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CE Marking Certification in Indore At Shark Certification Pvt. Ltd., we assist manufacturers, exporters, and importers in obtaining CE Marking, which is a critical requirement for products entering the European Economic Area (EEA). CE Marking signifies that a product complies with harmonized European standards and meets essential requirements related to health, safety, and environmental protection. What is CE Marking? CE stands for Conformité Européenne, meaning European Conformity. It is not a quality label, but a mandatory declaration of conformity indicating that a product adheres to applicable EU directives and regulations. By affixing the CE Mark, the manufacturer takes full responsibility for the product’s compliance with relevant EU legislation—allowing free movement and market access across all EU member states, including Iceland, Liechtenstein, and Norway. Why is CE Marking Important? ✔ Market Access to the EU – Acts as a trade passport for seamless entry into the European market ✔ Compliance with Unified Standards – Ensures that the product complies with standardized EU regulations instead of varying national rules ✔ Increased Buyer Confidence – Demonstrates product safety, regulatory compliance, and adherence to environmental standards ✔ Avoids Legal Barriers – Eliminates the need for re-certification across multiple EU countries ✔ Mandatory for Certain Products – Essential for machinery, electrical devices, toys, medical equipment, construction materials, and more Applicable EU Directives Include: Machinery Directive (2006/42/EC) – For safety in design and operation of machinery Low Voltage Directive (2014/35/EU) – Applies to electrical equipment operating between 50–1000V AC and 75–1500V DC EMC Directive (2014/30/EU) – Ensures electromagnetic compatibility of electrical and electronic devices Medical Device Directive, Toy Safety Directive, RoHS, and more – Based on product category Steps to Obtain CE Marking Identify Relevant Directives & Standards Determine which EU legislation applies to your product, including applicable harmonized standards. Product Evaluation Assess whether the product meets essential health, safety, and environmental protection requirements. Product Testing Conduct in-house or third-party testing based on specific directive requirements. Compile Technical Documentation Create a technical file including: Product specifications and risk assessment Test reports and certifications Declaration of conformity User manuals, safety data sheets, etc. Affix CE Marking Once conformity is ensured, apply the CE logo to your product and issue the formal EU Declaration of Conformity. Documents Required for CE Marking Product Specifications and Description Relevant Test Reports Risk Assessment Report Manufacturer’s Declaration Proof of Conformity with EU Regulations Technical Construction File Why Choose Shark Certification Pvt. Ltd. for CE Marking? At Shark Certification Pvt. Ltd., we bring deep regulatory expertise and a client-centric approach to guide you through the entire CE Marking process. Whether you're a domestic manufacturer or an international exporter, we support you in: ✅ Identifying applicable EU directives and standards ✅ Conducting gap analysis and risk assessments ✅ Coordinating required product testing ✅ Preparing all technical and regulatory documentation ✅ Liaising with notified bodies, where needed ✅ Achieving full CE compliance and affixing the CE logo Confidently Enter the EU Market with Shark Certification With a team of qualified experts and in-depth knowledge of EU compliance pathways, Shark Certification Pvt. Ltd. ensures that your product meets all legal obligations under CE Marking. Let us help you navigate regulatory complexity and unlock new global market opportunities. 📞 Contact us today for expert CE Certification support tailored to your industry and product type. Shark Certification Pvt. Ltd. provides reliable and expert CE Certification services in Indore, guiding businesses through the process of ensuring their products meet European Union standards. CE Certification is essential for verifying that products meet the safety, health, and environmental requirements set by the EU before being sold within its market. With years of experience in certification, Shark Certification Pvt. Ltd. offers professional advice and support, ensuring that your products comply with all necessary regulations. Their process is straightforward, covering everything from initial product assessment to testing and final certification, with customized solutions tailored to your specific needs. The company prioritizes efficiency, ensuring a swift certification process to help you bring your products to market quickly. Achieving CE Certification not only guarantees compliance but also enhances your product's global credibility. Shark Certification Pvt. Ltd. serves multiple industries such as electronics, machinery, medical devices, and toys, offering continuous assistance to ensure your products remain in compliance. For businesses in Indore looking for dependable CE Certification services, Shark Certification Pvt. Ltd. is the trusted partner to help you meet EU regulations and expand your market reach.

