Manuf

MANUFACTURING

The complete set of activities to produce a drug that comprises
production and quality control from dispensing of materials to
the release for distribution of the finished product.

Secondary Manufacturing

production of finished dosage
form or drug product from API and excipients

Tertiary Manufacturing

production of packaging,
labeling and repacking of bulk finished product

Toll Manufacturing

an arrangement whereby a competent
company processes raw materials, semi-finished goods, and
packages product for another company.

DRUG DISTRIBUTOR (IMPORTER/EXPORTER)

Imports or exports raw materials, active ingredients or finished
products for its own use or for wholesale distribution on whole
sale basis.

Extemporaneous Compounding

Small scale preparation of drug products
Prescription order
Specific for a particular patient

DRUG MANUFACTURER

Any establishment engaged in operations involved in the
production of drugs.

DRUG MANUFACTURER

a. Proprietary/Generic Manufacturer
b. Ethical Manufacturer
c. Biological Manufacturer
d. Veterinary products Manufacturer
e. Medicinal chemical Manufacturers
f. Toll/ Contract Manufacturer

DRUG DISTRIBUTOR (IMPORTER/EXPORTER)

Imports or exports raw materials, active ingredients or finished
products for its own use or for wholesale distribution on whole
sale basis.

DRUG DISTRIBUTOR (WHOLESALER)

Procure raw materials, active ingredients and or finished product
from local establishment or for local distribution on wholesale
basis.

DRUG TRADER

Registered owner of the drug product but subcontracts toll
manufacturer of such products to a licensed manufacturer.

May also engage in distribution and or marketing of products.

Research and Development Department

Formulates and develops new product, improves existing
products.

Does pharmaceutical, chemical and physiologic researchers.

Production Department

Manufacture drug products according to schedule (Manufacturing
order)

Warehousing,
Inventory control
Storage

Quality Control and Quality Assurance Department

Ensure that all operations involved meet the standards of quality,
purity, safety and efficacy.
Assures the compliance to CGMP.
"Heart and Soul" of a drug manufacturer
Sampling, testing

Engineering Department

Install maintains and repairs equipment and facilities
Ensures the safety of the plant and employees/personnel.

Marketing Department

Promotes maximum volume of sales of products (Advertisement)
Monitors product status, consumers behaviour and market
trends.

Purchasing Department

Purchases, receives and inventories of supplies

Medical Department

\#Does annual or quarter physical and medical examination of
employees and applicants.
\#Does the Clinical studies
\#Prepares product inserts and literature
\#Publishes company's

Regulatory Affairs Department

\#Responsible for the processing of all regulatory processes.
\#Responsible for product registration.

Primary Manufacturing

produce API and excipients

Types of Pharmaceutical Manufacturing:

Primary Manufacturing
Secondary Manufacturing
Tertiary Manufacturing
Toll Manufacturing

DEPARTMENTS IN A DRUG ESTABLISHMENT

1. Research and Development Department

2. Production Department

3. Quality Control and Quality Assurance Department

4. Marketing Department

5. Engineering Department

6. Purchasing Department

7. Medical Department

8. Regulatory Affairs Department

HEPA FILTER

In all manufacturing rooms, air supply
and air exhaust points
shall not be so close or so disposed as
to resist or
negate the
supply of clean air to worksites and or movement
of product
dust or other contaminants away from worksite.

Locker/Gowning room

shall be directly connected to
but separated from the processing areas.

Lighting

Adequate lighting shall be provided in all areas.

Aseptic processing

\#Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable
\#Temperature and humidity controls
\#An air supply filtered through high-efficiency particulate
air filters under positive pressure, regardless of whether flow is laminar

Plumbing

Potable water shall be supplied under continuous positive
pressure in a plumbing system free of defects that could contribute
contamination to any drug product. Potable water shall meet the
standards prescribed in the Environmental Protection Agency's
Primary Drinking Water Regulations set forth in 40 CFR part 141.

COMPOUNDING AREA

In this area the formula is compounded, and
although it is not essential that this area be aseptic,
control of microorganisms and particulates should
be more stringent than in the materials support area.

ASEPTIC AREA

Requires construction features designed
for maximum microbial and particulate control.

