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Global Manufacturing
Good Manufacturing Practices (GMP)
GMP Audit is system for ensuring that any drug, Biological products, medical device, food and its supplements are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any production that cannot be eliminated through testing the final product
GMP Audits will ensure the significant deficiencies and make necessary improvements from the starting materials, premises, equipment, training and personal hygiene of staff, written procedures for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made
Our GMP Audits spread across various industries from drug development of pharmaceutical, biopharmaceutical products, Food and food supplements and medical devices, Cosmetics to ensure the highest standard of quality, reliability, efficiency and compliance of respective local, national, international regulatory bodies
GMP Audits are crucial in selling and buying of any product which will create huge demand and credibility of the manufacturer or supplier in local or international market. Being third party audit agency, we assess the manufacturer or supplier through risk and quality driven strategic approach which makes the manufacturer, market holder remains in the intended market across globe
Good Documentation Practices (GDP)
GDP Audits are systematic review of standards by which documents, records are created and maintained at every stage of the product or service under Quality management operations
Our GDP Audit is an integral part of the all GxP audits, which will ensure the documents are accurate, concise, legible, traceable, contemporaneous, enduring and accessible across all the industries of pharmaceutical, biologics, medical devices, cosmetics, research and development, food and food based industries
GDP Audit not only ensure the quality it also helps in regulatory approvals, legal requirements of safety, efficacy in local and international markets
GDP are essential components of Quality Management System (QMS), Risk Management System (RMS), Information security Management System (ISMS) and our audits assure paper and electronic based records in GxP scope across various industries
Good Storage and Distribution Practices (Supplier Audits) (GSDP)
GSDP audit ensures the quality and integrity, compliance of regulatory standards during maintenance of adequate conditions. Storage of products for Internal or external purpose to sale or distribute of Medicinal, Food products, Clinical samples, Diagnostics, Chemicals throughout the supply chain from the manufacturer to the end user
Our GSDP Audits will ensure Medical, Food products which may be subjected to various risks at different stages in the supply chain, for example, purchasing, storage, repackaging, relabeling, transportation and distribution
GSDP is applicable in broad range includes all the parties involved in trade, storage, distribution of Medicinal, Food, manufacturers, wholesalers, as well as other parties such as brokers, consulting agencies, suppliers, distributors, logistics providers, traders, transporters, forwarding agents and their employees
We as an independent auditing agency conducts third party audits to assure the product safety, quality in defined conditions at various stages of trading till to reach at desired location and our audit will ensures your company, to be consistent with local or global legal requirements
GSDP Audit will also covers the Good Trade Practices especially in Food and Feed safety assurance scheme, Good Hygiene Practices (GHP) relating to operating sites, premises, equipment, transport, waste management, staff