They were originally applied to the manufacturing of food, pharmaceuticals, cosmetics, and medical products. However, today their application extends to other productive sectors. This is done through a set of standards and guidelines that manufacturers must follow. <\/p>\n
Its goal is to ensure the essential quality and <\/span>safety standards of the products produced<\/a>, from raw materials to the final consumer.<\/p>\n The main general, necessary, and common standards to comply with GMP are:<\/p>\n Additionally, other factors to consider include:<\/p>\n Many of these procedures are regulated by international, European, and, of course, Spanish legislation.<\/p>\n <\/p>\n In the pharmaceutical industry, everything is regulated and supervised by the Spanish Agency for Medicines and Health Products (AEMPS), which follows the guidelines of the European Medicines Agency (EMA). <\/p>\n We are talking about pharmaceutical laboratories, for human or veterinary medicines, where active ingredients and excipients are handled as raw materials. This requires the preparation of two technical reports with clear and concise information about the activity: <\/p>\n With this documentation, the AEMPS has the tools to plan and conduct inspections. In some cases, there are Autonomous Communities that are responsible for GMP and carry out these inspection visits. <\/p>\n Once compliance with GMP is verified, the compliance certificate is issued and executed within ninety days, which is necessary to enter the market.<\/p>\n To help companies in the sector meet these requirements, the AEMPS provides a <\/span>good manufacturing guide for medicines<\/a> and <\/span>a <\/span>guide outlining the content that technical reports should include<\/a>.<\/p>[\/et_pb_text][et_pb_image src=”https:\/\/puntazo.sixphere.com\/wp-content\/uploads\/2021\/01\/SIXPHERE-Normativa-GMP-y-buenas-practicas-de-fabricacion.jpg” _builder_version=”4.7.7″ _module_preset=”default” hover_enabled=”0″ sticky_enabled=”0″ alt=”SIXPHERE – GMP Regulations and good manufacturing practices” title_text=”SIXPHERE – GMP Regulations and good manufacturing practices” align=”center”][\/et_pb_image][et_pb_text _builder_version=”4.7.7″ text_font=”|300|||||||” hover_enabled=”0″ link_option_url_new_window=”on” sticky_enabled=”0″] In the case of cosmetic product <\/span>production<\/a>, although <\/span>the AEMPS can carry out inspections, it does not have the authority to issue GMP compliance certificates.<\/p>\n The only way to obtain them is through certification of the international standard <\/span>ISO 22716<\/a>, which is carried out through internal and external audits. <\/p>\n In these audits, the following must be ensured:<\/p>\n According to the WHO, most foodborne diseases (intoxications and even deaths) are caused by bacteria, viruses, parasites, or chemical contaminants. Therefore, food safety is a global concern. <\/p>\n Compliance with GMP is essential to ensure a product is safe for both the consumer’s health and the company’s own staff, whether it’s a farm, a processing plant, or a hotel, to name a few examples.<\/p>\n In this sector, the most important GMP certificates are: <\/p>\n And some specific measures included in these are:<\/p>\n Next year, just like this 2020, will be marked by the health crisis. Since last March, exceptional decisions have been applied to GMP regulations, affecting all sectors (beyond the mentioned ones). <\/p>\n As a fact, before all of this, the <\/span>traceability<\/a> <\/span>health-oriented traceability was more prevalent in the food industry, whereas in the pharmaceutical and cosmetic industries, it was more focused on detecting counterfeits and potential distribution issues. <\/p>\n In 2021, it will be crucial to follow this path: not only complying with GMP regulations but also reinforcing the importance of traceability throughout the entire process within those regulations.<\/p>\n For all types of environments, the Secretary of State for Trade has prepared a <\/span>‘Good Practice Guide’, <\/span><\/a>including general prevention measures relating to the <\/span>health protection<\/a>, which will be strictly monitored at least for the next 2021.<\/p>\n The AEMPS, for its part, published a <\/span>guide of recommendations in case of infection<\/a>. Since March, working on identifying companies that could make manufacturing lines available to the Ministry of Health for the production of masks and surgical gowns within our territory. <\/p>\n On the other hand, it also grants and will grant exceptional (and necessary) authorizations to cosmetic companies and bioethanol producers to ensure the manufacture, importation, and supply of hand sanitizers.<\/p>\n[\/et_pb_text][et_pb_image src=”https:\/\/puntazo.sixphere.com\/wp-content\/uploads\/2021\/01\/SIXPHERE-Normativa-GMP.jpg” _builder_version=”4.7.7″ _module_preset=”default” hover_enabled=”0″ sticky_enabled=”0″ alt=”SIXPHERE – GMP Regulations” title_text=”SIXPHERE – GMP Regulations” align=”center”][\/et_pb_image][et_pb_text _builder_version=”4.7.7″ text_font=”|300|||||||” link_option_url_new_window=”on” hover_enabled=”0″ sticky_enabled=”0″] As you can see, successfully meeting all the GMP requirements is closely related to having a detailed understanding of everything happening on the production floor.