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Apply For USFDA Certification In Indore Looking for comprehensive certification solutions? Shark Certification offers a wide range of services, including FSSC, BRC, HALAL, KOSHER, NGMO, GMP, USFDA, and ORGANIC. Let us guide you through the process. About the U.S. FDA The U.S. Food and Drug Administration (FDA) is a key federal agency under the United States Department of Health and Human Services. As part of the federal executive structure, the FDA plays a vital role in safeguarding public health by regulating a wide range of products including pharmaceuticals, food items, cosmetics, and medical devices. The FDA is responsible for the approval and oversight of: New pharmaceutical products, including biologics Food and feed additives for humans and animals Color additives used in consumables and cosmetics Select categories of medical equipment and devices To ensure that products entering the U.S. market meet stringent quality and safety standards, the FDA also conducts inspections in manufacturing units located outside the U.S., including facilities in India that export drugs and food items to the American market. These inspections are based on Current Good Manufacturing Practices (CGMP) standards set by the agency. Compliance and FDA Inspections During inspections, FDA officials assess the level of compliance with CGMP guidelines. If any deviations or concerns are observed, they are documented in Form 483. This form outlines specific areas of non-compliance and is discussed directly with the management team of the manufacturing facility. Alongside the Form 483, the agency provides an Establishment Inspection Report (EIR), indicating whether any further action is necessary. Companies are expected to respond to the Form 483 within 15 working days. While the response is not legally required, submitting a detailed reply outlining corrective actions is highly recommended to avoid escalation. If the response is inadequate or if violations are severe, the FDA may issue a Warning Letter. In critical cases, enforcement actions such as import alerts, product approval delays, or even revocation of manufacturing licenses can follow. The FDA Approval Process For a drug or high-risk medical device to receive FDA approval, the manufacturer must demonstrate that it is both safe and effective for its intended use. While the FDA itself does not conduct testing, it rigorously reviews the data and clinical trial results submitted by manufacturers. Approval is granted only after a thorough review by a multidisciplinary team of FDA experts—including statisticians, biologists, chemists, and clinicians. Why FDA Compliance Matters for Indian Manufacturers The U.S. remains one of the largest and most lucrative markets for pharmaceutical products. Over the past few decades, Indian pharmaceutical firms have gained a significant presence in the U.S. generics space. To maintain and grow this market share, ongoing compliance with FDA regulations is crucial. Shark Certification Pvt. Ltd. – Your FDA Compliance Partner At Shark Certification Pvt. Ltd., we specialize in helping pharmaceutical and medical device companies navigate the complex regulatory landscape of the U.S. FDA. Our goal is to provide tailored, efficient, and value-driven solutions that reduce compliance risks and enhance operational excellence. Our team comprises seasoned professionals with deep experience in FDA regulations, global quality standards, and risk-based auditing approaches. We support clients from audit readiness to submission preparation—ensuring both compliance and business continuity. Our Core Services CGMP and Pre-Inspection Audits Pre-Approval Inspection (PAI) Preparation Quality Assurance and Control System Development 21 CFR Part 11 & GAMP 5 Compliance & Audit Support IT System Validation and Audit Services Quality Risk Management System Development Process Analytical Technology (PAT) & Quality by Design (QbD) Process Validation and Documentation USFDA Audit Readiness Training Regulatory Submission Support: 510(k), PMA, NDA, ANDA, IND, IDE, DMF, PAS Specialized Expertise Areas End-to-end Quality System Implementation & Gap Analysis Data Integrity & Compliance Audits Vendor and Third-Party Audits Good Clinical Practice (GCP) Audits Risk Assessments and Due Diligence Reviews FDA Form 483 and Warning Letter Responses GMP Compliance for Pharmaceuticals and Medical Devices Partner with Shark Certification Pvt. Ltd. With an unwavering focus on regulatory excellence and global health standards, Shark Certification Pvt. Ltd. is your trusted partner for U.S. FDA compliance. Whether you're preparing for your first inspection or responding to regulatory observations, we provide the guidance, expertise, and support needed to achieve and sustain compliance.

