SAMPLE COMPANY                                       Page 1 of 9
SOP # 05-1  Revision: 0               Prepared by:             _
Effective Date:                       Approved by:             _


Title:         MASTER PRODUCT RECORD

Policy:   A Master Product Record will be prepared and
          maintained for all products manufactured or under
          development.

Purpose:  To prescribe the responsibilities for preparing Master
          Product Records (MPR) and to ensure the completeness
          of MPR Indexes.

Scope:    All products manufactured by the company are covered
          under this procedure.

Definitions:

     1.   Master Product Record (MPR) - A compilation of records
          containing the description, design, formulation,
          specifications, complete manufacturing
          procedures, quality assurance requirements and
          labeling of a finished product.  In addition to the
          Product specifications, a MPR contains documents that
          cover typical manufacturing activities including
          procurement, assembly, labeling, testing and
          inspection and packaging.

     2.   MPR Index - A table of contents for the master record
          of a product.  It also can contain information on the
          breakdown of the product into assemblies and/or
          manufacturing steps.  It is called a document plan
          during planning and early development of a new
          product.

Procedures:

1.0  Preparation of Master Record

1.1  Upon completion of the design phase of a product, a formal
     document plan will be initiated and will be called the
     Master Product Record.  The configuration and structure of
     the master record is determined by the Engineering and
     Manufacturing managers.  After agreement, the master record
     will be created, document numbers assigned, status of
     drawings indicated and the record approved by Engineering
     and Manufacturing (See Exhibit 1 for a listing of items
     that may appear in a Master Product Record).

1.2  Upon compilation of all documents to be included in the
     Master Record, a MPR Index will be prepared to identify all
     items in the record and location(s) of these records (See
     Exhibit 2 for a sample MPR Index).
MASTER PRODUCT RECORD                                Page 2 of 9


1.3  Complete specifications of the product will be prepared and
     included as part of the Master Record (See Exhibit 3 for
     items that may appear in a Product Specification).  The
     product or product specification is a specific document
     that briefly describes and gives all important details of
     the external and optionally internal characteristics of a
     product.

     Generally a product specification will contain the
     Product's:

           -   product trade and common name(s);
           -   intended use(s);
           -   performance characteristics and theory of
          operation;
           -   regulatory classification;
           -   physical characteristics;
           -   environmental limitations and product stability;
           -   important components and formula (if applicable);
           -   manufacturing cautions; and
           -   user safety characteristics.

     A preliminary product specification should be written at
     the beginning of a project and updated as the product is
     developed or modified.  Specifications are usually
     developed by the marketing and product development
     departments with review and consultation by quality
     assurance, manufacturing, and other departments.  The
     contents of the final specification must agree with the
     other elements of the product master record and with the
     actual product when it is manufactured.  Before the start
     of full-scale production and commercial distribution, the
     product specification must be dated, approved, and placed
     under change control.

     In addition to defining and describing a product, a
     specification is a communication tool which, if used in a
     timely manner, can help achieve some important results.
     First, it helps assure that everyone is talking about the
     same product and working toward the same objectives with
     respect to safety, effectiveness, human factors,
     configuration, etc.  Also, it is used as a guideline for
     developing test and inspection procedures for the finished
     product.

     Ultimately, the product specification or a condensed
     version of it should be used in catalogs, or other product
     documentation to aid communications between salespersons
     and customers.

MASTER PRODUCT RECORD                                Page 3 of 9


     The use of product specifications will result in:

           -   improved communications between employees on a
          departmental and interdepartmental basis;
           -   less confusion and increased morale;
           -   an improved state-of-control; and
           -   a higher probability of meeting cost, time,
          safety, effectiveness, and regulatory compliance
          objectives.

     Also, if the marketing department uses the specifications
     when preparing advertisements and catalog sheets, public
     relations with users will be enhanced because the marketing
     documents are based on proven scientific safety and
     performance claims for the actual product.  That is, the
     user has an opportunity to read the technical
     specifications of the item actually being offered for sale.

1.4  As part of the product documentation, the Master Record
     will contain when appropriate specific written assembly
     procedures for constructing or fabrication of the product
     or sub-assembly components.  These procedures are covered
     in the SOP for "Work Instructions."


2.0  Records Retention and Location

2.1  All records that pertain to a product shall be retained for
     a period of time equivalent to the design and expected life
     of the product, but in no case less than two years from the
     date of distribution.  For products that may be repaired or
     capital equipment products that probably will be updated,
     records should be retained as appropriate to support these
     repairs or modifications.

2.2  Master records will be stored at the company's
     manufacturing plant and shall be readily accessible to the
     company's employees and to outside regulatory authorities
     (e.g., FDA, UL, Federal Government, etc.).

     The master product record must be a single source document
     or file.  However, portions of this file may be kept in
     various locations.

     A master product record may exist as:

           -   one or more files or volumes of the actual
          records containing the information required;
           -   a reference list of such documents and their
          location; or
           -   any combination of actual documents or reference
          lists.
MASTER PRODUCT RECORD                                Page 4 of 9


     These documents must contain the latest revisions, be
     signed, and be dated to show they have been checked for
     accuracy and approved for use.

     It is acceptable to maintain records on microfiche and/or
     microfilm reductions and discard the original hard copies,
     if the following conditions are met:

           -   All reductions must be readily available for
          review and copying by investigators and designated
          company personnel at any reasonable time.
           -   All necessary equipment must be provided for
          viewing and copying the records.
           -   Reproductions must be true and accurate copies of
          the original record.

     If the reproduction process results in a copy that does not
     reveal changes or additions to the original record, the
     original must be retained.  In this situation, the
     reproduced copy and any image shown on a viewing screen
     must note any alteration from the original and indicate
     that the original record is available.

