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Presented by :- 
Mr. Shankar S.Yelmame 
M.Pharm 1st yr (QAT) 
Amrutvahini College of pharmacy, 
Sangamner 
1
 Introduction 
 Objective & importance 
 Principles of material management 
 Functions of material management 
 Purchasing 
 Vendor development 
 Types of Materials 
 References 
2
Definition 
It is an organizational concept, which has the 
authority & responsibility of all activities, 
principally concerned with the flow of materials in 
the organization. 
OR 
The International Federation of Purchasing and 
Materials Management accept the definition of 
materials management given below. 
“According to it, materials management is a total 
concept having its definite organization to plan and 
control all types of materials, its supply, and its flow 
from raw stage to finished stage so as to deliver the 
product to customer as per his requirements in time." 
3
 The prime objective of the pharmaceutical 
manufacturing operations is-to produce finished 
pharmaceutical pdts from active, inactive raw 
materials and various packaging material. 
 The quality of finished products is depend upon 
the quality inputs - hence material management is 
very important. 
4
Primary 
(i) Efficient materials 
planning 
(ii) Buying or Purchasing 
(iii) Procuring and receiving 
(iv) Storing and inventory 
control 
(v) Supply and distribution 
of materials 
(vi) Quality assurance 
(vii) Good supplier and 
customer relationship 
(viii) Improved departmental 
efficiency 
5
Secondary 
(i) Efficient production scheduling 
(ii) To take make or buy decisions 
(iii) Prepare specifications and standardization of materials 
(iv) To assist in product design and development 
(v) Forecasting demand and quantity of materials 
requirements 
(vi) Quality control of materials purchased 
(vii) Material handling 
(viii) Use of value analysis and value engineering 
(ix) Developing skills of workers in materials management 
6
 To procure right materials 
-In Right Quantity 
-Of Right Quality 
-At Right Time 
-From Right sources 
-At Right prices 
7
8
Centralized :- the purchasing 
procedure of materials for 
different department is done 
together from one 
purchasing department. This 
is seen in small 
organizations. 
Advantages 
 Efficient system 
 Bargaining capabilities 
increased 
 Good raw material obtained 
at lower price 
Decentralized:- different 
department purchase 
their requirement 
separately. This is 
basically seen in large 
organizations. 
Advantages 
 Flexible purchasing 
system 
 Procurement is faster 
9
 Vendor is a person who sells & supplies his products. 
 An intelligent purchasing process involves the rational 
selection of sources from which materials can be 
obtained. Considerable efforts are needed in 
identifying, developing & evaluating the prospective 
suppliers. 
 Factors to be considered in developing a vendor – 
- Quantity required to be purchased. 
- Time available for making such purchases. 
- If the material be required repeatedly or 
occasionally. 
10
Volume of the purchase of required materials. 
 Industry producing the required materials. 
Commercial viability of the materials. 
 For the purchase of items that are of repetitive 
nature, a detailed evaluation procedure of 
suppliers is adopted 
11
Need recognition 
Spell out of specifications & 
requirements 
Official requisitions 
Check specifications, 
prices/supplies 
Select suppliers 
Quotations & analysis prices and terms, negotiations, 
finalization 
Purchase order for supply 
Suppliers’ acceptance 
Specifications 
file 
Purchase 
records 
Supplier’s 
record 
Enquiry tender 
Follow-up 
12
13 
Delivery of materials 
Materials & reports, analysis 
Payment made 
Cont… 
Checking of invoice 
with purchase order
The various types of materials to be managed are: 
(i) Purchased materials: They are raw materials, 
packaging materials 
(ii) Work in process (WIP) materials: These are semi-finished 
and finished parts and components lying on 
the shop floor. 
(iii) Finished goods: These are the final products either 
waiting to be assembled in the assembly lines or in 
stores which are stocked for final delivery waiting 
to sell. 
14
 Supplier’s name –in companies approved vendor 
list. 
 all RM should be checked for-a) 
Name of supplier 
b) Name of the product 
c) Batch numbers 
d) Date of mfg and expiry 
e) Qty received & no. of containers 
f) Condition of containers and materials 
15
 All containers should be clean externally-if any 
damage-informed to QC Dept. 
 Should be protected from contamination during 
storage. 
