purchase specifications of raw materials, selection of vendors, control on raw materials and maintenance of stores of raw materials

1. SEMINAR
ON
RAW MATERIALS
Presented by
D.K.HARSHINI
Regd. No. 15ACISO405
M.Pharmacy 1st year 2nd semester
VIGNAN INSTITUTE OF PHARMACEUTICAL
TECHNOLOGY1

2. CONTENTS
a. PURCHASE SPECIFICATIONS
b. SELECTION OF VENDORS
c. MAINTENANCE OF STORES
d. CONTROL ON RAW MATERIALS
2

3. All materials that are used in the
manufacturing of a finished bulk (even
though it may not be present in final
product Eg. Certain solvents) are called
as raw materials.
 Raw materials can be either active drug
or inactive substance.
RAW MATERIALS
3

4. PURCHASING
Purchasing is an activity
directed towards
procuring the materials,
supplies, equipments
and services required in
the operations of an
enterprise.
4

5. SOURCE
QUALITY
QUANTITY
PRICE
TIME
PLACE
PURCHASE OBJECTIVES
5

6. PURCHASE
DEPARTMENT
The organizational setup of a
purchase department
depends on the size of the
company.
Purchase Manager is
responsible for the effective,
efficient and economic
operation of the department.
6

7. Ordering
section
Records
section
Service
section
FUNCTIONS OF PURCHASE
DEPARTMENT
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8. TYPES OF PURCHASING
CENTRALISED
 When different branches of a
company require similar type
of raw materials, then
centralised purchasing is
preferred.
DECENTRALISED
 When different branches of a
large organisation, require
different types of materials,
decentralised purchasing is
adopted.
8

9.  Recognition of need and receipt of
requisition
 Selection of potential sources of supply
 Inviting quotations
 Receipt and analysis of quotations
 Issuing the purchase order
 Receiving the material and inspecting it
 Checking of invoice and recording of bills
 Releasing the payment to the supplier
STEPS INVOLVED IN PURCHASE
PROCEDURE
9

10. First
stage
Survey stage Identifying potential
sources of suppliers
Second
stage
Enquiry stage Analysis of information in
standard enquiry format
Third
stage
Negotiations
and selection
stage
Quality control
specifications,
clarification, credit,
quantity discounts
Fourth
stage
Experience and
evaluation
stage
Performance appraisal
SELECTION OF VENDORS
10

11. SURVEY STAGE
Trade directories
Web browsing
Trade journals
Telephone directories
Supplier`s catalogues
Salesmen
11

12. Internal facilities of vendors
Financial adequacy and stability
Reputation of vendor
Location of vendor`s factory
Industrial relations
ENQUIRY STAGE
12

13. Credit
Quality specifications
Quantity discounts
PURCHASE ORDER
NEGOTIATION STAGE
13

14. The buyer evaluates and appraises the performance of
the vendor.
The objective is to improve the performance of vendors
in which they are deficient.
Evaluation is done especially on two counts viz.,
 Quality
 Delivery
EVALUATION OF VENDORS
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15. Location of stores :
The stores should be located adjacent to the
manufacturing area. The location depends upon the
nature and value of items to be stored and the
frequency with which items are received and issued.
Objectives of store location :
1. Minimum wastage of space
2. Maximum ease of operations
3. Minimum handling costs
4. Minimum other operating costs.
MAINTENANCE OF STORES
15

16.  Inspection centre
 Space for storing retained samples for quality control
 Centralised weighing room
 Washing room
 Quarantine room
FACILITIES
16

17.  Storage conditions :
- Room temperature should be 30° C and R. H. 60%
- A.C storage (25± 2 ° C & R.H. 45 – 55%)
- Low temperature storage 2 – 8 ° C
- Light sensitive material in amber color container
 Labeling of material in storage area :
- Designated name of product and internal code
reference
- Batch no. given by supplier
- Status of Content
- Expiry date or date beyond which retesting is
necessary
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18. FUNCTIONS OF STORE DEPARTMENT
a. General functions
18

19. b. Specific functions
Receiving and recording of
raw materials
Quarantine first storage
Positioning and final storage
Issuing and recording of
Materials
Receiving and dispatching
of finished goods
Sampling
and
approval
by QC
Distribution
Production
Vendors or
subsidiary
units
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20. S.NO Name of
material
Brand
name
Date of
receipt
Name of
supplier
Quality
receipt
Invoice
No. &
date
Raw material receiving observation
sheet
20

21. Ref. SOP No.
Raw material sampling observation
sheet
Name of material
Claimed grade (IP/BP/USP)
Import/ Mfg LIC No.
Name & Address of
Manufacturer
Name of Packer/ Trader if
any
Inner lining of bags
Checked against
Specification No. 21

22. S.No Batch No Quantity Mf
g.
dt.
Exp.
date
No. of
packs
sampled
Sample
quantity
Container
No. of
sample
Qty
per
pack
No. of
packs
Total
qty.
1.
2.
3.
S.No. Batch No. No. of pack
damaged
Type of
damage
Remarks
1.
2.
22

23. Observation during sampling:
1. Form :
2. Odour : Sampled by:
3. Spillage if any : Sample handed
4. Colour over to :
5. Foreign matter: Name: Date:
Ref. No:
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24. It is essential to:
Ensure the correctness of stocks held.
 Avoid shortage of materials
 Checks the losses in inventory
 Helps in assessing the insurance coverage
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25. METHODS OF PHYSICAL
VERIFICATION OF
STOCKS
1.Annual physical
verification system
2. Perpetual
inventory and
continuous stock
taking system
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26. Good raw material specifications must be
written in precise terminology and must be
complete.
 It should provide specific details of test
methods, type of instruments and manner of
sampling.
 CGMP states that raw materials be received,
sampled, tested and stored in a reasonable
way.
 The rejected materials should be disposed
 The records of these steps be maintained.
CONTROL ON RAW MATERIALS
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27.  In practise, the manufacturer physically inspects
and assigns lot numbers to all raw materials
received and quarantines them.
 Each raw material is sampled according to standard
sampling procedures and sent to the QC lab for
testing according to the written procedures.
 If acceptable, label is prepared including:
LOT NUMBER
NAME OF MATERIAL
ITEM NUMBER
DATE OF RELEASE
REASSAY DATE
SIGNATURE
and sent to the storage area.27

28. QA personnel should keep preservation samples of
active raw materials.
 All required tests are performed, to determine
whether the material meets the established
specifications.
 Approved materials should be used as per FIFO
rule.
 Any material not meeting specifications must be
isolated from the acceptable materials and labelled
as rejected.
 This procedure assures that cross- contamination
does not take place because of improperly cleaned
equipment.
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