PCEUTICS2 M1

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88 Terms

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SALES, PROMOTION AND MERCHANDISING DEPARTMENT

Promote maximum sales

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SALES, PROMOTION AND MERCHANDISING DEPARTMENT

Professional service or detailing

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SALES, PROMOTION AND MERCHANDISING DEPARTMENT

Advertising

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SALES, PROMOTION AND MERCHANDISING DEPARTMENT

Market Medical Survey

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RESEARCH AND DEVELOPMENT

This department introduces a completely new product or improves on an already existing product.

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RESEARCH AND DEVELOPMENT

Chemical Research

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RESEARCH AND DEVELOPMENT

Biological Research

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RESEARCH AND DEVELOPMENT

Pharmaceutical Research

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RESEARCH AND DEVELOPMENT

Pharmacological Research

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RESEARCH AND DEVELOPMENT

Clinical Research

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PRODUCTION DIVISION/CONTROL

PURCHASING
INVENTORY CONTROL
PLANNING AND SCHEDULING

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PURCHASING

Purchases requisitioned items for the company, both from local and imported sources

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INVENTORY CONTROL

Watches closely and records all materials used in production; controls the stock of both raw materials and finished products.

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PLANNING AND SCHEDULING

Coordinates with marketing on what products are required for supply, and then plans and schedules the manufacturing of the product.

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PRODUCTION DIVISION/CONTROL

Receiving materials and supplies to be used in the plant

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PRODUCTION DIVISION/CONTROL

Control of all process, equipment used and safeguards against mistakes in production

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WAREHOUSE DIVISION
Raw Materials In-process Finished Products Returned Goods Dispensing
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QUARANTINE AREA
Implies that the materials are subject to tests and assays
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QUARANTINE AREA
YELLOW STICKER is attached to quarantined materials
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APPROVED for USE AREA

Materials from the quarantine area found to conform to standards and specifications

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APPROVED for USE AREA
GREEN STICKER it attached to the material
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REJECTED AREA
Materials found to be substandard are transferred to this area
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REJECTED AREA
Has a RED LABEL containing the bold letters REJECTED
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IN-PROCESS
Consists of the products which have been bottled or stripped, packed but not yet labelled, or packed into boxes or cartons because the are awaiting Quality Control Department’s final disposition
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FINISHED PRODUCT

This area contains the products packaged and finished and are ready for distribution and sale.

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RETURNED GOODS
Goods returned are stored in this section of the warehouse pending disposition of Quality Control
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DISPENSING
An area in the warehouse where raw materials for use are weighed and/or measured. The supervisor here should be a pharmacist.
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ENGINEERING AND MAINTENANCE
Take charge of the care and maintenance of all machines used in the Plant department
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ENGINEERING AND MAINTENANCE
Maintains all plant services including electric lines, water line, air-conditioning units and computer systems.
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ENGINEERING AND MAINTENANCE
Takes care of ground beautification and Automation
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ENGINEERING AND MAINTENANCE
Insures safety measures of the plant and of the employees
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PURCHASING DEPARTMENT
Purchasing of all raw materials, containers, packaging supplies and machinery.
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PURCHASING DEPARTMENT
Accounting, Inventory, Personnel functions, Cafeteria Service
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MEDICAL DEPARTMENT

Takes care of the medical treatment

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MEDICAL DEPARTMENT
Physical and medical examinations of employees
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MEDICAL DEPARTMENT
Does the clinical research and prepares the literature
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PUBLIC RELATIONS
Takes care of labor-management relations
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PUBLIC RELATIONS
Receives complaints from customers
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QUALITY CONTROL DEPARTMENT
Considered as the HEART of the plant.
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QUALITY CONTROL DEPARTMENT
This department insures that only high quality products are produced and that they meet FDA and USP requirements for legal reasons.
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SPECIFICATIONS AND ANALYTICAL DEVELOPMENT
To coordinate the research, product development, production sales and management
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SPECIFICATIONS AND ANALYTICAL DEVELOPMENT
To establish specifications for raw materials
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SPECIFICATIONS AND ANALYTICAL DEVELOPMENT
To validate existing and tentative testing procedures
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SPECIFICATIONS AND ANALYTICAL DEVELOPMENT
To establish specifications based on validated procedures
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SPECIFICATIONS AND ANALYTICAL DEVELOPMENT
To develop assays procedure for in-house use
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SPECIFICATIONS AND ANALYTICAL DEVELOPMENT
To develop and improve specifications for the quality characteristics of the final product
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CHEMICAL OR ANALYTICAL TESTING LABORATORY
Located in an accessible area protected from NOISE and VIBRATIONS
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CHEMICAL OR ANALYTICAL TESTING LABORATORY
Every lot (raw materials & finished products) should be tested
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CHEMICAL OR ANALYTICAL TESTING LABORATORY
Volumetric and gravimetric analyses & Instrumentation (HPLC)
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BIOLOGICAL TESTING LABORATORY
To perform and evaluate microbiological and acute pharmacological assays, sterility, pyrogen bacteriological tests, irritation, safety or toxicity.
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BIOLOGICAL TESTING LABORATORY
To conduct environment monitoring
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CENTRAL RELEASE OFFICE OF QUALITY COORDINATING OFFICE

