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

BRC Certification

The BRC Global Standard is for Food Safety. This certification many times becomes necessary for doing business with UK and many European retailers and other global retailers. This food quality standard focuses on HACCP ( Hazard analysis critical control point), food safety management system, competence of personnel performing various processes that has effect on food quality and various controls on processes, raw materials, infrastructure and work environment, This standard is most applicable to manufacturers of food contact packaging for retailers labeled products and branded products as well. Manufacturers have an obligation to put appropriate systems and controls in place to ensure the suitability of their packaging for safe food use. The BRC and IOP (Institute of Packaging) have developed this standard to assist retailers and food manufacturers in the fulfillment of their legal obligations. This Standard will help in the protection of the consumer by providing a common basis for the audit of companies supplying packaging for food products to retailers. We provide BRC certification for food, consumer products, packaging and storage & distribution suppliers. The standard has been adopted by food manufacturers throughout the world, especially by those organizations supplying British retailers. Third-party certification to the standard helps manufacturers, brand owners and retailers fulfill their legal obligations and safeguard consumers. The standard covers a comprehensive scope of product safety areas, as well as the legal and due diligence responsibilities of both the supplier and the retailer. Benefits Of BRC Registration Customers, employees, stockholders and competitors develop sustainable respect for an organization which demonstrates its commitment to food safety and/or packaging regulations Operating costs drop as rework reduces, efficiencies increase and non-compliance penalties reduce Improved credentials to supply retailers An enhanced food safety and food safety management system A demonstrable commitment to producing safe food. Increased customer confidence in your product’s safety and quality.

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Food Safety Standards

GMP+ Feed Safety Standards

“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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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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QMS & EHS Standards

ISO 9001, ISO 14001, or ISO 45001 certification

Get ISO Certified with Shark Certification Pvt. Ltd. – Indore’s Trusted ISO Consultants Shark Certification Pvt. Ltd. is a leading ISO consultancy firm based in Indore, offering end-to-end support to organizations looking to implement internationally recognized management systems and obtain ISO certifications. With an expert team and a client-focused approach, we simplify the certification journey for businesses of all sizes. We specialize in providing consultancy services for the following key ISO standards: ✅ ISO 9001:2015 – Quality Management System (QMS) ISO 9001 is the world’s most recognized quality management system standard. It provides a framework for businesses to ensure consistent product and service quality, enhance customer satisfaction, and continuously improve operations. Benefits of ISO 9001 Certification: Improved customer satisfaction and loyalty Streamlined operations and enhanced internal processes Increased marketability and credibility Better decision-making based on data and performance insights Stronger focus on risk management and continual improvement Our Services Include: Gap analysis and QMS implementation support Internal audits and training Preparation for third-party audits Complete documentation and process alignment Assistance in maintaining and renewing certification ✅ ISO 14001:2015 – Environmental Management System (EMS) ISO 14001 helps organizations manage their environmental responsibilities efficiently. It enables companies to reduce environmental impact, comply with regulations, and demonstrate a commitment to sustainability. Benefits of ISO 14001 Certification: Reduction in waste and resource consumption Compliance with environmental laws and regulations Enhanced environmental performance and reputation Improved stakeholder and public trust Identification of environmental risks and opportunities Our Services Include: Environmental impact assessment and EMS setup Compliance analysis and legal requirement mapping Documentation and procedural implementation Internal audits and corrective action guidance Audit preparation and certification support ✅ ISO 45001:2018 – Occupational Health & Safety Management System (OHSMS) ISO 45001 is an international standard that focuses on reducing occupational injuries and diseases. It helps businesses create a safe and healthy workplace for employees, contractors, and visitors. Benefits of ISO 45001 Certification: Enhanced employee safety and workplace morale Reduction in accidents, incidents, and legal liabilities Compliance with national and international safety regulations Cost savings through fewer disruptions and improved productivity A proactive approach to risk prevention and hazard control Our Services Include: Health & Safety risk assessments OHSMS framework development and policy creation Staff training and safety awareness programs Internal safety audits and compliance reviews Support through the certification and surveillance process Why Choose Shark Certification Pvt. Ltd. in Indore? Expert ISO Consultants with industry-specific knowledge Tailored solutions based on your organization’s size and operations Transparent process with end-to-end documentation support Affordable pricing and fast-track certification Ongoing support for audit preparation, renewals, and training Trusted by 1000+ organizations across sectors Let’s Get Started! If you're ready to elevate your business through ISO 9001, ISO 14001, or ISO 45001 certification, partner with Shark Certification Pvt. Ltd. – Indore’s trusted name in ISO consultancy.

