m.pharm analysis, pharmaceutical analysis, food analysis, cosmetic analysis and evaluation, modern bio analytical techniques, advanced pharmaceutical analysis, phamaceutical validation

1. Subject: Quality control and
Quality assurance
Karnataka college of Pharmacy
Topic: Purchase specification &
maintenance of store for raw materials
Submitted by:
Abhishek
M Pharm 2nd semester
Dept of pharmaceutical analysis
submitted to:
Dr.C Sreedhar
prof. & HOD
Dept of pharmaceutical analysis
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Karnataka college of pharmacy

2. RA
W MATERIAL
• It is defined as the starting material used in manufacturing
of finished product.
• All materials that are used in the manufacturing of the finished
bulk and which are consumed by Person using it are called as raw
materials.
• Raw materials can be either active drug or inactivesubstances.
Eg.Hard Gelatin Capsules
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Karnataka college of pharmacy

3. PURCHASE SPECIFICATION :
It is a written guidelines that precisely define the
operational, physical, and chemical characteristics, as
well as the quality and quantity of a particular item to be
acquired.
Mode of purchasing :
• Inspection
• Sample
• Description of brand
• Grading
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Karnataka college of pharmacy

4. STEPS INVOLVED IN PURCHASE
PROCEDURE
• Purchase requisition
• Selection of supplier
• Inviting quotation
• Placing the order
• Receiving the material
• Checking the bill
• Recording of bill in book
• Receiving the payment to supplier
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Karnataka college of pharmacy

5. Regarding purchasing of raw materials
following points should be considered
• Cost of raw material.
• Identity, purity and quality of raw material.
• Vendor selection: Materials should be purchased and sourced
only from approved suppliers and manufacturers. Choice of
vendor should be primarily based on quality consideration
and Supplier/ Manufacturer of the material should have his
name listed in companies approved vendors list.
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Karnataka college of pharmacy

6. • All raw materials should be checked for following
things:
1. Name of the manufacturer/ supplier.
2. Name of the product/material.
3. Batch numbers
4. Date of manufacture and date of expiry.
5. Quantity received and number of containers or
packages.
6. Condition of containers and materials.
• Storage conditions: store at low temperature, low
humidity away from direct light etc.
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Karnataka college of pharmacy

7. • Labels on raw materials
1. The name and code number of the product.
2. The batch number given by the supplier/manufacturer.
3. Storage conditions.
4. Melting/ Boiling point.
5. Molecular weight.
6. Expiry date of the product
7. Handling hazards associated with raw material.
8. Precautions/Safety measures.
• Instructions for sampling.
• Frequency of re-examination of stored raw material
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Karnataka college of pharmacy

8. MAINTENANCE OF STORE
• Location of stores :
• the stores should be located adjacent to the
manufacture area, the location depends upon the
nature and value of item to be stored and the
frequency with which item are received and issued.
• Objective of store location:
• Minimum wastage of space.
• Minimum handling costs
• Minimum other operating costs.
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Karnataka college of pharmacy

9. STORAGEAREA
There should be a sufficient area/ Capacity for the storage of raw
materials.
The area used for storage of raw materials should be clean, dry and
maintained within acceptable limits of environmental conditions.
There should be a well equipped and appropriately designed
reception area for receipt of raw materials.
There should be a Separate area for sampling.
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Karnataka college of pharmacy

10. There should be separate areas for storage of
rejected, recalled or returned material.
There should be a separate Safe and secure area
for storage of narcotics, psychotropic, hormones,
steroids, highly active, dangerous and risky
material to avoid hazards and contamination of
other products.
There should be a separate area for in-process
materials, bulk products and finished products.
There should be separate areas for retained
samples.
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Karnataka college of pharmacy

11. STORAGE CONDITIONS
The raw materials in the store should be stored according to its
storage conditions required.
For general product: Room temperature should be 30◦C and
Relative humidity should be 60%.
Products requiring storage in air conditioning (Temperature
should be 25± 2◦C & Relative humidity should be 45 to 55%)
Products requiring Low temperature storage (Temperature should
be 2 to 8◦c)
Separate area for sterile product storage inAC under sterile
conditions.
Light sensitive material in amber color container.
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Karnataka college of pharmacy

12. Designated name of product and code
Batch no. given by supplier
Storage conditions
Handling procedure
Hazards and risks associated with it.
Precaution to be taken.
Safety Measures
Expiry date or date beyond which retesting is necessary
LABELLING OF MATERIAL IN STORAGEAREA
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Karnataka college of pharmacy

13. THANK YOU
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Karnataka college of pharmacy