 The materials received should be taken into account 
only after all the relevant documents are available-(e.g. 
bills,invoice,customs or excise gate passes,certificate 
of analysis etc.) 
 Sampling in specific sampling booths by Q.C. person 
and stored in sampled material quarantine. 
 Materials in the storage area should be appropriately 
labelled. label should bear – 
a) Name & internal code no. of the product 
b) Batch no. given by supplier and also given by 
receiver after analysis & release 
c) Status of material 
d) Retest & expiry date of the product 
e) Appropriate special storage conditions 
16
 Materials should be dispensed only by designated 
persons, following written procedure ,to ensure that the 
correct materials are accurately weighed or measured 
into clean and properly labelled container 
a) Correct name & category(IP/BP/USP) 
b) Correct wt. 
c) Batch no. of the product 
 All dispensed materials must be recorded in a register 
in chronological order of date and time.The record 
should have – 
a) Name of pdt & batch no. 
b) Time and date of starting and completion of the 
dispensing activity 
c) Name of weigher and checker of the dispensed 
materials. 
17
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 direct contact with the primary 
packaging materials. e.g.labels,carton etc. 
3) Printed packaging materials: all PM which have 
any thing printed on it;even error medical literature sent 
along with finished pdt is also put in this category. 
e.g.labels, cartons,foils etc. 
4) Tertiary & other packaging materials: All other 
PM other than those covered in the above three 
categories. 
18
 Intermediate & bulk product may be defined as the 
material , which has started processing but not yet 
got converted into the finished saleable product. 
 Intermediate & bulk product storage is the 
responsibility of the production dept. 
Examples. 
 Granulated materials ready for compression 
 Compressed tablets for coating or packaging. 
 Filtered or unfiltered liquids for oral or injectables. 
 These pdts should be kept under appropriate 
storage condition of temp, relative humidity, class 
of air etc. 
19
 Finished products are products which are in 
marketable pack. 
 Should be held in quarantine until their final 
release, after which they should be stored. 
 Each batch should be tested against its 
specifications and then released for distribution or 
sale. 
 Products faiing to meet the established 
specifications should be rejected. 
 Reprocessing may be performed,if feasible,but the 
reprocessed product should meet all specifications. 
20
 Materials at any stage, which have been tested 
against a set of predefined specification and found 
not meeting the specifications fully. We can deal 
with such material mainly in two ways: 
a) Reprocess and retest the materials to see whether 
it meets our specific requirements 
b) Destroy or send it to the supplier. 
 Clearly marked as such and stored separately in 
restricted areas.Such areas in industry are normally 
painted red in colour. 
21
 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. 
22
 Pharmaceutical products can be returned from 
market for various reasons. e.g.quality problems, 
accidental damage of goods etc. 
 physically examine the condition of the goods 
returned. 
 Ask Q.C. dept. to evaluate the quality. 
 If it is possible to reprocess and recover-may 
considered for relabelling, repacking & resaling 
23
 Reagents made up in the lab should be prepared according 
to written procedures and appropriately labelled.such labels 
should indicate following information. 
a) Name of the reagent 
b) Nominal concentration 
c) Standardisation factor 
d) Shelf life 
e) Date when re-standardisation is required. 
f) The storage conditions. 
g) Name/signature and date of the person who has prepared 
and standardised the reagent. 
A register be maintained giving details of the reagents 
made,standardised,restandardised & used and destroyed if any. 
24
Pharmaceutical manufacturing operations generate lot of waste 
materials. These materials can be classified in two categories: 
a) Trash : which do not have any resale value and may be 
disposed off by proper method depending upon the nature 
of the trash. 
b) Scrap : which do have a resale value and may be sold to 
scrap dealers,after proper segregation. 
Before disposal of these materials,they can be segregated in 
different categories: 
1) Paper 
2) Aluminium foils 
3) Plastic 
4) Glass 
5) Metallic containers. 
25
 May be available in the form of official reference 
standards. 
 Reference std. 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. 
Rodenticides, insecticides, fumigating agents and 
sanitising materials fall under this category, these 
materials should not be permitted to contaminate 
equipment, raw materials, packaging materials, in-process 
materials or finished products. 
26
 It reduces considerably the idle time of the workers. 
