Certificate of Good Manufacturing Practices: Steps, Laws and MORE

The Certificate of Good Manufacturing Practices, It is a document of great importance, which contains all the rules set officially to regulate the plants with which certain foods are processed in particular.

For this reason, in the following article we explain: what are the necessary requirements to obtain the certificate, the steps you must follow for it, who must request it and where to do it, the legal bases, and finally, its definition.

Requirements for the Certificate of Good Manufacturing Practices

It is very common that, when wanting to request any type of certificate, the organizations or institutions require a series of specific documents to be able to start the procedure. Next, we will develop the necessary requirements to obtain this certificate:

  • The mandatory requirement to start this process is to have the Unique Code of Good Manufacturing Practices.

If you have this document, and you want to include a new stage in the production process or, failing that, you want to include a new production line in the processing plant, you must meet the following requirements:

  • Organize the inspection of line extension or inclusion with the inspection body that is accredited for it.
  • Carry out the inspection of the extension or line inclusion with the same accredited inspection body.
  • Obtain the respective favorable report of the inclusion corresponding to the new stage or the new production line.
  • Obtain the renewed document or certificate with the inclusion of the new production line.

Now, to be able to include a new product in the validated production line, you need to have and comply with a series of different requirements, we will present them below, pay attention:

  • Mainly, you should have basic information and data on hand. As the following:
  • Brand of the product.
  • Denomination.
  • Presentation of the same.
  • Product shelf life.
  • Both internal and external packaging.
  • Additives
  • Graphic system.
  • Conditions of conservation.
  • Among others.
  • In addition, the product must have the draft label.
  • Have its respective formulation.
  • Finally, the product must have the description of the batch.

To finalize this point, it is important to note that there are other requirements requested to: change the name and company name of the manufacturer, and also requirements to change the technical representative.

Steps to Obtain the Certificate of Good Manufacturing Practices

Once the explanation of all the requested and necessary requirements to start and obtain this procedure is finished, we continue with the steps you must follow to finally have the certificate of good manufacturing practices.

We must mention that there are two different procedures to obtain this document, the first is for the inclusion of a new stage in the production process, and the second is for the inclusion of a new production line in the establishment.

Inclusion of a new stage in the production process:
  • Organize the respective inspection of expansion of the new stage with the authorized body.
  • Make the due inspection of expansion of the new stage in the certified line.
  • Now, the corresponding inspection body must deliver the documentation of the inspection carried out for the new stage.
  • Finally, the agency is in charge of notifying the inspection documentation.
Inclusion of the new production line inside the establishment:
  • Plan the respective inspection for the inclusion of the new production line inside the establishment with the authorized body.
  • Perform the inclusion observation for the new production line within the establishment.
  • Then, the corresponding inspection body must deliver the respective documentation of the inspection carried out for the new stage.
  • Likewise, the authorized body must deliver the certificate and, in turn, the list of processed foods with their presentation and corresponding classification.
  • Once the previous steps have been completed, you must enter the Good Practices application.
  • Once on the page, you must ask for the request for Inclusion of Production Lines, place the requirements and click on: Line to Include in the Request.
  • Subsequently, ARCSA will carry out a technical analysis of said request.
  • Finally, you have the option to print the communication of the updated BPM Unique Code.

Who should apply and where can you do it?

It is very important to dedicate a part of the article to that particular aspect. Since, it is a fairly common question for all those Ecuadorian citizens who do not know who and where this certificate can be requested.

Likewise, any citizen or company name that has the Sole Taxpayer Registry -RUC- of a person, either natural or legal, national or foreign, public or private, can request the certificate of good manufacturing practices.

In short, this specific document or certificate is aimed at: legal persons – private and, in turn, legal persons – public that reside in the national territory of Ecuador and have the corresponding RUC.

Now, answering the following question, the place and the hours of attention in which any Ecuadorian citizen can request the certificate of good manufacturing practices is the one that we will show you below:

  • ARCSA Central Plant – Ciudadela Samanes, Av. Francisco de Orellana and Av. Paseo del Parque, Parque Samanes, Block 5, Guayaquil – Ecuador-.

The postal code of this organization is the following: 090703. And, the hours that it offers for customer service is, from Monday to Friday, between the hours of 08:00 in the morning, until 17:00 the afternoon.

On the other hand, there are nine organizations that are dedicated to customer service in Ecuador. They are located in different areas so that the interested party can select the most convenient coordination.

  • Guayaquil is the central plant.
  1. Esmeraldas, Imbabura, Carchi and Sucumbíos.
  2. Pichincha, Napo and Orellana.
  3. Cotopaxi, Tungurahua, Chimborazo and Pastaza.
  4. Manabí, Santo Domingo de los Tsáchilas.
  5. Santa Elena, Bolívar, Los Ríos, Galapagos and Guayas.
  6. Cañar, Azuay and Morona Santiago.
  7. El Oro, Loja and Zamora Chinchipe.

Legal base

The legal bases for this type of specific certificate are comprised of three articles, which are: article 155, article 156 and article 157. This last article is divided into seven clauses, which we will explain below.

Article 155

This article focuses on notifying the changes or modifications that are established in article 157 of the current technical sanitary regulations. However, the maximum time to do so is 30 days.

Likewise, and as is established and established in the corresponding clauses A and B of article 157, if necessary, a verification or inspection of said establishment will be carried out.

Article 156

Article 156, proposes the change or modification of the certificate. When the respective verification or inspection is carried out at the establishment, the authorized inspection body must deliver the change or modification of the plant to the user or owner.

This delivery must be made within a maximum time of 15 business days. In this way, the holder of this type of certificate must promptly register the respective extension or modification of said document in the ARCSA.

Article 157

The last article corresponds to the changes and modifications that must be notified. As we mentioned earlier, article 157 is divided or comprises seven different literals or clauses, which we will develop below:

  • A: inclusion of a new stage of a production line.
  • B: inclusion of a new production line inside the processing plant or processing establishment food.
  • C: entry of a new product in the certified production line.
  • D: vary the name or company name of the manufacturer.
  • E: change of name or company name of the person responsible for the registration of the food product
  • F: modify the technical representative.
  • G: change of manufacturer’s address.

What is the Certificate of Good Manufacturing Practices?

To finish this article, we will show a brief definition of this specific certificate. Well, it is nothing more than a presentation of officially established norms which regulate various aspects for human use and consumption.

The aspects that this certificate regulates are: the respective food processing plants, manufacturing procedures, cleaning and disinfection, personal hygiene, handling, control, registration and storage that guarantee quality and food safety.

Likewise, good manufacturing practices are a basic instrument to obtain products that are officially safe for human consumption. In this way, they should focus on hygiene and ways of handling.

For this reason, and many more, this tool is very important and indispensable for the application of the Hazard Analysis and Critical Control Points (HACCP) system, as well as for a TQM Program, or for other Quality Management systems.

In addition to this, good manufacturing practices include a series of standards that define the management and handling of actions. The objective or purpose of these guidelines is to ensure that food production is safe for human use and consumption.

Finally, it includes certain basic conditions and procedures that every food company must comply with, we can mention: good training for workers, maintenance of equipment and tools, good use of chemical products.

To end our writing, we invite you to help us share the information.

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