In this article we discuss session VIII of RDC 658/22 (Good Manufacturing Practices) which deals with packaging operations, specifically article 215 on online product checks. The article points out that it is necessary to do online checks in order to ensure that the items listed below have no failures:

I – General appearance of the packaging;

II – Whether the packages are complete;

III – Whether the correct packaging products or materials were used;

IV – Whether printing done during the packaging process is correct;

V – Correct functioning of line monitors. 



The first item, “general appearance of the packaging” has resulted in a lot of questions because it is so broad. After all, what does verifying the general appearance of the packaging really mean? Well, it is very difficult to give a single interpretation. In this case, the recommendation of both the market and Anvisa is to perform assessments through sampling, basing decisions on a risk analysis. This analysis should contain historical market data that demonstrate the absence of problems in this area.


When we talk about complete packaging, item (II) of Article 214, the items to be verified and the solutions necessary will vary according to the type of packaging. In the case of a product in a blister pack, for example, verifying that the packaging is complete means ensuring that all the capsules or tablets are in their own blisters. But in the case of a vial, the requirement can be met by weighing (using a check weigher or dynamic scales) or by inspection of the liquid level inside the container; and so on.


The third item focuses on the implementation of solutions for verifying that all the packaging materials on the production line are correct, in order to eliminate the possibility of cross-contamination. To this end, online checking must be done on the codes present on the primary and secondary packaging materials, such as blister aluminum, cartons, package inserts and labels. Most companies in the market have opted to attach the relevant 1D (Pharmacode etc.) or 2D codes to these materials; hence, they can perform online checking on 100% of the items using vision systems.


With regard to item (IV), this provides that we have to ensure that the codes used in the packaging process are correct (in both primary and secondary packaging). Consequently, we need to inspect the codes on labels, blister aluminum and cartons. In the case of packages with the batch data pre-printed as part of the layout, the tendency is to inspect these through sampling.

Finally, the fifth item mentions checking the correct functioning of the line monitors. In this case, we can use warning lights (traffic light systems/lines of LEDs) and even stop the process if an error is identified.


Article 371. Article 214 comes into force 4 (four) years after the regulation itself comes into force. — It entered into force on October 6, 2019. 

Proof of implementation of the measures described below must be made available in accordance with the time limits set out, between the entry into force of the regulation and the entry into force of the article:

I – by October 7, 2020, the Elaboration of User Requirements (ERU) and prospection of manufacturers must have been carried out;
II – by April 7, 2021, the manufacturer selection and Design Qualification must have been carried out;

III – by October 7, 2021, the purchase must be confirmed;

IV – by October 7, 2023, the installation of the equipment must have been carried out; and

V – by October 7, 2024, the other stages of qualification of the equipment necessary for the operationalization of art. 215 and its start of operation in routine must be carried out.