Raw Material : PURCHASE SPECIFICATIONS AND MAINTENANCE OF STORES FOR RAW MATERIALS

PURCHASE SPECIFICATIONS AND
MAINTENANCE OF STORES FOR RAW MATERIALS:-
All materials that used into manufacturing of a finished bulk, and
which are consumed by a person using it are called Raw material.

Raw material can be either active dung or inactive substances.
1. Purchasing must be done by staff with a thorough knowledge of
those materials and their suppliers.
2. Materials must be procured only from approved suppliers who have
consented to provide materials in keeping with quality specifications
of the drug product manufacturer.
3. It is advisable for pharmaceutical manufacturer’s to enter into
contracts with specific vendors after performing a vendor audit that
provides an assurance of raw materials and packaging materials of
the desired level of safety and meeting quality standards.

1. PURCHASE SPECIFICATIONS AND
MAINTENANCE OF STORES FOR RAW
MATERIALS

2. RAW MATERIALS

that help produce a Mm

—

Raw Materials are Final Product

Primary Materials

© Example ®

4.8.8.6

Cocoa Beans Sugar Milk Chocolate Bars

Raw Materials Final Product

3. PURCHASE SPECIFICATIONS FOR
RAW MATERIALS

1. Purchasing must be done by staff with a thorough knowledge of
those materials and their suppliers.

2. Materials must be procured only from approved suppliers who have
consented to provide materials in keeping with quality specifications
of the drug product manufacturer.

3. It is advisable for pharmaceutical manufacturer’s to enter into
contracts with specific vendors after performing a vendor audit that
provides an assurance of raw materials and packaging materials of
the desired level of safety and meeting quality standards.

4. . Specific written procedures must be prepared to describe how materials
will be received, identified, stored, handled, sampled, tested and
accordingly approved or rejected, and these procedures must be followed
as written.

. When receiving materials, the consignment must be visually examined
and the labels checked to confirm the content, quantity, integrity of seals
and to verify that there is no damage or contamination.

. Any damaged containers found must be separated, and details recorded
and informed to the supplier.

. The materials must be stored under quarantine until samples have been
drawn and tests have been performed.

. The storage must be done in a way that suitable space is left for proper
cleaning and inspection of the materials.

5. - Sampling

« Representative samples must be drawn from each shipment of each lot.

+ If different batches are present in a single shipment, samples must be
drawn from each of those.

“ The quantity must be sufficient to perform all required tests and reserve
when specified.

“+ Samples must be drawn from the bottom, middle and top of the
containers, and marked accordingly.

“ Sample-holding containers shall be labeled with details of name of
material, lot number, container number, date of sampling, and name of
person collecting the sample.

6. We nent

The Slot Sampler

7. e
.

Testing of Samples

At least one specific test must be performed to verify the material’s
identity.

Tests must be carried out to determine conformity with predetermined
specifications for quality, strength and purity.

In case of supplied along with a certificate of analysis by the supplier, it
may be used without sampling and testing, if the supplier is a reliable,
validated vendor and at least one specific identity test has been performed
and mentioned in the certificate.

Materials that are liable to contamination with adulterants, or insect
infestations or filth must be examined for such contaminants.

If materials are prone to microbial contamination, microbiological tests
must be performed to test for it.

8. « All materials that meet the manufacturer’s quality requirements of
identity, quality, purity and strength and other tests are to be approved
for use.

« Materials not meeting these requirements must be rejected.

9. _ Labeling

“* Labels must carry the name of the product, the company’s unique
reference code, manufacturer’s name and address, and their assigned
batch number.

« It must also state the status of the contents (For example — “Sampled”,
“Quarantined”, “Approved” and “Rejected”), manufacturing and expiry
dates and re-test date.

“ Rejected materials must be labeled and stored in a separate area to avoid
chances of mix-ups or misuse.

10. ANNEXURE -I

{COMPANY NAME}
QUARANTINE
MATERIAL NAME:

ITEM CODE:
GRN NO. DATE:
VENDOR BATCH NO.:
MANUFACTURING DATE:
EXPIRY DATE:

TOTAL QTY:

DATE OF RECEIPT:

CONTAINER NO.:
MANUFACTURER:

SUPPLIER:

PREPARED BY (SIGN / DATE):

ANNEXURE -II

{COMPANY NAME}
UNDER TEST

ITEM
BNO: DT. RECPT. :
QTY.
MFG.DT. : EXP DT. :
MFD.BY
SUPP.BY :
ARNO, :
SMPL.DI. : REF.NO. :
SAMPLED BY ;
SAMPLE DRAWN BY :

ANNEXURE - III

ANNEXURE - IV

11. Handling Rejected Materials
< Rejected materials must be identified with appropriate labels and kept in

quarantine until safely disposed.

of such materials in manufacturing

REJECT

EQUIPMENT/COMPONENT/MATERIAL
PART NO. DATE OF RECEIPT
C) P.O. NO. VENDOR

THIS ITEM IS UNACCEPTABLE BECAUSE

operations.

TAG APPLIED BY DATE
COMMENTS.

12. Containers and Closures

< Containers and closures are used for packing of drug products must not be
additive, reactive or absorptive.

< This is important to ensure that they do not cause a change in the identity,
safety, quality, strength, or purity of the drugs beyond specifications.

« Closures and containers must be capable of protecting the drug product
from external conditions that may cause its contamination or
deterioration.

« Containers and closures must be clean and if required, sterilized to
remove contamination by microorganisms and pyrogens.

13. %)
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