FROM ALCOA TO ALCOA PLUS- DATA INTEGRITY
ALCOA:- Coined By: – Stan Woollen in Early 1990s. 1999 FDA Guidance:- ALCOA- To be acceptable; the data from the Clinical Trials should meet…
Category: Quality Control
PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]- Guidelines & Links
All Reference Category Section AIDE MEMOIRE ON ASSESSMENT OF QUALITY RISK MANAGEMENT (QRM) IMPLEMENTATION PI 038-1 Documents for Inspectors Aide-Memoires AIDE…
REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES
(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…
REQUIREMENT OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS.
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.…
SCHEDULE M-I
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…
SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR MANUFACTURE OF ACTIVE PHARMACEUTICAL INGREDIENTS (BULK DRUGS)
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,…
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED-DOSE-INHALERS(MDI)
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…
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS
Note: – External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting powders and identical products used for external applications). In addition to these requirements, following…
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS)
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…
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES)
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…
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