implementing Good Manufacturing Practice is crucial for ensuring the quality, safety, and efficacy of pharmaceuticals and other regulated products. As we delve into the intricate world of GMP, it’s essential to stay updated on regulatory standards and guidelines. For the latest insights and updates on FDA regulations and industry news, visit GOL today!
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