7.5.5 | Preservation of Product |
7.5.5 Preservation of product
The company preserves the
conformity of the product during internal processing and delivery to the
customer. The systems are designed to address the identification, handling,
packaging, storage, preservation and delivery requirements of our in-process
and final product.
Identification: The
products at different stages of processing are identified as per point 7.5.3.
Handling and preservation: Production
is responsible for product handling and preservation; and in particular for
ensuring that containers holding products are suitable and are in good
condition (this includes containers closure systems, pallets, platforms etc.),
that the equipments used for internal transportation of products is well
maintained and is properly operated (this includes transport trolleys, fork
lifters, lift trucks, loaders and other vehicles), and that products are
adequately protected during production and storage. Methods and precautions for
handling hazardous materials (biological, chemical etc.) are part of Standard
Operating Procedure. Warehouse is responsible for storage of materials such as
raw materials and finished product under the specified conditions. Personnel are
trained for handling procedures.
Packaging:
Procedures are in place for packaging of the materials (intermediate and
finished product) where such requirements are necessary for storage and
transportation. Wherever the packaging is performed the process of packaging is
qualified and validated before selecting the method/material of packaging. The
records of such validations are maintained. The process of packaging is then
defined in a standard operating procedure/work/packaging instruction. Packaging
is done as primary packaging, secondary packaging, tertiary packaging or
special packaging so as to prevent damage from vibration, shock, abrasion,
corrosion, humidity, temperature, or any other conditions occurring during
handling, storage and shipping as per requirements. Packaging and labeling are
production processes and are controlled and defined. Final packaging for
shipping of release product is a warehouse function and is controlled and
defined.
Storage: Defined storage areas
(stock rooms and storage, staging, and holding areas) are designed for product
to prevent damage or deterioration of the product and meet the storage
specifications. These areas are maintained and controlled by the department which
is responsible for the particular processing stage. Limited shelf life
materials are issued on a “first in, first out basis”. Records of appropriate
storage conditions are maintained. Procedures and/or work instructions are
established for control of all the products.
In general raw materials
are stored in their shipping container in warehouse stores with designated
stock location (segregated and identified) under appropriate environmental
conditions. Intermediates and finished product prior to release are stored in
production store rooms with designated stock location under appropriate
environmental conditions. Released finished product ready for shipping is
stored in warehouse with designated stock location (segregated and identified)
under appropriate environmental conditions.
Delivery: The Company utilizes
company owned as well as sub-contracted transportation firm for product
transportation and delivery. Sub-contractors are approved and reevaluated
periodically as per the supplier qualification procedure and list of approved
sub-contractors is maintained. Product being prepared for shipping shall pass
the final release criteria. Before materials are dispatched, person authorized
verifies that the shipment contains the same products and quantities as
specified in the shipping/purchase order and the packaging and labeling
confirms to in-house requirements, customer and/or carrier requirements. Products
are delivered to the customers in a manner that prevents damage and conforms to
legal and customer requirements. Distribution records are maintained identifying
the consignee name and address, date shipped, product quantity and control
numbers (batch/lot numbers) along with mode of transportation in order to
maintain traceability and facilitate and corrective action post marketing.
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