SAMPLE COMPANY                                        Page 1 of 3
SOP # 15-1  Revision: 0                Prepared by:             _
Effective Date:                        Approved by:             _


Title:         PACKAGING, STORAGE AND DISTRIBUTION

Policy:   Product packaging and any shipping container for the
          product will be designed and constructed to protect the
          product from alteration or damage during the customary
          conditions of processing, storage, handling and
          distribution.

Purpose:  To outline the steps for package design and controls
          for safe storage and distribution of manufactured
          products.

Scope:    This statement applies to all products manufactured and
          distributed by the company.

Procedures:

1.0  Packaging Design and Materials

1.1  During the product development process, adequate packaging
     will be designed and developed as appropriate for the
     product. Product packaging and any shipping container for
     the product will be designed and constructed to protect the
     product from alteration or damage during the customary
     conditions of processing, storage, handling and
     distribution.  Items to be considered can include:

         -     Product Characteristics including composition,
          size and shape
         -     Sterilization Process Requirements
         -     Labeling
         -     Secondary Packaging
         -     Shipping Methods
         -     Environment
         -     End Use
         -     Temperature and Thermal Capacity
         -     Moisture Resistance and Package Porosity
         -     Pressure or Vacuum
         -     Regulations

1.2  Developed, tested and approved packaging and labeling
     components and materials will be adequately described and
     designated in the master product record.  All packaging
     materials are required to be received, inspected and
     accepted/rejected in accordance with those applicable
     procedure statements.



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2.0  Packaging Process

2.1  Upon final approval of a product by quality control, a
     Finished Product Release form will be completed.  The
     product serial number identification label will then be
     attached to the product as a means for
     controlling/identifying finished and unfinished products.
     The product can then be released for distribution.

2.2  Proper labeling procedures will followed for finished
     products and distribution as follows:

         -     A separate label or printed on the package should
          properly reflect the package contents.
         -     The delivery label should be placed on the top of
          the carton or package.  "Top" should be the most stable
          orientation of the package as it might ride on a
          conveyor.  If using packing slip information, place on
          the same carton/package surface as the address label.
         -     Complete address information shall be placed on
          the delivery label including suite, unit numbers,
          street address and ZIP codes.  Telephone numbers of the
          recipient often can aid shippers if problems arise with
          delivery.
         -     Do not place delivery labels over a package seam,
          closure or on top of sealing tape.
         -     All packages shall have a complete return address
          for the company including street address and ZIP code.


3.0  Storage

3.1  Storage of products will be maintained in the designated
     storage room to prevent inadvertent damage to the products
     pending distribution.  All products will be rotated through
     storage on a first-in, first-out (FIFO) basis to prevent
     deterioration of products and to aid in tracking production
     lots.


4.0  Distribution

4.1  The Shipping Clerk will arrange for appropriate shipping
     methods for products to ensure the protection and
     maintenance of quality during shipping and through delivery
     to destination (or to recipient's carrier).




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4.2  The Shipping Clerk will also prepare and maintain
     distribution records for shipments of all products.  A
     Shipping Log will be prepared and should contain the
     following information:

         -     Date Shipped
         -     Consignee Name
         -     Consignee Address
         -     Method (Carrier) of Shipment
         -     Quantity Shipped
         -     Control Number