The document discusses material management in the pharmaceutical industry. It defines material management as the planning, organizing, and control of materials from initial purchase through their destination. The key functions of material management include purchasing, handling raw materials, packaging materials, intermediate and bulk products, finished products, rejected materials, recalled products, returned goods, and reagents. Maintaining proper documentation and quality control is important at each stage to ensure consistency and quality of pharmaceutical products.

1. MATERIAL
MANAGEMENT
Presented by: DESAI BHAKTI R.
Class: M-pharm ( Sem-I )
Sub: AQAT
Guided by: Mrs. S. MAHAPARALE

2. CONTENTS
 Introduction.
 Defination.
 Objectives.
 Functions of Material Management.
 Advantages.
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3. INTRODUCTION
 The prime objective of the pharmaceutical manufacturing
operations is to produce finished pharmaceutical products
from active, inactive raw materials and various packaging
materials.
 The quality of finished products produced solely depends
upon the quality inputs and hence MATERIAL
MANAGEMENT becomes a very important activity in
pharmaceutical manufacturing operations.
 The total material management activity starts from
selection of vendors for raw materials to packaging
materials to dispatch of finished products to its destination.
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4. DEFINATION
 Material managementis a scientific technique, concerned
with Planning, Organizing & Control of flow of materials,
from their initial purchase to destination.
 The scope of material management lies on :
1. Material Planning.
2. Material Obtaining.
3. Material Controlling.
4. Material Storing.
5. Material Handling.
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5. OBJECTIVE
1. Maintain steady flow of material.
2. Achieve economy in terms of material.
3. Ensure consistency of quality.
4. Reduction of inventory cost.
5. Conservation of the materials.
6. Minimize operational cost.
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6. FUNCTIONS OF MATERIAL
MANAGEMENT
 The following points should be considered for the
pharmaceutical material management:
1. Purchasing.
2. Raw materials.
3. Packaging materials.
4. Intermediate and bulk products.
5. Finished products.
6. Rejected and Recovered materials.
7. Recalled products.
8. Returned goods.
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7. 6
9. Reagents and culture media.
10. Waste materials.
11. Reference standards.
12. Miscellaneous materials.

8. PURCHASING
 All materials should be purchased against an approved
and adequate specification which defines not only the
grade and quality of the materials, but also the nature of
the packaging and container to be used.
 Materials should be purchased and sourced only from
approved suppliers and manufacturers.
 Raw materials and Packaging materials should only be
purchased by buyers who are trained and who possess
sufficient technical knowledge.
 DOCUMENT REQUIRED:
1. SOP/R vendor certification.
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9. RAW MATERIALS
 Supplier/ Manufacturer of the received material should
have his name listed in companies approved vendors list.
Such list should be available with the receiving
department.
 All raw materials and other related materials should be
checked for following things, after receiving:
1. Name of the manufacturer/supplier.
2. Name of the product.
3. Batch numbers.
4. Date of manufacturer and date of expiry.
5. Quantity received and number of containers.
6. Condition of containers and materials. 8