<\/p>\n In this context, traceability and quality control standards are not just important, but absolutely essential. That\u2019s why having digital solutions that simplify these processes and deliver effective results provides a significant advantage. <\/p>\n At <\/span>Sixphere<\/a>, we <\/span>have a set of tools that will help you achieve these goals.<\/p>\n To start, we have <\/span>Polaris Production Management<\/a>, which provides you with a real-time snapshot of all processes. Additionally, with <\/span>Polaris quality audits 5S<\/a> <\/span>you will be able to manage the inspections we have described more efficiently.<\/p>\n Finally, you can also benefit from the features offered by <\/span>Blockchain<\/a> technology, through which all links in the <\/span>supply chain<\/a> will <\/span>have access to key manufacturing and logistics information.<\/p>\n Surely, the GMP regulations will be with us, and very closely, in the coming years. In fact, they are evolving to adapt to these challenging times. Do you think this is your opportunity to incorporate them into the <\/span>digitalization plan<\/a> <\/span>of your company? <\/span>Tell us your case<\/a> <\/span>and we will help you achieve it.<\/p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ specialty=”on” prev_background_color=”#ffffff” _builder_version=”3.24″ use_background_color_gradient=”on” background_color_gradient_start=”rgba(104,168,222,0.1)” background_color_gradient_end=”rgba(41,196,169,0)” min_height=”477px” top_divider_style=”slant” top_divider_height=”8px”][et_pb_column type=”2_3″ specialty_columns=”2″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_row_inner _builder_version=”3.25″ custom_padding=”22px|||||”][et_pb_column_inner saved_specialty_column_type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blog fullwidth=”off” posts_number=”2″ include_categories=”current” meta_date=”j M Y” show_author=”off” show_date=”off” show_categories=”off” show_pagination=”off” _builder_version=”3.24″ header_level=”h4″ header_font=”||||||||” header_text_align=”center” body_font=”|300|||||||” body_text_align=”center” meta_font=”||||||||” meta_text_align=”center” read_more_font=”|600||on|||||” read_more_text_color=”#dc911b” custom_padding=”|25px||25px” animation_style=”fade” border_radii=”on|4px|4px|4px|4px” border_width_all=”0px” box_shadow_style=”preset1″][\/et_pb_blog][et_pb_button button_url=”\/blog” button_text=”All blogs” button_alignment=”center” _builder_version=”3.23.3″ custom_button=”on” button_text_color=”#67ab6a ” button_font=”||||||||” custom_margin=”||0px|||”][\/et_pb_button][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_cta title=”The success stories of Sixphere” button_url=”\/casos-de-exito” button_text=”Success stories” _builder_version=”3.23.3″ header_font=”||||||||” header_text_align=”right” header_font_size=”30px” background_color=”#67ab6a” text_orientation=”right” custom_margin=”|16px||16px” custom_padding=”|16px||16px” animation_style=”slide” animation_direction=”right” border_radii=”on|4px|4px|4px|4px” box_shadow_style=”preset1″] <\/i><\/p>\n Do you want to know what we do and how we do it? Visit our success stories and ask us anything you need to know. <\/p>[\/et_pb_cta][\/et_pb_column][\/et_pb_section]\n","protected":false},"excerpt":{"rendered":" If you’ve made it here, it’s because the acronym GMP has crossed your path. Some time ago, we would have assumed you belonged to the pharmaceutical or food sectors, but now everything has changed. Why? Due to the current health situation, many companies in the industrial sector must comply with GMP regulations. Below, we explain what lies behind these initials, their purpose, and how digitalization contributes to them. Will you join us? <\/p>\n","protected":false},"author":3,"featured_media":23944,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","content-type":"","footnotes":""},"categories":[197,189,169],"tags":[204],"class_list":["post-24617","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-automation-iiot","category-business-world","category-production","tag-regulations"],"acf":{"cuerpo":" GMP stands for Good Manufacturing Practices. In Spain, we have two ways of referring to them: <\/p>\n They were originally applied to the manufacturing of food, pharmaceuticals, cosmetics, and medical products. However, today their application extends to other productive sectors. This is done through a set of standards and guidelines that manufacturers must follow. <\/p>\n Its goal is to ensure the essential quality and <\/span>safety standards of the products produced<\/a>, from raw materials to the final consumer.<\/p>\n The main general, necessary, and common standards to comply with GMP are:<\/p>\n Additionally, other factors to consider include:<\/p>\n Many of these procedures are regulated by international, European, and, of course, Spanish legislation.<\/p>\n In the pharmaceutical industry, everything is regulated and supervised by the Spanish Agency for Medicines and Health Products (AEMPS), which follows the guidelines of the European Medicines Agency (EMA). <\/p>\n We are talking about pharmaceutical laboratories, for human or veterinary medicines, where active ingredients and excipients are handled as raw materials. This requires the preparation of two technical reports with clear and concise information about the activity: <\/p>\n With this documentation, the AEMPS has the tools to plan and conduct inspections. In some cases, there are Autonomous Communities that are responsible for GMP and carry out these inspection visits. <\/p>\n Once compliance with GMP is verified, the compliance certificate is issued and executed within ninety days, which is necessary to enter the market.