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Promoting Responsible Soy Cultivation with RTRS Certification By Shark Certification Pvt. Ltd., Indore At Shark Certification Pvt. Ltd., we are committed to advancing responsible agricultural practices through globally recognized certifications. Our RTRS (Round Table on Responsible Soy) Certification services are designed to support soy and corn producers, processors, and supply chain partners in aligning with sustainable and ethical production standards. What is RTRS Certification? The RTRS Certification is an international standard promoting environmentally sound, socially responsible, and economically viable soy production. It is a voluntary initiative that brings together stakeholders from across the soy and corn value chains to ensure sustainability, respect for local communities, and protection of ecosystems. RTRS also meets the sustainability criteria of the European Renewable Energy Directive, adding further value for companies operating globally. Key Objectives of RTRS Encourage sustainable and responsible soy production and trade practices Support inclusive decision-making through stakeholder engagement Promote biodiversity conservation and environmental protection Uphold labor rights and respect for local land ownership Ensure economic viability and positive impact on local communities Benefits of RTRS Certification for Your Business Strengthened Supply Chain Credibility: Show your stakeholders that your soy products come from responsible and traceable sources Access to Global Markets: Align with international sustainability standards and meet the expectations of environmentally conscious consumers Support for Sustainable Development: Help reduce deforestation and encourage economic growth in soy-producing regions Compliance with International Regulations: Meet the sustainability criteria of key regulatory frameworks such as the EU Renewable Energy Directive RTRS Production Standard Highlights The RTRS Production Standard covers a wide range of criteria to ensure ethical and sustainable soy cultivation. Key focus areas include: Protection of biodiversity and high conservation value areas Soil health and responsible pesticide use Water management and preservation Fair treatment of workers and respect for indigenous communities Responsible land use and legal land ownership Improvement of local infrastructure and community well-being Who Can Get Certified? RTRS Certification is open to: Small and large-scale soy producers Processing and trading companies in the soy supply chain Organizations using soy in food, feed, and biofuel products Smaller producers can benefit from group certification models, which make the process more cost-effective and accessible. How to Become RTRS Certified with Shark Certification Pvt. Ltd. Shark Certification Pvt. Ltd. offers end-to-end support for RTRS certification, from preparation to final audit. The process includes: Initial Consultation – Understanding your business needs and identifying the applicable RTRS standards Pre-Audit Readiness Check – Helping your team align documentation and practices with RTRS criteria Stakeholder Consultation – A two-week public consultation phase before the main audit On-Site Audit – Conducted by our trained and accredited auditors Certification Decision – Based on full compliance with RTRS standards Why Choose Shark Certification Pvt. Ltd.? Based in Indore, Shark Certification Pvt. Ltd. brings a strong reputation for transparent, credible, and globally aligned certification services. With deep industry knowledge and experience in sustainable agriculture, we are the right partner to guide your organization toward RTRS compliance. Our expert auditors are trained in various sustainability frameworks, making it easy for you to combine RTRS with other certifications such as: ProTerra Certification ISCC PLUS & EU Bonsucro & RSPO Food Safety & Non-GMO Compliance Programs Take the Lead in Sustainable Soy Production Becoming RTRS certified is more than a certification—it's a commitment to a better future for the planet and its people. Whether you're a producer, processor, or trader, Shark Certification Pvt. Ltd. is here to help you demonstrate your values, build consumer trust, and meet global sustainability expectations. Reach out today to start your RTRS certification journey with Shark Certification Pvt. Ltd., your trusted sustainability partner in Indore.

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.

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.

