Dispensing of Starting Materials

Winthrox labouratories (Pvt) Ltd
Plot number:k-219-A,S.I.T.E. phase II
Super highwaykarachi. Pakistan.
STANDARAD OPERATING Department: Issued on: Effective date:

PROCEDURE Ware house
TITLE: FOR DISPENSING OF STARTING Document num: Status num:01 Revision num: 00
MATERIALS
WT/WH/SOP-007
Written by: Reviewed by: Approved by:

Name: Name: Name:
Designation: Designation: Designation:
Signature Signature Signature
PURPOSE:
The purpose of this SOP is to describe the Procedure for dispensing of Starting
Materials.
1. SCOPE:
This Standard Operating Procedure is applicable to Dispensing Section of
Material Control Department.
2. RESPONSIBILITY:
 Manager Materials Control is responsible:
 To ensure that this SOP is being followed in its entirety.
 He is also liable to ensure compliance of general requirement for
dispensing.
 Stores Officer is over all responsible for all dispensing activities.
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
 He is also responsible to ensure that “four eye” principle is

followed during dispensing of all APIs and some other materials as
specified in this SOP.
 He is also liable to maintain the Log of dispensing and rotation of
dispensing staff that are exposed to potent APIs.
 Quality Assurance Officer is responsible:To give clearance to
dispensing section and ensure the fulfillment of other requirement
as per dispensing checklist prior to commencement of dispensing
activities.
 He is also responsible to ensure his presence during the dispensing
of APIs and other specified materials.
 For dispensing of all APIs, presence of Stores Officer and Quality
Assurance Officer is mandatory during the dispensing activity to ensure
the implementation of “four eye” principle.
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
 In case of absence of Stores Officer, Production Officer will serve in his

place with Quality Assurance Officer to witness the dispensing of APIs
and other specified materials.
 Production Officer is liable to acknowledge the receiving of dispensed
materials on MO (manufacturing order).
 Workers of the dispensing section are responsible to follow this SOP
during dispensing.
3. DESCRIPTION
4.1 Equipments used during Dispensing
i) Dispensing Sections and Booth

The Dispensing section is equipped with a dispensing booth which is supplied with
filtered air through HVAC and is equipped with HEPA filters at both supply and
exhaust.
a) Dispensing Booth
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MATERIALS
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Name: Name: Name:
This booth is adjacent to the Raw Material Storage area and is used for
dispensing of all starting materials (APIs and auxiliaries) and is supplied with
HEPA filter for dispensing.
ii) Balances
There are two balances available in the dispensing facility for weighing/dispensing
purpose;
 Balances No.1 is used in Dispensing Room for weighing of relatively smaller

quantities.
 Balances No. 2 is used in Dispensing Room for dispensing of relatively large quantity
weighing’s.
iii) Scoops
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MATERIALS
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Name: Name: Name:
Dedicated stainless steel scoops of different sizes are provided for dispensing purpose.
After dispensing, scoops are properly cleaned and stored in new polyethylene bags
afterwards.
iv) Containers
In warehouse, materials are present in bulk quantities stored in large container such as
drums, plastic bags, cartons, etc. For dispensing purpose, these containers are brought
into dispensing room and raw materials are dispensed in appropriate container as per
cGMP requirements.
a) Polyethylene bags
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
 Only new poly bags are allowed to be used.
 These bags are usually used for dispensing of solid material.
 After weighing the material, the bag is sealed with the sealing machine present in
dispensing section.
 Store Officer attaches the Starting Material identification Slip containing all
information about material and product with Polyethylene bag with the help of scotch
tape.
b) Stainless Steel containers
 S.S containers are used for dispensing of liquids.
 After weighing of raw material, lid of the container is placed properly.
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
 Then container is labeled with Starting Material identification Slip containing all the
information about the material and product.
 Tare weight of the container also includes weight of the lid of that container.
v) Gloves
 Disposable gloves packets are present in dispensing section.
 These are only allowed to use for single material.
 These have to be used by the workers and officers while handling the open raw
materials without touching the outer containers or other surfaces unnecessarily.
 Opening, closing and shifting of the outer containers has to be performed by the
worker without using gloves.
 Used gloves should be disposed off in dust bin lying in air lock.
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
vi) Secondary Gowning
 Secondary gowning made up of Parachute is worn by the dispensing workers.
 One secondary gown is used only for single dispensing and is sent for washing after
each dispensing.
vii) Masks
 Two types of masks i.e. air masks and cotton masks are stored in specified cabinet.
 All persons in dispensing area have to wear masks during the dispensing according
to the nature of material being weighed.
 Mask should be changed after dispensing of materials in campaign or earlier if

