The document discusses requirements for weighing and dispensing operations during pharmaceutical production. It outlines that dispensing should take place in a clean room environment maintained at controlled temperature, humidity, and positive pressure. Specific facilities like dispensing booths, balances, utensils storage, and pass boxes are needed, separated from personnel and material flows. Standard operating procedures and documentation must also be established to validate the dispensing system.

1. TRAINING ON WEIGHING & DISPENSING

2. TRAINING ON WEIGHING & DISPENSING
A K M Nurul Alam Chowdhury
AGM, Production (ASPL)

3.  Requirements for production
 Facility
 Man
 Machine
 Material
 Method (Process)

4. Facility for Solid Dosages Form Production (Contd.)
Production Processing up to Primary packaging.
Clean room-class D
Maintain pressure difference 10-15 Pascal and negative pressure for production
room.
Unidirectional flow
Air Lock with interlocking system.
Dynamic Pass box.
Controlled temperature and humidity where required.
Separate Man Material entrance.
Spares wash dry and storage.
IPQC
WIP
Spares room
Maintenance area
Technical area.

5. Facility for Solid Dosages Form (Production) Dispensing
Clean room-class D
Dispensing booth, Balance, Utensils
Maintain pressure difference 10-15 Pascal
Controlled temperature and humidity
Separate Man Material entrance
Utensil wash, dry and storage
Weighing Material Day Store
Dynamic pass box
Air lock

6. Facility for Solid Dosages Form Production (Contd.)
Secondary Packaging Area
Controlled Area
Maintain pressure difference10-15 Pascal and negative pressure
Controlled temperature
Secondary Packaging Material Day Store
Printing Area
Airlock
WIP
IPQC
Spares room
Dynamic Pass box (if required)

7. Facility for Solid Dosages Form Production (Contd.)
Personnel Garments Change area:
Controlled Area/Clean Area-class D
Maintain pressure difference 10-15 Pascal
Airlock
Air shower
Water shower system
Disinfections system
Individual Dress locker

8. Man
 Establishment and maintenance of satisfactory system of manufacture
and control of products and actives rely on people
 Must be sufficient qualified personnel to carry out tasks
 Individual responsibilities must be clearly defined and understood by
individuals concerned
 Written job descriptions
 All personnel should be aware of the principles of GMP that affect them
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
 All responsible staff should have specific duties recorded in individual
written job descriptions

9. Facility design that meets WHO cGMP and UK-MHRA stands
Environment controlled and monitored through integrated Building Management System
(IBMS) supported by latest dynamic software networking to ensure central monitoring and
complete automatic operation of the plant.
Plant designed with smooth impervious and easy to clean sandwich panels and self-leveling
epoxy finish through out all manufacturing area, QC & PDD area.
All QC equipments maintained NIST traceable calibration standard.
Most modern Purified Water generation with loop system is available to maintain highest
quality of purified water as per latest USP guideline.
Most modern fire management system also available to manage any fire incident .
Environment friendly Effluent Treatment Plant and incinerator are available for management
of liquid and solid waste disposal as per local regulatory requirements.

10. GMP DISPENSING
ENVIRONMENT
PRODUCT
PROTECTION
PERSONNEL
PROTECTION
ENVIRONMENT
PROTECTION
Contamination
(Product & Staff)
Prevent Contact
with dust
Avoid dust
discharge
Protect from Product
Cross-Contamination
Prevent Contact
with
Avoid fumc
discharge
Correct temperature
& humidity
Acceptable Comfort
Conditions
Avoid effluent
discharge
SYSTEM
SYSTEM VALIDATION

11. Areas where pharmaceutical starting materials, utensils and equipments are exposed to the environment
should be classified as clean areas.
Weighing and Dispensing operations in separated area.
Smooth, impervious (not to be penetrated), durable (permanent) easy to clean finished.
Appropriate design – say
-Dispensing Booth, Balance, Utensils
-Maintain Room pressure
-Temperature Control
-Humidity Control
-Location of Air terminates and direction airflow
-Separate personnel flow
-Separate material flow
-Utensil wash, dry and storage
-Dynamic pass box
-Air lock
-Cleaning procedures and records
-Documentation, e.g. SOPs.

12. Dispensing Booth
To Prevent cross contamination of material by environment, human and
others during dispensing of pharmaceutical raw materials, a dedicated
and confined area under laminar air flow (LAF) unit are used that are
called dispensing booth. It facilities with conditioned air through HEPA
filter and Maintains positive air pressure in respect adjacent area to
prevent flow of external air.
Procedures
Preparatory phase
Personnel must wear clean cloths, headgear, facemask, shoe and hand
gloves before entering in dispensing area.