GMP certificate is one of the highest standards for manufacturing and quality control in the food, pharmaceutical, and cosmetic industries. To answer some questions about the GMP standard: What is GMP? What does a GMP-certified factory need? What is the role of this standard in the production of functional foods? We’ll answer all these questions below.
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1. About GMP certificate
1.1 What is GMP certificate?
GMP stands for Good Manufacturing practice and is a set of regulations established by the Food and Drug Administration (FDA) to ensure consistent quality in the production of goods, including supplements and pharmaceuticals.
Read more: What is the ISO 9001:2015 standard? Benefits & 7 Principles [updated]
Good manufacturing practices certificate (GMP) covers every aspect of production, from materials and location to staff training and equipment. Written procedures are a critical part of any process that could affect the finished product’s quality. Each step of the manufacturing process must come with documented proof of methods used to ensure consistency across all products.
These standards are applicable to the production of:
- Food
- Beverages
- Cosmetics
- Pharmaceutical goods
- Dietary supplements
- Medical devices
The GMP regulations address a variety of issues, including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. These are general and open-ended requirements that give manufacturers flexibility in implementing controls that make sense for their businesses.
GMP is often referred to as cGMP, which stands for current Good Manufacturing Practices. The “c” reminds manufacturers that they must employ up-to-date systems and technologies in order to comply with regulations. Some of the systems and equipment used to prevent contamination, mixups, or errors in a processing plant may have been first-rate 20 years ago but are less than adequate by today’s standards.
1.2 Benefits of GMP
Here are some benefits for a good manufacturing practices certificate:
1.2.1 For The Manufacturer
Businesses and organizations that apply GMP certification requirements to the production process can gain significant benefits, including:
- Make products/services easily marketable, gain approval from partners or customers.
- Increase product consumption by making consumers feel confident that they are getting a safe and quality.
- Minimize product safety risks by improving your systems and operations, ensuring that you don’t waste money on over- or under-investment.
- Reduce product recalls, customer complaints, and risk of liability by testing products/services to ensure they are stable.
- Increase work efficiency by clearly defining roles and responsibilities.
1.2.2 For The Customer
Consumers will benefit from GMP standards because they are made to feel safe, assured that the products/services they choose meet high quality standards, and know their health is not in danger.
This is the answer for question “Is GMP certificate important to manufacturing?” – Good manufacturing practices (GMP) certificates are crucial, not only for earning customers’ trust but also building long-term loyalty and increasing profits.
2. Requirements to apply for GMP certificate
Here are five components (Product – People – Processes – Procedures – Premises) that manufacturers need to know to obtain good manufacturing practices certificate quickly:
1 – Products
Primary materials are the raw ingredients used to produce a finished product, which is sold to consumers. If primary materials are of low quality, flaws can occur in the end result. Therefore, one of the core GMP certification requirements is that all products must have a master formula that is followed exactly throughout manufacturing. A quality assurance system composed of regular testing and comparisons ensures this.
2 – People
All employees are expected to be familiar with and adhere to strict manufacturing processes and regulations. A current GMP training must be undertaken by all staff members so that they understand their roles and responsibilities in regard to these policies. Staff assessment helps boost productivity, efficiency, competency—and ultimately the bottom line of your company’s financial statements.
3 – Processes
Processes should be documented, clear, consistent, and accessible to all employees. Regular evaluation should be conducted to ensure that all employees are complying with current processes and meeting the organization’s standards.
4 – Procedures
Procedures are sets of guidelines put in place to ensure that a process or part of it is carried out consistently. All employees should be made aware of these procedures and instructed on how they work. Any deviation from standard procedure should be reported and investigated immediately.
5 – Premises
Facilities, laboratories, and equipment must be maintained in a safe, sanitary, and effective manner. These include proper cleaning and storage along with other measures that can be taken to achieve consistent results, lower the risk of equipment failure, and ensure timely repairs. The goal is to reduce product variations and protect customers, and team members from operational issues onsite.
3. Procedure to get GMP Certification
Application
The initial step to obtaining a GMP certification is submitting an application that covers essential information about the company and its operations.The affirmation body must acknowledge the application, record all data and ensure that database is kept up-to-date.
Review Of Application
The application will be evaluated by the group to ensure that it meets consistency requirements.