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GMP+ Certification for Feed Industry Ensuring Feed Safety and Quality Across the Supply Chain At Shark Certification Pvt. Ltd., we provide GMP+ certification services for feed manufacturers and supply chain partners. The GMP+ standard is a globally recognized certification system that ensures the safety and quality of animal feed, while helping businesses demonstrate compliance, build customer trust, and access international markets—especially within the European Union. What is GMP+ Certification? GMP+ (pronounced "GMP Plus") is an independent certification standard tailored specifically for the feed industry. Built on the foundation of ISO 9001 and incorporating Hazard Analysis and Critical Control Points (HACCP) principles, GMP+ sets comprehensive requirements for the entire feed production and distribution process. It ensures that all steps—from raw material procurement to final product delivery—are performed under strict quality and safety guidelines. Benefits of GMP+ Certification ✅ Proven Product Safety and Quality ✅ Minimized Risk of Contamination and Non-Conformance ✅ Improved Market Access, Especially in the EU ✅ Stronger Customer Confidence and Brand Image ✅ Competitive Edge in the Global Feed Industry Who Should Get GMP+ Certified? GMP+ certification is suitable for all participants in the feed supply chain, including: Feed and feed additive manufacturers Storage and warehousing providers Feed transport and logistics companies Traders and distributors of feed and raw materials Whether you operate a small-scale plant or a large multinational operation, GMP+ can be adapted to your business size and needs. What Does the GMP+ Standard Include? The GMP+ framework integrates: ISO 9001-based quality management principles HACCP-based risk assessment and control measures Additional sector-specific requirements for feed safety A structure tailored to specific operational roles within the feed chain Certification is divided into several modules, addressing production, transport, storage, trading, and laboratory services in the feed sector. The Certification Process with Shark Certification Pvt. Ltd. Initial Consultation & Quotation – We assess your readiness and provide a tailored proposal Implementation Support – Guidance on aligning processes and documentation with GMP+ requirements Audit & Certification – Formal audit conducted by our experienced assessors Certification Award – Issuance of GMP+ certificate and certification mark Surveillance Audits – Periodic checks to ensure ongoing compliance Recertification – A full review to renew your certification after the cycle ends Cost of GMP+ Certification Certification costs vary depending on your company's size, the scope of certification, and process complexity. We offer customized, no-obligation quotes based on your specific requirements. Reach out to our team for a personalized estimate. Why Choose Shark Certification Pvt. Ltd. for GMP+? ✔ Deep knowledge of global feed and agri-supply chain regulations ✔ Extensive experience conducting feed-related audits ✔ Seamless integration with other quality certifications like ISO 9001 ✔ End-to-end support—from gap analysis to audit readiness ✔ Personal, responsive service with a global reach Ready to Strengthen Your Feed Safety Credentials? Contact Shark Certification Pvt. Ltd. today to explore GMP+ certification for your business. Our team will guide you through every step, helping you meet international feed safety standards and unlock new market opportunities.