 The quality of the materials is also maintained 
through minimum human touches, elimination of 
breakages, etc. 
 Every inch of the factory space is properly utilized. 
 It helps in maintaining effective production 
planning and control. 
 Reduced operating costs and timely production. 
 Greater job satisfaction on the part of both the 
workers and the employer. 
27
1. Pharmaceutical Quality Assurance by Manohar 
A.Potdar , Nirali Prakashan, page no. 4.1-4.18 
28
29

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Material management

  • 1. Presented by :- Mr. Shankar S.Yelmame M.Pharm 1st yr (QAT) Amrutvahini College of pharmacy, Sangamner 1
  • 2.  Introduction  Objective & importance  Principles of material management  Functions of material management  Purchasing  Vendor development  Types of Materials  References 2
  • 3. Definition It is an organizational concept, which has the authority & responsibility of all activities, principally concerned with the flow of materials in the organization. OR The International Federation of Purchasing and Materials Management accept the definition of materials management given below. “According to it, materials management is a total concept having its definite organization to plan and control all types of materials, its supply, and its flow from raw stage to finished stage so as to deliver the product to customer as per his requirements in time." 3
  • 4.  The prime objective of the pharmaceutical manufacturing operations is-to produce finished pharmaceutical pdts from active, inactive raw materials and various packaging material.  The quality of finished products is depend upon the quality inputs - hence material management is very important. 4
  • 5. Primary (i) Efficient materials planning (ii) Buying or Purchasing (iii) Procuring and receiving (iv) Storing and inventory control (v) Supply and distribution of materials (vi) Quality assurance (vii) Good supplier and customer relationship (viii) Improved departmental efficiency 5
  • 6. Secondary (i) Efficient production scheduling (ii) To take make or buy decisions (iii) Prepare specifications and standardization of materials (iv) To assist in product design and development (v) Forecasting demand and quantity of materials requirements (vi) Quality control of materials purchased (vii) Material handling (viii) Use of value analysis and value engineering (ix) Developing skills of workers in materials management 6
  • 7.  To procure right materials -In Right Quantity -Of Right Quality -At Right Time -From Right sources -At Right prices 7
  • 8. 8
  • 9. Centralized :- the purchasing procedure of materials for different department is done together from one purchasing department. This is seen in small organizations. Advantages  Efficient system  Bargaining capabilities increased  Good raw material obtained at lower price Decentralized:- different department purchase their requirement separately. This is basically seen in large organizations. Advantages  Flexible purchasing system  Procurement is faster 9
  • 10.  Vendor is a person who sells & supplies his products.  An intelligent purchasing process involves the rational selection of sources from which materials can be obtained. Considerable efforts are needed in identifying, developing & evaluating the prospective suppliers.  Factors to be considered in developing a vendor – - Quantity required to be purchased. - Time available for making such purchases. - If the material be required repeatedly or occasionally. 10
  • 11. Volume of the purchase of required materials.  Industry producing the required materials. Commercial viability of the materials.  For the purchase of items that are of repetitive nature, a detailed evaluation procedure of suppliers is adopted 11
  • 12. Need recognition Spell out of specifications & requirements Official requisitions Check specifications, prices/supplies Select suppliers Quotations & analysis prices and terms, negotiations, finalization Purchase order for supply Suppliers’ acceptance Specifications file Purchase records Supplier’s record Enquiry tender Follow-up 12
  • 13. 13 Delivery of materials Materials & reports, analysis Payment made Cont… Checking of invoice with purchase order
  • 14. The various types of materials to be managed are: (i) Purchased materials: They are raw materials, packaging materials (ii) Work in process (WIP) materials: These are semi-finished and finished parts and components lying on the shop floor. (iii) Finished goods: These are the final products either waiting to be assembled in the assembly lines or in stores which are stocked for final delivery waiting to sell. 14
  • 15.  Supplier’s name –in companies approved vendor list.  all RM should be checked for-a) Name of supplier b) Name of the product c) Batch numbers d) Date of mfg and expiry e) Qty received & no. of containers f) Condition of containers and materials 15
