A Normative Instruction (IN) from Anvisa (National Health Surveillance Agency) is a document that establishes the rules to be complied with by companies and professionals in various areas. With IN 134, quality standards were established for the computerized systems used in the manufacture of medicines.
Thus, IN 134 includes in the form of Good Manufacturing Practices (GMP) the guidelines for the use of these software and hardware, as well as the characteristics they need to have. Thus, it ensures that both the tools used and the data and products that result from this have the quality and safety necessary to go to the market without posing a danger to the health of the population.
Keep reading and see more about how IN 134 seeks to modernize quality management in pharmacovigilance.
Read also: See the changes caused by RDC 749 in the pharmaceutical sector
What is a Normative Instruction
As with the Resolutions of the Collegiate Board of Directors (RDC), the Normative Instructions also aim to create guidelines, rules, and standards that guide companies and public agencies. The main objective is to ensure the quality and safety of the equipment, products, activities and services offered to consumers.
These normative instructions can cover a variety of topics, such as the production and marketing of medicines, food, cosmetics, and medical devices, as well as guidance on sanitary inspection and control.
The Normative Instructions are mandatory and serve to guide both health professionals and companies operating in the areas regulated by Anvisa.
Free Ebook: How to Implement GMP in the Pharmaceutical Industry
What is IN 134
In the specific case of Normative Instruction 134, the main objective was to make it clearer what are the acceptable parameters concerning the use of software and hardware in the manufacture of medicines.
IN 134 was created in 2022 and according to its publication, its main objective is:
“This Normative Instruction aims to adopt the Good Manufacturing Practices guidelines related to the computerized systems of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), as complementary requirements to be followed in the manufacture of medicines in addition to the General Guidelines for Good Manufacturing Practices for Medicines”.
Its scope encompasses various forms of computerized systems and equipment, as long as they are used in the manufacture of medicines:
“This Normative Instruction applies to all forms of computerized systems used as part of activities regulated by Good Manufacturing Practices for medicines, including investigational medicines.”
IN 134 aims to ensure the quality standard of this equipment and, consequently, of the medicines produced by them. In addition, it also brings the following guidelines:
- The information technology infrastructure must be qualified;
- Whenever a computerized system replaces manual operation, there should be no decrease in product quality, process control, or quality assurance. Nor can there be any increase in the overall risk to the process;
- Risk management should be applied throughout the life cycle of the computerized system, taking into account patient safety, data integrity, and product quality;
- If critical data is entered manually, there must be an additional check of the accuracy of this information;
- The criticality and potential consequences of erroneous or incorrectly entered data into a system should be covered by the company’s risk assessment;
- The data stored and used in the computer system must be protected by physical and electronic means against damage;
- In addition, this data needs to have its accessibility, legibility and accuracy checked periodically;
- Access to the stored data must be guaranteed throughout the storage period. It is also mandatory to perform backups of all relevant data.
In addition to the items above, IN 134 also defines the frequency of audits that need to be carried out, the forms of change management, control of access to the system and accident management.
In this way, the Normative Instruction makes it clear to companies, professionals and regulatory entities what needs to be done so that a computerized system can be used to manufacture medicines in compliance with Anvisa.
Thus, the agency helps all parties to have an easier time ensuring quality and effectiveness in activities and processes involving these systems. At the same time, this protects the population’s health, as it reduces the chances of a product going to the market with some harmful factor generated by failures in a computerized system.
Learn more: How to do Risk Management in the pharmaceutical sector
Conclusion
Now you know what IN 134 is — as well as the Normative Instructions in general — and how this specific regulation aims to bring more confidence, quality, and safety in the use of computerized systems for the production of medicines.
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