<\/p>\n To help companies in the sector meet these requirements, the AEMPS provides a <\/span>good manufacturing guide for medicines<\/a> and <\/span>a <\/span>guide outlining the content that technical reports should include<\/a>.<\/p> In the case of cosmetic product <\/span>production<\/a>, although <\/span>the AEMPS can carry out inspections, it does not have the authority to issue GMP compliance certificates.<\/p>\n The only way to obtain them is through certification of the international standard <\/span>ISO 22716<\/a>, which is carried out through internal and external audits. <\/p>\n In these audits, the following must be ensured:<\/p>\n According to the WHO, most foodborne diseases (intoxications and even deaths) are caused by bacteria, viruses, parasites, or chemical contaminants. Therefore, food safety is a global concern. <\/p>\n Compliance with GMP is essential to ensure a product is safe for both the consumer's health and the company's own staff, whether it's a farm, a processing plant, or a hotel, to name a few examples.<\/p>\n In this sector, the most important GMP certificates are: <\/p>\n And some specific measures included in these are:<\/p>\n Next year, just like this 2020, will be marked by the health crisis. Since last March, exceptional decisions have been applied to GMP regulations, affecting all sectors (beyond the mentioned ones). <\/p>\n As a fact, before all of this, the <\/span>traceability<\/a> <\/span>health-oriented traceability was more prevalent in the food industry, whereas in the pharmaceutical and cosmetic industries, it was more focused on detecting counterfeits and potential distribution issues. <\/p>\n In 2021, it will be crucial to follow this path: not only complying with GMP regulations but also reinforcing the importance of traceability throughout the entire process within those regulations.<\/p>\n For all types of environments, the Secretary of State for Trade has prepared a <\/span>'Good Practice Guide', <\/span><\/a>including general prevention measures relating to the <\/span>health protection<\/a>, which will be strictly monitored at least for the next 2021.<\/p>\n The AEMPS, for its part, published a <\/span>guide of recommendations in case of infection<\/a>. Since March, working on identifying companies that could make manufacturing lines available to the Ministry of Health for the production of masks and surgical gowns within our territory. <\/p>\n On the other hand, it also grants and will grant exceptional (and necessary) authorizations to cosmetic companies and bioethanol producers to ensure the manufacture, importation, and supply of hand sanitizers.<\/p>\n As you can see, successfully meeting all the GMP requirements is closely related to having a detailed understanding of everything happening on the production floor.<\/p>\n In this context, traceability and quality control standards are not just important, but absolutely essential. That\u2019s why having digital solutions that simplify these processes and deliver effective results provides a significant advantage. <\/p>\n At <\/span>Sixphere<\/a>, we <\/span>have a set of tools that will help you achieve these goals.<\/p>\n To start, we have <\/span>Polaris Production Management<\/a>, which provides you with a real-time snapshot of all processes. Additionally, with <\/span>Polaris quality audits 5S<\/a> <\/span>you will be able to manage the inspections we have described more efficiently.<\/p>\n Finally, you can also benefit from the features offered by <\/span>Blockchain<\/a> technology, through which all links in the <\/span>supply chain<\/a> will <\/span>have access to key manufacturing and logistics information.<\/p>\n Surely, the GMP regulations will be with us, and very closely, in the coming years. In fact, they are evolving to adapt to these challenging times. Do you think this is your opportunity to incorporate them into the <\/span>digitalization plan<\/a> <\/span>of your company? <\/span>Tell us your case<\/a> <\/span>and we will help you achieve it.<\/p>\n <\/i><\/p>\n Do you want to know what we do and how we do it? Visit our success stories and ask us anything you need to know. <\/p>","clasificacion":"Normal"},"yoast_head":"\n\n
\n
GMP in Spain. Application in different industries <\/h2>\n
Pharmaceutical industry<\/h3>\n
\n
Cosmetic industry<\/h3>\n
\n
Food industry<\/h3>\n
\n
\n
\n
Good manufacturing practices in 2021<\/h2>\n
Digitalization to ensure GMP compliance<\/h2>\n
What is GMP regulation?<\/h2>\n
\n
\n
\n
GMP in Spain. Application in different industries <\/h2>\n
Pharmaceutical industry<\/h3>\n
\n
![\"SIXPHERE](\"https:\/\/sixphere.com\/wp-content\/uploads\/2021\/01\/SIXPHERE-Normativa-GMP-y-buenas-practicas-de-fabricacion.jpg\")
Cosmetic industry<\/h3>\n
\n
Food industry<\/h3>\n
\n
\n
\n
Good manufacturing practices in 2021<\/h2>\n
![\"SIXPHERE](\"https:\/\/sixphere.com\/wp-content\/uploads\/2021\/01\/SIXPHERE-Normativa-GMP.jpg\")
Digitalization to ensure GMP compliance<\/h2>\n