ANVISA's technical documentation requirements for registration certificates may vary depending on the type of product, type of registration and regulatory changes. The following is an overview of the general technical documentation requirements, but please note that the specific requirements may vary depending on the product:
Application Form & Basic Information:Include a completed application form that provides basic information about the registration application, such as the applicant's identity, manufacturing site, product description, etc.
Product quality and safety information:Provide a detailed description of the product, including ingredients, manufacturing methods, quality control standards, and other information to ensure the quality and safety of the product.
Quality Management System:Provide detailed information about the quality management system of the production process to ensure compliance with standards such as GMP (good Manufacturing Practice).
Non-clinical and clinical study data:For some products, data from non-clinical and clinical studies may be required to support the safety and efficacy of the product.
Technical Documentation Support:Documentation that provides supporting technical documentation such as product specifications, test methods, stability data, etc.
Labels and instructions:Provide product labels and instructions to ensure they meet ANVISA's requirements, including proper usage and precautions.
Manufacturing Site Information:Provide detailed information about the manufacturing site, including production equipment, environmental conditions, personnel training, etc., to ensure compliance with relevant regulations.
Quality Control Documentation:Provide documentation on product quality control, including inspection records, quality standards, quality control of raw materials, etc.
Notice of Technical Changes:If any technical changes have been made during the validity period of the registration certificate, it may be necessary to provide the appropriate notice of change and supporting documentation.
The above is only a general overview of the technical documentation requirements, which may vary depending on the product type. Applicants for the Certificate of Registration should carefully read the relevant regulations, guidelines and requirements of ANVISA to ensure that their technical documents are prepared in accordance with the requirements.