RDC 658/22: Increase in Quality Standards for Pharmaceuticals
Nearly all countries worldwide are making efforts to enhance quality standards in production. This effort is even more significant in the pharmaceutical industry, since it concerns public health. In line with this approach, Brazil has also witnessed developments. Now, let’s take a closer look at the significance of RDC 658/22, which has become an important part of these developments.
The Brazilian Health Regulatory Agency (ANVISA) published RDC 658, which contains general guidelines for Good Manufacturing Practices (GMP) for Pharmaceuticals, on March 30, 2022. With this new decision, RDC 301/19, which was published in 2019 and considered as a regulatory framework, was cancelled. In broad terms,
RDC 658 sets the standards for pharmaceutical manufacturers. It defines all minimum requirements necessary for production, quality control, documentation, training, storage, etc. Particularly, Article 215 of RDC 658 stands out as the section related to online product control.
What Does RDC 658/22 Cover?
As VISIOTT TPS, we follow international requirements and believe that there is no room for errors. Therefore, we are examining the requirements of RDC 658/22, focusing on the key points of online control.
General Appearance of Packaging:
Pharmaceutical packaging must meet certain requirements. The presence and completeness of informative texts for consumers, as well as the legibility of brand and informative writings, are the most general packaging requirements. In addition to these, any deformities in the packaging structure are considered contrary to quality requirements.
Complete or incomplete packaging (Article 214, Chapter II) must be handled with sensitivity, and as VISIOTT TPS, we tailor our solutions to meet your specific needs. There are multiple methods to guarantee packaging integrity. Manufacturers can prefer vision inspection technologies in this regard or/and automatic checkweighers. VISIOTT TPS offers a wide range of vision inspection technologies and automatic checkweighers that provide all the solutions for complete packaging in line with the requirements of RDC 658/22.
Correct Packaging Products and Materials:
Chapter III of RDC 658/22 is highly significant. According to the requirements in this section, packaging materials must be controllable and verifiable. With VISIOTT TPS’s high-precision vision inspection technologies, the presence and accuracy of bottle, carton box, label, and label information are flawlessly verified.
Precise and Accurate Printing:
According to Article IV of RDC 658/22, codes applied to packaging must be precise, accurate, and clean. VISIOTT TPS excels in code applications with its expertise and leaves no room for doubt. With advanced coding and vision inspection technologies, VISIOTT TPS applies codes to your packaging, guarantees their accuracy, and does so with high speed and high quality. The structure of the packaging is not important for coding and verification. Our innovative solutions provide solutions for all types of packaging, from primary and secondary packaging to blisters, bottles, and vials; ensuring precise application and verification.
Sustainable Production Operations:
Production operations that are vitally important to be continuous can be disrupted for various reasons. Incorrect packaging applications, coding applications, deficiencies in controls, and insufficient software can disrupt your production operations. With VISIOTT TPS’s state-of-the-art hardware and up-to-date software, your production operations never stop, and you meet the requirements seamlessly.
RDC 658/22 – Deadlines
Just like every regulation that is published, RDC 658/22 requirements also have deadlines. Especially the two dates mentioned below are crucial for manufacturers:
October 7, 2023 – The installation must be completed by this date. This way, you can show that you are ready for the next step.
October 7, 2024 – The final stages of equipment qualification must be completed, and Article 215 must be put into operation.
Creating a Difference in Quality While Meeting RDC 658/22
As seen, RDC 658/22 covers processes related to quality requirements. If companies do not perform their quality processes in line with expectations with high-quality hardware and software, the results will not be favorable. This is where VISIOTT Traceability Packaging Solutions’ vision inspection technologies, successfully used worldwide, come into play.
OCR/OCV Vision Inspection Technologies
The vision inspection technologies known as OCR (Optical Character Recognition), which identifies information printed on product packaging, and OCV (Optical Character Verification), that verifies it, are at high importance for the supply chain. Incorrect or missing information on product packaging can jeopardize brand security and lead to financial losses for companies. To prevent these negative outcomes, VISIOTT TPS introduces OCR/OCV technologies to you.
Pharmacode Analysis and Verification
Pharmacode analysis and verification, which ensure the consistency of packaging and product, as well as the correct inclusion of the product in the supply chain with the right supporting documents, are important stages of packaging. Pharmacode checks, commonly used in the pharmaceutical industry, should be performed with advanced vision inspection technologies. VISIOTT TPS, with its many years of expertise in image processing technologies, produces solutions that successfully perform pharmacode analysis and verification.
Bulk Code Reading and Analysis
Reading codes in bulk is important for operation speed and efficiency. Reading individual codes manually consumes extra time and labor. Especially in today’s processes where speed is crucial, bulk code reading and analysis are essential factors. VISIOTT TPS offers technologies for bulk code reading and analysis in the systems you use for production and shipping operations. With high-resolution industrial cameras and specially designed lighting systems, codes under transparent film and codes inside boxes are automatically analyzed in one time.
Presence/absence control is a crucial production stage for ensuring that products are delivered to consumers without errors and omissions. Under the control scope, determinations are made regarding the presence and absence of labels, product components inside the package, and packaging components. VISIOTT TPS’s vision inspection technologies can check for the presence of missing or deformed products in blister or package, as well as the presence of multiple parts in one product. Additionally, level detections of liquid products are also within the control scope.
VISIOTT TPS’s approach that makes a difference in image processing technologies has always succeeded in satisfying its users. VISIOTT TPS Vision Inspection Technologies are ready to meet all your requirements in line with RDC 658/22 obligations and for all processes you need.
You can contact us immediately to get more information about RDC 658/22 and VISIOTT TPS solutions.