This section has documentation is its main responsibility.

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CENTRAL RELEASE OFFICE OF QUALITY COORDINATING OFFICE

To maintain and store records

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CENTRAL RELEASE OFFICE OF QUALITY COORDINATING OFFICE

Furnish data on stability studies and returned goods reports

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CENTRAL RELEASE OFFICE OF QUALITY COORDINATING OFFICE

Investigate customer complaints or inquiries on product quality

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CENTRAL RELEASE OFFICE OF QUALITY COORDINATING OFFICE

Provide data that give scientific and legal status

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CENTRAL RELEASE OFFICE OF QUALITY COORDINATING OFFICE

To maintain and develop SOP’

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CHECKING AND INSPECTION DIVISION
To sample and examine all raw materials received
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CHECKING AND INSPECTION DIVISION

To sample and conduct physical tests

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CHECKING AND INSPECTION DIVISION
To maintain periodic examination on the quality of inventories through out all phases of storage, shipping and distribution
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CHECKING AND INSPECTION DIVISION
To perform an audit
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MULTINATIONALS

Glaxosmithkline Philippines, Pfizer, Wyeth, Abbott Laboratories, Novartis, Astrazeneca, Sanifi-aventis, Johnson & Johnsons, Boehringer Ingelheim, Roche, Bristol Myers Squibb, Bayer, Schering Plough, Merck Inc

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FILIPINO OWNED

United Laboratories, Pascual Laboratories, Natrapharm, GX International, AM Europharma, Euro-med

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TOLL MANUFACTURERS

Lloyd Laboratories, Hizon Laboratories, Interphil Laboratories, La Croseus Pharma, EL Pharma, Swiss Pharma, Interchemix Pharma

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Pharmaceutical Development

Drug Substance Development, Formulation Development, Manufacture of Investigational Products, Delivery System Development, Manufacturing Process Development, Scale-up Analytical Method Development

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Technology Transfer

New Product Transfers, Transfer of Marketed Products

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Commercial Manufacturing

Acquisition and control of materials, Provision of facilities, utilities and equipment, Production Quality Control / Quality Assurance, Product Release, Product Distribution

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Product Discontinuation

Retention of Documentation, Sample Retention, Continued product assessment and reporting

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PHARMACEUTICAL DEVELOPMENT
To design a product and its manufacturing process to consistently deliver the intended performance and needs of patients and healthcare professionals, and regulatory authorities and internal customers’ requirement.
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TECHNOLOGY TRANSFER
To transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization
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COMMERCIAL MANUFACTURING
Achieving product realization, establishing and maintaining a stage of control, and facilitating continual improvement.
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PRODUCT DISCONTINUATION
To manage the terminal stage of the lifecycle effectively.
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Both Ethical and Over-the-Counter Spaces

UNITED LABORATORIES

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Both Ethical and Over-the-Counter Spaces

PFIZER

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Both Ethical and Over-the-Counter Spaces

GLAXO SMITHKLINE

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Both Ethical and Over-the-Counter Spaces

BOEHRINGER INGELHEIM

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Both Ethical and Over-the-Counter Spaces

SANOFI AVENTIS

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Ethical Spaces only

MERCK SHARP & DOHME

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Ethical Spaces only

NOVARTIS

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Ethical Spaces only

ASTRAZENECA

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Ethical Spaces only

CATHAY DRUG

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Ethical Spaces only

NATRAPHARM

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Over-the-Counter Spaces only

JOHNSON & JOHNSON

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Over-the-Counter Spaces only

TAISHO

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Over-the-Counter Spaces only

INTERMED MARKETING

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Over-the-Counter Spaces only

PASCUAL LABORATORIES

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Over-the-Counter Spaces only

ABBOTT LABORATORIES