10.  All received materials must be properly identified with
their status (e.g. received, sampled, approved, rejected, to
be returned back, etc.) labels and materials identification
like, product name, batch number, code number, sterility
status, etc.
 Materials in the storage area should be appropriately
labelled. Labels should bear atleast the following
information:
1. The name and internal code number of the product.
2. The batch number.
3. Status of the material.
4. Retest and expiry date of the product.
5. Appropriate special storage conditions.
 Containers from which samples have been taken out
should be identified.
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11.  Each dispensed material and its weight or volume should
be independently checked and the check recorded.
 DOCUMENT REQUIRED:
1. List of approved vendors with materials.
2. List of materials classified according to storage
conditions.
3. SOP on sampling, storage and dispensing of materials.
4. Register of sampling and dispensing activities.
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12. PACKAGING MATERIALS
 Packaging materials are divided into following categories:
1.Primary Packaging Materials: Materials which come in
direct contact with the medicinal product. E.g. bottles,
ampoules, vials, foils, etc.
2.Secondary Packaging Materials: Materials which come in
contact with the primary packaging materials, e.g. labels,
carton etc.
3.Printed Packaging Materials: All packaging materials
which have any thing printed on it; even error medical
literature sent along with finished product is also put in
this category. Such materials include labels, cartons, foils,
etc.
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13. 4. Tertiary and other Packaging Materials: All other packaging
materials other than those covered in the above three categories.
 While handling all these materials following points should be
kept in mind.
1. The purchase, handling and control of primary and printed
packaging materials shall be as for raw materials.
2. Access to all storage areas should be limited to authorised
personnel only.
3. A separate sampling room should be provided for sampling of
primary packaging materials, which should be a fairly clean area.
 DOCUMENT REQUIRED:
1. A list of approved vendors along with names of materials.
2. Sampling and dispensing register in chronological order.
3. A list of materials based on their storage conditions.
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14. INTERMEDIATE AND BULK
PRODUCTS
 Intermediate and bulk product storage is the
responsibility of the production department.
 Intermediate or bulk product may be defined as the
material, which has started processing but not yet got
converted into the finished saleable product e.g.
1. Granulated materials ready for compression.
2. Compressed tablets for coating or packaging.
3. Filtered or unfiltered liquids for oral or injectable etc.
 These products should be kept under appropriate
storage conditions of temp, relative humidity, class of
air etc.
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15.  Intermediate or bulk products purchased as such should
be handled on receipt as though they were raw
materials.
 DOCUMENT REQUIRED:
1. List of categories of intermediate and bulk products
along with their storage conditions.
2. Other requirements if any e.g. how much time such
materials can be stored for further processing etc.
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16. FINISHED PRODUCTS
 Finished products are products which are in the
marketable pack.
 These products should be held in quarantine until their
final release,after which they should be stored as usable
stock under conditions established by the manufacturer.
 Each batch of the finished product should be tested as
per laid down testing procedure against its specifications
and then only released for distribution or sale.
 DOCUMENT REQUIRED:
1. SOP on releasing of the finished product.
2. SOP on reprocessing of rejected finished product. 15

17. REJECTED AND RECOVERED
MATERIALS
 Rejected materials may be defined as materials at any
stage, which have been tested against a set of predefined
specifications and found not meeting the specification
fully.
 We can deal with such materials mainly in two ways:
1. Reprocess and retest the materials to see whether it
meets our specific requirements.
2. Destroy or send it to the supplier.
 Rejected materials and products should clearly marked
as such and stored separately in restricted areas.
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18.  Such areas in industry are normally painted RED in
colour to make it distinguishable easily.
 Such materials should either be returned to the
suppliers or reprocessed or destroyed.
 Rejected production batches should be reprocessed in
exceptional situations.
 Reprocessed batches should be given a new number by
means of which, such batches can be identified as
reprocessed batches.
 DOCUMENT REQUIRED:
1. SOP on handling of rejected materials.
2. Record of disposal of rejected materials.
3. SOP on handling of recovered materials.
4. Record of disposal of recovered materials. 17