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Social Accountability & Sustanibility

FSC Certification

FSC Certification in Indore Your Trusted Partner – Shark Certification Pvt. Ltd., Indore With increasing global demand for environmentally responsible products, FSC® (Forest Stewardship Council®) Certification has become a critical requirement for businesses engaged in the wood, paper, packaging, printing, and furniture industries. At Shark Certification Pvt. Ltd., we provide expert consulting and end-to-end support for obtaining FSC and PEFC certifications across India. What is FSC Certification? FSC Certification ensures that products sourced from forests—such as timber, paper, and packaging—are obtained responsibly and sustainably, with due consideration for the environment, communities, and economies. Businesses certified under FSC are allowed to use FSC labels, providing assurance to consumers and buyers that their products meet global sustainability standards. Why is FSC Certification Important in India? India’s growing export markets, especially in packaging, furniture, handicrafts, pulp & paper, and print, increasingly demand FSC-certified products. Global buyers now require FSC-labeled goods like corrugated boxes, paper bags, hang tags, and other wood-based materials. While large Indian companies have paved the way, now SMEs are also realizing the value of FSC certification to expand their global reach and credibility. Types of FSC Certificates The type of FSC certification you need depends on your role in the supply chain: FSC Forest Management (FM) – For forest owners and managers to demonstrate responsible forestry practices FSC Chain of Custody (CoC) – For manufacturers, traders, and processors ensuring traceability from forest to final product FSC Controlled Wood – For companies that mix FSC and non-certified wood, verifying the non-certified portion meets FSC’s risk mitigation requirements FSC Labels You Can Use Once certified, your business may use one of the following FSC labels based on sourcing and production: FSC 100% – Made entirely from FSC-certified forests FSC Mix / FSC Mix % / FSC Credit – Blend of FSC-certified and controlled sources FSC Recycled – Made from reclaimed materials Challenges in the Indian Market – and How We Help Despite the rising demand, several challenges remain in the Indian ecosystem: Limited FSC Certified Forests: Most FSC-certified timber is imported due to low domestic coverage under Forest Management certification Few FSC Certified Traders: While manufacturers and mills may be certified, FSC-certified traders and distributors are still scarce Gaps in Awareness: Many SMEs are unaware of the process, cost, or benefits of certification Shark Certification Pvt. Ltd. bridges this gap by providing: Complete certification roadmaps and training Help with locating FSC-certified suppliers and materials Pre-audit assessments and documentation support Ongoing consultation to maintain compliance and renewals FAQs: Your FSC Questions Answered Do I need FSC certification if my supplier is certified? ✅ Yes. If you wish to sell your products as FSC-certified, your company must also be certified—even if you use FSC-certified raw materials. How do I get FSC certified? ✅ The process begins with identifying the applicable FSC certificate type. Then, an accredited FSC Certification Body conducts an audit of your operations. On successful completion, you’re issued an FSC certificate and added to the global FSC database. How much does it cost? ✅ Cost depends on company size, scope, and audit complexity. We offer transparent pricing and affordable options tailored for MSMEs and larger organizations alike. Why Choose Shark Certification Pvt. Ltd.? ✅ Located in Indore, serving pan-India clients ✅ Expertise in FSC, PEFC, and other sustainability certifications ✅ Fast, efficient turnaround with practical guidance ✅ Support in finding FSC-certified materials and vendors ✅ Personalized, end-to-end support—from readiness to certification and beyond Get FSC Certified with Confidence If you’re looking to unlock export potential, win global clients, or contribute to sustainable practices, FSC certification is the way forward. Let Shark Certification Pvt. Ltd. guide you with clarity, speed, and reliability.

