一、研究背景及意义
The manufacturing of a pharmaceutical as a biologically active compound require fundamentally an Active pharmaceutical Ingredient (API). An API of good quality are the core to the manufacturing of effective and safe essential medication, can be a material purchased from one or more suppliers or manufacturers of medications under commercial agreements and contracts. The production of an API for synthetic process must follow a regulation and a determinate manufacturing process where GMP should be applied for the validation of the steps in the process conducted according to this guidance. Each manufacturer must implement an effective system for managing quality. API are normally of defined chemical properties and structure.
The global market of API is in a continuous growth, facing a high demand of this organic compound, this market is broadly segmented based on API synthesis, type of manufacturing, and type of drug, application and by region. Based on type of manufacturing, the market is divided into API contract manufacturing; the contract manufacturing appeared as major segment due to the lower cost and higher quality of production of the API.
China is a major source of APIs used by drug manufacturers around the world, China has witnessed phenomenal growth of its API production sector over the past decade, a growth based at least in part of government policy preference. China has become more open and economically affluent, hoarding the global market in volume of exports.
China mass production is well established globally, involving domestic manufactures of the bulk drugs, including those involving advance chemistry skills. China possess huge capacities of manufacturing units in a substantial number and now moving towards the best regulatory standards to make efforts to implement quality in its pharma manufacturing industry.
Currently, the industry is comprised mainly of large international companies, drugs are marketed globally. The demand is dependent on markets trends, yet they are affected by a variety of factors, such as seasonality, disease outbreaks, tenders results of health service organizations, demand of third-party customers, increasing value to customers due to optimization in the chain, demand for materials, etc.
Supply chain management in the pharmaceutical industry includes a variety of aspects, such as regulation, quality operations, health, safety, and environmental protection. The supply chain may be focused on business partners (such as production or distribution) and spread across different countries.
API supply chain management include transportation by sea, air or land, production, storage logistics, local distribution, etc. The main objective of Supply Chain management is to monitor and relate production, distribution, and shipment of products and services to other regions.
Generally, API are being commercialized to many countries, and the package of the drug, the drug leaflet and its labels must be matched to the package of the drug, according to the requirements of the regulatory authority in the target country.
二、研究目的
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