What is GMP certification? Is it related to health food OEM?

GMP (Good Manufacturing Practice, Good Manufacturing Practice) is an internationally common manufacturing management and quality control system designed to ensure product quality and safety during the manufacturing process.

In the field of health food, GMP certification means that the manufacturer of the product follows the requirements of GMP for production and is certified by a certification body to ensure the quality and safety of the product. GMP certification usually requires strict audit procedures, including standards for production facilities, equipment, process flow, personnel training, and product testing.

GMP-certified health food OEM can improve product quality and reputation Attract more consumers, but also help maintain market order and promote industrial development.

The Importance of GMP Certification

The importance of GMP certification is to ensure that manufacturers can follow a set of strict production standards when producing health food to ensure product quality and safety.

The following are the importance of GMP certification:

1. Protect Consumer Health:
   GMP certification requires manufacturers to adopt good production standards and quality control systems to ensure product quality and safety. This is critical to the health of consumers.
   
   
2. Improve product quality:
   Compliance with GMP standards can help manufacturers improve product quality, thereby enhancing product reputation and market competitiveness.
   
   
3. Complies with legal requirements:
   In some countries and regions, the manufacture of health food must comply with GMP requirements. Obtaining GMP certification can help manufacturers ensure that their products comply with local laws and regulations.
   
   
4. Increase productivity:
   GMP requires manufacturers to establish a complete quality management system to improve production efficiency and product quality, and reduce errors and waste in the production process.

In short, GMP certification is an effective way to ensure the quality and safety of health food, and can help manufacturers improve product quality and market competitiveness, while also complying with local legal requirements.

Taiwan GMP certification requirements

Taiwan's GMP certification requirements mainly include the following aspects:

1. Manufacturing equipment and facilities:
   Plants and equipment for the production of health foods and medicines must comply with relevant regulations and, if necessary, need to be improved and updated.
   
   
2. Manufacturing process:
   The production process must comply with GMP standards, including raw material control, process parameter control, product inspection and analysis, etc.
   
   
3. Personnel training:
   All personnel in the production process must receive sufficient training to understand and comply with GMP requirements.
   
   
4. Documentation:
   The production process requires complete documentation, including manufacturing process records, product inspection records, equipment maintenance records, etc., for tracking and backtracking.
   
   
5. Site Inspection:
   TFDA will conduct on-site inspections to ensure that product production meets GMP requirements.

Through GMP certification, enterprises can improve the quality and safety of products, enhance the competitiveness of enterprises, and have the opportunity to participate in government procurement plans.

What is the competent authority of GMP in each country?

GMP (Good Manufacturing Practice) authorities are government agencies responsible for formulating and supervising GMP standards. The GMP authorities in different countries may be different, the following are the GMP authorities in some major countries:

• United States: US Food and Drug Administration (FDA)
• European Union: European Medicines Agency (EMA)
• Japan: Japan Pharmaceutical Medical Devices and Other Legal Agency (PMDA)
• China: State Food and Drug Administration (CFDA)
• Taiwan: Food and Drug Administration (TFDA), Ministry of Health and Welfare

These GMP competent authorities are responsible for formulating and updating GMP standards, supervising and auditing applicants, issuing certification certificates, and taking enforcement measures when necessary to ensure that the production of health food and pharmaceuticals meets high quality and safety standards. During the GMP certification application process, the applicant unit needs to comply with the requirements and guidance of the competent authority to ensure that the product meets international standards.

Taiwan's GMP Competent Authority

The Food and Drug Administration (TFDA) of the Ministry of Health and Welfare is the GMP competent authority in Taiwan, responsible for supervising and certifying the production of health food and pharmaceuticals in Taiwan. TFDA's GMP requirements comply with international standards and incorporate them into relevant regulations and guidelines in Taiwan.

Products applying for GMP certification need to pass the audit and on-site inspection of TFDA to ensure that the production process complies with GMP standards. TFDA will review the manufacturing equipment, facilities, processes, personnel training, document records and other aspects of the product, and conduct on-site inspections to ensure that the product production meets GMP requirements.

Passing GMP certification can improve the quality and safety of products and enhance the competitiveness of enterprises. In Taiwan, companies that have obtained GMP certification can obtain priority audit rights and have the opportunity to participate in government procurement programs.

Taiwan applies for GMP certification authorities and other certification bodies

Institutions applying for GMP certification in Taiwan mainly include the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare and its designated certification bodies. TFDA is Taiwan's GMP competent authority, responsible for supervising and certifying the production of health food and pharmaceuticals in Taiwan, and conducting audits and on-site inspections of products applying for GMP certification.

In addition, TFDA will also designate inspection agencies with relevant certification qualifications to conduct on-site inspections of GMP certification to ensure that the production process meets GMP requirements. Applicants can choose to be audited and inspected directly by TFDA, or to have the application and audit performed by a designated certification body on their behalf. Applicants can obtain relevant application information and guidelines from the TFDA official website to understand the application procedures and required documents, and can also consult relevant questions with designated certification bodies.

Designated by Taiwan Food and Drug Administration (TFDA) GMP certification bodies include:

• Food Industry Development Institute (FIRDI)
• Taiwan Food and Drug Safety Promotion Association (TFPA)
• China Chemical Fiber Industry Technology Research Institute (CPTI)
• National Biotechnology and Pharmaceutical Quality Management Center (NCF)

These certification bodies are non-profit organizations with rich experience and professional knowledge in GMP certification, and can provide relevant product audit, on-site inspection and certification services. Applicants can choose to be applied and audited by these certification bodies and pay the corresponding fees. During the application process, applicants need to submit product information and related documents to the certification body, and accept on-site inspection and evaluation. If the production process meets the GMP requirements, the certification body will issue a GMP certification certificate to the applicant.