In the era of industrialization and modernization, the demand for cosmetic, pharmaceutical, and food products is continually rising. However, there are numerous low-quality products in the current market that do not guarantee the safety of consumers’ health.

To address this issue, regulatory agencies have established standards for Good Manufacturing Practices (GMP), including cGMP. This is a system of principles and minimum requirements that cosmetic, pharmaceutical, and food manufacturing facilities must adhere to in order to ensure the quality, safety, and efficacy of their products. Let’s delve deeper into what cGMP is and explore the essential considerations that consumers need to be aware of regarding cGMP in the following article with GOL!

1. What is cGMP?

cGMP stands for Current Good Manufacturing Practice, a regulation issued by the United States Food and Drug Administration (FDA) to ensure the quality of pharmaceuticals. cGMP requires drug manufacturers to establish a rigorous control system throughout every stage, from design and monitoring to process control and production facilities.

2. Requirements of cGMP

Adhering to cGMP ensures assurance regarding the origin, composition, quality, and purity of pharmaceuticals. Manufacturers must meet stringent standards, including:

• Establishing a robust quality management system.
• Using high-quality raw materials.
• Developing detailed and strict operating procedures.
• Detecting and investigating deviations in product quality.
• Maintaining a reliable testing laboratory.

If implemented rigorously, this formalized control system will help pharmaceutical companies:

• Prevent contamination, mix-ups, deviations, errors, and failures in production.
• Ensure that pharmaceutical products meet quality standards.

The cGMP requirements were designed to offer flexibility, allowing each manufacturer to determine individually the most effective way to implement necessary controls through scientifically sound design, processing methods, and testing procedures. This adaptability within the regulations permits companies to leverage modern technologies and innovative approaches for continual improvement, contributing to enhanced product quality.

The “C” in cGMP signifies “current,” emphasizing the need for companies to employ up-to-date technologies and systems to comply with the regulations. Systems and equipment that may have been considered cutting-edge for preventing contamination, mix-ups, and errors a decade or two ago may now fall short of today’s standards.

It’s crucial to understand that cGMP regulations for drugs establish the baseline requirements. Many pharmaceutical manufacturers already go beyond these minimum standards by implementing comprehensive, contemporary quality systems, and risk management approaches.

The important requirements of cGMP that manufacturing facilities need to adhere

• The team comprises educated personnel with specialized expertise and strong work skills. There is a plan for professional training and skill development to enhance employees’ knowledge and understanding of the manufacturing process.
• Modern machinery and equipment undergo regular inspections, periodic checks, and routine maintenance to ensure compliance with current quality standards.
• Raw material components for production undergo verification before manufacturing.
• Clear examination and assessment of chemical components, including their origin and safety certifications for consumers. The manufacturing environment is enclosed, and strict checks are conducted.
• The factory maintains hygiene standards through the use of modern tools and equipment.

3. Why is cGMP so important?

A consumer is typically unable to ascertain the safety or effectiveness of a drug product through sensory cues such as smell, touch, or sight. Although cGMP mandates testing, relying solely on testing is insufficient to guarantee quality. Often, testing is conducted on a small sample from a batch (e.g., a drug manufacturer might test 100 tablets from a batch of 2 million) to preserve the majority of the batch for patient use rather than discarding it through testing. Therefore, it is crucial for drugs to be manufactured in accordance with the conditions and practices mandated by cGMP regulations to ensure that quality is ingrained into the design and manufacturing process at each stage. Facilities in optimal condition, well-maintained and calibrated equipment, qualified and well-trained employees, and dependable and reproducible processes exemplify how cGMP requirements contribute to ensuring the safety and efficacy of drug products.

4. What is the difference between cGMP and GMP?

4.1 Definition

The first noticeable difference is the letter “c” in cGMP, where “c” stands for “current.” This means that every step used in manufacturing a product is not only conducted according to GMP guidelines but also completed using the latest available methods. Therefore, the rules and regulations of the cGMP standard are continuously improved and updated with current technology.

4.2 Availability of Standards

It is evident that the applications of GMP are broader when compared to those of cGMP. Due to the readily available nature and high cost of the latest technologies and equipment, many businesses may find it challenging to pursue cGMP.

4.3 Scale of Usage

In reality, over 100 different countries worldwide tend to use GMP. Only a limited number of countries adhere to the principles of the cGMP standard.

4.4 Applicability

Numerous manufacturing industries globally need to implement GMP standards. Currently, GMP is used to ensure the operations in various aspects of a business, including record-keeping, cleanliness assurance, compliance with personnel qualifications, and manufacturing equipment. This standard is also employed to determine quality in a business’s procedures. In contrast, the applicability of cGMP is somewhat limited, primarily used for the production phase of goods.

4.5 Cost

Certainly, cGMP is more expensive compared to GMP. This is because manufacturers have to invest significantly in new technologies compared to readily available ones.

4.6 Product Quality

Due to the use of the latest technologies, ensuring product quality with cGMP is more reliable compared to its counterpart, GMP. Products are analyzed from multiple perspectives to ensure the highest quality.

