schedule M

REQUIREMENTS OF PLANT AND EQUIPMENT – PART-II

A. External Preparations:- The following equipments are recommended for the manufacture of External preparations (Ointments, Emulsion, Lotions, Solutions, Pastes, Creams, Dusting powders and such identical products) used for external applications and their associated equipments...

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, Beta- Lactum antibiotics. Steroids and Steroidal Hormones / Cytotoxic substances...

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...

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