is presently considered as an advance

course, it deals with the “technology of

various official and non-official products
manufactured in a semi-commercial and
commercial scale”.
refers to pharmaceutical research and
manufacturing companies providing
pharmacists with medicines in pre-
fabricated or ready-to-take forms.
This relates to the following:
1. Practice of pharmacy in
some hospitals
2. Large scale production
carried out in modern
pharmaceutical plants
VS
Compounding (as defined by NABP):
- preparation
- Mixing
- Assembling
- Packaging
- or labeling of drug or device
as the result of a practitioner’s prescription drug
order or initiative based on the pharmacist or patient
or prescriber relationship in the course of
professional practice.
Compounding (as defined by NABP):

- preparation of drugs and

devices in anticipation of
prescription drug orders
based on routine, regularly
observed patterns
Compounding (as defined by NABP):

- for the purpose of, as an

incident to research, teaching,
or chemical analysis and not
for sale or dispensing
Manufacturing
- production
- preparation
- propagation
- conversion
- processing of a drug or device
Manufacturing
- packaging or repackaging
- substances labeling or
relabeling of container
- promotion and marketing of
such drugs or devices
Manufacturing
- also includes the preparation
and promotion of commercially
available products from bulk
compounds for resale by
pharmacies, practitioners, or
other persons.
 TERMS in the USP
• “preparation” is used to refer to
compounded prescriptions

• while “products” is used to refer to

manufactured pharmaceuticals
Elements of an Organization
1. Organization
- a mechanism for determining
and assigning duties to people,
in order to work effectively.
2. Business Organization
- combination of manpower,
money, machines and methods
BUSINESS ORGANIZATION

MAN
MONEY
POWER

MACHINE METHODS
Basic Elements of an Organization
1. Division of Responsibility (Obligation
or Duty)

2. Delegation of Authority

3. Determination of the Interrelationship

among the functions of each of the
component of the organizational plan
1. Division of Responsibility
(Obligation or Duty)

 Responsibility must be delegated.

 The company objectives must be

determined and the organizational
plan must be consulted with the
aim of achieving them.
2. Delegation of Authority
 Authority
must be defined and
delegated to avoid negligence
of duty.
3) Determination of the
Interrelationship among the
functions of each of the
component of the
organizational plan

 Topromote harmonious
teamwork.
Basic Tools in an Organization

I. Organizational Planning
II. Position Description
III. Organizational Manual
 I. Organizational
Planning
- interpreted as a “chart”
PRESIDE
NT

TECHNICAL
PERSONNEL FINANCE MARKETING
DIRECTOR
PLANT

Research and Product QC

Dev’t
1.Characteristics
It lists all important
of an positions
and functions
Organizational Chart of each
divisions or department

2. It is a means of quickly
showing the shape or structure
of the company to employees
and other interested parties
outside the company
 Importance of a Chart
1. Can analyze organizational problems
like overlapping of functions

2. Can assess the strengths and

weaknesses in the functions and
personnel

3. Can plan changes in the structure, if

not applicable
Some Drawbacks in the Chart
1. Cannot reveal company objectives and
policies

2. Cannot indicate a delegated authority

3. Reveals little about working relationships

 II. Position Description
• This will clearly define the authority,
duty or responsibility of the areas in
the chart.
III. Organizational Manual

• “Management Guide”

• It combines the chart and

position descriptions, with
description materials about the
organization
Basic Levels of Top
Management and their
Functions
Level I- Board of Trustees or
Board of Directors
Functions:
1. To protect and make the
most effective use of the assets
of the company
2. Establishes objective and
determines the basic policies and
general course of the business
3. Represents and safeguards
the interests of the stockholders.
Level II- President

Function:
Active planning, direction,
coordination and control of the
business within the scope of
policies established and
authorized by Level I
management.
Level III- Vice President, General
Managers and Department Managers
Functions:
1. Manages the major departments
of the company
2. They are fully responsible and
accountable to the Level II
management for the success of their
respective operations.
3. They embraces the topmost level
of executives concerned with a
particular division of the company
rather than the enterprise, as a
whole.
Forms and Organizational
Structure
1. Functional Structure
- it groups all activities on the basis
of the functions alone. This is
more appropriate for a small
company or one with closely
related products.
Forms and Organizational
Structure
1. Functional Structure
- All production, sales, and financial
activities are under one head. It is
flexible, facilities and coordination,
and encourages specialization in
the field.
2. Divisionalized Structure
- it combines into one unit, all
different kinds of work necessary
to accomplish a specific result.
The kinds of work necessary may
be grouped on a geographical
basis or more commonly on a
product basis.
Definition of Line and
Staff
• LINE

- it is identified as the chain of command

from top to the bottom of the organization.
- constitutes the framework of the
organizational structure
- have direct responsibility to accomplish
the objectives of the enterprise
- have the power or authority to initiate and
carry through other primary activities
necessary to reach the stated goal of the
company.
• STAFF
- constitutes the work functions
or the organization component
that are required to supply
information and services to the
“line” components.
ORGANIZATIONAL CHART
FIVE (5) MAJOR
DEPARTMENTS
I. Personnel
II. Finance
III. Marketing
IV. Technical Director
1. Research & Product Development
and QC
V. Plant
1) Personnel department
-coordinates labor and management
relationship