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Small Scale and ancillary units (i.e. undertaking with investment in plant and machinery of less than Rs. 10 million) should seek registration with the Director of Industries of the concerned State Government. What Is The Benefit Of Registering With SSI? The registration scheme has no statutory basis. Units would normally get registered to avail some benefits, incentives or support given either by the central or state government. The regime of incentives offered by the centre generally contains the following : Credit prescription (Priority sector lending), differential rates of interest etc Excise Exemption Scheme Exemption under Direct Tax Laws Statutory support such as reservation and the Interest on Delayed Payments Act States/UTs have their own package of facilities and incentives for small scale. They relate to development of industrial estates, tax subsidies, power tariff subsidies, capital investment subsidies and other support. Both the centre and the state, whether under law or otherwise, target their incentives and support packages generally to units registered with them. What Are The Objective Of Registration Scheme Of SSI? They are summarized as follows : To enumerate and maintain a roll of small industries to which the package of incentives and support are targeted. To provide a certificate enabling the units to avail statutory benefits mainly in terms of protection. To serve the purpose of collection of statistics. To create nodal centers at the Centre, State and District levels to promote SSI What Are The Features Of Scheme in SSI? Features Of The Scheme Are As Follows : DIC is the primary registering centre Registration is voluntary and not compulsory Two types of registration are done in all States. First, a provisional registration certificate is given. And after that, commencement of production, a permanent registration certificate is given. PRC is normally valid for 5 years and permanent registration is given in perpetuity. What is Provisional Registration Certificate (PRC)? This is given for the pre-operative period and enables the units to obtain the term loans and working capital from financial institutions/banks under priority sector lending. Obtain facilities for accommodation, land, other approvals etc. Obtain various necessary NOC’s and clearances from regulatory bodies such as Pollution Control Board, Labour Regulations etc. Permanent Registration Certificate Enables The Unit To Get The Following Incentives/Concessions Income-Tax exemption and Sales Tax exemption as per State Govt. Policy Incentives and concessions in power tariff.Price and purchase preference for goods produced Availability of raw material depending on existing policy Permanent registration of tiny units should be renewed after 5 years What is Procedure for Registration of SSI? Features of the present procedures are as follows : A unit can apply for PRC for any item that does not require industrial license which means items listed in Schedule-III and items not listed in Schedule-I or Schedule-II of the licensing exemption notification. Units employing less than 50/100 workers with/without power can apply for registration even for those items that are included in Schedule-II. Unit applies for PRC in prescribed application form. No field enquiry is done and PRC is issued. PRC is valid for five years. If the entrepreneur is unable to set up the unit in this period, he can apply afresh at the end of five years period. Once the unit commences production; it has to apply for permanent registration on the prescribed form. The Following Form Basis Of Evaluation The unit has obtained all necessary clearances whether statutory or administrative. E.g. drug license under drug control order, NOC from Pollution Control Board, if required etc. Unit does not violate any location restrictions in force, at the time of evaluation. Value of plant and machinery is within prescribed limits. Unit is not owned, controlled or subsidiary of any other industrial undertaking as per notification. What Is Requirement For Application Of SSI? Detail Of Application Form As Per Below : Applicant’s name & address Company/Industries name & address Name of products/Item Coast of Machineries

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The SA 8000 certification is the Social Accountability System standard. It is applicable to companies of any size that wish to address the social and ethical aspects of their business. A Social Accountability System proves to customers that the company holds adequate provisions for the protection of workers’ rights. Further, it ensures ethical production of all goods manufactured by the company. SA 8000 certification enables organization’s to demonstrate your commitment to social accountability standards as well as employee and customer satisfaction. SA 8000 is an international certification standard that encourages organization to develop, maintain and apply socially acceptable practices in the workplace. It was created in 1989 by Social Accountability International (SAI), an affiliate of the Council on Economic Priorities, and is viewed as the most globally accepted independent workplace standard. It can be applied to any company, of any size, anywhere in the world. The areas it addresses include forced and child labor, health and safety, freedom of association and collective bargaining, discrimination, disciplinary practices, working hours, compensation and management systems. Along with setting standards for employees worldwide, SA 8000 also embraces existing international agreements, including conventions from the International Labor Organization, the Universal Declaration on Human Rights, and the United Nations Convention on the Rights of the Child. SA 8000 Key Requirements Be senior management led Be focused on continuous improvement Be focused on prevention rather than reaction Be supportive of workers rights and workers participation Be compliant with local laws/codes Be compliant with local laws/codes Be systematic in addressing problems-Car’s Process Benefits of SA 8000 Certification Marketing advantage -more demand and value for goods from socially Responsible manufacturers and suppliers Enhancement of company’s productivity. Compliance to the laws of the land Improvement of relationship with the Govt., NGOs, trade unions Better image and position in labor markets Cost reduction in monitoring Better corporate image Increased value for the products Trust building with the analysts and investors when evaluated against social performance

