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Food Safety Standards

FSSC 22000 v6 Certification Food Safety Compliance Made Easy with Shark Certification Pvt. Ltd., Indore In today’s global food market, food safety is not just a requirement—it’s a responsibility. The FSSC 22000 Version 6 Certification is a globally recognized food safety standard that combines ISO-based systems with specific sector requirements to help organizations ensure food safety across the supply chain. At Shark Certification Pvt. Ltd., we provide expert guidance and end-to-end support to help your business in Indore and across India achieve FSSC 22000 v6 Certification smoothly and efficiently. 🌐 What is FSSC 22000 v6? FSSC 22000 (Food Safety System Certification) is a robust, ISO-based food safety management system recognized by the Global Food Safety Initiative (GFSI). Version 6 brings new and enhanced requirements, focusing on risk management, food fraud prevention, and sustainability. It is applicable to organizations across the entire food supply chain, including: Food manufacturers Animal feed producers Packaging material manufacturers Catering and food service providers Retailers and wholesalers Logistics and transportation companies 🔍 What’s New in FSSC 22000 Version 6? Enhanced focus on food safety culture Updated requirements for equipment management Stronger control of allergens Greater emphasis on environmental monitoring and validation Clearer definitions for food fraud and food defense programs Our team stays up to date with every change in the standard so you don’t have to worry about what’s new—we guide you every step of the way. 🛠️ Our FSSC 22000 v6 Certification Services At Shark Certification Pvt. Ltd., we offer complete support for companies seeking FSSC 22000 certification: ✅ Gap Assessment & Readiness Check We begin with a full review of your current systems and identify areas needing improvement to meet FSSC 22000 v6 requirements. ✅ Implementation Support Our team helps design and implement a food safety management system (FSMS) tailored to your business, ensuring compliance with all key clauses of FSSC 22000 v6. ✅ Internal Audit & Pre-Certification Checks We conduct detailed audits to prepare your team for the final certification. This includes food defense, food fraud, traceability, risk control, and GMP reviews. ✅ Training for Staff & Management Customized training programs are provided to improve awareness and ensure team readiness—from floor workers to top management. ✅ Support During Certification Audit We assist in coordinating with certification bodies, handling documentation, and providing on-site support during your audit. 🎯 Why Choose Shark Certification Pvt. Ltd. in Indore? 🏢 Local presence, global reach – Based in Indore, we support clients throughout India 👨‍💼 Experienced consultants & auditors – Deep knowledge of FSSC, ISO, and GFSI frameworks 🧩 Custom solutions – Whether you’re a small processor or a large manufacturer, we tailor our approach to your business 💼 End-to-end service – From documentation to audit closure 💡 Up-to-date with Version 6 – Fully aligned with the latest version of FSSC 22000 standard 📞 Let’s Get Started Today! Become FSSC 22000 v6 certified with confidence and unlock global opportunities in food production and export.

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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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Food Safety Standards

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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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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