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Module 3

Basic Principles of GMP

Materials

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Materials

General requirements for materials All incoming materials and fnished products:

sourced from approved vendor sites in suitable packs

should carry unique identication codes

quarantined after receipt,

until released for use distribution

each material dened should be identied in a manner so that itshistory can be known

tested as per the specication Retested at dened frequency up to shelf life

stored

under appropriate conditions orderly fashion (batch sereation!

materials manaement

stock rotation ("#"$!

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Module 3

Materials

Purchasing

Suppliers

approved vendor

Consignment:

interity

seal

$rder (quantity!

delivery note supplier%s labels

Cleaned and labelled

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Materials

Damaged containers

container damae

storae to avoid contamination

Re&ection

Dierent batches in one consignment

sereation Material label:

name and internal code if any

batch number(s!, (supplier and manufacturer on receipt!

status

e'piry date or retest date

Sampled containers identifed

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Module 3

Materials

Use only released material

Dispensing :

desinated persons

written procedure accurately weihed

clean, labelled containers

Independent checs

material and weiht

Dispensed material :

batch materials kept toether and labelled

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Module 3

Materials

Packaging materials Primary and printed materials:

as for startin materials purchasin, handlin and control

!o unauthori"ed access

Storage and transport

avoid mi'ups issue and return) *$P

Specifc re#erence number #or batch or consignment

Pacaging department checs:

quantity, identity and conformity

$utdated or obsolete material

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Materials

In-Process, Bulk and Finished products

%uarantine until released

Storage conditions &'aluation and documentation

testin

product release

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Materials

Rejected materials

(e)ected materials

+learly marked *tored separately in restricted areas

ction

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Materials

Recalled products and returned goods

(ecalled products:

identied

stored separately

access controlled fate

(eturned goods:

*$P) decision reardin the fate

nature of product, storae conditions

history, time lapse records

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Materials

Reagents and culture media (ecorded upon receipt or preparation

(eagents:

preparation in accordance with *$P

label)

concentration* standardisation #actor* shel#+li#e* date that re+standardisation is due* storage conditions

signed and dated

Culture media:

positive and neative controls

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Materials

Reference standards $,cial re#erence standards

use only as per monoraph

storae

(e#erence standards prepared by the producer: tested, released

stored in same way as o-cial reference standards

Secondary or -oring standards:

appropriate checks and tests

reular intervals

based on o-cial reference standards

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Materials

Waste materials and miscellaneousmaterials

.aste materials

proper and safe storae

to'ic and .ammable materials separate, enclosed, as per leislation

not allowed to accumulate

collected for safe disposal

reular intervals

Miscellaneous rodenticides, insecticides, saniti/in material

contamination risks