The document discusses requirements for solid dosage form production including facility, man, machine, material and method requirements. It outlines the necessary facility features for weighing and dispensing operations such as clean rooms, air pressure controls, temperature and humidity controls, and material and personnel flow separation. Proper procedures are described for dispensing including preparatory checks, dispensing phases while maintaining material separation, and post-dispensing cleaning and documentation. Clean room classifications and types including unidirectional flow are also summarized.

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 fumes
Avoid fumes
discharge
Correct temperature
& humidity
Acceptable Comfort
Conditions
Avoid effluent
discharge
SYSTEM
SYSTEM VALIDATION

11.  Some of the Basic Criteria to be considered during Weighing & Dispensing.
 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.

13. Procedures
Preparatory phase
 Personnel must wear clean cloths, headgear, facemask, shoe and hand gloves before entering in
dispensing area.
 Make sure that the dispensing area has the relative humidity below and temperature below.
 Check that the dispensing booth is cleaned and mentioned in the respective booths log sheet.
 Switch on the dispensing booth 15-20 minutes prior any operation and ensure magnehelic pressure (across
HEPA Filter) is within
 Make sure the selected balance’s calibration sticker is valid that ensure correct performances with two
standard weights everyday before weighing.
 Clean the exterior surface of bulk container and bring it to material air lock prior entering to dispensing area.
 Ensure all required bulk containers are brought in front of dispensing booth and the QA Ref. No. &
containers number coincide with numbers mentioned in requisition sheet.
 Take required apparatus from cleaned cabinet and check that the poly bag in which the scoop, utensil or
spoon was packed, has the tag “ Cleaned with valid signature and date.”

14.  Dispensing phase
 Dispensing pharmacist shall raise approved BMR to warehouse to supply the relevant ingredients.
 Dispensing pharmacist shall receives the raw materials through aerodynamic pass box followed by check the parameters
involves:
-QA approval affix on the bag/drum/container.
-Name of ingredients that are correspond to the formula stated in BMR.
-QA ref. No. set down in BMR by warehouse personnel are correspond to the reference stated in QA release tags.
-Date of Expiry of each ingredients.
 Followed by checking, materials shall preserve in the Day Materials Store Room prior to dispensing.
 Dispensing shall carry out in the dispensing booth under the active control of laminar air unit.
 Dispensing shall bring off in presence of dispensing pharmacist and relevant QA Executive.
 On getting QA approval, Operator/workers shall convey the materials to the relevant booth and carry out the operation
maintaining following sequences:
-Outer bag, container lid shall be open with the help of cutting devices or other means.
-fresh & dried poly bag shall be put on the balance and tare.
-On weighing, close the material container and poly bag immediately to avoid moisture including loss as well as cross
contamination.
-Label of material name, quantity and potency shall be fasten with the poly bag using rubber bent.
 Keep all corresponding materials of batch of product in a s s drum or pallet with a label of product Name, Batch number & transfer
to the dispensed materials day store room.
 Take all used apparatus, scoops, utensils in a closed bucket to wash room for cleaning followed by during.

15.  Clean Room
 A clean room is defined as a room in which the concentration of airborne particles is controlled.
 The clean rooms have a defined environmental control of particulate and microbial contamination and are
constructed, maintained and used in such a way as to minimize the introduction, generation and retention of
contaminates.
 Clean room classifications are established by measurement of the number of particles 0.5 micron and
larger that are contained in 1ft3 (one cubic foot) of sampled air Generally class 100 to 100000 room are
used in the pharmaceutical industry.
 General acceptance of all pharmaceutical facilities:
-Tab letting facilities -class 100000 equivalent (Grade D)
-Topical & oral liquids -class 10000 equivalent (Grade C)
-Injectables class -class 100 equivalent (Grade A & B)
 So, class D is the area where the particle count must no exceed a total of 100000 particles per cubic foot of
a size 0.5 micron and larger.

16.  Types of Clean Room
 Clean rooms are also categorized by the way supply air is distributed. There are generally two air supply configurations used in
clean room design:
1. Non-unidirectional
2. Unidirectional
 Non-unidirectional air flow may provide satisfactory control for cleanliness levels of class 1000 to class 100000.
 The Unidirectional Air flow pattern is a single direction air flow of parallel streams. It is also called laminar air flow since the
parallel streams are maintained within 18 dag.-20deg. deviation. The velocity of air flow is maintained at 90 foot per minutes  20.
 Unidirectional clean rooms are used where low air borne contaminant levels are required and where internal contaminants are the
main concern.
They are generally two types
1. Vertical down flow clean room - where the air flow is vertical directional
2. Horizontal flow - where the air flow is horizontal directional.
 Between the two the vertical down flow pattern yield better result and is more adaptable to pharmaceutical production.