Legal Procedure of the Entry of Drug Manufacture in China and USA:A Comparative Study / 中国药房

OBJECTIVE: To put forward suggestions for perfecting the Chinese legal procedure of the entry of drug manufacture.METHODS: The defects existing in Chinese legal procedure for the entry of pharmaceutical industry were analyzed by comparing the legal procedure for establishing pharmaceutical enterprise,permission of drug manufacturing and marketing between China and USA.RESULTS & CONCLUSIONS: The Chinese legislature should draw useful legal experiences from USA to amend the legislation defects,substitute the approval procedure of drug manufacturing licence with the procedure of enterprise registration to implement the GMP certification for special drug product,and merge the validation procedure of GMP certification and the review procedure of the pharmaceutical development program and industry policies into the procedure of drug registration and approval.

Study on manufacturing method and some biological properties of the drug Monkshood Root in Sapa region

A study for processing Radix Aconiti carmichaelii in Sapa (Lao Cai province) by traditional method. Radix Aconiti was immersed in sodium and magnesium chloride solutions for 12 to 14 days until having or without slightly pungent and numb taste. Studying the chemical ingredients showed that the content of total alcaloids and aconitin were reduced. Radix Aconiti processed in different ways had different action of cardiotonic. Studying acute toxicity found that no death of mice with oral maximum dose of 320g radix aconiti per kg body weight of animals

Some opinions to discuss with Vietnamese drug manufactures during the period of integration

In recent years the pharmaceutical industry of Viet Nam have had important advancement. Viet Nam have the fourth largest pharmaceutical market in South East Asia region with the average growing rate at third. It is estimated that the pharmaceutical market of Viet Nam will achieve 677 millions USD by 2005. From now to 2005 the pharmaceutical companies of Viet Nam should only focus on manufacturing forms of generic drugs, direct to invest and research new products and be soon active in changing the product strategy which based on export trend and specific demand of regional market

Preliminary study on manufacture process of transdermal patch of nitroglycerin

Nitroglycerin, a vasoactive substance, has been used in the treatment of vagina for more than 100 years. To sustain the pharmaceutical effect, doses were administered every 2 hours. Recently the transdermal delivery systems have became popular. Based on eudragit E 100, we combined it with plasticizer (dibutyl sebacate/triethyl citrate), crosslinker (succinic acid), active ingredient (nitroglycerin) and further excipients (e.g. permation enhances: ethyl alcohol) to form a self adhesive matrix system for use in nitroglycerin patch. The concentration of nitroglycerin in the patch was determined by HPLC assay

Some subjects about manufacture of Vietnamese essential drugs

Introduce nation policy about essential drugs (TTY) in background of nation economic recently. Provide essential drugs ability for people include: produce ability drugs in the fourth essential drugs list, which was promulgated at 28/7/1999 consist of drug list, traditional medicine, providing supplement essential drugs ability from foreign companies. A few proposes and comments of author.

Some issues on the good manufacturing practice (GMP) in Vietnam

To attain the standard of drug GMP that is all-sided investment process for all problems that relate to business and manufactured activity of enterprises and only base on the cautious consideration, accurate scientific calculation could been attained the definitive purpose that have been raised competitive ability of domestic products and economic effect, A step raise level for the industrialization-modernization of the pharmaceutical industry of our country

Application of the Shewhart diagram to control the mean mass of tablets in the examination of manufacture process

Process validation is strictly required in good manufacturing practice. For doing so, Shewhart charts can be used effectively. In this work, two types of Shewhart charts including X-bar chart and R chart were applied to validate the production processes of Rantitidin tablets and Tryotricin lozenges. By using six rules of evaluation, the statistical process control of the mean tablet weights were clearly shown

Combination of planning optimization formula with revision before manufacture process

The objectives of prospective process validation are to evaluate the key variables and their operational ranges and to predict the "worst cases" for each investigated variable. The targets of formulation design and optimization are to establish the quantitative relationships between input variables (ingredients/ processing conditions) and output variables (product properties). There are some intersectional ideas between validation and optimization as input-output relationships, quantifiable and predictable behaviours of input and output variables, constraints of independent and dependent variables, etc. The formulation design and optimization for paracetamol tablets, in combination with process prospective validation, using the optimization and what if prediction performed by INForm v3.0 as a frame work, was successfully done to (a) determine the critical variables as well as to estimate their optimized values, (b) to investigate the variable limits as well as to predict some worst cases

Some opinions and study on the protection of the labour force capital and labour market in pharmaceutical manufacturing enterprises

Objects: labour force capital and labour market in some pharmaceutical manufacturing enterprises during years of 1991-1994. Methods: efficacy of working, labour cost, studying and building a period of business, manufacture. High evaluation on needs of human resource, who were trained to become enough standard for moral and talent in arranged sites and close technical process.

Validation, an essential requirement of Good Manufacture Practice (GMP)

Validation is an essential requirement of GMP in current World. Requirement of GMP Validation of ASEAN: (1) Validation on manufacturing process. (2) Validation on quantitative method. 3. Validation on equipment. 4. Validation on hygienic standard and hygienic procedures. Results: (1) Guarantee manufacture to have a products, which respond regulated quality. (2) Respond regulated requirement of decree