Organic Certification

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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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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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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Food Safety Standards

Kosher certification

Go Kosher with Shark Certification Pvt. Ltd. – Indore Expand Your Market. Build Consumer Trust. Ensure Global Compliance. In today’s highly competitive and quality-conscious food market, Kosher Certification is not just about meeting religious dietary laws—it's a strategic business move. At Shark Certification Pvt. Ltd., Indore, we help businesses unlock new market potential by providing authentic, efficient, and recognized Kosher certification services. Why Kosher Certification Matters Kosher-certified products are trusted for their purity, quality, and adherence to strict food safety and preparation standards. In fact, many consumers—regardless of religious affiliation—actively seek out Kosher-labeled goods due to their perceived safety and cleanliness. Over $150 billion in Kosher-certified products are consumed annually Nearly 70% of supermarket shelves in the U.S. feature Kosher-certified items Major brands, from snacks to beverages, rely on Kosher compliance to enter and dominate new markets Why Choose Shark Kosher Certification Pvt. Ltd.? Trusted Certification Partner Since 1997 Expert Consultation and End-to-End Certification Support Streamlined, Transparent, and Cost-Effective Process Compliant with International Kosher Guidelines Support for all food categories: meat, dairy, and pareve Customized solutions for small businesses and large-scale manufacturers Whether you’re in the food processing, poultry, meat, fishery, or beverage industry, Kosher certification offers a clear path to growth. Benefits of Kosher Certification with Shark Certification Access to global export markets Greater consumer trust and brand value Increased shelf space and retailer preference Clear quality assurance recognized worldwide Compliance with international food safety and labeling regulations Who Can Get Certified? Kosher Certification is ideal for businesses involved in: Food manufacturing and processing Meat and poultry production Fish and seafood industries Dairy and beverage processing Packaged goods and ready-to-eat meals Our Process at a Glance Initial Consultation & Eligibility Check Application Review & Documentation Support On-Site Audit and Facility Evaluation Final Certification & Ongoing Support Ready to Get Started? Join the growing number of companies achieving Kosher Certification and expanding their reach with confidence. Shark Certification Pvt. Ltd., Indore is here to guide you through every step of the journey.

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Food Safety Standards

GMP+ Certification

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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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.