Introduction to Manufacturing Pharmacy and Production Life Cycle Management

Flashcards covering the fundamentals of manufacturing pharmacy, organizational structures, pharmaceutical classifications, and Product Lifecycle Management based on Student Activity Sheet #1.

Manufacturing Pharmacy

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.

Organization

A mechanism for determining and assigning duties to people so that they can work together effectively.

Business organization

A combination of people, money and machines so coordinated that they can fulfil an economic objective.

Division of responsibility

Also known as obligation of duty; the process where responsibility must be delegated and types of work are identified and grouped logically.

Delegation of Authority

The power or right to give commands, enforce obedience, and make final decisions, which must be clearly defined to avoid negligence of duty.

Organizational Chart

A basic tool interpreted in a chart that lists all important positions and functions of each division or department to show the structure of the company.

Position Description

A tool that defines the authority, duty, or responsibility of the specific areas identified in the organizational chart.

Organizational Manual

Also called a Management Guide, it combines the organizational chart and position descriptions with materials about company philosophy and objectives.

Level I Management

Consists of the Board of Trustees or Board of Directors who protect company assets, establish basic policies, and safeguard stockholders interests.

Level II Management

Consists of the President whose function is general management, including active planning, direction, coordination, and control of the business.

Level III Management

Consists of Vice Presidents, General Managers, and Department Managers who are responsible for the success of specific major departments.

Functional Structure

An organizational structure that groups all activities based on similarity of functions alone; appropriate for small companies.

Divisionalized Structure

Combines into one unit all different kinds of work necessary to accomplish a specific result, often grouped by product or geography.

Line

The framework for organizational structure constituting the Chain of Command with direct responsibility to accomplish enterprise objectives.

Staff

Organization components required to supply information and service to the 'line' components.

Inventory Control

A section that watches and records all materials used in production and periodically checks stocks of raw materials and finished products.

Quarantine Area

An area in the warehouse where materials are labeled with a yellow label, indicating they are subject to tests and assays by Quality Control.

Approved for Use Area

An area in the warehouse where materials found to conform to standards are labeled with a green label with bold letters.

Rejected Area

An area for substandard materials labeled with a red label; these are either returned to suppliers or destroyed.

In-process

A section consisting of products that have been processed (bottled, stripped, or packed) but not yet labeled, awaiting final Quality Control disposition.

Dispensing Area

An area in the warehouse supervised by a pharmacist where raw materials for use in production are weighed or measured.

Master Formula

A document containing the name of the product, potency, batch size, list of ingredients, specifications, quantities, and necessary signatures.

Manufacturing Order (M.O.)

A document prepared by Production Control based on the Master Formula that includes a scheduled date of production and an M.O. number.

Finishing Order (F.O.)

Contains a list of packaging materials with the corresponding quantity necessary for the batch size indicated in the Manufacturing Order.

Waters

Aqueous solutions used mainly as a vehicle and as a solvent for flavoring or medicinal ingredients.

Solutions

Liquid preparations containing one or more soluble chemical substances dissolved in water for internal or external therapeutic effect.

Douches

Aqueous solutions directed against a part or into a cavity of the body, functioning as cleaning or antiseptic agents.

Enemas

Rectal injections used to evacuate the bowel or to influence the general system by absorption.

Syrups

Concentrated solutions of sugar, such as sucrose, in water or other aqueous liquids.

Mucilage

Thick, viscid, adhesive liquids produced by dispersing gum in water or extracting mucilaginous principles from vegetables.

Jellies

A class of gels where the structural coherent matrix contains a high proportion of liquid, usually water, often used as surgical lubricants.

Colloidions

Liquid preparations containing pyroxylin in a mixture of ethyl ether and ethanol; leaves a film on the skin after evaporation.

Elixirs

Clear, pleasantly flavored sweetened hydroalcoholic liquids intended for oral use.

Glycerites

Solutions or mixtures of medicinal substances in not less than $50\%$ by weight of glycerin.

Liniments

Solutions or mixtures in oil, alcoholic solutions of soap, or emulsions intended to be rubbed onto the skin.

Spirits

Also known as essences; alcoholic or hydroalcoholic solutions of volatile substances.

Emulsion

A two-phase system prepared by combining two immiscible liquids using an emulsifying agent to prevent separation.

Suspensions

A two-phase system consisting of finely divided solid dispersed in a solid, liquid, or gas.

Gels

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

Magmas and Milk

Aqueous insoluble inorganic drugs that differ from gels mainly in that the suspended particles are layers.

Tinctures

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

Fluidextracts

Liquid preparations of vegetable drugs where each $mL$ contains the therapeutic constituents of $1\,g$ of the standard drug.

Ointments

Semisolid preparations intended for external application to the skin or mucous membranes.

Cataplasm (Poultices)

A soft moist mass of meals or herb seeds applied hot in clothes to localize infection or act as a counterirritant.

Pastes

Concentrates of absorptive powders in petrolatum; stiff to the point of dryness and used for treating oozing lesions.

Suppositories

Solid dosage forms for insertion into the rectum, vagina, or urethra.

Triturations

Dilutions of potent powdered drugs prepared by mixing them with suitable diluents in a $1:10$ dilution.

Product Life Cycle (PLC)

The course of a product's sales and profits over its lifetime, involving stages from development to decline.

Product Development

The PLC stage where research and design occur and prototypes are tested with no received revenue.

Introduction

The PLC stage where the product first appears in the marketplace after development, focusing on attracting customers and awareness.

Growth

The PLC stage where sales rise rapidly and profits reach a peak before leveling off.

Maturity

The PLC stage where the market becomes saturated, sales growth slows, and the focus is on maintaining market share and cash flow.

Decline

The final PLC stage where sales are low, revenues decrease, and customers move to other products.

Product Lifecycle Management (PLM)

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