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With the rising need to save energy, most companies today are putting their maximum efforts to promote better energy consumption. Having the best energy efficiency credentials are a must for your business and also for the promotion of your business too. Having an ISO 50001 certification would mean better savings and also better commitment towards the environment. Because you would be using an energy management system with a quality standard you would be able to reduce wastage within your organization. When you look at this event on a long term basis, you would be saving a lot of money and thus protecting the environment too. We at SHARK make sure that the entire certification process is simple and easy. We understand your existing set up first and figure out the drawbacks when compared to ISO 50001 requirements. This will help your organization understand business areas where you need to focus on more to receive your certification. These changes could be processes and procedures that need to be added to your existing setup for better productivity. This would help you understand the areas to be worked upon before a formal assessment, thus saving you valuable time and money. Once the conduct the formal assessment for ISO 50001 certification, we will share details of our study that will show the areas to develop. If all the requirements are in place, we will assess the different implementations and proceed with the energy management system quality certification. Having such a quality standard for your EMS would mean that your business is managing energy efficiently. It would mean that your greenhouse gas emissions are within the permissible limits and that EMS is working towards meeting environmental targets. Such a certification would prove that your business is a responsible one and keeps energy management as its most important target. With the rising need to save energy, most companies today are putting their maximum efforts to promote better energy consumption. Having the best energy efficiency credentials are a must for your business and also for the promotion of your business too. What is ISO 50001 Certification? It is a quality system model that aims at continuous improvement that is focused towards the energy management of a company. With standards like this, you can be assured to integrate energy management as the top priorities of the company. Once the conduct the formal assessment for ISO 50001 certification, we will share details of our study that will show the areas to develop. If all the requirements are in place, we will assess the different implementations and proceed with the energy management system quality certification. Benefits of ISO 50001 Certification Having such a quality standard for your EMS would mean that your business is managing energy efficiently. It would mean that your greenhouse gas emissions are within the permissible limits and that EMS is working towards meeting environmental standards. Such a certification would prove that your business is a responsible one and keeps energy management as its most important target.

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“License to operate in the International Feeds Sector.” FEED SAFETY CHALLENGE Feed Safety and Quality are key issues for all companies handling feedstuffs and can have serious consequences when control is lost. A systematic approach is imperative for reducing risk and improving quality. Companies seeking to internationalize their business in Europe must be certified to a standard recognized by the GMP+ International (former PDV) organization. The GMP+ certification is also recognized by other feed certification schemes. Knowledge of GMP+ is spreading and the certificate is requested at a continuously greater extent throughout the world. The GMP+ regulations are in a process of continuous development and improvement and changes are relevant to all organizations in the international supply chain. WHAT ARE GMP+ STANDARDS BASED ON? The GMP+ standards have been developed to harmonize requirements for feed in order to ensure quality and safety throughout the entire feed chain. It is based on widely recognized principles of quality assurance, Hazard Analysis Critical Control Point (HACCP). Choosing which standard (B1, B2, etc.) and certification scope (production of feed materials, trade, etc.) depends on the organization’s role in the feed chain. GMP+ B1 is mandatory for the production of compound feed, but can also be used for the production of feed materials and transport. B2 can be used for the production of feed materials and feed additives, while B3 is intended for trade and transshipment. Each of these standards is intended for different means of feed transport (e.g. B4.1 is intended for truck transport). All steps in the supply chain are thus covered by the given requirements. Advantages of GMP+ certification Companies benefit from GMP+ certification, because it: is focused on quality management (ISO 9001) and risk management (HACCP); provides access to supporting information and services, such as risk assessments, fact sheets, storing and sharing your monitoring data, newsletters, Early Warning messages etc); Offers new sales opportunities and to a great degree, ensures the retention of current customers; Guarantees the continuity of business operations, because the corporate structure is set up more efficiently and the costs and financial risks are limited; Helps improve the company image and the reliability; Makes your company part of a globally operating feed safety system (the GMP+ certificate is accepted internationally by about 12000 companies in 66 countries); Is accepted by other (inter)national schemes; Can easily be combined with multiple certifications (feed safety and sustainability); Contributes to uniformity in the feed chain.