necessary.
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MATERIALS
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Name: Name: Name:
viii) Shoes
Canvas shoes are provided in the dispensing sections and are to be worn throughout
dispensing activity by the dispensing staff.
These shoes are not allowed to be worn outside the dispensing area.
During dispensing of APIs, shoe covers are also to be used for prevention of cross
contamination and must be changed upon material change over.
ix) Dusters and IPA spray bottle for cleaning
 Clean cotton dusters are used in dispensing area. To clean balance top, or dispensing
stool, same duster can be used which will be washed after dispensing of complete
batch or earlier if required.
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
 After dispensing each material in campaign, scoop is cleaned with IPA soaked
duster. Duster cannot be used for cleaning of scoop with which an active material or
adhesive material is dispensed.
x) Labels, Stationery, Calculator, Scotch tape
 Labels, stationery, calculator, Scotch tape are stored in the drawers of the table
placed in the Dispensing Office.
 Stationary and calculator is used according to the need.
xi) Dust bin for Waste Disposal
 A dust bin is provided in dispensing section air lock.
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
 Dust bin is emptied after completion of dispensing of each material in campaign and
sent for disposal. Dispensing waste and emptied containers (poly bags) of hazardous
materials and APIs are disposed off in yellow bags, while other non-hazardous
waste is disposed off in white bags.
4.2) Flow of Activities during Dispensing of Starting Materials
i) Switch on the dispensing booth (LFH) at least 10 - 15 before commencement of

dispensing activity.
ii) Clean and mop the balances, table and booth.
iii) Ensure that dispensing booth is working properly and negative pressure inside the
booth is maintained.
iv) Before start of dispensing / weighing, Quality Assurance Officer gives line clearance
as per checklist and Checks the working of the balances and the range of possible
weighing.
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MATERIALS
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Name: Name: Name:
v) One raw material is transferred to the dispensing area at a time.
vi) Stores Officer and Quality Assurance Officer verify all the details on the "Starting
Material Identification Slips".
Note: In case of APIs dispensing, “Four Eye” principle is followed.
vii) Incase potency adjustment is required, Stores Officer fills the potency Adjustment
form attached with Manufacturing order while Production Officer and Quality
Assurance Officer verifies it.
viii) Store Officer enters the net weight based on the potency adjustment on the“Starting
Material Identification Slips".
ix) Determine the tare weight of the polyethylene bags/containers and record it on the
“Starting Material Identification Slips".
x) Then one (of the two) helper (not wearing gloves) opens the lid of the outer
container, and the other helper, wearing gloves, opens the immediate container and
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
starts transferring the material into the container (Polyethylene bag) with the help of
scoop.
xi) Record the gross weight and net weight on the “Starting Material Identification
Slips".
xii) Store Officer records the name of the Starting Material dispensed and it’s Batch No.
xiii) The container of used raw material is closed and sent back to warehouse.
xiv) Incase of campaign manufacturing, bulk container of the active materials required
for dispensing should be transferred to airlock.
xv) After completion of the dispensing (API and excipients), switch off the booth and
clean the section including balances and booth as per SOP.
4.3) Instructions upon material Change Over
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MATERIALS
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Name: Name: Name:
 Dispensing helper cleans balances plate with IPA soaked duster.
 Sweeper mops the floor of the area with IPA.
 Empty containers of raw materials are removed by sweeper after dispensing of

complete batch or earlier if necessary (e.g. in case of large containers of oils, waxes,
etc).
4.4) Instruction for Oxygen sensitive materials
Those materials which are sensitive to oxygen (resulting in high peroxide values when
exposed to air) are to be stored under nitrogen pressure. Nitrogenation is to be carried
out as per SOP to avoid Oxidation.
4.5) Instructions for Personnel and Material Flow during Dispensing
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MATERIALS
WT/WH/SOP-007

Name: Name: Name:
i) Only two workers, Store Officer, Production Officer and / orQuality Assurance
Officer need to be present during dispensing. Avoid unnecessary personnel presence
and movement.
ii) Movement of Personnel should be slow during dispensing.
iii) Both dispensing room doors should be locked.
iv) Dispensed materials should not be placed in warehouse. S.S cupboards are used and
the dispensed of all the materials related to a product, are hand over to the
Production department.
4. DISTRIBUTION: SIGNATURE DATE

 Material Control Manager
 Production Manager
 QA Manager
 Store Officer
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Dispensing of Starting Materials

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Winthrox labouratories (Pvt) Ltd

Plot number:k-219-A,S.I.T.E. phase II

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

 He is also responsible to ensure that “four eye” principle is

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

 In case of absence of Stores Officer, Production Officer will serve in his

4.1 Equipments used during Dispensing

i) Dispensing Sections and Booth

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

 Balances No.1 is used in Dispensing Room for weighing of relatively smaller

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

 Only new poly bags are allowed to be used.

 These bags are usually used for dispensing of solid material.

b) Stainless Steel containers

 S.S containers are used for dispensing of liquids.

 After weighing of raw material, lid of the container is placed properly.

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

 Disposable gloves packets are present in dispensing section.

 These are only allowed to use for single material.

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

vi) Secondary Gowning

 Secondary gowning made up of Parachute is worn by the dispensing workers.

 Mask should be changed after dispensing of materials in campaign or earlier if

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

ix) Dusters and IPA spray bottle for cleaning

Super highwaykarachi. Pakistan.

STANDARAD OPERATING Department: Issued on: Effective date:

Written by: Reviewed by: Approved by:

Signature Signature Signature

x) Labels, Stationery, Calculator, Scotch tape

 Stationary and calculator is used according to the need.

xi) Dust bin for Waste Disposal

 A dust bin is provided in dispensing section air lock.