{"id":99052,"date":"2019-06-19T00:00:00","date_gmt":"2019-06-19T03:00:00","guid":{"rendered":"https:\/\/tecnotri.com.br\/blog\/how-to-adapt-to-anvisa-and-mapa-standards-in-the-pharmaceutical-sector\/"},"modified":"2019-06-19T00:00:00","modified_gmt":"2019-06-19T03:00:00","slug":"how-to-adapt-to-anvisa-and-mapa-standards-in-the-pharmaceutical-sector","status":"publish","type":"post","link":"https:\/\/tecnotri.com.br\/en\/blog\/how-to-adapt-to-anvisa-and-mapa-standards-in-the-pharmaceutical-sector\/","title":{"rendered":"How to adapt to Anvisa and MAPA standards in the pharmaceutical sector"},"content":{"rendered":"

In the pharmaceutical sector, hygiene, sanitary control and adequate storage of products are fundamental factors to ensure the quality of medicines and meet the health requirements of health surveillance agencies.<\/p>\n

Compliance with the standards of regulatory agencies, such as Anvisa and MAPA, is mandatory for product certification, and non-compliance constitutes a health infraction. And even interruption of production due to non-compliance with standards.<\/p>\n

See how to properly transport medications<\/h2>\n

The transportation of medicines is a crucial step for them to reach the end consumer in the ideal condition for consumption, without changing their formula and having the effect proposed by the manufacturer.<\/p>\n

The transport of medicines must be carried out in accordance with good practices for the transport of pharmaceutical products. Furthermore, products that require specific temperatures for storage must be transported respecting the conditions recommended by the manufacturer.<\/p>\n

When exposed to adverse conditions, medications may suffer a decrease in their effectiveness, a reduction in their shelf life and even changes in their toxicity.<\/p>\n

\"Tecnotri<\/p>\n

According to Ordinance No. 1052 of 1998, for a company to carry out the activity of transporting medicines, it is necessary to have a Manual of Good Transport Practices, in accordance with the Good Transport Practices guidelines of the Ministry of Health; prove that the vehicles used are capable of transporting pharmaceutical products; prove the technical assistance of a pharmacist; have an Operating Authorization (AFE), Special Authorization (AE) for the transport of controlled medicines and a Health License issued by state and\/or municipal health surveillance.<\/p>\n

It is recommended that vehicles that transport thermolabile medicines have an isothermal coating, a smooth and washable surface and adequate refrigeration elements.<\/p>\n

Furthermore, to ensure optimal transport and stability of medicines, it is necessary to make sure that the product is being transported in suitable thermal packaging. Thermal packaging must be designed in accordance with the criteria and requirements of good transport practices.<\/p>\n

The stability of a medicine is its ability to remain within already determined conditions for a period of time, ensuring its identity, potency, purity and effectiveness. According to Anvisa Resolution No. 01 of 2005, stability depends on environmental factors such as temperature, humidity, light and intrinsic factors, such as the physical and chemical properties of active substances and pharmaceutical excipients.<\/p>\n

Temperature must be monitored and recorded during transport, and these records must be stored for the duration of the product’s shelf life. Furthermore, monitoring equipment needs to be calibrated regularly.<\/p>\n

Learn about the rules established by health agencies<\/h2>\n

Anvisa provides in article 402 of RDC 17\/2010<\/a> on Good Medicine Manufacturing Practices.<\/p>\n

The standard establishes that the areas involved in the drug manufacturing process must always be clean and all exposed surfaces must be smooth and impermeable, in order to minimize the accumulation or release of particles or microorganisms and allow the repeated application of cleaning agents and disinfectants.<\/p>\n

Anvisa determines that packaging must protect its contents and that pallets for transport and storage must be manufactured from inert material that does not absorb water.<\/p>\n

