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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 product is very important. Where medicaments are in suspended...

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 shall also be followed; (1). The entrance to the...

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 design of the manufacturing area shall strive to minimize the...

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 use of premises and equipment in order to overcome...

SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES & LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS

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 to be avoided to ensure aseptic conditions in all...

GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS

**To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for...

TYPES OF AIRLOCKS USED IN PHARMA

There are three basic classifications of airlocks that are physically the same, but only the pressure cascade regime differs. Cascade Airlock:- These airlock are very common having higher pressure on one side and lower pressure...

BOOKS & STANDARDS FOR PHARMACEUTICAL INDUSTRY

    HVAC DESIGN ASHRAE 62.1 Ventilation for ACC - Acceptable Indoor Air Quality   ASHRAE 189 Standard for the Design of High-Performance Green Buildings   ASHRAE 90.1 Energy Standard for Buildings Except Low-Rise Residential Buildings   ASHRAE RP - 1673 ASHRAE Supertall & Mega-tall Building Systems   ASHRAE...

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