2) Finance department
-consist of cost accounting, forecast
and budget and general accounting
3) Marketing department
-consist of market research, sales
and detailing and advertising

4) Technical director
- research and product
development, quality control of
drugs and cosmetics
5) Plant department

- production control,
warehouse, manufacture of
pharmaceuticals, manufacture of
cosmetics and maintenance.
FIVE (5) MAJOR DEPARTMENTS

I. Personnel
II. Finance
III. Marketing
IV. Technical Director
1. Research & Product
Development and QC
V. Plant
Research & Product
Development
1) Chemical research
2) Biological research
3) Pharmaceutical research
 CHEMICAL
RESEARCH

CHEMICAL CHEMICAL ANALYTICAL

DEVELOPMENT SYNTHESIS CHEMISTRY
 BIOLOGIC
AL
RESEARC
H

PHARMACOL ANIMAL MICROBIOLO

OGY RESEARCH GY
 PHARMACEUTICAL
RESEARCH

PHARMACEUTICAL CHEMICAL
DEVELOPMENT SYNTHESIS
3 STAGES OF RESEARCH

Clinical
Applied Research

Preliminary Research Stage

Stage Stage
Preliminary stage
- consist of market research,
literature review, patent
search and raw materials.
Applied research stage
- consist of chemical studies,
development of chemical
process and cost research.
Clinical research stage
- consist of manufacturing
requirements, research on
label, review of basic
information, product control,
contract with therapeutic trial
committee, patent application,
and cost of clinical trial.
QC FOR DRUGS &
COSMETICS
1) Specifications & Assay Dev’t
Section
2) Central Release Section
3) Chemical Control Section
4) Plant Inspection Section
5) Biological-Microbiological Section
I. Specification & Assay
Development Section

PURPOSE:
1) Conform to appropriate standards of
identity, purity, potency, quality,
physiological availability and therapeutic
activity
2) meet government rules and regulations
3) prevent potential hazard to public health
I. Specification & Assay Development Section

A. Raw materials & containers

specifications
B. Finished product specifications
A. Raw Materials
• Usual criteria: *Additional:
• Description • particle size
• Solubility • crystal shape
• ID • surface tension
• melting point • Viscosity
• loss on ignition • irritation
• residue on
ignition • foreign
• specific rotation substance
• refractive index • Allergenic
• specific gravity substance
• assay • toxicity
Containers
1) Physical changes of containers
upon prolonged contact with
product
2) Moisture & gaseous permeability
3) Compatibility between container &
product
4) Toxicity and safety considerations
B. FINISHED PROUCT
SPECIFICATION

• Developed jointly by:

– QC
– Research and Product Development
– Sales or Marketing Production
– Management Individuals
Usual criteria: Additional:
• Description • Dissolution rate
• ID • content uniformity
• moisture content • related foreign substances
• Ph • Irritation
• specific gravity • microbial content
• alcohol content • stability
• Hardness
• disintegration time
• wt variation
• Sterility
• Pyrogenicity
• Safety
• assay
Specifications
for a product are developed
not only to assure quality but
to detect and identify
impurities
2 Kinds of Impurities
1) Product specific impurities
(eg, degradation)

2) Product unspecific
impurities
(external)
Factors to be considered in the
development of specifications
for dosage form or finished
products:
1) Ascertain which physical, chemical
and biological characteristics of
dosage forms are critical, which are
important, which are helpful, and
which are not particularly important,
but useful
2) Decide which dosage form
characteristics shall be established as
the criteria for evaluating routine
production batches.

3) Establish appropriate test methods

4) Determine the acceptable tolerances

for each of the dosage form
characteristics
Assay Development
Section
Purpose of varying or completely
changing assay methods:
1) Greater accuracy in testing
2) More rapid results thus contribute
to reduction in cost of operation
3) Increase in the number of samples
tested without increase in cost or time
especially with the growing use of
automation in testing
QC FOR DRUGS &
COSMETICS
1) Specifications & Assay Dev’t
Section
2) Central Release Section
3) Chemical Control Section
4) Plant Inspection Section
5) Biological-Microbiological Section
II. Central Release
Section
Functions:
1) To examine meticulously the
records resulting from the exercise
of QC functions throughout all
steps of manufacturing and
packaging for completeness and
accuracy and to assume
responsibility for their safekeeping
and storage
2) To investigate customer complains
or inquiries on product quality
since this section has an easy
access to records of
manufacturing and packaging
operations
3) To maintain complete and accurate
records of the receipt and
distribution of every lot of raw
material and finished product
4) To keep retention samples in
locked areas under similar
conditions comparable to the
market conditions
5) To properly record and handle
finished products returned by
pharmacies and hospitals
QC FOR DRUGS &
COSMETICS
1) Specifications & Assay Dev’t
Section
2) Central Release Section
3) Chemical Control Section
4) Plant Inspection Section
5) Biological-Microbiological Section
III. Chemical Control
Section
Functions:
1) To test and assay every lot of raw
material, in-process products and
every lot of finished product
2) To conduct stability studies
QC FOR DRUGS &
COSMETICS
1) Specifications & Assay Dev’t
Section
2) Central Release Section
3) Chemical Control Section
4) Plant Inspection Section
5) Biological-Microbiological Section
IV. Inspection & Checking
Section
Functions:
1) To inspect sample every shipment
of raw materials and every lot of
finished product
2) To conduct stability studies
3) To inspect and check all
manufacturing operations, including
in-process filling and labeling as well
as periodic examination on the quality
of stocks in the warehouse.

