MANUF SAS 1 & LAS 1

Manufacturing Pharmacy

Manufacturing Pharmacy

deals with the technology of various official and non-official products manufactured in a semi-commercial and commercial scale.

Industrial Pharmacy

refers to the pharmaceutical research and manufacturing companies providing pharmacists with medicines in prefabricated or ready-to-take form.

Functional Structure

grows all activities based on similarity of functions alone

Divisionalized Structure

combines into one unit all different kinds of work necessary to accomplish a specific result.

LINE

those that have direct responsibility to accomplish the objectives of the enterprise

staff

constitutes work functions or as organization components that are required to supply information and service to the „line‟ components

PURCHASING

watches closely and records all materials used in production

Planning and scheduling

coordinate with Marketing in what products are required for supply, and they plans and schedules the manufacturing of the product.

DISPENSING

an area in the warehouse where raw materials for use in production are weighed and/or measured.

Solutions

a liquid preparation that contains one or more soluble chemical substances dissolved in water

DOUCHES

aqueous solutions directed against a part or into a cavity of the body

Colloidions

They are applied to the skin by the means of a soft brush or other suitable applicator and when the ether and ethanol have evaporated, they leave a film of pyroxyllin on the surface.

ELIXIRS

clear, pleasantly flavoured sweetened hydroalcoholic liquids intended for oral use.

Glycerites

solutions or mixtures of medicinal substances in not less than 50% by weight of glycerin.

Nebulizers

are used for the administration of inhalations.

LINIMENTS

solutions or mixtures of various substances in oil, alcoholic solutions of soap or emulsions.

SPIRITS

popularly known as essences, are alcoholic or hydroalcoholic solutions of volatile substances

SUSPENSIONS

Two-phase system prepared by combining two immiscible liquids one which is uniformly dispersed through the other and consists of globules that have diameter equal to or greater than those of the largest colloidal particles

GELS

semisolid system of either suspension made up of small inorganic particles or large organic molecules interpenetrated by a liquid.

LOTIONS

usually liquid suspensions or dispersions intended for external application to the body

TINCTURES

alcoholic or hydroalcoholic solutions prepared from vegetable material or from chemical substances.

OINTMENTS

semisolid preparations intended for external applications to the skin, mucous membranes, usually but not always, contain medicinal substances.

CREAMS

viscous liquid or semisolid emulsions of their oil-or-water or water-in-oil type

product life cycle

is course of a product‟s sales and profits over its lifetime.

GROWTH

This is the stage at which a product’s sales rise rapidly and profits reach a peak, before levelling off into maturity

growth

It is marked by rapid increase in sales and profits of the new product.

maturity

The market becomes saturated in this stage

This is the stage in which sales growth is slows or levels off

Product lifecycle management

The process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal.

decline

During this stage, the company's product loses more and more market share, and competition tends to cause sales to deteriorate

In – process section

The section of the manufacturing plant which consist of packed products without labels

level III

Consists of the Vice President, General Managers and Department Managers

level II

The function being general management or administrative, includes the active planning, direction, coordination and control of the business within the scope of policies established

level I

Represents and safeguards stockholders interests

staff

This constitutes work functions or as organization components that are required to supply information and service to the “line‟ components

Drug manufacturing

is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry

actual yield

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

Active Ingredient or Active

Any component which is intended to furnish pharmacological activity or other effects on the diagnosis, cure, mitigation, treatment or prevention of disease, or to effect the structure or function 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 number

A designation of number or letter or combination thereof that identifies the batch and permits the tracing of the complete history if batch, including all stages of its production, control and distribution. (Also known as Lot Number)

bulk product

Any processed material which has to undergo 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.

dispensing

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

Date of manufacture

The date indicating the start of processing of every batch

expiration date

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

finished product

A product which has undergone all stages of manufacturing operations

Good Manufacturing Practices (GMP)

It is the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use

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 which have to undergo one or more states of processing to become finished product.

lot

A batch or any portion of a batch produced by a continuous process, an amount 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 a uniform character and quality within specified limits

manufacturing /manufacture

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

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 derived

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 materials to processing, packaging, to a finished product.

quarantine

An act of holding off a material for use, or a product for packaging or distribution by physically setting it apart or by a system duly validated, pending a decision on release or rejection

raw material

All substances whether active or excipients that are employed in the processing of a finished product

diluent/filler/bulking agent

lactose is widely used as

lubricant

magnesium stearate

disintegrants

are added to a formulation to promote the drug release.

tablet lubricants

are essential components of all tablet formulations, since they prevent sticking of the tablets in the dies.

are added to tablet formulations primarily to reduce friction between the die wall and granules as the tablet is formed and ejected

Tablet glidant

is a substance that is added to a powder to improve its flowability

preservatives

is a substance or a chemical that is added to products such as food products, beverages, pharmaceutical drugs, paints, biological samples, cosmetics, wood, and many other products to prevent decomposition by microbial growth or by undesirable chemical changes.

antioxidants

are substances that may protect your cells against free radicals, which may play a role in heart disease, cancer and other diseases.

wetting agents

increase the spreading and penetrating properties of a liquid by lowering its surface tension.

emulsifying agent/ ointment base

lanolin

emulsifying agent

lauric acid

surfactant

linoleic acid

lubricant

magnesium stearate

Antimicrobial preservative

Propylparaben Sodium

diluent/binder/thickening agent/disintegrant

starch

stiffening agent

stearyl alcohol

binder/sweetener/filler/suspending agent/coating agent

sucrose

glidant/lubricant/diluent

talc

flavoring agent

vanillin

emulsifier/ stiffening/ coating/polishing

wax