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Product Certification

CE Certification

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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Social Accountability & Sustanibility

ECO VADIS Certification

Strengthen Your Sustainability Profile with Ecovadis Certification By Shark Certification Pvt. Ltd., Indore In today’s global marketplace, sustainability isn’t just a buzzword—it’s a business imperative. At Shark Certification Pvt. Ltd., we help organizations across industries demonstrate their commitment to ethical, environmental, and socially responsible practices through Ecovadis Certification Assessment Support. What is Ecovadis Certification? Ecovadis is the world’s leading platform for evaluating and sharing sustainability performance in business-to-business supply chains. It provides a comprehensive assessment of a company’s environmental, social, and governance (ESG) performance through a cloud-based platform, enabling businesses to benchmark their practices and show measurable improvements. The Ecovadis evaluation focuses on four key pillars: Environment Labor & Human Rights Ethics Sustainable Procurement Each company is rated based on its policies, practices, and results, with scores reflecting compliance with major global sustainability frameworks like the UN Global Compact, ILO Conventions, and the Global Reporting Initiative (GRI). Why Ecovadis Certification Matters Ecovadis is increasingly becoming a standard requirement for doing business with global clients and supply chains that prioritize sustainability. It helps companies: Showcase their commitment to responsible business practices Build trust with stakeholders and customers Attract sustainability-conscious investors and partners Identify and close gaps in current ESG strategies Improve supply chain transparency and accountability With a scorecard system that ranges from 0 to 100, the assessment not only highlights performance but also points toward areas for improvement and long-term growth. Our Ecovadis Certification Support Services Shark Certification Pvt. Ltd. provides end-to-end consulting and support to help your business prepare for and succeed in the Ecovadis assessment. Our services include: Gap Analysis – Review of current systems and processes against Ecovadis requirements Documentation Guidance – Help in preparing or refining policies, procedures, and records Training & Awareness – Workshops for your internal teams on sustainability expectations Submission Support – Hands-on help with uploading data and responding to assessment questions Improvement Roadmap – Post-assessment strategy for scoring higher and driving progress Whether you're applying for the first time or working to improve your previous rating, we tailor our services to fit your business size, structure, and sector. Why Partner with Shark Certification Pvt. Ltd.? Based in Indore, we bring deep expertise in sustainability certifications and a client-focused approach to every engagement. Our team understands the nuances of global sustainability standards and how to align your business practices with Ecovadis’ expectations. With our support, you’ll be able to strengthen your ESG profile, build stakeholder trust, and stay competitive in a fast-evolving marketplace. Take the Next Step Toward Sustainable Business Success As global supply chains prioritize ethical sourcing and sustainability, Ecovadis Certification is more than just a rating—it’s your company’s credibility in action. Let Shark Certification Pvt. Ltd. guide you through the process with clarity and confidence. Get in touch today to learn how we can support your Ecovadis certification journey and help your business lead with responsibility and integrity.

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Food Safety Standards

GMP WHO Certification

We provide consultancy service for GMP WHO certification to our clients. GMP (Good Manufacturing Practices) is a standard defined by WHO (World Health Organization). GMP WHO certification ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. W.H.O. defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization”. GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures taken; full traceability of a product through batch processing records and distribution records; and systems for recall and investigation of complaints. The guiding principle of GMP is that quality is built into a product, and not just tested into a finished product. Therefore, the assurance is that the product not only meets the final specifications, but that it has been made by the same procedures under the same conditions each and every time it is made. There are many ways this is controlled – controlling the quality of the facility and its systems, controlling the quality of the starting materials, controlling the quality of production at all stages, controlling the quality of the testing of the product, controlling the identity of materials by adequate labeling and segregation, controlling the quality of materials and product by adequate storage, etc. All of these controls must follow prescribed, formal, approved procedures, written as protocols, SOPs, or Master Formulae, describing all the tasks carried out in an entire manufacturing and control process. GMP covers all aspects of the manufacturing process including : Defined manufacturing process Validated critical manufacturing steps Suitable premises, storage, transport, qualified and trained production and quality control personnel Adequate laboratory facilities Approved written procedures and instructions Records to show all steps of defined procedures have been taken Full traceability of a product through batch records and distribution records Systems for recall and investigation of complaints