4. Background
It is concerned with planning, organizing and
controlling the flow of materials from their
initial purchase through internal operations to
the service point through distribution.
The aim of pharmaceutical material
management is provide good quality product
with the proper manner that is under the
planning and organization.
5. Aim of Material Management
To Get-
1. The Right quality
2. Right quantity of supplies
3. At the Right time
4. At the Right place
5. For the Right cost
6. Introduction
The prime objective of the pharmaceutical manufacturing
operation to produce finished pharmaceutical product from
active, inactive raw material and various packaging material.
Vendor Selection
Receiving: (Bill, Invoice, Custom Excise gate pass, COA)
Quarantine
Inspection: Cleaned, stacked on non wooden pallet damaged,
abnormality reported to QC.
Storage: RH, RT, FIFO, FEFO, segregated properly to avoid
mix-up
Sampling: Coordinate with QCL
Identification (Label): Status, approved, sampled rejected,
Batch NO, manufacturer’s name
Dispatch: Finished good to customer, rejected material from
supplier etc.
Importance:
Quality material Quality finished product
(R.M. P.M)
7. Purchasing
The purchase of raw materials is an important operation
that should involve staff who have a particular and
thorough knowledge of the products and suppliers.
Starting materials should be purchased only from
approved suppliers and , where possible, directly from
the producer.
The quality parameters should also specify
characteristics like, bulk density, particle size amorphous
or crystalline nature of the material, specificity of
isomers.
8. Cont….
For each consignment, the containers should be checked
for at least integrity of package and seal and for
correspondence between the order, the delivery note, and
the supplier’s labels.
Damage to containers and any other problem that might
adversely affect the quality of a material should be
recorded and reported to the quality control department
and investigated.
R.M. and P.M. should only be purchased by buyer who
are trained and possess sufficient technical knowledge.
9. Raw material
Supplier of the received material should have his name listed in companies
approved vendors list. Such list should available with in receiving
department.
● Approved Vendor: RM is ensured that has come from approved supplier,
list of vendor is available in stores
● Checking:
i) Name of product
ii) Batch No.
iii) MFG. Date EXP Date.
iv) Quantity Received
v) Condition of container
vi) Name of material and supplier
After receiving of raw material should be check –
i) Name of Supplier.
ii) Name of the Product.
iii) Batch Number.
iv) Mfg. Date & Exp. Date.
v) Quantity Received or No of containers or Packages.
vi) Condition of Container and Material.
10. Cont….
All containers should be cleaned externally and damage
if any report to Q.C. department . all the received have
proper document such as bills, gate passes, log book
records and COA.
From the received sample material place in sampling
area with proper label by Q.C person.
All received material must have identified label status
e.g.
i) Received Sampled.
ii) Approved.
iii) Rejected.
● Material Identification like
i) Product Name.
ii) Batch No.
iii) Code No.
iv) Sterility Status.
11. Cont…
If one delivery of material is made up of different
batches ,each must be considered as separate for
sampling ,testing and release.
Material storage room should have properly
labeled and have following information
Name and internal code number.
Batch no given by supplier and given by receiver after
analysis and release.
Status of the contents (e.g. quarantine, on test, released,
rejected, returned, recalled).
Retest and expiry date of the product.
Appropriate special storage condition.
12. Cont….
Only starting materials released by the quality
control department and within their shelf-life
should be used.
Starting materials should be dispensed only by
designated persons.
Following a written procedure, to ensure that the
correct materials are accurately weighed or
measured into clean and properly labeled
containers.
13. Cont….
Each dispensed material and its weight or
volume should be independently checked and
the recorded.
All the dispensed material have proper label and
record in the log book in chronological order .
The record must have following points.
i) Name of the product and Batch no. for which material
is dispensed.
ii) Time and date of starting material and completion of
dispensing activity.
iii) Name of weigher and checker.
14. Packaging Materials
It is having four types.
