The document discusses the analysis of raw materials used in pharmaceutical manufacturing, noting that raw materials must be tested to ensure suitability, identity, purity and quality through various analytical techniques as outlined in pharmacopeial monographs, and that quality assurance procedures like instrument validation and deviation management are critical factors for raw materials laboratories.

1. ANALYSIS OF RAW MATERIALS
Submitted to,
Dr.R.S Chandan
Department of pharmaceutical
analysis ,
JSS college of pharmacy , mysuru.
Submitted by,
A SOWMYA
1st year. M.Pharm
Dpt.Pharamaceutical Analysis

2. What is raw material..?
• All materials that are used in the manufacturing of a
finished bulk (even though it may not be present in final
product E.g.. Certain solvents) are called as raw
materials.
• Raw materials can be either active drug or inactive
substances
• Raw materials used in industry are categorized into 3
types
• Raw materials for excipients
• Raw materials for API
• Raw materials for packaging
• e.g.. Hard gelatin capsules: even though it is used to fill
the blend of medicine, it is not considered as package
materials because it is consumed by person using medicines

3.  Raw materials testing ensures that the raw materials used in pharmaceutical products
are suitable for their intended use.
 Conducting raw materials analysis using appropriate test methods and successfully
meeting the challenges of such testing can prevent costly production problems and
delay.
 Before finished pharmaceutical dosage forms are produced, the identity, purity, and
quality of raw materials must be established with the use of suitable test methods.
 Pharmacopeial and formulary monographs such as the US Pharmacopeia–National
Formulary (USP–NF), the European Pharmacopeia, and the Japanese Pharmacopeia
provide standardized test methods for the most common and widely used materials.

4. ANALYTICAL APPROACH AND INSTRUMENTATION:
 Raw materials analysis requires a wide range of analytical chemistry expertise.
The most common tests performed in a raw materials laboratory include
1.Titrations
2.Loss on drying
3.Karl Fischer moisture determination
4.Heavy metals limit tests, and infrared spectrophotometry.
 Full monograph testing often requires many different analytical
techniques.
 For example, to perform full USP monograph testing for methyl
paraben, eight different tests using six analytical techniques ranging
from infrared absorption to gas chromatography are required.

5. QUALITY ASSURANCE
 From a quality assurance standpoint, three critical factors should be considered
when assessing a raw materials laboratory: instrument validation/qualification,
deviation management, and out-of specification (OOS) procedures.
 The diversity of instrumentation used by raw materials laboratories places a
heavy burden on validation efforts.
 In a raw materials testing laboratory, analytical chemists must be
experienced in troubleshooting methods using various analytical techniques
and instruments.
 Often working with raw materials supplier laboratory staff, the chemists
must balance scientific need for deviations or modifications with the
regulatory requirement to adhere to compendial methods.

6. SOP ON RECEIPT , STORAGE ,SAMPLING OF
MATERIALS.
A. Receipt of materials:
i. Visual examination for all incoming materials
Intact container, lid, seals
Evidence of any physical damage to the containers
Evidence of rodent or insect specification.
Proper labeling in specified manner
ii. Points to be checked & recorded
Date of receipt
Name of product, batch no., control no. assigned by
manufacturer.
Quantity received against document
Name of supplier
Purchase order no.
Excise gate pass etc.

7. B. Storage of materials:
i. External cleaning of container after receiving &before
storage
ii. Quantity verification
iii. Storage in specified area as per condition
R.T./ A.C./ Cool /cold/ low humidity area.
iv. Storage as per quarantine status of the material
received, sampled, approved, rejected .
C. Sampling of materials:
i. Sampling responsibility
ii. Sampling formula used
iii. Method of sampling e.g. top, mi
bottom sample is required.

8. Indian Pharmaceuticals Limited
Raw material receiving observation sheet
Sr no Material
name
Synonymous
Name/brand
name
Date of
receipt
Name of
manufacturer
supplier
Quality
receipt
1
2

10. CONTROL ON RAW
MATERIALS:

12.  Quality assurance should make periodic sanitation and follow up to assure that
deficiencies are corrected.
 Raw materials with abnormally high microbial contamination may have to be subjected
to a sterilization procedure like heat treatment, radiation or crystallization from a
bactericidal solvent like alcohol.
 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 .
19

14. REFERENCES:
 Pharmaceutical technology – analytical chemistry and testing
2003 by Gregory D Kupp
 CGMP for Pharmaceuticals by Manohar A. Potdar
 Equipments and raw materials R.S Bhatt