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ANALYSIS OF RAW MATERIALS

Presentation · October 2019

DOI: 10.13140/RG.2.2.15932.77444

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Pritam Kolge Firoj A. Tamboli

Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra, India Bharati Vidyapeeth college of Pharmacy, Kolhapur,(M.S.), India
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 ANALYSIS OF RAW
MATERIALS

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

➢ Definition.
➢ Purchase specifications.
➢ Control on raw materials
➢ Sampling of raw materials
➢ Raw material’s testing

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 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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 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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 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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 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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 ▪ 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.

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 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.
- containers should be resealed after sampling.
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 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.
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 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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 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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 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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 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 sterilization
procedure like heat treatment, radiation or crystallization
from bactericidal solvent like alcohol
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  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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 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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 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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 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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 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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 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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 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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 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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 THANK
YOU

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