LAS 1

Actual Yield

The quality that is actually produced at any phase of production of a particular drug based on the initial input.

Active Ingredient

Any component which is intended to furnish pharmacologic activity or other effects on the diagnosis, cure, mitigation, treatment or prevention of disease, or to effect the structure or funcion of the body.

Batch

A quantity of drug product/device that is homogeneous in character and quality produced during a given cycle of manufacturing and from a specific manufacturing order.

Batch/Lot Number

A designation of number or letter or combination there of that identifies the batch and permits the tracing of the complete history of batch, including all stages of its production, control and distribution.

Bulk Product

Any processed material which has to undego another process including packaging operation to become a finished product.

Component

Any material intended to be used for the manufacturer of a product, whether raw materials or packaging materials.

Cosmetics

Articles that intended to be rubbed, poured, sprinkled, or otherwise applied to the human body or any part thereof, for cleansing, beautifying, promoting attractiveness, or altering the appearance. Articles intended or used as a component of any such articles, except that such term shall not include soap.

Date of Manufacture

The date indicating the start of processing of every batch.

Dispensing

The activity of weighing, counting, or measuring and checking of starting materials and issuing these materials to the appropriate production personnel, detailsof the activity being duly and properly documented.

Drug Product

Any substance or mixture of substances finished dosage forms that are manufactured, offered for sale or presented for use in the treatment, mitigation, cure, prevention, or diagnosis of disease, abnormal physical state or the symptoms thereof in man or animal; the restoration, correction or modification of organic functions in man or anial whether it is in package form.

Device

an instrument, apparatus or contrivances, including their components, parts and accessories intended; for use in the diagnosis, cure, mitigaton or prevention of disease in man and animals; to affect the structure or any function of the body of man or animal.

Expiration Date

a date fixed for each individual batch on or before which the batch is expected to meet the standard specifications forr quality, safety, and efficacy.

Finished Product

A product which has undergone all stage of manufacturing operations.

Good Manufacturing Practices (GMP)

is the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures.

In-Process Control

Checks and tests instituted and carried out in the course of the manufacture of a drug to ensure identity, strength, quality and purity.

Intermediate Product

Any processed substance or mixture of substances or mixture of substances which have to undergo one or more states of processing to become finished product.

Lot

A batch or any portin of a batch produced by a continuous proceess, an amunt of drugs produced in a unit of time, or quantity in a manner that ensures its uniformity and in either case is identified by a distinctive lot number and has uniform character and quality within specified imits.

Manufacture/Manufacturing

The complete set of activities to produce a drug, comprising production and quality control from dispensing of materials to the distribution of the finished product.

Manufacture Order (MO)

It is an instruction to the Production or Manufacturing Department to produce a drug distribution.

Master Formula

The standard form where the Manufacturing Order is derivd. It is prepared by the competent people of the company.

Packaging

The process of packing, the part of the production cycle applied to a bulk product to obtain finished product.

Packaging Material

Any material used in the packaging of a bulk product to obtain a finished product.

Procedures

Description of the operations to be executed, the precautions to be implemented directly or indirectly related to the manufacture of a drug.

Processing

The part of the production cycle from weighing of raw materials to finished product.

Production

All operations starting from dispensing mateerials to processing, packaging, to a finished product.

Quality Control

All control measure designed to ensure that finished products consistently condor, to established specification of identity, purity, strength and quality.

Quarantine