MATERIALS SUPPORT AREA

-Constructed to withstand moisture, steam and detergents
and is usually a Class 100,000 clean room.
Ceiling, walls and floor should be constructed of
impervious materials
Finishes with vinyl or epoxy-scaling coat provides a
continuous surface free from all holes or crevices.

CLEAN ROOM CLASSIFICATIONS

Clean room designations assigned by the
International Society of Pharmaceutical Engineers.

The objective of Pharmaceutical R&D

defined as "converting ideas into candidate drugs for development"

The objective of product development

defined as "converting candidate drugs into products for registration and sale"

Product Lifecycle Management (PLM)

to maximize the early growth of the product on
the market, sustain peak sales for as long as the product is in patent and delay the post-patent expiry decline for as long as possible.

Product Life cycle

refers to all phases in the life of a product from the initial development through marketing until product's discontinuation.

BREATH-ACTUATED AEROSOL

\#Designed to co-ordinate drug delivery with the patient's inhalation to achieve this.
\#This improvement in inhaler technology to ensure a more efficient delivery to the lungs, with minimal drug deposition in the mouth and trachea

BIOERODIBLE POLYMERS

That can be implanted or injected within the body to administer drugs from a matrix which can be formulated to degrade over a long duration from one day to six months, and do not require retrieval.

ELECTROPHORESIS

This method could be particularly useful for the delivery of
peptides and proteins which are not adequately transported by
passive transdermal therapy.
The drug absorption rate is very rapid and more controlled
compared with passive diffusion across the skin.

8. Regulatory Affairs Department

Responsible for the processing of all regulatory processes.
Responsible for product

DRUG ESTABLISHMENT

Any organization or company involved in the manufacture,
importation, repacking and/or distribution of drugs or medicines.
1.Drug manufacturer
2.Drug distributor (Importer/Exporter/Wholesaler)
3.Drug trader

Production Department

Manufacture drug products according to schedule (Manufacturing order)
Warehousing,
Inventory control
Storage

Engineering Department

Install maintains and repairs equipment and facilities
Ensures the safety of the plant and employees/personnel.

Purchasing Department

Purchases, receives and inventories of supplies

Marketing/commercial

Competitive
Meets customer needs
Value for money
Commercial return

Regulatory

Quality of
data/documentation

Manufacturing

Manufacturable
Able to pass pre-approval
inspection

Research

Novel compound
(patentable?)
Novel biological
mechanism (patentable?)
Unmet medical needs
Potent

Clinical

Tolerable side effects
profile
Efficacious
Acceptable duration of
action

Safety

High margin of safety
Non-toxic (not
carcinogenic, tetratogenic,
mutagenic, etc.)

Drug process

Bulk drug can be
synthesized/scaled up

Pharmaceutical

Acceptable
formulation/pack (meets
customer needs)
Drug delivery/product
performance acceptable

"over-the-counter" (OTC) status.

The rapid introduction of generic products when patents expire and moves to \_________

Give 3 Current Trends In The Pharmaceutical Industry

Trend 1. Source of Drugs
Trend 2. Sophisticated Drug Delivery Systems
Trend 3. more comprehensive documentation to demonstrate compliance CGMP & CGLP

Example of proprietary manufacturer

rite med/unilab

Example of Ethical manufacturer

Rx drugs or Prescribed drugs

Example of Biological manufacturer

Vaccine

Veterinary product manufacturer

Drugs for animals

Example of Medicinal chemical manufacturer

Reagents /Alcohol /Disinfectants

Give the process of Product life cycle

Initiation
Planning
Execution
Closing

Clean Area

An area with defined environmental control of particulate and microbial contamination constructed and used in such a way as to minimize the introduction, generation and retention of contaminants within the area.

Contaminants

Any biological or chemical agent, foreign matter, or
other substances that are not intentionally added to food, which may compromise food safety or suitability.

Component

Any ingredient intended for use in the manufacture of a product, which include raw and packaging materials, including those that may not appear in the finished product.

Accuracy

An indicator of how near an obtained value is, during
measurement or analysis, to a true value.

Acid foods or acidified foods

-Food that have an equilibrium pH of 4.6 or below.

