Analysis of Raw materials….. This topic comes under Quality Control and Quality Assurance……. This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I...... This Presentation Contain following... #Definition #Purchase Specification #GMP & WHO guidelines for handling of raw materials #Control on Raw Materials #Sampling of Raw Materials #Raw Materials Testing Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam

1. Presented By
Mr. Pritam P. Kolge
First Year M. Pharm
Department Of Pharmaceutical
Quality Assurance
Bharati Vidyapeeth College Of
Pharmacy, Kolhapur
ANALYSIS OF RAW MATERIALS
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Guided By
Dr. F. A. Tamboli
Assistant Professor and Head
Department Of Pharmacognosy

2. CONTENTS :
 Definition.
 Purchase specifications.
 Control on raw materials
 Sampling of raw materials
 Raw material’s testing
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3. RAW MATERIALS
 It is basically the chemical ingredients of a
process. Basic raw materials are starting
material, which is used in production of final
product.
 Raw materials can be either active drug or
inactive substances
 The basic material from which a product is made.
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4. PURCHASE SPECIFICATION
 Definition :
 Written guidelines that precisely define the
operational, physical, or chemical characteristics,
as well as the quality and quantity of a particular
item to be acquired.
 Mode of purchasing :
 By inspection
 By sample
 By description of brand
 By grading
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5. Steps involved in purchase procedure :
1. Purchase requisition
2. Selection of supplies
3. Inviting Quotation
4. Placing the order
5. Receiving the material
6. Checking of invoice or bill
7. Recording of bills in books
8. Releasing the payment to the supplier
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6. Criteria for raw materials purchase
specification
 It must be noted that pharmacopoeial standards
are minimum.
 Where no such stds. are applicable to raw
material, the specifications should include at
least requirements for identification, limits for
purity and potency and limits for impurities.
 Where such standard exist for raw material,
alternative test methods may be used but there
should be written evidence to show that such
method are at least as precise and specific as
the official methods.
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7.  Staff involved in purchasing have a particular
and thorough knowledge of products and
suppliers.
 Raw material can be purchased from supplier
named in relevant specification or directly from
procedure.
 Specification established by manufacturer for the
starting materials be discussed with suppliers.
 Pharmacist or chemist, who is familiar with
quality requirement of various material purchase
department can be head of purchase
department.7

8. As per GMP & WHO guidelines for handling
of raw materials
 On receipt , each delivery of raw materials
should be visually examined for labels, damage
to containers.
 Raw materials, then should be transferred to
quarantine area and labels over printed with
words under test.
 Quality control for sampling.
 Quality control persons should withdraw the
sample from quarantine. While sampling, the
point should be kept in mind :
- sample should be representative of the
batches.
- all sampling equipment must be clean.8

9.  On receipt of approval or rejection of the raw
material, it should be transferred to area marked for
approved materials or rejected materials.
 Raw material should be stored in clean container.
 Raw material should be stored at optimum
temperature and humidity.
 It should be inspected at some intervals.
 It should be stored in such a manner that material
received first is issued first.
 The clean equipment should be used for
dispensing.
 Raw materials are used only when are approved by
quality control department.9

10. Preparing A Prospective Supplier List
 You can search for the potential vendors by
looking at several information sources :
- Past experiences
- Interviewing with the salesperson of the
supplier
- Catalogs published by the vendors
- trade directories
 Classifies suppliers according to the products
they make
 Includes names of company personnel, financial
status, and location of sales offices.
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11. Types of suppliers
 In the search for suppliers, all available types
that is distributors, manufacturers, and foreign
sources should be considered.
 The number of suppliers to be used should
also be considered.
 Trade-offs between price, delivery, and
service and community relations and good will
must be weighed when selecting various
types of vendors.
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12. Local VS. National Suppliers
 There are inherent natural advantages to buying
from local suppliers whenever possible.
 Among the most significant are the following :
1. Saving of money when the distance between firms is
relatively short.
2. Close proximity permits for communication and
service; shorter lead times , and exchanges .
 There are also considerations that favor
national suppliers:
1. Low price
2. Large inventory
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13. Raw Material Control
 There is sufficient management systems in place
to control the handling and use of all raw
materials on site.
 The staff is sufficiently informed, instructed ,
trained and supervised to minimize a potential
human failing during raw material delivery, test
and storage.
 The procedures in place to test the suppliers of
raw materials ( Audits, supplier history, reputation
).
 Raw materials with abnormally high microbial
contamination may have to be subjected to a
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14.  Quality assurance should make periodic
sanitation and follow up to assure that
deficiencies are corrected.
 Warehouses are the first operational area
observed by the auditor to check operational
compliance with cGMP & FDA regulation.
 Following elements need to be considered when
establishing warehouses operation :
Cleanliness , floors , lighting & SOPs
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15. Sampling Of Raw Materials
 After sampling instrument under laminar flow.
They are to be tested on sterile cloths throughout
sampling process to prevent contamination.
 Prior to containers being opened, they need to
be marked in numerical order on the outer
container. This identified the container number
from which will be taken.
 Sterile jar are marked with marker with the
information relating to their type of sample.
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16. o Print out the sampling labels which has the
following information.
Laboratory batch number
Product description
Sample type
Number of samples
o Examine all material containers for damage
before sampling. Report any damage to
laboratory manager.
o Don’t touch any material with your hand. Always
use appropriate sampling tools.
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17. o The analyst should wear gloves for sampling of
raw materials.
o Samplers are to clean room with respect to
absence of watches, rings, nail polish etc.
o Before sampling any raw material, read carefully
the given instruction on raw material
specifications.
o The air conditioning setting and timer are not to
be alter in any way
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18. Raw Material’s Testing
o Raw materials testing ensures that the raw
materials used in pharmaceutical products are
suitable for their intended use.
o Conducting raw materials analysis using
appropriate test methods and successfully
meeting the challenges of such testing can
prevent costly production problems and delays.
o Before finished pharmaceutical dosage forms are
produced, the identity, purity, & quality of raw
materials must be established with the use of
suitable test methods.
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19. oAnalytical Chemistry & Testing
• Ph meters
• Balances
• Gas chromatography
• HPLC
• UV spectrophotometers
• Vacuum ovens
• Melting point apparatus
• TLC
• Polari meters
• Refractometers
• viscometers
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20. Quality control of packed raw materials in
pharmaceutical industry
 The possibility of routine testing of
pharmaceutical substances directly in warehouse
is of great importance for manufactures
 The application of NIR instruments with remote
fiber optic probe makes these measurements
simple and rapid.
 On the other hand carrying out measurements
through closed polyethylene bags is a real
challenge.
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21. o As a result, testing can be performed not only in
the lab but also directly in a warehouse.
o Raw materials are quickly tested for identity and
quality conformance.
o Once a model for a substance is developed,
routine testing takes place in few seconds,
making it possible to test every unit of incoming
ingredient to verify the identity.
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22. THANK
YOU
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