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The Global Organic Textile Standard (GOTS) is recognized as the world’s leading processing standard for textiles made from organic fibers. It defines high-level environmental criteria along the entire organic textiles supply chain and requires compliance with social criteria as well. GOTS Version 5.0 The new version of GOTS is a result of a comprehensive stakeholder input process in which various organizations with expertise in organic production, textile processing and social criteria participated. It follows the overall approach of GOTS to define high level verifiable environmental criteria throughout the entire processing chain of apparel and home textiles (including spinning, knitting, weaving, wet processing, manufacturing, and trading) made from a minimum of 70% certified organic fibers and requiring social criteria while still providing for a practical set of requirements that is technically achievable even in large scale industrial textile production and for mass market brands and retailers in order to achieve a considerable environmental and social impact in the textile industry. The implementation deadline for GOTS certified entities to fully comply with Version 5.0 is 1 March 2018. Benefit with GOTS Certification: There are numerous ways in which companies benefit from becoming certified to the Global Organic Textile Standard (GOTS). Below we list the top five reasons how and why becoming certified to GOTS supports a company’s business case for sustainability. RISK REDUCTION GOTS is a comprehensive risk management instrument for your supply chain. GOTS sets strict and extensive environmental and social criteria for the entire supply chain GOTS criteria are explicit CREDIBILITY Third party certification serves as independent external verification versus self-claims Certification includes dual quality assurance – onsite inspection and product testing Certification provides the credibility and verification of claims that investors,ü and the public, expect. EFFICIENCY AND PRODUCTIVITY GOTS’ wastewater management and other requirements result in improved eco-efficiency GOTS’ social compliance management requirements results in improved socio-efficiency GOTS certification facilitates sustainable supply chain management, cutting companies’ costs as they do not need to trace the whole supply chain themselves INNOVATION AND DIFFERENTIATION GOTS certification can grant access to new markets, e.g. public procurement GOTS is explicitly recognized by governments and leading textile, sport, environmental, and organic organizations worldwide Sustainability innovation provides added value over conventional products. SUSTAINABLE MARKET DEVELOPMENT Enables companies to be market drivers. Readies companies for the increasingly stringent regulatory climate. GOTS is recognized as the leading processing standard for textiles made from organic fiber worldwide.

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Promoting organic production standards to meet consumer demand BUSINESS CHALLENGE Increased cases of unsafe food due to over use of chemical fertilizers and chemicals in food production system, has created an increasing worldwide demand for organic food. The challenge facing the organic agriculture industry is to produce foodstuffs and agricultural products using methods, which respect the environment and animal welfare. Globally, these demands are defined by regulations, particularly in those countries, which consume organic products. The principal standards are NPOP standard (India Organic- APEDA), EU Regulation 834/2007 and the US National Organic Program (NOP). To take into account the regulations in place, the certification scheme depends both on the country of production and the country of destination. This certification is aimed at producer organizations or members of food industries who want to commercialize organic products for a particular market. The organic certification considered as a guarantee of quality and safety by the consumers. What is Organic Certification? Organic certification is a nationally and internationally recognized set of standards aimed at proving that agricultural and food products have been produced without the use of synthetic chemical products, while using methods, which respect the environment and animal welfare. Organic requirements involve a set of production specifications for growing, storage, processing, packaging and shipping. All organic assessment and qualification references require control and certification by an accredited independent body. Organic Certification Requirements vary from country to country and generally involve a set of production standards for growing, storage, processing, packaging and shipping that include: avoidance of synthetic chemical inputs (e.g. fertilizer, pesticides, antibiotics, food additives), irradiation, and the use of sewage sludge; avoidance of genetically modified seed; use of farmland that has been free from prohibited chemical inputs for a number of years (often, three or more); for livestock, adhering to specific requirements for feed, housing, and breeding; keeping detailed written production and sales records (audit trail); maintaining strict physical separation of organic products from non-certified products; Undergoing periodic on-site inspections. Certified organic foods are not necessarily pesticide-free, certain pesticides are allowed. What are the key benefits? Demonstrate Organic Standards compliance of products to clients (retailers, traders, importers) Inspire consumer confidence Ensure greater access to existing and target markets Help protect the environment from harmful products and processes Preserve animal welfare WHY CHOOSE SCPL We are working with USOCA that is accredited for certification according to the NPOP, Swiss, European and NOP (USDA) organic production standard. With the NPOP, the client will also get certificate for Swiss and European Organic certification (EU Regulation No. 834/2007), which will make it recognized by all European Union member countries. In order to access the US market, you have to certify your products to the National Organic Program (NOP).

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