Adequate

That which is needed to accomplish the intended purpose in keeping with good public health practice.

Controlled Area

An area constructed and operated to control the
introduction of potential contaminants.

Cross Contamination

Contamination of raw materials, in-process
and finished products brought about by other ingredients that may compromise food safety and suitability.

Critical Control Point

A step at which control can be applied and is
essential to prevent or eliminate a food safety hazard or reduce it to acceptable level.

Component

Any ingredient intended for use in the manufacture of a product, which include raw and packaging materials, including those that may not appear in the finished product.

Plant

the building or the facilities or parts thereof, used for or in connection to the manufacturing, packing, labeling or holding of food products.

Adulteration

To make impure by mixing in a foreign or inferior
substance.

Batter

A semi fluid substance, usually composed of flour and other ingredients, into which principal ingredients of food are dipped or with which they are coated, or which may be used directly to form bakery foods.

Pest

Any objectionable animals or insects including, but not limited to birds, rodents, flies, and larvae.

Calibration

Combination of checking an instrument and adjusting it to bring it within its limit for accuracy according to recognized standards.

Disinfection

The reduction by means of chemical agents and/or
physical methods, of the number of microorganisms in the environment, to a level that does not compromise food safety or suitability.

Packaging

The process of packing that is part of the production cycle applied to a bulk product to obtain the finished product. Any material, including printed material, employed in the packaging of a product, including any outer packaging used for transportation of shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.

Documentation

All written procedures, instructions and records
involved in the manufacture and quality control of products.

Facilities

Refers to the building, premises and equipment necessary for the manufacture, packing, repacking and holding of food.

Microorganisms

- Refers to yeasts, molds, bacteria and viruses and
includes, but is not limited to, species having public health significance. The term "undesirable microorganisms" includes those microorganisms that are of public health significance, that subject food
to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of RA 3720 as amended and other issuances.

Food

Any substance, whether processed, semi processed or raw which is intended for human consumption and including beverages, chewing gum and any substance which has been used as an ingredient on the manufacture, preparation or treatment of "food"

Food Allergens

usually proteins or protein fragments that trigger
well defined adverse reaction involving the immune system, most often mediated by immunoglobulin E. Examples of critical food allergens are: eggs, peanuts, tree nuts, milk, soya, fish, crustacean,
wheat and other gluten containing cereals.

Manufacture or Manufacturing

The complete set of activities to produce a product that comprise production and quality control from acquisition of all materials through processing and subsequent packaging to the release for distribution of the finished product.

Food Handling

Any operation in the preparation, processing,
packaging, repacking, storage, transport, distribution and sale of food product.

Food Hygiene

All conditions and measures necessary to ensure the
safety and suitability of food at all stages of the food chain.

Good Manufacturing Practice

A quality assurance system aimed at
ensuring that products are consistently manufactured, packed, repacked or held to a quality appropriate for the intended use. It is thus concerned with both manufacturing and quality controlnprocedures.

Lot

food produced during a period of time and under more or less the same manufacturing condition indicated by a specific code.

Holding

An indication that something is to be reserved or stored.

Ingredient

Any substance including food additive, used as a
component in the manufacture or preparation of a food and present in the final product in its original or modified form.

Premises

Plant and grounds within the bounds of the
industrial establishment.

Procedures

Description of the operations to be executed, the
precautions to be implemented directly or indirectly related to the manufacture and the repacking of food products.

Processing

The part of production cycle starting from weighing of raw materials to the obtaining of a bulk product.

Production

All operations involved in the preparation of a product, starting from acquisition of starting materials through processing and packaging, to its completion as a finished product.

Quality Assurance

The activity of providing the evidence needed to
establish confidence that the quality function is being performed adequately.

Quality Control Operation

A planned and systematic procedure for
taking all actions necessary to prevent food from being adulterated and thereby achieve its quality and safety.

Raw Material

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

Should

A term used to state recommended or advisory procedures or identify recommended equipment.

Shall

A term used to state specific minimum mandatory
requirements.

Sanitize

To adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, an in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the
product or the safety of the consumer.

Water Activity (aw)

A measure of the free moisture in food. It is the
quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.