Primary Packaging Material
Material is direct contact with product
e.g. Bottles, ampoules, vials, foils.
Secondary Packaging Material
Material which comes contact with primary product.
e.g. Label, carton.
Printed Packaging Materials
All packaging materials which have any thing printed on
it. Material like labels, cartons, foils.
Tertiary and other Packaging Material
All other packaging material other than those cover
Primary, Secondary, Printed material.
e.g. Shipper, Box.
15. Cont….
All the secured area like storage room having
authorised access.
Maintain log book records for access.
Each delivery of packaging material have
unique code or batch no.
All the packaging should be checked by
packaging department.
16. Intermediate and Bulk Products
This are the starting material in the process but not
converted to finished product.
e.g. I) Granules ready for compression.
II) Compressed tablets, awaiting coating.
III) Filtered or unfiltered liquid for oral injectable.
Handling By :
Production dept.
Storage: Temp :
RH class is critical.
Receipt:
When purchased, to be treated like RM
17. Finished Products
Held in quarantine until their final release
Then stored as unable stock under suitable storage
conditions
Evaluation and documentation necessary for
release
Product release procedure
Batch record review and related procedure
18. Rejected and recovered materials
These are the materials at any stage which have
been tested against set of predefined and found
not meeting the specification completely.
Clearly marked
Stored separately in restricted areas
Action-
Return to suppliers or destroyed
Action approved by authorised personnel maintain
records
19. Cont….
Recovered materials should be exceptional cases
Only if
Risk involved have been evaluated and final product will
not be affected
Specification are met
Defined procedure
Record maintain and new batch no.
Such products stored in separate area in industry
painted in Red color.
20. Cont….
Recovered products normally between 5-10 %
are added in fresh batches including any
possible effects on shelf life.
The record should be maintained by authorised
personnel or Q.C. department
21. Recalled Products
These are the product which are sold or
distribute which recall after some time.
It is due to improper handling of material during
process.
Stored in secure area with proper label
Accessible by authorised personnel
Record should be maintain
Decision taken on their fate
22. Returned goods
These are the goods returned from market for
various reasons
Q.C. department evaluates physical
examinations and quality of goods received.
Decision on their fate
Reprocessed
Recovered
Need to be destroyed
24. Reagent and culture media
Records for receipt or preparation
Reagents
Preparation according to SOP
Appropriate labeling
i) Name of reagent
ii) Conc (1N, 2N 20 % etc.)
iii) Standardization factor
iv) Shelf life / use before
v) Date of re-standardization
vi) Storage condition-
vii) Sign: Prepared by, Checked by
25. Cont….
● Culture media
Positive and negative controls should be applied
to verify stability of culture media
26. Waste materials
Pharmaceutical manufacturing operation generate
lot of waste material
It is of two types
Trash- No resale value and disposed by proper
method depend upon nature of trash
Scrap- Have resale value and maybe sold to scrap
dealers
1. Paper .
2. Aluminium Foils.
3. Plastic.
4. Glass.
5. Metallic containers.
Toxic substance and flammable material storage
stored at safe area
27. Reference Standards
These are the official reference standards
Reference standard are prepared by the
producers should be tested released and stored
in the same way official standards
Stored in secure area
Accessible by authorised personnel
Record should be maintained
It is only used for the purpose described in the
appropriate monograph
28. Cont….
Secondary reference standard
Appropriate label
Name
Batch, lot number
Date of preparation
Shelf life
Storage condition
29. Miscellaneous materials
This type of materials do not falls under the
category R.M/P.M
Materials like
Rodenticide, insecticide, fumigating agents
Sanitizing materials
No contamination risk to equipment raw materials,
packaging materials, in-process materials or finish
products
30. References
Pharmaceutical Quality Assurance by Manohar
Potdar Page no-4.1- 4.18.
Quality Assurance Volume II second updated
edition Page no.34 - 39
