Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Various people and entities are generally responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The objective of these guidelines is to assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and record-keeping practices. The nature of the risks involved is likely to be similar to that for risks encountered in the manufacturing environment, e.g. mix-ups, adulteration, contamination and cross-contamination. When the distribution chain is interrupted by manufacturing steps such as repackaging and relabeling, the principles of good manufacturing practices (GMP) should be applied to these processes. Different models for the distribution of pharmaceutical products are used in different countries and sometimes within the same country, for example, in the public and the private sector. These guidelines are intended to be applicable to all persons and outlets involved in any aspect of the distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent. This includes all parties involved in trade and distribution of medicines, pharmaceutical manufacturers, including the manufacturers of fi nished products and pharmaceutical wholesalers as well as other parties such as brokers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees.

A Pharmaceutical Professional, having more than 18 years diversified experience in Pharma Sector. Part of Strategic Leadership team, achieved major milestones based on Product quality and audit compliance. Leading Quality Operations right from development cycle till deliverance of targeted volumes in accordance with GMP standards to ensure consistent quality production by developing and enforcing Good Manufacturing Practices (GMP), Quality Management System (QMS), Process Optimization, Productivity enhancement and Operational Excellence. A Certified Lead Auditor of ISO Integrated Systems with an exposure of more than 500 audits of Pharmaceutical Manufacturing Sites, Raw & Packaging Materials Vendors/ Suppliers, Calibration Agencies, Contract Laboratories, Distributors and Service Agencies. A highly motivated person having strength to excel in conveying complex ideas clearly and persuasively, deeply enthusiastic and committed to contributing to the success of team and company. A Self Motivator with High Energy, Passionate, Confident, Results Oriented, Solution Focused, Critical Thinking capabilities and Compliance to Norms & Discipline. I am looking to target a leading position in the pharmaceutical industry, where I may flourish organizational dynamics to another level by applying my utmost experience, knowledge and skills. Also lead Vendor Qualification Program right from sourcing, budgeting, auditing, testing, trial/ scale-up batch manufacturing, Stability & commercialization. Expert in handling and management of all QMS functions including Out of Specification, Out of Trend (OOS/ OOT), Deviation, Change Control, Investigation, CAPA, Product Quality Review, Internal Audit, Quality Risk Management System, Batch Record auditing and market release, GMP and Scientific Trainings, Management Review, etc. Have gone through several International audits/ inspections/ accreditations successfully which include WHO Prequalification, PIC/S (Pharmaceutical Inspection Co-operation Scheme) Inspection and about 25 countries Regulatory agencies Inspections.