The importance of using smooth and impermeable surfaces is also addressed by RDC 48\/2013<\/a>, which provides for good Manufacturing Practices for Products of Personal Hygiene, Cosmetics and Perfumes, and by RDC 47\/2013<\/a>, which determines the Good Manufacturing Practices of Sanitizing.
\nAccording to IN 13\/2003 of the Ministry of Agriculture, Livestock and Supply (MAPA), raw materials, primary packaging materials, intermediate or bulk products exposed to ambient air must have smooth interior surfaces free from cracks and open joints. Furthermore, these surfaces cannot release particles and must allow easy cleaning and disinfection, when necessary.<\/p>\n

According to MERCOSUR Resolution No. 49 of 2002, to guarantee the quality of the pharmaceutical product, storage must be carried out under appropriate conditions of temperature, humidity and lighting, in accordance with the manufacturer’s guidelines.<\/p>\n

The storage area must be designed to ensure good storage conditions. The environments must be clean, dry and maintained within acceptable temperature limits. Medications must be stored away from the floor, with the help of pallets in good condition and organized with adequate spacing, to allow for cleaning and inspection.<\/p>\n

See why plastic pallets meet Anvisa’s requirements<\/h2>\n

The rotomolded plastic pallet (Super Roto\u00ae) has a smooth, waterproof surface, which minimizes the accumulation or release of particles or microorganisms and allows the application of cleaning agents and disinfectants that act on the entire surface.<\/p>\n

\"Logistics<\/p>\n

As it is made from sanitizeable and non-toxic material, the plastic pallet helps to avoid contamination. In addition to receiving antimicrobial protection, which prevents the proliferation of fungi and bacteria. The antimicrobial agent (KHER\u00ae protection) uses nanotechnology to increase the action potential, remaining active, eliminating fungi and microorganisms through contact and reducing the risks of contamination.<\/p>\n

The plastic pallet is also resistant to mechanical shock, avoiding cracks and cracks, which are anchoring points for fungi and microorganisms that are difficult to clean and disinfect.<\/p>\n

Because it is light and resistant, rotomolded or super-rotomized plastic pallets are the most suitable for the pharmaceutical industry, as they do not damage the floor and walls of the factory, preventing the accumulation of dust and the presence of microorganisms, such as fungi and bacteria.<\/p>\n

The plastic pallet also has the advantage of being stackable, allowing it to be stored on shelves and reducing the space used. Furthermore, plastic pallets do not have sharp corners, nails or splinters, which can hurt the hands of the people involved and facilitate the emergence of microorganisms.<\/p>\n

As we have seen, the transport and storage of pharmaceutical products requires special care to comply with the many requirements of regulatory agencies and ensure the quality of the medicines. By following these recommendations, you will be able to comply with the rules and avoid problems with inspection.<\/p>\n","protected":false},"excerpt":{"rendered":"

In the pharmaceutical sector, hygiene, sanitary control and adequate storage of products are fundamental factors to ensure the quality of medicines and meet the health requirements of health surveillance agencies. Compliance with the standards of regulatory agencies, such as Anvisa and MAPA, is mandatory for product certification, and non-compliance constitutes a health infraction. And even […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2771,2754,2762,2513,2462,2444],"tags":[3066,2861,2763,2470],"linha-blog":[],"class_list":["post-99052","post","type-post","status-publish","format-standard","hentry","category-certifications","category-news","category-pharmaceutical","category-regulations","category-logistics","category-industria","tag-map","tag-norms","tag-pharmaceutical-industry","tag-anvisa"],"acf":[],"yoast_head":"\nHow to adapt to Anvisa and MAPA standards in the pharmaceutical sector - Tecnotri<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/tecnotri.com.br\/blog\/how-to-adapt-to-anvisa-and-mapa-standards-in-the-pharmaceutical-sector\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to adapt to Anvisa and MAPA standards in the pharmaceutical sector - Tecnotri\" \/>\n<meta property=\"og:description\" content=\"In the pharmaceutical sector, hygiene, sanitary control and adequate storage of products are fundamental factors to ensure the quality of medicines and meet the health requirements of health surveillance agencies. Compliance with the standards of regulatory agencies, such as Anvisa and MAPA, is mandatory for product certification, and non-compliance constitutes a health infraction. 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