5. The significance of applying cGMP in manufacturing

5.1 For Businesses

• Ensuring Product Quality: cGMP mandates manufacturers to implement strict control measures at every stage of the production process, from design and raw materials to processes and quality testing. This helps prevent risks of contamination, mix-ups, errors, etc., leading to poor-quality products. Additionally, cGMP creates favorable conditions for implementing HACCP and ISO 22000.
• Enhancing Business Reputation: Compliance with cGMP serves as evidence of a business’s commitment to ensuring product quality. This helps enhance the reputation and brand image in the eyes of customers and partners.
• Risk Minimization: cGMP helps businesses minimize the risk of complaints, recalls, and product withdrawals. This not only saves costs and time but also protects the business’s reputation.
• Increasing Productivity and Production Efficiency: cGMP helps businesses improve production efficiency by minimizing errors and waste.

5.2 For Consumers

• Ensuring Safety and Effectiveness of Products: cGMP ensures that products are manufactured in a clean and safe environment, meeting quality standards. This helps protect the health and rights of consumers.
• Building Trust and Satisfaction with the Business: Compliance with cGMP demonstrates a business’s commitment to product quality. This helps consumers trust and feel satisfied when using the business’s products.
• In conclusion, the application of cGMP in production is a necessary requirement for manufacturing businesses, especially those in the pharmaceutical, food, and other consumer product industries. This not only benefits the business but also ensures the rights and health of consumers.

6. Some frequently asked questions related to cGMP.

6.1 The FDA determines whether a company complies with cGMP regulations through the following methods

• Direct Inspections of Pharmaceutical Manufacturing Facilities Worldwide: This includes inspections of both active ingredient and finished product manufacturing facilities. These inspections are carried out by FDA-trained professional staff following standardized procedures.
• Based on Reports of Suspected Defective Pharmaceutical Products from the Public and the Industry: The FDA often relies on reports from the public and the pharmaceutical industry to identify facilities that need to be inspected or investigated.
• The majority of companies inspected are found to be in full compliance with CGMP regulations.

6.2 If a manufacturer does not comply with cGMP, is their medication safe to use?

If a company fails to adhere to cGMP regulations, any medication they produce is considered “adulterated” under the law. This means that the drug is not manufactured under cGMP-compliant conditions. However, it does not necessarily imply that there is something inherently wrong with the medication.

For individuals using medications from a company that does not comply with cGMP, the FDA typically advises against discontinuing treatment, as this could have serious health implications. Instead, they recommend consulting a physician before stopping or altering any medication.

Regulatory actions against companies with poor cGMP practices are often aimed at preventing the potential distribution of unsafe and/or ineffective drugs. In rare cases, FDA regulatory actions may seek to halt the distribution or production of violating products.

The impact of cGMP violations depends on the nature of the specific violations and the type of drug involved. A drug produced in violation of cGMP may still meet the labeled specifications, and the risk of the drug being unsafe or ineffective may be minimal. Therefore, FDA advice varies depending on each specific case, and healthcare professionals are best suited to weigh the risks and benefits, making appropriate decisions for their patients.

In summary:

• Medications produced in violation of cGMP are considered “adulterated” but not necessarily dangerous.
• Users should consult a doctor before discontinuing medication.
• FDA takes regulatory actions to prevent unsafe drugs.
• The impact of cGMP violations varies case by case.

6.3 How can the FDA protect the public in the event of cGMP violations?

If a failure to comply with cGMP results in the distribution of a drug that does not provide the labeled benefits, such as having insufficient active ingredients, the company may choose to recall the product voluntarily. This action serves to safeguard the public by removing these drugs from circulation. While the FDA lacks the authority to force a company to recall a drug, companies typically initiate recalls voluntarily or at the request of the FDA. In situations where a company refuses to recall a drug, the FDA has the ability to issue public warnings and take steps to seize the drug.

Moreover, the FDA can pursue legal actions, such as seizure or injunction cases, to address cGMP violations, even when there is no direct evidence of a defect affecting the drug’s performance. In a seizure case, the FDA requests a court order that allows federal officials to take possession of “adulterated” drugs. In an injunction case, the FDA seeks a court order instructing a company to stop violating cGMP. Both types of legal actions often result in court orders mandating corrective measures by companies, including repairing facilities and equipment, improving sanitation and cleanliness, conducting additional quality testing, and enhancing employee training. The FDA also has the authority to initiate criminal cases for cGMP violations, seeking fines and imprisonment

6.4 Where can I find quality information about FDA and cGMP?

The GOL, which is a FDA registration service, GOL serves as a valuable resource for new pharmaceutical companies. The website provides updated information on the latest regulations, guidelines, and policies from the FDA related to cGMP. Additionally, GOL offers online training courses and other supporting materials to help new pharmaceutical companies understand and comply with cGMP.

If you have any questions or concerns regarding cGMP, please reach out to GOL. We are always ready to assist new pharmaceutical companies in meeting the FDA’s requirements.

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