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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...

Guidance for Industry: Microbiology Laboratories

This guideline is intended to provide general guidance on the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP) with respect to requirements for microbiology laboratories engaged...

BUOYANCY EFFECT CONSIDERATIONS IN THE USE OF WEIGHING BALANCE

  Weighing machines are calibrated by accredited laboratories on a conventional mass basis. If the true mass of an object is to be found, or if conventional mass is required but the air density...

WEIGHTS OF DIFFERENT CLASS AS PER INTERNATIONAL ORGANIZATION OF LEGAL METROLOGY

The OIML weight classes are defined as follows:   Class E1:- Weights intended to ensure traceability between national mass standards (with values derived from the International Prototype of the kilogram) and weights of class E2 and...

CONSTRUCTION OF WEIGHTS OF DIFFERENT CLASS AS PER INTERNATIONAL ORGANIZATION OF LEGAL METROLOGY

CONSTRUCTION OF WEIGHTS OF DIFFERENT CLASS AS PER OIML (INTERNATIONAL ORGANIZATION OF LEGAL METROLOGY) Class E weights  A.Class E weights from 1 mg to 50 kg:- Class E weights from 1 mg to 50 kg...

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