Empowering Ethical Business Practices with SEDEX SMETA Audit By Shark Certification Pvt. Ltd., Indore In today’s global marketplace, ethical sourcing and transparent business practices have become key differentiators. At Shark Certification Pvt. Ltd., we help organizations align with internationally recognized ethical standards through guidance and support for SEDEX SMETA (Sedex Members Ethical Trade Audit). Understanding SEDEX and SMETA It’s important to clarify that SEDEX (Supplier Ethical Data Exchange) is not a certification body, and there is no official “SEDEX certification.” Instead, SEDEX provides a collaborative platform where businesses can manage and share data related to ethical performance across global supply chains. The SMETA audit methodology, developed by the SEDEX membership, is a recognized audit protocol designed to evaluate ethical business practices in four key areas: Labour Standards Health & Safety Environmental Management Business Ethics SMETA allows companies to undergo a single audit and share the results with multiple customers, reducing the need for repeated assessments and saving time and resources. Benefits of SMETA Audit Participation By conducting a SMETA audit and becoming a member of SEDEX, your organization can: Demonstrate compliance with ethical and social standards Meet legal, regulatory, and contractual obligations Boost supplier credibility and win customer trust Enhance access to global markets and export opportunities Increase productivity through improved working conditions Mitigate risks using SEDEX’s risk assessment tools Reduce audit fatigue by sharing reports with multiple clients Whether your customer is requesting an audit or you're proactively building a more transparent supply chain, SMETA adds measurable value to your business operations. SMETA Audit Types: 2-Pillar vs 4-Pillar There are two types of SMETA audits: 2-Pillar Audit: Covers Labour Standards and Health & Safety 4-Pillar Audit: Includes the 2-pillar components, plus Environmental Practices and Business Ethics The type of audit depends on customer requirements and the nature of your business. SMETA Audit Process with Shark Certification Pvt. Ltd. At Shark Certification Pvt. Ltd. in Indore, we provide comprehensive consulting and audit preparedness services for SMETA audits. Our step-by-step approach ensures a smooth and efficient process: Gap Analysis – Evaluation of current systems against SMETA criteria Documentation Review – Guidance on policies, procedures, and legal compliance Employee Training – Sessions to raise awareness across the workforce Mock Audit – Simulated audit to identify potential non-conformities Remedial Action Plan – Assistance in closing any gaps or findings Audit Coordination – Liaison with SEDEX-approved auditors and platform support Ongoing Compliance Support – Post-audit improvements and re-evaluation assistance Why Choose Shark Certification Pvt. Ltd.? ✅ Located in Indore, serving businesses across India ✅ Experienced consultants well-versed in SEDEX SMETA protocols ✅ Personalized services tailored to your business needs ✅ Transparent and reliable support throughout the audit lifecycle ✅ Cost-effective solutions for both SMEs and large-scale manufacturers ✅ Training and tools to help maintain long-term compliance Get Started with SEDEX SMETA Today If your customers are requesting ethical trade assessments or you're ready to elevate your sustainability credentials, let Shark Certification Pvt. Ltd. guide your journey. We ensure that your business not only meets SEDEX expectations but also stands out as a socially responsible organization in your industry. Contact us today to learn more about SEDEX SMETA audits, and how our expert consultants can support your success.

HALAL Certification in Indore with Shark Certification Pvt. Ltd. Expand Your Reach. Strengthen Customer Trust. Meet Global Standards. Are you planning to expand into international markets or serve a wider consumer base, including the growing Muslim population? Shark Certification Pvt. Ltd. in Indore offers comprehensive HALAL Certification services that help businesses meet Islamic dietary laws and gain a competitive edge. What is HALAL Certification? HALAL is an Arabic term meaning “permissible” or “lawful.” In the food and product context, HALAL Certification confirms that the items are produced, processed, and handled according to Islamic law (Shariah). This applies not only to food but also to cosmetics, pharmaceuticals, packaging, and more. Why HALAL Certification Matters for Your Business Tap into a global consumer base of over 1.8 billion Muslims Meet export requirements for countries that mandate HALAL compliance Build credibility and consumer trust among Muslim and non-Muslim consumers alike Ensure transparency in sourcing, processing, labeling, and logistics Boost your brand value by showing a commitment to ethical and religious standards Industries That Benefit from HALAL Certification HALAL Certification is essential for a variety of sectors, including: Food and Beverage Manufacturing Meat and Poultry Processing Pharmaceuticals and Healthcare Cosmetics and Personal Care Products Hospitality and Catering Logistics and Packaging Steps to Get HALAL Certified with Shark Certification Pvt. Ltd. Initial Consultation We evaluate your business type, products, and markets to understand your specific HALAL requirements. Gap Analysis Our team assesses current processes to identify areas that need to be aligned with HALAL standards. System Development We help you build a HALAL-compliant system including ingredient sourcing, manufacturing practices, documentation, labeling, and hygiene protocols. Employee Training We train your staff to ensure full understanding and implementation of HALAL principles across your operations. Internal Audit A pre-audit is conducted to ensure readiness before the final certification audit. Third-Party Certification Audit We coordinate with accredited HALAL certification bodies to carry out the official audit and secure your certification. Certification Issuance On successful audit completion, your organization is issued a HALAL certificate, valid for a specified duration. Continual Compliance Support We provide ongoing guidance for surveillance audits, renewals, and system improvements. Why Choose Shark Certification Pvt. Ltd. in Indore? ✅ 25+ Years of Certification Expertise ✅ Trusted by Leading Brands Across India ✅ Affordable and Transparent Pricing ✅ 100% Success Rate in Certification ✅ Dedicated Consultant Support ✅ Fast Turnaround Time ✅ Customized Solutions for All Industry Sizes Benefits of HALAL Certification Increase customer trust and brand loyalty Access global HALAL markets with confidence Qualify for government and private tenders Improve internal systems and food safety protocols Demonstrate compliance with international standards Reduce risks of consumer complaints or regulatory non-compliance Start Your HALAL Certification Journey Today At Shark Certification Pvt. Ltd., we are committed to helping businesses in Indore and across India achieve global certification standards. With our HALAL Certification services, you can build a brand that’s credible, ethical, and future-ready.