19. RECALLED PRODUCTS
 Products, which are already distributed or sold, may be
required at times to be recalled from market for various
reasons e.g. substandard quality detected after the
product was distributed, damage of goods during transit.
 Such recalled products should be clearly identified and
stored separately in a secure area until a decision is
taken on their fate.
 DOCUMENT REQUIRED:
1. SOP on handling of recalled products.
2. Records of recalled products and action taken on such
recalled products.
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20. RETURNED GOODS
 Pharmaceutical products can be returned from the
market for various reasons. E.g. quality problems,
accidental damage of goods etc.
 Such products when returned from the market should
have the following action immediately taken on it.
1. Physically examine the condition of the goods returned.
Also check all the relevant documents.
2. Ask Q.C department to evaluate the quality of the goods
received, and take a decision on whether these products
can be reprocessed and recovered or needs to be
destroyed.
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21.  If it is possible to reprocess and recover, then such
products after reprocessing and retesting may be
considered for relabelling, repacking and resaling the
same.
 Q.C. department should evaluate all aspects like
condition of the received material, time elapsed since it
was first processed etc. along with the chemical,
microbiological or any other technical evaluations.
 Any action taken should be recorded.
 DOCUMENT REQUIRED:
1. SOP/R on handling of returned goods.
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22. REAGENTS AND CULTURE
MEDIA
 All reagents and culture media should be recorded upon
receipt or preparation.
 Reagents made up in the laboratories should be
prepared according to written procedures and
appropriately labelled. Such labels should indicate
following information viz.
a) Name of the reagent.
b) Nominal concentration (e.g. 1 N, 0.1 N etc.).
c) Standardisation factor (1N=0.996 N etc.).
d) Shelf life ( or use before date).
e) Date when re-standardisation is required.
f) The storage conditions. 21

23.  A register be maintained giving details of the reagents
made, standardised, restandardised and used and
destroyed if any.
 Both positive and negative controls should be applied
to verify suitability of the culture media.
 The size of the inoculum used in positive controls
should be appropriate to the sensitivity required.
 DOCUMENT REQUIRED:
1. Register of reagents and culture media.
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24. WASTE MATERIALS
 The waste materials can be classified mainly in two
categories:
1. Trash : which do not have any resale value and may be
disposed off by proper method depending upon the
nature of the trash.
2. Scrap : which do have a resale value and may be sold to
scrap dealers, after proper segregation.
 Toxic substances and flammable materials should be
stored in suitably enclosed cupboard, as required by
national legislation.
 Waste materials should not be allowed to accumulate.
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25.  It should be collected in suitable containers for removal to
collection points outside the buildings, and disposed off
safely and in a sanitary manner at regular intervals.
 Before disposal of these materials, they can be segregated
in different categories:
1) Paper
2) Aluminium foils
3) Plastic
4) Glass
5) Metallic containers etc.
 DOCUMENT REQUIRED:
1. SOP and Records of handling waste work materials. 24

26. REFERENCE STANDARDS
 Reference standards may be available in the form of
official reference standards.
 Reference standards prepared by the producer should
be tested, released and then stored in the same way as
official standards.
 They should be kept under the responsibility of a
designated person in a secure area.
 Official reference standards should be used only for the
purpose described in the appropriate monograph.
 All such reference standards should be stored and used
in a manner that will not adversely affect their quality.
 DOCUMENT REQUIRED:
1. SOP and Records on handling of reference and
working standards.
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27. MISCELLANEOUS MATERIALS
 All those materials, which do not specifically fall under
the category of raw materials and packaging materials,
intermediates, bulk and finished pharmaceuticals may be
considered under this category of miscellaneous
materials.
 Such materials like,rodenticides, insecticides, fumigating
agents and sanitising materials fall under this category,
these materials should not be permitted to contaminate
equipment, raw materials, packaging materials, inprocess
materials or finished products.
 DOCUMENT REQUIRED:
1. List of miscellaneous materials handled in
pharmaceutical plants.
2. SOP on handling of miscellaneous materials.
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28. ADVANTAGES OF MATERIAL
MANAGEMENT
1) Reducing the overall costs of materials.
2) Better handling of materials.
3) Reduction in duplicated orders.
4) Materials will be on site when needed and in the
quantities required.
5) Improvements in labour productivity.
6) Improvements in project schedule.
7) Quality control.
8) Better field material control.
9) Better relations with suppliers.
10) Reduce storage of materials on site.
11) Stock reduction, purchase savings and better cash flow
management.
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29. REFERENCE
1. Manohar A. Potdar, “Pharmaceutical Quality
Assurance”, Nirali Prakashan, Fourth Edition : April
2015, page no: 4.1-4.18.
2. J.R. Tony Arnold, Stephen N. Chapman, “ Introduction to
Material Management”, Pearson Publication, Sixth
Edition, page no: 2-10.
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