STANDARD OPERATING PROCEDURE

Title: Materials Control - Work in Process (WIP)

Effective Date: _________________

Approvals (Signature and Date):

____________________________ ____________________________ ____________________________

Responsible Department Head Technical Authority QA/QC

1. PURPOSE

1.1 To ensure the proper issuing, receiving, handling, storage of all work in process (WIP) materials, and
lot tracking to prevent damage, mix-up, contamination, or other adverse effects.

2. SCOPE

2.1 This procedure applies to all work in process (WIP) materials in support of production.

3. RESPONSIBILITY

3.1 It is the responsibility of Materials Control to ensure only QA/QC approved/released materials are
issued to manufacturing. Materials Control will ensure only those materials within the expiration/re-
test dating period are issued to manufacturing. Additionally, Materials Control will monitor and verify
(per documentation) that only those materials specified for a particular work order are used.

3.2 It is the responsibility of Manufacturing to verify that only correct, released components are used in
production, and that the correct quantities of those components are used. Manufacturing is responsible
for the proper completion of all documentation used in the support of production.

3.3 It is the responsibility of Quality Assurance/Control to verify all pertinent information is recorded and
properly documented in support of production. QA/QC will collect and review all control, in process
QC, and test data as well as any retention samples required for that component.

4. REFERENCES AND APPLICABLE DOCUMENTS

4.1 10-0002-SOP-1.0, Materials Control- Receiving Procedures

4.2 10-0003-SOP-1.0, Materials Control- Finished Goods
4.3 10-0012-SOP-1.0, Material & Cost Transfer (MCT) Procedures
4.4 10-0020-SOP-1.0, Materials Control- Inventory Expiration
4.5 12-0014-SOP-1.0, Production Documentation Flow
4.6 QA/QC Inspection Services Request and Lot Summary Form

5. MATERIALS AND EQUIPMENT

5.1 Manufacturing Status Labels (i.e. Work in Process)

5.2 Quality Control Status Labels (i.e. Quarantine, Approved, Rejected, etc.)
5.3 Cold Room (2 to 8°C), -10 to -20° C freezer, -70°C or below freezer
5.4 Weigh Scales

Property of Doxpub, Inc. 10-0008-SOP-1.0

All proprietary rights reserved. Page 1 of 4
6. HEALTH AND SAFETY CONSIDERATIONS

6.1 All activities are to be performed in accordance with Company Safety Manual and the individual PNS
for each product.

7. DOCUMENTATION REQUIREMENTS

7.1 Work Order Request Form (WORF)

7.2 MRP generated Pick list

8. PROCEDURE-GENERAL

8.1 Materials Control issues materials to Manufacturing from QA/QC approved inventory.

8.2 Materials Handler issues materials to Manufacturing on a FIFO basis unless specifically authorized by
the Materials Control Supervisor or designee to issue outside of FIFO to control expiration dating.
Parts issued from a clean room or Inventory staging area are issued by Manufacturing personnel.

8.3 Materials Control and Manufacturing issue only those materials with an Approved label affixed to the
container showing the Part number, description, lot number and expiration date (if applicable).

8.4 Material Handler and Manufacturing WILL NOT issue material if there is incomplete or missing
information on the Approval label for that material.

8.5 Material part numbers, lot numbers and quantities issued to Manufacturing will be based on the pick
list generated by the work order for that particular job.

9. DISTRIBUTION OF MATERIAL TO WIP

9.1 Upon receipt of a Work Order Request Form (WORF), Materials Control generates a work order in the
Inventory Management/MRP database to create demand for the component items required.

9.2 Materials Control enters the following information in the database:

Work Order Number (same as the manufacturing lot number issued by Document Control)
Planner/Product Family
Gateway Work Center (as applicable-work center/operation description)
Deliver To: (Individual to whom the materials are issued)
Order Quantity
Line Status (1 through 5 indicates the status of the order in MRP)
Line Number Type (Customer Order, Manufacturing Order, or Purchase Order)
Schedule Date (Date product will be complete-including QC inspection time). From this
information, the MRP system will calculate the needed Start Date.

9.3 Material Handler (upon receipt of the WORF) prints a Pick list for the Work Order.

9.4 Material Handler pulls the required available quantities of materials requested on the Pick list, FIFO
unless otherwise directed, and writes in the exact quantity issued next to the lot number from which the
material was pulled.

9.4.1 Any materials pulled in excess of the quantity required, due to packaging, will be included in
the quantity issued for accountability.

9.4.2 If material is pulled from a labeled container or issued in smaller than labeled lot size, an
identifying label is placed on the issue container. The label will state the Approval status, part
number, lot number, expiration date, issue quantity, initials of individual performing the issue,
and the destination of the materials (i.e. Work Order or MCT number).

Property of Doxpub, Inc. 10-0008-SOP-1.0

All proprietary rights reserved. Page 2 of 4