Europe is a competitive but prize market, easier to access than ever before. Too many Indian exporters, especially small and medium sized enterprises, avoid it because the technical requirements for entry seem too complicated, too difficult, or too expensive. Indian manufacturers who have successfully accessed the European market know that the time to understand the European system is well worth the effort. The European Union alone is filled with affluent consumers, approximately 450 million of them. The European market is a large area that comprises more than 25 countries. For the exporter, therefore, Europe as a whole has become a market whose technical requirements have been greatly simplified. Before the creation of the European Union, each country imposed its own technical requirements. Different standards and conformity assessment procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of these European countries into a European Union, and the consequent harmonization of laws, standards, and conformity assessment procedures, changed all that. Perhaps more importantly, ISO 9001 Certification is used extensively in Europe as a condition of acceptance of a manufacturer’s product or as a means of recognition of the manufacturer’s credibility. It is important to note that a manufacturer with a quality system in place (such as ISO 9001 QMS) should not automatically assume that his or her products are CE compliant because of the quality system alone. The appropriate New Approach Directive(s) will prescribe the correct and full route to conformity assessment. The CE Mark, which is affixed to a product or its packaging, is considered a proof that the product has met the requirements of the harmonized European standard, or directives; refers to Communauté European. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a passport for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product. The first step to compliance is determining which directives apply to the product. A product may be regulated by more than one directive. The CE mark does not disclose which directive(s) or standards apply to the product, nor will it indicate the method of conformity assessment used to bring the product into compliance. This information is provided by other accompanying documents, such as the Declaration of Conformity. The Manufacturer or the Authorized Representative affixes the CE marking to the product. It is not affixed by a Notified Body.

The SA 8000 certification is the Social Accountability System standard. It is applicable to companies of any size that wish to address the social and ethical aspects of their business. A Social Accountability System proves to customers that the company holds adequate provisions for the protection of workers’ rights. Further, it ensures ethical production of all goods manufactured by the company. SA 8000 certification enables organization’s to demonstrate your commitment to social accountability standards as well as employee and customer satisfaction. SA 8000 is an international certification standard that encourages organization to develop, maintain and apply socially acceptable practices in the workplace. It was created in 1989 by Social Accountability International (SAI), an affiliate of the Council on Economic Priorities, and is viewed as the most globally accepted independent workplace standard. It can be applied to any company, of any size, anywhere in the world. The areas it addresses include forced and child labor, health and safety, freedom of association and collective bargaining, discrimination, disciplinary practices, working hours, compensation and management systems. Along with setting standards for employees worldwide, SA 8000 also embraces existing international agreements, including conventions from the International Labor Organization, the Universal Declaration on Human Rights, and the United Nations Convention on the Rights of the Child. SA 8000 Key Requirements Be senior management led Be focused on continuous improvement Be focused on prevention rather than reaction Be supportive of workers rights and workers participation Be compliant with local laws/codes Be compliant with local laws/codes Be systematic in addressing problems-Car’s Process Benefits of SA 8000 Certification Marketing advantage -more demand and value for goods from socially Responsible manufacturers and suppliers Enhancement of company’s productivity. Compliance to the laws of the land Improvement of relationship with the Govt., NGOs, trade unions Better image and position in labor markets Cost reduction in monitoring Better corporate image Increased value for the products Trust building with the analysts and investors when evaluated against social performance

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.

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