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5.1
Storage of Starting and Packaging Materials shall be in an orderly
manner.
Materials, Intermediates, Bulk
and Finished Products
(Section 5)

5.1 Materials shall be in an orderly

manner.
5.2 Shall be stored under a suitable
environment.

5.1 Materials shall be in an orderly manner.

5.2 Shall be stored under a suitable environment.
5.3 Outdoor storage is permissible for materials in
secured containers.

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5.1 Materials shall be in an orderly manner.

5.2 Shall be stored under a suitable environment.
5.3 Outdoor storage is permissible for materials in
secured containers.
5.4 Operations shall be segregated.

5.1 Materials shall be in an orderly manner.

5.2 Shall be stored under a suitable environment.
5.3 Outdoor storage is permissible for materials in
secured containers.
5.4 Operations shall be segregated.
5.5 Proper Documentations

5.1 Materials shall be in an orderly manner.

5.2 Shall be stored under a suitable environment.
5.3 Outdoor storage is permissible for materials in
secured containers.
5.4 Operations shall be segregated.
5.5 Proper Documentations
5.6 Inventory shall be reconciled.

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5.1 Materials shall be in an orderly manner.

5.2 Shall be stored under a suitable environment.
5.3 Outdoor storage is permissible for materials in
secured containers.
5.4 Operations shall be segregated.
5.5 Proper Documentations
5.6 Inventory shall be reconciled.
5.7 Shall be returned to storage unless defined specs.
Are met.

5.8 All raw materials, packaging

materials, intermediate and bulk
products returned to storage areas
shall be properly documented and
reconciled.

5.8.1. All raw materials and packaging materials

5.8.3. Printed packaging materials shall be
shall be checked for proper identity,
condition of container and approval of stored in a restricted storage are and
dispensed under strict supervision.
quality control unit.

5.8.2. Rejected raw materials and packaging

5.8.4. The First Expiry First Out system (FEFO)
materials shall not be stored together with
on approved raw materials shall be used.
approved materials. They are to be stored
in the assigned location for rejects.

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5.8.5. Raw materials shall be re-tested for

identity, strength, quality and purity as
necessary e.g. after storage periods, or after
exposure to air, heat or other conditions
that may adversely affect their quality.
5.8.6. There shall be written procedure or
system on reevaluation of residual
and packaging materials before use.
5.8.7. All incoming, outgoing and
remaining materials shall be recorded.
The record shall contain information on
suppliers, batch or lot number, quantity
and lot number of containers, control
number, date of receipt or issuance, date
release and date of expiry if any.

5.8.8 CONTROL NUMBER

• Control number or assigned reference number
shall appear on the labels of the containers of
each starting materials delivered.
- This will identify the delivered materials or batch
throughout the storage and processing.
- This will permit access to records for checking of full
details of the delivery or batch.
- Different batches within one delivery shall have
different or separate batches for sampling, testing
and release purposes

5.8.9
• Each starting material shall be in compliance
with its material specification prior to release
for use. It should be labelled with the name
designated in the specification.
- Unauthorized abbreviations, codes or names
Identifying and checking of should not be used.
the raw material by their
control number

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5.8.10
• Each delivery shall be visually checked on
receipt for general condition, integrity of
containers, spillage and possible
deterioration.
-Each delivery shall be sampled by personnel and
shall be approved by the QC manager.
- Separate batches upon delivery shall be regarded as
separate for sampling, testing and release purposes.

5.8.11
Steps shall be taken to assure that all containers
in the delivery should contain the correct raw
materials.
- This is to safeguard against mislabelling of the
containers by the supplier.
-A reference for the standard names of chemical
materials shall be made available.

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5.8.12
• Delivery of raw materials is held or stored in
the quarantine until approved by the QC
manager or his/her designate for release for
use.

5.8.13
• QC authorized personnel shall
be responsible for attaching the
labels indicating status of the
raw materials.
- Labels shall be of a nature or
form to prevent confusion with
any similar labels previously
used by the material supplier.
e.g. labels shall bear
company name or logo
- Status labels of materials shall
be changed accordingly as the
status of the material changes

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• 5.8.15 Starting materials, particularly those
that may deteriorate on exposure to heat shall
stored in a strictly controlled temperature.
• 5.8.16 Only an authorized person using an
approved procedure shall issue starting
materials. Stock record shall be maintained so
that stock reconciliation can be made or
equivalent.
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5.8.14
• Stocks of raw materials shall be inspected
at intervals to ensure its stability and good
condition, also securing the containers to
be properly closed to avoid contamination.
• Stored products shall undergo re-sampling
and retesting thus status labels should be
changed.
• 5.8.17 Segregated-dispensing areas suitably
equipped to avoid cross-contamination shall be
provided. Specially equipped production areas
may be solely designated for the dispensing of
sensitizing or highly toxic materials such as
hormones, cytotoxic agents and certain
antibiotics.
• 5.8.18 All rejected starting materials shall be
conspicuously identified, placed separately under
lock and key and shall be destroyed or returned
to supplier as soon as possible.
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5.9 INTERMEDIATE, BULK AND
FINISHED PRODUCTS
• 5.9.1 Intermediates, bulk products and
finished products shall be held pending quality
control testing and disposition.
• 5.9.2 Intermediates, bulk products and
finished products shall be checked to verify
that the material delivered agrees with the
delivery documentation.
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• 5.9.3 Each container of intermediates, bulk
products and finished products delivered to
the storage area shall be checked for proper
identification and condition.
• 5.9.4 If the identity or condition of any
container of intermediates, bulk products and
finished products is suspected; or does not
comply with the requirements of identity or
condition, that container shall be retained in
the quarantine for quality control inspection
and disposition.