3.0  Authorization and Change Control

3.1  The control of changes to products, processes and the
     associated master records is one of the most important
     elements of a quality assurance system.  Any changes to the
     master product record must be authorized by the signature
     of the designated individual.



MASTER PRODUCT RECORD                                Page 5 of 9


      DOCUMENTS THAT MAY APPEAR IN A MASTER PRODUCT RECORD



I.        MASTER PRODUCT RECORD Index

          The MPR Index is a table of contents which is used for
convenience.  It may be  known as a:

               Documentation of Master Record Unit;
          Documentation Plan;
          Product Tree;
          Documentation Index;
          Product Structure.

II.  Product Specifications

III.      Manufacturing Information

     A.   Bill of materials (i.e., component list usually
          arranged by subassembly or other sub-product level or
          by process steps)

     B.   Procurement documentation

          1.   Specifications
          2.   Drawings
          3.   Certificate of compliance requirements
          4.   Vendor evaluation procedures

     C.   Product documentation

          1.   Fabrication drawings
          2.   Surface finish procedures
          3.   Subassembly drawings
          4.   Wiring and piping diagrams
          5.   Assembly procedures
          6.   Assembly drawings
          7.   Reference documentation
               a.   Wiring and piping schematics
               b.   Test specifications
          8.   Final formulation procedures

                                                       EXHIBIT 1
MASTER PRODUCT RECORD                            Page 6 of 9


     D.   Precautions and special notations

          1.   Cleaning
          2.   Storage conditions
          3.   Hazards and safety precautions


     E.   Equipment, lines, and procedures

          1.   Process lines
          2.   Assembly lines
          3.   Molds
          4.   Machine maintenance procedures
          5.   Calibration procedures
          6.   Setup procedures
          7.   Operating procedures
          8.   Process flow charts

     F.   Production control documentation

          1.   Inspection procedures
          2.   Test procedures
          3.   Blank inspection/test forms
          4.   Instruments charts
          5.   Reporting forms
          6.   Approved deviations

IV.  Labeling and Packaging

     A.   Labeling

          1.   Label drawings
          2.   Labeling drawings
          3.   Label/Labeling review procedures and forms
          4.   Production control procedures and history record
forms
          5.   Instruction manuals
          6.   Service manuals
          7.   Customer feedback forms
MASTER PRODUCT RECORD                            Page 7 of 9


     B.   Packaging

          1.   Package drawings
          2.   Closure drawings
          3.   Filling and/or packaging procedures
          4.   Packing procedures
          5.   Special shipment procedures

     C.   Storage requirements

          1.   Temperature
          2.   Humidity


V.   Control Procedures and Activities

     A.   Inspection procedures

          1.   Incoming
          2.   In-process
          3.   Finished products
          4.   Process control charts
          5.   Blank data reporting forms

     B.   Test procedures

          1.   Incoming
          2.   In-process
          3.   Pretest conditioning
          4.   Finished product
          5.   Process control charts
          6.   Blank product history record forms

VI.  Final Release

     A.   Release document

     B.   Distribution procedures

     C.   Blank Product history record forms

MASTER PRODUCT RECORD                            Page 8 of 9


                               Prepared By:                    _
                               Approved By:                    _

                         Sample Company
        Master Product Record Index - Model 1000 Widget
                     Current as of XX/XX/XX


                                        Location of Documents:

     Description                             Originals Working
Copies

I.        Product Specification                        Mfg. File

II.  Product Literature (i.e. Brochures, etc.)              Mfg.
                                        File

III. Bill of Materials                       Mfg. File
Purchasing/Engineering

IV.  Manufacturing Procedures(Assemblers Manual)       Mfg. File
                                        Manufacturing

V.   Inspection and Q.C. Forms                    Mfg. File
Manufacturing

VI.  Drawings/Schematics                     Mfg. File





















                                                        EXHIBIT 2
MASTER PRODUCT RECORD                                  Page 9 of 9


_
          ITEMS THAT MAY APPEAR IN A PRODUCT SPECIFICATION

_

1.   Name of Product

     a.   Trade name                    d.   Chemical name
     b.   Trademark                e.   Official name
     c.   Generic name                  f.   Common name

2.   Performance Characteristics

     a.   Description/Intended use      e.   Contraindications
     b.   Accessories                   f.   Input/Output
requirements
     c.   Functional parameters              g.   Human
                              interface
     d.   Limitations                   h.   Other

3.   Classifications

     a.   Regulatory                    c.   Functional
     b.   Commercial                    d.   Other

4.   Physical Characteristics

     a.   Weight                        e.   Consistency
     b.   Size                     f.   Packaging
     c.   Color                         g.   Power requirements
     d.   Form/Shape                    h.   Other

5.   Environmental Limitations

     a.   Operating temperature              f.   Moisture
                              protection
     b.   Storage temperature           g.   Pressure, altitude
     c.   Vibration and shock           h.   Electromagnetic
interference
     d.   Voltage limits                i.   Electrical
                                   transients
     e.   Humidity                 j.   Other

6.   Important Components

     a.   Active ingredients            f.   Service labeling
     b.   Major subsystems              g.   Components supplied
by user
     c.   Diagnostic kit materials           h.   Software
     d.   Accessories                   i.   Other
     e.   Labeling

7.   User Safety and Performance Considerations

     a.   Chemical                 e.   Personnel training
     b.   Electrical                    f.   Periodic testing
     c.   Heat                     g.   Maintenance
     d.   Sharp, moving parts           h.   Other








                                                   EXHIBIT 3