All Reference Category Section AIDE MEMOIRE ON ASSESSMENT OF QUALITY RISK MANAGEMENT (QRM) IMPLEMENTATION PI 038-1 Documents for Inspectors Aide-Memoires AIDE…
(A). GENERAL REQUIREMENTS: (i) Location and surroundings: The factory building(s) shall be located in a sanitary place and hygienic conditions shall be maintained in the…
A. GENERAL REQUIREMENTS: (a). Location and surroundings: The factory shall be located in a sanitary place and hygienic conditions shall be maintained in the premises.…
A. Requirements of factory premises for manufacture of Homoeopathic preparations: (1). Location and surroundings: The factory shall be situated in a place which shall not…
A. Building and Civil Works:- (1). Apart from the building requirements contained Part-I, General note, the active pharmaceutical ingredients facilities for manufacture of hazardous reactions,…
Manufacture of Metered-Dose-Inhalers shall be done under conditions which shall ensure minimum microbial and particulate contamination. Assurance of the quality of components and the bulk…
Note: – External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting powders and identical products used for external applications). In addition to these requirements, following…
A. Building and Equipment:- (1). The premises and equipment shall be designed, constructed and maintained to suit the manufacturing of Oral Liquids. The layout and…
Note: The processing of dry materials and products creates problems of dust control and cross-contamination. Special attention is therefore, needed in the design, maintenance and…
Sterile products are very critical and sensitive in nature need very high degree of precautions, prevention and preparations and needed. Dampness, dirt and darkness are…
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