Good pharmaceutical manufacturing

Packaging, storage and transport 4 Guide to Good Pharmaceutical Manufacturing Practice... 

Good pharmaceutical manufacturing practice applied to the hospital preparation of radiopharmaceuticals (1977) Dept, of Health and Social Security, notes for guidance issued by the Medicines Inspectorate, London... 

Guide to Good Pharmaceutical Manufacturing Practice 1983. London, Her Majesty s Stationery Office, 1983 ("Orange Guide"). [Superseded by the 1992 EEC guide.]... 

In order to be in control of quality, the pharmaceutical establishment must devise and implement a system of quality assurance, this system must cover all phases of development, manufacture and distribution of medicines. The part of the system concerned with manufacture constitutes good pharmaceutical manufacturing practices. 

These measures must be worked out on the basis of scientific and technical data concerning the medicines. They must be adapted to the conditions of production at each establishment and thus constitute for that establishment the internal rules which are implemented in conformity with the principles of good pharmaceutical manufacturing practices. 

Within the system of quality assurance, good pharmaceutical manufacturing practices represent that part which is concerned with manufacture. 

Quality control refers to that part of good pharmaceutical manufacturing practices concerned with the operations of verification of quality levels acceptance or rejection of raw materials, acceptance or rejection of semifinished or finished products, estimation of the stability of products, examination of returned products and supervision of retained sample stores. 

In order to assess the effectiveness of the quality assurance system and to ensure the application of good pharmaceutical manufacturing practices, it is recommended that self-inspection and quality audits be undertaken. 

Self-inspection consists of a periodic, detailed examination of the conditions and working procedures by a team from the production plant. The aims are to verify that good pharmaceutical manufacturing practices are being applied and to propose possible corrective measures to supervisory personnel. 

The manufacture of medicines for homeopathic use us most often concerned with infinitesimal doses of the active principle. This special characteristic usually makes analytical control of the finished product impossible. Consequently, the guarantee of the quality of a homeopathic medicine can be obtained only by the control of the raw materials and above all, by the implementation of good pharmaceutical manufacturing practices. 

Date processing systems and programmable controllers should be used in compliance with good pharmaceutical manufacturing practices. The replacement of manual operations by such systems must not entail an increase in the risk of error. 

Good Pharmaceutical Manufacturing Practices in Korea (KGMP) Ministry of Health and Social Affairs (MOSHA)... 

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