  • 16.  All containers should be clean externally-if any damage-informed to QC Dept.  Should be protected from contamination during storage.  The materials received should be taken into account only after all the relevant documents are available-(e.g. bills,invoice,customs or excise gate passes,certificate of analysis etc.)  Sampling in specific sampling booths by Q.C. person and stored in sampled material quarantine.  Materials in the storage area should be appropriately labelled. label should bear – a) Name & internal code no. of the product b) Batch no. given by supplier and also given by receiver after analysis & release c) Status of material d) Retest & expiry date of the product e) Appropriate special storage conditions 16
  • 17.  Materials should be dispensed only by designated persons, following written procedure ,to ensure that the correct materials are accurately weighed or measured into clean and properly labelled container a) Correct name & category(IP/BP/USP) b) Correct wt. c) Batch no. of the product  All dispensed materials must be recorded in a register in chronological order of date and time.The record should have – a) Name of pdt & batch no. b) Time and date of starting and completion of the dispensing activity c) Name of weigher and checker of the dispensed materials. 17
  • 18. 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 direct contact with the primary packaging materials. e.g.labels,carton etc. 3) Printed packaging materials: all PM which have any thing printed on it;even error medical literature sent along with finished pdt is also put in this category. e.g.labels, cartons,foils etc. 4) Tertiary & other packaging materials: All other PM other than those covered in the above three categories. 18
  • 19.  Intermediate & bulk product may be defined as the material , which has started processing but not yet got converted into the finished saleable product.  Intermediate & bulk product storage is the responsibility of the production dept. Examples.  Granulated materials ready for compression  Compressed tablets for coating or packaging.  Filtered or unfiltered liquids for oral or injectables.  These pdts should be kept under appropriate storage condition of temp, relative humidity, class of air etc. 19
  • 20.  Finished products are products which are in marketable pack.  Should be held in quarantine until their final release, after which they should be stored.  Each batch should be tested against its specifications and then released for distribution or sale.  Products faiing to meet the established specifications should be rejected.  Reprocessing may be performed,if feasible,but the reprocessed product should meet all specifications. 20
  • 21.  Materials at any stage, which have been tested against a set of predefined specification and found not meeting the specifications fully. We can deal with such material mainly in two ways: a) Reprocess and retest the materials to see whether it meets our specific requirements b) Destroy or send it to the supplier.  Clearly marked as such and stored separately in restricted areas.Such areas in industry are normally painted red in colour. 21
  • 22.  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. 22
  • 23.  Pharmaceutical products can be returned from market for various reasons. e.g.quality problems, accidental damage of goods etc.  physically examine the condition of the goods returned.  Ask Q.C. dept. to evaluate the quality.  If it is possible to reprocess and recover-may considered for relabelling, repacking & resaling 23
  • 24.  Reagents made up in the lab should be prepared according to written procedures and appropriately labelled.such labels should indicate following information. a) Name of the reagent b) Nominal concentration c) Standardisation factor d) Shelf life e) Date when re-standardisation is required. f) The storage conditions. g) Name/signature and date of the person who has prepared and standardised the reagent. A register be maintained giving details of the reagents made,standardised,restandardised & used and destroyed if any. 24
  • 25. Pharmaceutical manufacturing operations generate lot of waste materials. These materials can be classified in two categories: a) Trash : which do not have any resale value and may be disposed off by proper method depending upon the nature of the trash. b) Scrap : which do have a resale value and may be sold to scrap dealers,after proper segregation. Before disposal of these materials,they can be segregated in different categories: 1) Paper 2) Aluminium foils 3) Plastic 4) Glass 5) Metallic containers. 25
  • 26.  May be available in the form of official reference standards.  Reference std. 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. Rodenticides, insecticides, fumigating agents and sanitising materials fall under this category, these materials should not be permitted to contaminate equipment, raw materials, packaging materials, in-process materials or finished products. 26
  • 27.  It reduces considerably the idle time of the workers.  The quality of the materials is also maintained through minimum human touches, elimination of breakages, etc.  Every inch of the factory space is properly utilized.  It helps in maintaining effective production planning and control.  Reduced operating costs and timely production.  Greater job satisfaction on the part of both the workers and the employer. 27
  • 28. 1. Pharmaceutical Quality Assurance by Manohar A.Potdar , Nirali Prakashan, page no. 4.1-4.18 28
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