4) To sample retention or reserved

samples withdrawn from the
packaging line for finished products
and from the warehouse for raw
materials
Retention samples
- are portions of materials or
finished products taken from the
same lot tested and assayed
Retention samples
• at least 2 labeled containers of
the final dosage form

• 2 times the quantity required for

testing.

• at least 2 years after distribution

or 2 years after expiry,
whichever is shorter.
QC FOR DRUGS &
COSMETICS
1) Specifications & Assay Dev’t
Section
2) Central Release Section
3) Chemical Control Section
4) Plant Inspection Section
5) Biological-Microbiological Section
V. Biological-Microbiological
Control Section
Functions:
1) To perform and evaluate
microbiological and
pharmacological assays
2) To do sterility, pyrogenicity,
bacteriological, irritation, and
safety/toxicity tests.
Description of QC
Department
• Director of QC
– is the individual directly responsible
for the quality of drug products in a
manufacturing company.
– he should report directly only to the
President, Vice President or Technical
director (same level as the Production
manager)
QUALITY CONTROL
– is a staff function as a service
department supporting but not
subordinate to production
supervision

– Responsibility for quality is shared

by all, but QC has ultimate
jurisdiction over the release of
every product manufactured and/or
filled and packaged
PLANT DEPARTMENT

I. Production control
II. Warehouse division
III. Engineering &
Maintenance
IV. Manufacture of
pharmaceuticals
V. Manufacture of cosmetics
I. Production Control
1) Purchasing – requisitioned items for
the company, both from local and imported
sources

2) Inventory control – watches closely

and records all materials used in
production;

3) Planning & Scheduling - coordinates

with marketing on what products are
required for supply and then plans and
schedules the manufacturing order (MO);
manufacturing at the time limit allowed.
 PRODUCTION
CONTROL
DIVISION

PLANNING AND
PURCHASING INVENTORY
SCHEDULING
SECTION SECTION
SECTION
II. Warehouse division
Consists of 5 sections
1) Raw material – consists of 3
subdivisions
– Quarantined area
– Approved for use area
– Rejected area
 WAREHOUSE
DIVISION

RAW FINISHED RETURN

IN- PROCESS DISPENSING
MATERIALS GOOD GOODS
SECTION SECTION
SECTION AREA AREA
2) In-process
- consists of products which
have been bottled or
stripped, packed but not yet
labeled, or packed into
boxes or cartons because
they are awaiting QC tests
and assays for final
3) Finished Product:
- this area contains the
products packaged and
finished and are ready for
distribution and sale
4) Returned goods
- In as much as returns
cannot be avoided, goods
returned are stored in a
section of the warehouse
pending disposition by QC
control
5) Dispensing:
- area where raw materials for use in
production are weighed and/or
measured.

* Supervisor should be pharmacist,

checker is required to avoid errors
*QC inspectors do routine checks on
all areas of warehouse
 MANUFACTURE
OF
PHARMACEUTIC
ALS

MEDICATED PACKAGING
STERILE
LIQUIDS APPLICATIO SOLIDS AND
PRODUCTS
NS FINISHING
 MANUFACTURE
OF
COSMETICS

PERSONAL
HAIR FACE SHAVING
CLEANLINES
PREPARATIO CREAMS PREPARATIO
S
NS POWDERS NS
ITEMS
III. Engineering & Maintenance
section
• care and maintenance of all
machines used in the plant
department including electric
lines, water lines, repair of
defective equipment.
IV. Manufacturing of
Pharmaceuticals
• Prepares master formula
GOOD MANUFACTURING
PRACTICES (GMPs)
• GMPs are regulations
developed by the FDA.
• GMPs are minimum
requirement that the industry
must meet when
manufacturing, processing,
packing, or holding human and
veterinary drugs.
• These regulations. Also known as
cGMPs, establish criteria for
personnel, facilities, and
manufacturing processes to ensure
that the finished drug product has
the correct identity, strength,
quality, and purity characteristics
QUALITY CONTROL
• Group within the manufacturer
that is responsible for
establishing process and
product specifications.
• Specifications: criteria to
which a drug product should
conform to be considered
acceptable quality for its
intended use.
• The QC unit tests the product and
verifies that the specifications are
met .
• QC testing includes the acceptance
and rejection of the incoming raw
materials, packaging components,
drug products, water system, and
environmental conditions that exist
during the manufacturing process.
QUALITY ASSURANCE
• is the group within the
manufacturer that determines
that the systems and facilities
are adequate, and that the
written procedures are followed
to ensure that the finished drug
product meets the applicable
specifications for quality.