ProTerra Certification

Promoting Sustainable, Traceable, and Non-GMO Agriculture with ProTerra Certification By Shark Certification Pvt. Ltd., Indore At Shark Certification Pvt. Ltd., we are proud to offer ProTerra Certification, a globally respected standard for sustainable, non-GMO agriculture and food systems. Designed to ensure transparency, traceability, and ethical practices across the entire supply chain, ProTerra Certification helps organizations demonstrate their commitment to responsible production and environmental stewardship. What is ProTerra Certification? ProTerra is a comprehensive sustainability standard focused on promoting responsible agricultural practices, protection of natural resources, and the exclusion of genetically modified organisms (GMOs). It supports traceability and accountability at every stage—from farms to processing facilities and trading entities—helping companies meet growing consumer and regulatory demands for sustainability. Three Levels of Certification Offered Depending on your role in the supply chain, Shark Certification Pvt. Ltd. can assist with the appropriate level of certification: Level I – Agricultural Production: For farms and growers, this includes the entire production area, encompassing both cultivated and non-cultivated zones. Level II – Storage, Transport & Trading: Focused on ensuring traceability and GMO-free integrity during handling and distribution of goods. Level III – Industrial Processing: Tailored for facilities involved in processing, manufacturing, or transforming raw agricultural products. Industries and Products Covered ProTerra Certification applies across a wide range of sectors such as agriculture, floriculture, horticulture, food processing, retail, and transport. Eligible products include but are not limited to: Soy, maize, rice, sugarcane, sunflower, rapeseed Fruits, vegetables, nuts, spices, and tea Bananas, coconut, palm oil, flowers, and plants Why Choose Shark Certification Pvt. Ltd.? Located in Indore, Shark Certification Pvt. Ltd. is your trusted partner for achieving ProTerra Certification. We combine industry expertise, global standards, and local knowledge to deliver reliable, timely, and cost-effective certification services. Our auditors are trained to work across multiple sustainability frameworks, allowing clients to bundle ProTerra Certification with complementary programs such as: Bonsucro ISCC Plus & ISCC EU RSPO Food Safety & Non-GMO Labeling Programs Key Benefits of ProTerra Certification Market Advantage: Meet rising global demand for sustainably sourced, GMO-free products. Brand Credibility: Enhance trust and reputation with independent third-party verification. Supply Chain Transparency: Ensure full traceability from farm to final product. Environmental Responsibility: Contribute to biodiversity conservation and climate action. Corporate Social Responsibility: Show commitment to fair labor practices and community welfare. Join the Global Movement for Sustainable Agriculture At Shark Certification Pvt. Ltd., we’re committed to helping producers, processors, and traders align with global best practices through ProTerra Certification. With rising awareness around the environmental and social impact of food systems, now is the time to showcase your dedication to a better future.

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Medical / Pharma Standards

USFDA Certification

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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NABL Certification

What are the aims and objectives of NABL…? National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide government, industry and society in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for testing and calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC 17025. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence. What Is Laboratory Accreditation? The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the government in reducing trade barriers and providing greater thrust to exports that makes it imperative for accredited laboratories to be at international level of competence. What Are Benefits Of Accreditation? Potential increase in business due to enhanced customer confidence and satisfaction. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. Increase of confidence in Testing / Calibration data and personnel performing work. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory of accredited laboratories. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories. What types of laboratories can seek accreditation…? The laboratories should be legally identifiable & appropriately registered. They can be a part of a big organization or an independent entity. NABL can provide accreditation to: Laboratories undertaking any sort of testing or calibration in the specified fields, private or government laboratories, small operations to large multi-field laboratories, site facilities, temporary field operations and mobile laboratories.

