Good Distribution and Storage Practices (BPDA) is a set of actions that ensure the quality of a health product through proper control during the distribution and storage process, as well as provide tools to protect the distribution system against counterfeit, failed, illegally imported, stolen, damaged and/or tampered products.
The Certificate of Good Distribution and/or Storage Practices (CBPDA) is the document issued by Anvisa attesting that a certain establishment complies with the Good Distribution and Storage Practices or Good Storage Practices set forth in the legislation in force.
Anvisa has changed the list of documents related to the petitions for Good Distribution and/or Storage Practices Certification and for the Renewal of this Certification.
Table 1: BPDA Petition Documents
Other Consideration & Timelines:
As a consequence of this change, the inspection report issued by the competent Sanitary Surveillance, which attests to compliance with Good Distribution and Storage Practices, must be sent by the company itself to Anvisa. In other words, the forwarding will no longer be done by the Sanitary Surveillance Centers.
Another alteration deals with the validity period of the CBPDA inspection report, which is now 48 months, counted from the inspection date – before it was 24 months.
It is important to clarify that the change applies only to CBPDA. There were no changes to the requests for Good Manufacturing Practices Certification (CBPF), nor in the validity period of this type of inspection report.
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 and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at firstname.lastname@example.org