ANVISA – Deadline extension for the implementation of packaging process online control and 100% integrity test

After some deliberations between the regulated sector and the regulatory authority, on December 1st, 2021, ANVISA published in the Official Gazette (DOU) the extension to five years of the transitional periods of articles 215, of Resolution RDC 301/2019, and 161, of Normative Instruction IN 35/2019. The extensions were published, respectively, by Resolution RDC 580, of November 26th, 2021, and by Normative Instruction IN 109, of November 26th, 2021.

Resolution RDC 301/2019, which provides the General Guidelines for Medicinal Products Good Manufacturing Practices, in its article 215, establishes the online product control during the packaging process. Its article 372 defined the transience period of four years for the implementation of the activities related to the operationalization of the online control. With the publication of Resolution RDC 580/2021, the transience period is now defined as five years after Resolution 301/2019 is in force. The following changes to the transience period are also in place:

  • 48 months to carry out the equipment installation;

  • 60 months to carry out the other stages of equipment qualification necessary for the operation of the product online control during the packaging process pursuant to article 215.

The other deadlines established by article 372 of Resolution 301/2019 remain unchanged.

Normative Instruction IN 35/2019, which provides the supplemental Good Manufacturing Practices for Sterile Medicinal Products, in its article 161, establishes the need for submitting 100% of containers closed by fusion (such as glass or plastic ampoules) to the integrity test. Its article 175 defined the transience period of four years for the implementation of the activities related to the integrity tests. With the publication of the Normative Instruction IN 109/2021, the transience period is now defined as five years after Normative Instruction IN 35/2019 is in force. Similarly, there are further changes in the following transience periods:

  • 42 months to carry out the equipment installation;

  • 60 months to carry out the other stages of equipment qualification necessary for the operation of activities pursuant to article 161.

Likewise, the other deadlines established by article 175 of the Normative Instruction IN 35/2019 are maintained.

The full text for the mentioned publications may be accessed through the following links:

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