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SSI Registration

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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Food Safety Standards

Ayush Certification

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS Introduction The Ayush products are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India through the State Governments. The Department of AYUSH has been exploring the possibility of introducing a voluntary product certification scheme for selected AYUSH products to enhance consumer confidence. The matter was discussed in a series of meetings taken by the Secretary (AYUSH) beginning 24 Dec 2008 and the Quality Council of India (QCI) offered to develop a concept paper on the subject. On approval of the concept, the Department of AYUSH signed an agreement with the QCI on 27 July 2009 to design the Scheme with Department of AYUSH being the Scheme owner and QCI being responsible for managing the Scheme. The draft Scheme was given to the Department of AYUSH on 3 Aug 2009 and Simultaneously placed on the websites of Department of AYUSH and QCI for public consultation. The Scheme will be overseen by a Multi stakeholder Steering Committee (MSC) chaired by the Secretary (AYUSH) with secretariat in QCI. The MSC will be supported by a Technical Committee and a Certification Committee constituted by QCI. The Scheme is based on a criteria for certification. It has two levels: Ayush Standard Mark which is based on compliance to the domestic regulatory requirements Ayush Premium Mark which is based on GMP requirements based on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria. Under this scheme, each manufacturing unit would obtain a certification from a approved certification body (CB) which is accredited to appropriate international standards by the National Accreditation Board For Certification Bodies (NABCB) and will be under regular surveillance of the certification body.

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Organic Standards

The Global Organic Textile Standard (GOTS)

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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QMS & EHS Standards

ISO 9001:2015 QMS Certification

The International Standards specify requirements for quality management systems where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and aim to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. The ISO 9001 certification defines good management practices and aims at providing a global standard that spells out quality and trust. A Quality management system can be used by an company in any industry. Since the standard is neither industry- nor product-specific, it may be used by any organization that provides a product or service. The ISO 9001 standard enable company to develop a Quality Management System (QMS) to meet customer quality requirements while progressively improving operational processes. It provides company with a set of principles that ensure a common sense approach to the management of your business activities to consistently achieve customer satisfaction. What is quality management system? It is the much desired framework that is needed to monitor and improve performance in any specialized area of your business. It could improve the way your business operates or it could help you bring down your operating costs. Benefits of quality management system Higher levels of efficiency: With the ISO 9001 Certification, you can be assured of better performances within the company. Your employees would be working towards a common goal and this would increase the performance of each department. Better belief in the company: Employees always want to work with the best quality standards in place. Better brand image: having the right brand image is an important part of every business. Having a QMS implemented would lead to a good brand image within the industry, clientele and your competitors. Why ISO 9001:2015 certification? ISO 9001:2015 is a standard that sets out the requirements for a quality management system. It helps businesses and organizations to be more efficient and improve customer satisfaction. This is generic standard can be deployed across all industries. ISO 9001:2015 now follows the same overall structure as other ISO management system standards (known as the High-Level Structure), making it easier integrate multiple management systems. Another major difference is the focus on risk-based thinking; the new version gives it increased prominence. ISO 9001:2015 brings a number of benefits ISO 9001:2015 puts greater emphasis on leadership engagement Helps address organizational risks and opportunities in a structured manner Uses simplified language and a common structure and terms, which are particularly helpful to organizations using multiple management systems, such as those for the environment, health & safety, or business continuity Addresses supply chain management more effectively Is more user-friendly for service and knowledge-based organizations Advantages: Greater Assurance of meeting objectives as risk based thinking applied all across in the organization. Integration of QMS into business processes, as accountability of QMS lies with top management. Clear strategic direction of an organization as context of the organization is part of QMS. Promotion of leadership across organization. More reliable Product/Services as risk based approach is used for more effective and efficient service/product provision processes Customer satisfaction – through delivery of products that consistently meet customer requirements More Specific Benefits Reduces cost Improves product reliability Better process control and flow Better documentation of the processes Greater employee quality awareness Increased Productivity Certification Procedure The Certification Procedure is a multiple-step process. The certification cycle is described briefly: Applying for Certification (Turnkey Project) Consultancy/ Documentation & System Development as per Standard Pre audit (optional) Certification audit – (Stage 1 + Stage 2) Issue of certificate on successful completion of certification audit Surveillance audits at defined period Recertification audit after 3 years