Good Manufacturing Practices - how to obtain it?

Certification of Good Manufacturing Practices - Understand its importance and how to obtain it

The Certification of Good Manufacturing Practices can be a great differential in your company. It is related to the Quality System implemented in your company and offers several benefits in several areas.

Get to know a little more about this process, when it's mandatory, what the advantages of applying it and how Stone Okamont can help you!

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What is and what is the role of Good Manufacturing Practices Certification (CBPF)?

CBPF is the certification granted to a company that has implemented a Quality System that has been audited and approved, in the standards and legislation applicable to its segment by an OCP - (Primary Certifying Agency) or Competent Government Agency (ANVISA / MAPA).

We can use as an example the Brazilian Health Regulatory Agency (ANVISA). The auditors of ANVISA go to the company to inspect the Quality System and know if it corresponds to the applicable standards and if it is functional.

Once this audit is carried out - and with satisfactory results - the company receives the Certification of Good Manufacturing Practices.

It exists to prove the quality of what is accomplished in the company.

And what is Quality System?

The Quality System is a set of manuals, procedures and records that establish parameters that must be followed by the company to ensure that all processes follow the quality prerogatives required by the Ministry of Health or any other agency that the company is subject to.

The Quality System establishes standards that optimize the operation of the company, bringing benefits.

All creation of this documentation is established according to the operation of the company and with the regulations of the related regulatory bodies.

From this, manuals, standard operating procedures, internal standards, tokens, forms, among several other documents are created. This information, when ready, should guide both the company and its employees.

When can the Quality System and Good Practices be applied?

The Quality System can be applied in any company, regardless of its size, number of employees, performance or service provided. This system, as the name itself says, creates a control, which allows to minimize errors, disorganization, losses, rework, loss of time and capital, among others.

The Certification of Good Manufacturing Practices is an evaluation of the Quality System by the certifying agency. It can be applied to any company that has a consolidated Quality System.

In some cases, the Certification of Good Manufacturing Practices is mandatory.

In the Product Registration processes, items that need to be registered by the Brazilian Health Regulatory Agency (ANVISA) belong to the Risk Classification III and IV. To enter a Registration Process companies are required to have the Certification of Good Manufacturing Practices.

This is because Risk Classes III and IV generally encompass drugs and correlates, requiring more complex and judicious processes, requiring more detailed procedures.

What are the benefits?

Among the many benefits, one of the first to appear when adopting a Quality System is the financial return. The investment made returns in a short time, besides bringing other advantages such as competitiveness, profitability, production, avoiding unnecessary expenses, better organization, greater consumer / public reliability.

How does Stone Okamont help in the process of applying the Quality System?

Stone Okamont has qualified consultants to audit and implement the Quality System.

She goes to the company, knows the protocols, manufacturing methods, what is done in the place and with this information she develops all the material of the Quality System.

Stone Okamont assembles the system, validates and tracks the audit of the certifying agency.

It is also possible to apply Stone Okamont's expertise in companies that already have a Quality System in place, but have difficulties in achieving the Certification of Good Operating Practices.

In these cases, Stone Okamont's expert technicians go to the company, evaluate the system, perform audits, make the necessary changes and corrections, adjust the nonconformities, and prepare the system so that it becomes eligible to receive Good Manufacturing Practices Certification.

How does Stone Okamont assist in the process of obtaining the Certification of Good Manufacturing Practices?

In order to obtain the Certification of Good Manufacturing Practices, a petition is filed with ANVISA (or other related certifying body). The auditors of the organ go to the company and there they make judicious evaluations in the Quality System implanted. If the result is satisfactory and the rules required by the standards are in compliance, then the company receives the certification.

Stone Okamont accompanies this process, assists in the implementation and improvements of the Quality System, and conducts audits to prove the effectiveness of the Quality System.

Reaching Your Goals

Stone Okamont helps you achieve success with excellence! Streamline and improve your internal processes, organize your company, achieve your maximum without having extra and unnecessary expenses, all without bureaucratic paperwork, because Stone Okamont offers the Zero Bureaucracy method!

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