Basic Principles of GMP

Materials

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Materials
General requirements for materials

All incoming materials and finished products:

sourced from approved vendor sites in suitable packs
should carry unique identification codes
quarantined after receipt,
until released for use
distribution
each material defined should be identified in a manner so that its
history can be known

tested as per the specification

Retested at defined frequency up to shelf life

stored

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under appropriate conditions

orderly fashion (batch segregation)
materials management
stock rotation (FIFO)

Materials

Purchasing

Suppliers
approved vendor

Consignment:
integrity
seal
Order (quantity)
delivery note
suppliers labels

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Cleaned and labelled

Materials

Damaged containers
container damage
storage to avoid contamination
Rejection

Different batches in one consignment

segregation

Material label:
name and internal code if any
batch number(s), (supplier and manufacturer on receipt)
status
expiry date or re-test date

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Sampled containers identified

Materials

Use only released material

Dispensing :
designated persons
written procedure
accurately weighed
clean, labelled containers

Independent checks
material and weight

Dispensed material :
batch materials kept together and labelled

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Materials
Packaging materials

Primary and printed materials:

as for starting materials

purchasing, handling and control

No unauthorized access
Storage and transport
avoid mix-ups
issue and return: SOP

Specific reference number for batch or consignment

Packaging department checks:

quantity, identity and conformity

Outdated or obsolete material

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Materials
In-Process, Bulk and Finished products

Quarantine until released

Storage conditions

Evaluation and documentation

testing
product release

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Materials
Rejected materials

Rejected materials
Clearly marked
Stored separately in restricted areas
Action

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Materials
Recalled products and returned goods

Recalled products:
identified
stored separately
access controlled
fate

Returned goods:
SOP: decision regarding the fate
nature of product, storage conditions
history, time lapse
records

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Materials
Reagents and culture media

Recorded upon receipt or preparation

Reagents:
preparation in accordance with SOP
label:
concentration, standardisation factor, shelf-life, date that restandardisation is due, storage conditions
signed and dated

Culture media:
positive and negative controls

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Materials
Reference standards

Official reference standards

use only as per monograph
storage

Reference standards prepared by the producer:

tested, released
stored in same way as official reference standards

Secondary or working standards:

appropriate checks and tests
regular intervals
based on official reference standards

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Materials
Waste materials and miscellaneous
materials

Waste materials
proper and safe storage
toxic and flammable materials
separate, enclosed, as per legislation

not allowed to accumulate

collected for safe disposal
regular intervals

Miscellaneous
rodenticides, insecticides, sanitizing material
contamination risks

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