Analysis & Agreement
After the audit of documents, a gap analysis is performed to make sure that all areas are covered by quality guidelines. The gap analysis compares what is supposed to be done with what has been accomplished.
Documentation Review
Check the organization’s documentation to confirm that it meets compliance standards.
Stage-1
- Audit
Analyze your associations’ recorded approaches and strategies for consistency.
- Survey
Then, review the documentation of your administration structure to ensure that consistency requirements have been met.
- Restorative Activity
When a noncompliance occurs, corrective action must be taken.
- Check
Verify the documentation of an establishment to conform to standard requirements.
Stage-2
- Audit
The inspector checks that the association is in compliance with its documentation, and an examiner of an authoritative body verifies the noncompliance. Afterward, the reviewer offers a chance to address the noncompliance. Then review the execution procedure as per the association’s report.
- Restorative Action
If there is any non-similarity between the actual and planned results, then remedial action has to be taken.
- Check
Ensure that your representatives are following the work guidance and then executing on those instructions.
Granting Of Certification
The Certification Body will grant a certificate of compliance that is valid for many years.
Surveillance Audit
Surveillance review is required in order to guarantee that the association meets the prerequisites of its administration framework. Observational monitoring must be carried out every six months or one year, depending on when it was first issued with a certificate.
4. Validity of GMP certificates
A GMP certificate is valid for three years from the date of the most recent inspection; however, the period of validity can be shortened if circumstances warrant. A good manufacturing practices certificate refers to a specific inspection and cannot be renewed until a new inspection is conducted.
5. How much does it cost to obtain GMP certificates?
The cost of getting a Good Manufacturing Practice certificate is determined by the size of a business.
The following table shows the average cost per establishment by size:
| Number of
Employees |
Annual Revenue | Setup Costs* | Annual Costs* | |
| Small
Establishments |
<20 | Under $1 Million | $26,000 | $46,000 |
| Medium
Establishments |
20 – 500 | $5 to $10 Million | $20,000 | $184,000 |
The Food and Drug Administration (FDA) has calculated that:
- Small firms with less than 20 employees and annual revenue of under $1M can expect to spend about $26,000 initially on their compliance systems, as well as about $46,000 annually to maintain them.
- Medium-sized companies with 20 to 500 employees and $5 million to $10 million in annual revenue should plan to spend about $20,000 in set up costs and about $184,000 each year on maintenance. The estimates take into account that medium-sized firms will already have most of the required systems in place whereas small firms will be starting from scratch.
6. GMP Non-Compliance: What Happens?
When you work in any manufacturing industry, compliance with good manufacturing practices is vital for your business. Not only does it help you make a high-quality product, but it also upholds consumer and ecological health. . However, if manufacturers do not comply with GMP guidelines, there will be consequences; let’s take a look at some of them:
1 – Strike To Reputation & Goodwill
For all businesses, reputation is crucial. Without satisfied customers, you can’t build a successful business. With poor manufacturing practices, your reputation will suffer. Customers won’t trust a company they believe produces shoddy products.
2- Failure Of Consumer Confidence
Good manufacturing practices are in place to keep your clients safe. If you do not adhere to these guidelines, consumers will lose confidence in your product. But the penalties for not following the guidelines are greater than just a business break for your company; they could result in legal action or even jail time if severe enough violations are occurring.
3 – Criminal Prosecution
The Food and Drug Administration (FDA) has the authority to stop production of a drug through a court injunction. If circumstances warrant it, the Department of Justice (DOJ) and Health and Human Services (HHS) also have the authority to take legal action against any company that violates good manufacturing practices.
4 – License Cancellations
When manufacturing a product, several licenses are required. These include building permits, licensed physicians at the facility, and facility licenses. Failure to comply with good manufacturing practices guidelines puts a company at risk of losing these licenses.
5 – Indictment Of Fraud
Failure to comply with good manufacturing practices can lead to fraud charges. Mislabeling ingredients or failing to advertise a product in compliance with good manufacturing practices guidelines are examples of fraudulent acts. When a company accused of fraudulent behavior is in the manufacturing sector, the consequences can be severe.
The GMP regulations prohibit fraudulent labeling and branding practices. Violations of these regulations can lead to serious consequences for manufacturers.
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GMP certificate is a prestigious qualification for manufacturers. We hope that the information above has been helpful in obtaining this certification, and we also recommend following our other related articles to stay up-to-date with important news in your field of manufacturing.
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