Obtaining the Good Manufacturing Practices Certificate is a mandatory step for Class III and IV pharmaceutical and healthcare product companies.
To obtain certification, your company must meet all hygienic-sanitary requirements.
Continue reading and understand about the Good Manufacturing Practices Certificate
What will be covered:
It is the certificate issued by ANVISA, attesting that a given establishment meets the hygienic-sanitary requirements established in specific rules of the Agency. Certification can be Good Manufacturing Practices (CBPF) or Distribution and Storage (CBPDA).
It is the set of operations adopted in order to manufacture safe products in accordance with the hygienic and sanitary requirements established in specific legislation.
The Certificate of Good Manufacturing Practices applies to companies that manufacture medicine, health products, cosmetics, perfumes, personal hygiene products, sanitizing products and pharmaceutical supplies located throughout the national and international territory.
Class I and II health products; Cosmetics and sanitizing products are produced in accordance with the requirements of Good Practices, however, Certification is not mandatory.
To obtain this certification, establishments must undergo an inspection, which must be carried out on each production line that intends to obtain certification, even if it is a single industrial unit. As a result, no matter how many different production lines there are, companies are required to submit documentation for each one separately and pay all fees associated with the service separately.
RDC No. 497/2021 provides for the administrative procedures for granting Certification of Good Manufacturing Practices and Certification of Good Distribution and/or Storage Practices.
The standard refers to the procedures for:
Certificate of Good Distribution and/or Storage Practices (CBPDA);
Good Manufacturing Practices Certificate (CBPF);
Personal hygiene items, cosmetics and perfumes;
And more: it clarifies the general certification conditions and how the certificate is granted and its criteria according to the segment in which it operates.
If your company needs CBPF? Stone can help you, we have qualified professionals in several areas to assist you in conducting your certification process.
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