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Food Safety Standards

Ensure Transparency and Trust with Non-GMO Certification Offered by Shark Certification Pvt. Ltd., Indore As global consumers grow increasingly conscious about the origins of their food and feed, demonstrating that your products are free from genetically modified organisms (GMOs) has never been more important. At Shark Certification Pvt. Ltd., we help businesses build consumer confidence through Non-GMO Supply Chain Certification that verifies every step of production meets stringent non-GMO standards. What is Non-GMO Certification? Our Non-GMO Supply Chain Standard ensures that your product—whether it's a single ingredient or a fully processed food item—is traceable and compliant from seed to shelf. Certification is based on key EU regulations, including Directive 2001/18/EC, and Regulations 1829/2003 & 1830/2003, providing a robust foundation for global market access. This certification applies to: Seed Providers and Farmers Traders and Processors Storage and Transport Providers Sampling and Testing Laboratories We conduct independent audits of your quality management systems, focusing on GMO traceability, legal compliance, and proper labelling practices throughout the entire supply chain. Certified organizations are subject to annual surveillance audits to maintain ongoing compliance and market credibility. Key Areas Covered Under the Standard Seed selection and GMO-free verification Crop cultivation, harvest, and post-harvest handling Transportation and warehousing procedures Processing and packaging operations Sampling, testing, and analytical methods Final product labelling and legal compliance This certification is ideal for companies aiming to demonstrate full transparency, reduce risk, and meet consumer expectations in the non-GMO food and feed markets. Protect Ecosystems with Non-Biome Supply Chain Certification In response to increasing concern over deforestation and biodiversity loss—particularly in sensitive regions like the Brazilian Amazon Biome—Shark Certification Pvt. Ltd. also offers Non-Biome Supply Chain Certification for organizations sourcing soybeans from Brazil. Since 2006, a collective agreement has prevented the trade of soybeans grown in the Amazon Biome, helping curb illegal land conversion and environmental degradation. Our certification verifies that your soy products are sourced exclusively from areas outside the protected biome, in line with this long-standing agreement. Benefits of Non-Biome Certification Ensure soy sourcing aligns with global sustainability efforts Reduce environmental impact associated with deforestation Strengthen your brand’s environmental responsibility Maintain traceability and accountability in sourcing Meet buyer and stakeholder demands for eco-conscious sourcing Like our other services, this certification does not replace compliance with national or international regulations, but it does enhance your market reputation by demonstrating responsible sourcing practices. Why Choose Shark Certification Pvt. Ltd.? Located in the heart of Indore, Shark Certification Pvt. Ltd. is a trusted partner for businesses seeking credible, third-party verification in the areas of sustainable agriculture, food safety, and supply chain integrity. Our team of experienced auditors and compliance experts are here to guide you through every step of the Non-GMO or Non-Biome certification process, ensuring a smooth, efficient, and transparent experience. Certify Non-GMO Products with Confidence If you're ready to showcase your commitment to safe, traceable, and environmentally responsible products, Shark Certification Pvt. Ltd. is here to help. Whether you're a farmer, food processor, trader, or logistics provider—we provide end-to-end certification solutions tailored to your role in the supply chain. Contact us today to begin your certification journey and strengthen your position in the sustainable and non-GMO marketplace.

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Medical / Pharma Standards

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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Product Certification

‘Agmark’ is a Quality Certification Mark of the Government of India given to products confirming to scientifically laid down quality standards. Products commonly certified under AGMARK Honey Ghee, Butter Chillies, Turmeric, Curry powder, Garam Masalas, Cardamom, Cumin, Coriander and other curry powders. Vegetable Oils Spices Wheat, Atta, Maida, Suji, Besan, Pulses and many more items required by customers. Certificate of Authorization It is given to the packers authorizing them to grade their Commodity under AGMARK. Period of Validity will be 5 years. For granting new certificate of authorization separate application for each commodity should be produced. Documents to be given along with application Sketch of the premises:- Declaration regarding Proprietorship/Partnership etc Ownership of the premises Ownership of trade brand label Use of good grade quality containers for packing commodities. All declarations has to given in five rupees stamp label attested by notary public. A copy of licence from Panchayat/Municipality. Bank reference:- Letter from the bank regarding the transaction to the packer with the bank List of machineries. Specimen signature of authorised persons attested by the proprietor / managing partner. Medical fitness certificate of employee. Specimen copy and sketch of trade brand label

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QMS & EHS Standards

Testing & Calibration Laboratories Quality Management System Consultancy ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. ISO/IEC 17025 : 2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025 : 2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply. ISO/IEC 17025 : 2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025 : 2005 is not intended to be used as the basis for certification of laboratories. Compliance with regulatory and safety requirements on the operation of laboratories is not covered by ISO/IEC 17025 : 2005.

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QMS & EHS Standards

Learning services for non-formal education and training – Basic requirements for service providers The objective of this International Standard is to provide a generic model for quality professional practice and performance, and a common reference for learning service providers (LSPs) and their clients in the design, development and delivery of non-formal education, training and development. This International Standard uses the term “learning services” rather than “training” in order to encourage a focus on the learner and the results of the process, and to emphasize the full range of options available for delivering learning services. This International Standard focuses on the competency of LSPs. It is intended to assist organizations and individuals to select an LSP who will meet the organization’s needs and expectations for competency and capability development and can be used to certify LSPs. ISO 29990:2010 is an International Standard for providers of training and further training. It offers a certifiable and state of the art Standard according to ISO requirements for Management Systems. The Standard addresses – for the first time with international validity – all types of educational institutions. This includes single trainers, private seminar providers, organizations providing further training with courses, curricula and internal training as well as further training up to higher educational institutions and universities. The Standard has some congruent features with other management systems, above all with ISO 9001 .ISO 29990 is basically subdivided into two areas: learning services (for example, these services include designing, providing and monitoring of learning services) and management at the learning service provider for example business planning, financial management, risk management as well as human resources management. This Standard is the first Standard for learning providers that is valid and applied on an international scale. The advantages for learning providers are transparency of their own services, international comparability and defined processes for quality assurance. BENEFITS of ISO 29990:2010 Advantages for Learning Service Providers:- Outstanding performance during tendering work from official bodies. Globally marketability. Enhancement in internal quality potential. Transparently defined & documented processes. Enthusiastic and active trained experts participation in the development. Work on (PDCA) Cycle. Advantages for Learner:- Adequate resources, including trainers with suitable competence, infrastructure and learning environment. Evaluating criteria for Education. Advanced & Authentic processes. Transparency/comparability of services. Assuring quality, transparency and comparability in educational institutions. Benefits for Global Cooperation Base of development for international cooperation in the area of education and training Globally comparable benchmarks for existence of quality. No deformation of the globally competitive market. Common unified standards/common understanding of quality

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