Overview
The QCC (Quality Control Certificate) is indeed associated with ANVISA’s Good Manufacturing Practices (GMP), but they are not exactly the same thing. ANVISA’s GMP (Good Manufacturing Practices) is a regulatory requirement that certifies that health product companies, such as medicines and medical devices, follow safe and effective manufacturing practices. QCC certification is a type of quality control documentation that can be used to certify compliance with ANVISA’s GMP standards, but QCC itself is more of a type of control certification and does not replace the formal GMP authorization issued by ANVISA
Introduction
In the health sector, guaranteeing the safety and quality of products is essential. Brazil, through ANVISA (National Health Surveillance Agency), requires companies in the sector to comply with strict manufacturing and quality control standards, especially for products such as medicines, cosmetics, food and medical devices. In this context, terms such as QCC (Quality Control Certificate) and GMP (Good Manufacturing Practices) appear frequently. Although they may seem similar, there are important differences between these concepts and the way they apply to the Brazilian regulated market
In this blog, we’ll explain what QCC is and how it relates to the Good Manufacturing Practices (GMP) required by ANVISA. We’ll understand the main aspects involved in obtaining these certifications, what they mean for companies and how compliance with these standards impacts consumer confidence and the safety of products on the market.
To obtain a Quality Control Certificate (QCC) from ANVISA, the process can vary according to the type of product and the sector of the company. Normally, the QCC is not issued directly by ANVISA as a formal document, but rather as part of the GMP (Good Manufacturing Practices) certification and other quality control requirements for regulated products.
What is QCC?
The Quality Control Certificate (QCC) is quality documentation that certifies that a batch or unit of product has undergone thorough quality control, meeting the established safety, efficacy and conformity criteria. In other words, the QCC is a certificate stating that the finished product has undergone a series of control analyses and is fit for sale. This certificate guarantees the consumer and the regulatory authorities that the product meets all the safety and quality requirements
QCC is essential for many regulated sectors, such as the pharmaceutical and cosmetics industries, where safety and efficacy are paramount. It provides additional security for the end consumer, confirming that the product has been analyzed and complies with the defined specifications.
What is the relationship between QCC and GMP?
GMP (Good Manufacturing Practices), known in Brazil Good Manufacturing Practices,is a set of standards that regulates production processes and quality control in industries. Companies seeking GMP certification need to demonstrate that they adopt safe, documented and consistent practices and processes, minimizing the risk of errors, contamination and quality failures. In Brazil, GMP certification is issued by ANVISA, which carries out rigorous audits to ensure that all internal processes comply with regulations
Although QCC and GMP are closely related, they are not the same thing. QCC refers specifically to the quality control certificate that can be issued for each batch of products. GMP, on the other hand, covers the entire production and manufacturing system, ensuring that all stages of the process, from the receipt of raw materials to the final product, are under strict quality control.
How to obtain QCC and GMP from ANVISA?
To obtain GMP certification from ANVISA, companies must undergo an audit and inspection process. This process includes a detailed analysis of all the manufacturing and quality control protocols adopted by the company. During the inspection, ANVISA assesses the company’s processes and validates that the products undergo rigorous control, fulfilling the requirements that guarantee compliance.
By following Good Manufacturing Practices, the production process guarantees quality control that meets the requirements necessary to issue the QCC. Thus, the QCC is, in essence, a reflection of compliance with GMP, certifying that each batch or unit of product complies with the quality requirements demanded for the Brazilian market.
Summary
- Consult ANVISA standards for the product.
- Implement the Quality System with a focus on the required controls.
- Apply for GMP certification from ANVISA.
- Pass inspection and compliance audit.
- Receive the GMP Certification, which includes the quality control certificate (QCC).
- These steps will ensure that the company operates in compliance and that each batch of products meets the established standards.
Conclusion
- The QCC is an important document that reinforces the compliance of a batch of products with quality standards.
- GMP certification by ANVISA is a more comprehensive process, involving inspection and compliance of the entire facility and manufacturing process, and is required for any company wishing to produce and market healthcare products in Brazil.
If the company has a GMP certification, this already covers the issue of quality control that the QCC attests to, but the reverse is not true, as the QCC does not guarantee that the entire production line complies with ANVISA’s GMP.
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References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.