Organization Chart

Principle : All personnel should be aware of

GMP
Must receive training in GMP:
 A satisfactory system of QA,
manufacture and control of ä initial training
products and APIs rely on people.
ä continuing training
 Must be sufficient qualified
personnel to carry out tasks. ä including hygiene standards
 Individual responsibilities must be
Motivated to
clearly defined and understood by
individuals concerned. ä support the establishment
 Written job descriptions.
ä maintain high-quality
 All personnel should be aware of standards
the principles of GMP that affect
them.

Personal Requirements
Adequate number of persons
With necessary qualifications
With practical experience
An individual’s
responsibilities should not be
so extensive as to present a
risk to quality

Key Personnel
  Authorized person
 Head of Production
 Head of Quality Unit
- Quality Assurance
and Quality Control
Should have appropriate qualifications :
Scientific education such as:
chemistry or biochemistry, chemical
engineering, microbiology,
pharmaceutical sciences and technology,
pharmacology and toxicology, physiology
Should have appropriate experience
 Practical experience
 Manufacture and quality
assurance
 Preparatory period under
professional guidance
sometimes needed
 Education and experience should
enable personnel to take difficult
decisions in an independent,
professional and scientific way
 resolve the problems
encountered in
manufacturing and QC
Shared Responsibilities
Heads of Production and Quality Unit
may share some responsibilities :
1. Authorization of written
procedures (SOPs) and other
documents
2. Monitoring and control of
manufacturing environment
3. Hygiene
4. Process validation and calibration
5. Training, including application
and principles of QA
6. Approval and monitoring of
suppliers and contract acceptors
7. Designation and monitoring of
storage conditions for materials
and products
8. Performing and evaluating in-
process controls
9. Retention of records
10. Monitoring compliance with GMP
11. Inspection, investigation, and
taking of samples to monitor
factors which may affect quality
Responsibilities
:
Head of Production Head of Quality Unit Authorized person
 Product production  Approve or reject  Approval of the
and storage starting materials, release of finished
according to packaging materials, product for sale
appropriate and intermediate,  No batch of product
documentation bulk and finished is to be released for
 Approval and products in relation sale or supply prior
implementation of with their to certification by the
production specifications authorized person(s).
instructions, in-  Evaluate batch  Assessment of
process QC and records finished product
ensure strict  Maintenance of the
implementation department, premises
 Checks maintenance and equipment
of production
department, premises
and equipment

Trai
ning
Induction and continuing training

on theory and practice of GMP

Training, in accordance with a written,
approved programme
and their duties
training records should be kept
practical effectiveness checked
training before undertaking any
new task

all personnel whose duties take

them into production areas;
into control laboratories; and
for others whose activities could
affect the quality of the product
including technical, maintenance
and cleaning personnel
Specific training for staff in special areas,
e.g.
 Where contamination is a hazard
 Clean areas
  Areas where highly active, toxic,
infectious, sensitizing materials
are handled
Equipment
 Manufacturing equipment should
be adequate for the operations
performed and should be
designed, constructed, placed and
maintained in such a way to:
i. be suitable for its intended use
ii. be easily dismantled for inspection or it
should be demonstrated that routine
cleaning procedures eliminate the
possibility of contamination;
iii. minimise any contamination, risk of
confusion or the omission of a processing
step during manufacturing;
 Weighing and testing equipment
used in manufacture and quality
control should be calibrated,
checked and properly recorded at
regular intervals and maintained
properly to enable them to
perform their proper functions.
 Written procedures should be
established and followed for
cleaning and maintenance of
equipment, including utensils used
in the manufacture, processing,
packing or holding of traditional
medicines and health supplements.
 Equipment used for the
preparation of internal products
should be separated from that of
external products.
Cleaning And Sanitisation
Of Equipment
Equipments and utensils should be
cleaned both inside and outside after use
according to established procedures and
should be kept or stored in a clean
condition and be checked for cleanliness
prior to each use to ensure that all
products or materials from the previous
batch are removed.
Any missing components such as nuts,
springs, clips, etc. should be reported and
investigated immediately.
Vacuum or wet cleaning methods are
preferred. Compressed air, fibrous
material and brushes should be used with
care and avoided if possible, as they
increase the risk of product
contamination.
Adequate space, preferably separated
from processing areas, should be provided
for cleaning and storing mobile
equipment and the storage of cleaning
materials.
Written procedures should be established
and followed for cleaning and sanitising
equipments, utensils and containers used
in the manufacture of traditional
medicines and health supplements.

These procedures should be designed to

prevent equipment contamination by
cleaning or sanitising agents and should at
least include the following:

i. responsibility for cleaning,

ii. cleaning schedule,

iii. cleaning methods,

iv. equipment and materials used in

cleaning operations,

v. methods of disassembling and

reassembling equipment.

vi. removal of previous batch

identification

vii. protection of clean equipment and

utensils from contamination prior to use.

Records of cleaning, where appropriate

sanitising and inspection prior to use
should be maintained.

premise
LOCATION AND DESIGN :
 Premises must be located at a
suitable site approved or in
accordance with the relevant
authorities.
 Premises should be so located as
to avoid contamination from the
surrounding environment such as
air, earth and water pollutants as
well as from other nearby
activities. Should it occur that the
premises are unsuitably located,
effective measures should be taken
to avoid such contamination.
 Defined areas for the following
operations are required:
i. incoming goods and quarantine;
ii. storage of starting materials;
iii. weighing and dispensing;
iv. processing;
v. storage of bulk products;
vi. packaging; vii. quarantine
storage before final release of
products;
viii. storage of finished products;
ix. laboratories;
x. equipment washing.
CLEANING AND
SANITISATION OF PREMISES:
There should be written
procedures assigning
responsibility for sanitation and
describing cleaning schedules,
methods, equipment, materials to
be used and facilities to be cleaned
in sufficient detail. Such written
procedures should be followed.
Changing rooms into the
production areas should have
adequate hand washing facilities.
Suitable locker facilities should be
provided at appropriate locations
for the storage of employees
clothing and personal property.
Waste material should not be
allowed to accumulate. It should
be collected in suitable receptacles
for removal to collection points
outside the buildings and disposed
off safely and in a sanitary manner
at regular and frequent intervals.
Prouduction
Area
Interior surfaces (walls, floors and
ceilings) should be
i. smooth and free from
cracks and open joints;
ii. should not retain and shed
particulate matter;
iii. should permit easy
cleaning and if necessary
disinfecting.
Buildings should be effectively lit
and ventilated with air control
facilities (including temperature,
humidity and filtration)
The condition of buildings should
be reviewed regularly, and
repaired where necessary.
Quality
Control Area
Laboratories or quality control
areas should be separated from
production areas. There should be
adequate suitable storage space for
samples and records.
Storage Area
Storage areas should be of adequate
space, provided with suitable lighting,
arranged and equipped to allow dry, clean
and orderly placement of stored materials
and products.
Such areas should be suitable for effective
separation of quarantined,
recalled/returned, rejected and
approved/passed materials and finished
products.
Special and segregated areas should be
available for storage of flammable and
explosive substances, highly toxic
substances, rejected and recalled materials
and products.
Crude (i.e. unprocessed) natural materials
should be stored in separate areas. The
store area should be well ventilated and
equipped in such a way as to give
protection against insects, or other
animals, especially rodents. Effective
measures should be taken to prevent the
spread of any such animals and
microorganisms brought in with the crude
natural materials to prevent fermentation,
mould growth and cross-contamination.
Containers should be located in such a
way as to allow free air circulation.
Labels and other printed materials should
be stored in a proper manner to avoid
mix-up.