Receiving Process for Raw Materials and Packaging Components

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1.0 Purpose 
 
 This procedure defines the process for receiving raw materials (including bulk finished product
 
 received for packaging only), packaging and printed packaging into the warehouse and
 assignment of unique identifying numbers to each receipt. 
 
 2.0 Scope 
 
 This procedure applies to raw materials (including bulk finished product received for
 packaging only) and packaging components received for manufacture and packaging of dietary
 
 supplements, pet products, drugs, and cosmetics. This procedure does not apply to equipment,
 laboratory chemicals, or ordinary business orders. 
 
 3.0 Responsibility 
 
 3.1 It is the responsibility of Warehouse personnel to follow this procedure.
 
 3.2 It is the responsibility of Quality to make final the determination of the suitability of all
 
 materials. 
 
 3.3. It is the responsibility of the QC Laboratory to ensure that data logger information is
 
 recorded upon receipt of raw material, if applicable. 
 
 4.0 Definitions 
 
 4.1 PO — Purchase Order 
 
 4.2 R#-— Receiving Number; a unique identifying number assigned to raw materials and
 packaging components upon receipt 
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Receiving Process for Raw Materials & Packaging E-204 14 Page 2 of 5 
 Components 
 
 4.3 RM — Raw Material 
 
 4.4 COA - Certificate of Analysis 
 
 4.5 COC ~— Certificate of Compliance 
 
 4.6 DC — Document Control 
 
 4.7 BOL -— Bill of Lading 
 
 5.0 References 
 
 5.1 E-801, SOP, Return of Materials and Destruction of Non-Hazardous Waste Materials
 
 nw E-901, SOP, Shipping and Receiving Transport Inspection 
 
 ns E-901-F1, Form, Trailer Inspection Log 
 
 5.4 21 CFR Part 111, 211 
 
 6.0 Procedure 
 
 6.1 Purchasing will make available in Batchmaster approved POs to warehouse personnel.
 
 Note: If allergens are ordered, the item master will be set up with detailed information.
 
 6.1.1 Purchasing will request appropriate component technical drawings and
 specifications from the supplier and forward them to Production for approval
 
 and retention. 
 
 6.2 The warehouse associate will compare incoming materials to the packing list and
 Batchmaster item description. The warehouse will place into QC Hold any material
 
 that does not match for quality, grade, material description, or manufacturer/distributor
 name. Purchasing/Quality will be notified of the discrepancy and will determine the
 
 suitability of the material. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Receiving Process for Raw Materials & Packaging E-204 14 | Page 3 of 5 
 Components 
 
 6.2.1 Partial orders may be accepted. However, unique R#s must be assigned to
 
 materials delivered on different days, even if they are the same manufacturer’s
 
 lot #. 
 
 6.2.2 Visually inspect the received items(s) for damage and/or broken seals. Verify the
 
 count and weight received against the PO, to confirm ordered quantity. If any
 discrepancy is noted, notify Purchasing Department and Quality immediately.
 
 6.2.3 If damage is observed and the identity, composition, or purity is in question, the
 
 material(s) will be placed into QC Hold. Note any damages on the BOL and
 attach photographs to the email notification. 
 
 6.2.4 Damages must be noted on the BOL for all freight inbound orders. Photographs
 of the damage must be taken as soon as it is seen. The warehouse should obtain a
 
 claim number from the freight carrier if available. Notify Shipping and Purchasing
 of any damages. The damaged material(s) are to be placed into QC Hold. Follow
 
 SOP E-801 Return of Materials and Destruction of Non-Hazardous Waste
 
 Materials or for disposition of the damaged materials. 
 
 6.3 If a COA or COC is received with the order, it is to be given to Quality for inclusion
 
 with the test record. Quality will contact Purchasing to acquire certifications on
 materials that were not initially delivered. 
 
 6.4 All incoming raw materials (including bulk finished product received for packaging
 only) and packaging (including printed packaging) will be entered into the electronic
 
 inventory system and assigned a sequential auto-generated number in the format of
 R####H#. The electronic inventory system contains the following information:
 
 6.4.1 R# 
 
 6.4.2 Date/Time Received 
 
 6.4.3. Material Name 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Receiving Process for Raw Materials & Packaging E-204 14 | Page 4 of 5 
 Components 
 
 6.4.4 Allergen (if applicable) 
 
 6.4.5 Non GMO Project Verified (if applicable) 
 
 6.4.6 Certified Organic (if applicable) 
 
 6.4.7 Kosher (if applicable) 
 
 6.4.8 Halal (if applicable) 
 
 6.4.9 Gluten (if applicable) 
 
 6.4.10 Quantity 
 
 6.4.11 Manufacturer/Vendor 
 
 6.4.12 Manufacturer/Vendor’s Lot # 
 
 6.4.13 PO# 
 
 6.4.14 Goods Receipt Document Number 
 
 6.4.15 Received By 
 
 6.5 The warehouse creates barcoded labels for the raw material and packaging component
 containers indicating the material ID#, material name matching the PO, R#, Vendor
 
 name, and Vendor Lot#. A label is then placed onto each container of the material.
 
 6.6 The warehouse records the R# and a goods receipt document number on the packing list
 
 and electronically scans them to the following folder location: F:\RECEIVING
 
 PAPERWORK. 
 
 Note: Materials that contain allergens are stored in a separate area, away from non-
 
 allergens in the warehouse and/or according to manufacturer’s specific
 requirements. Materials that are used for Non-GMO Project Verified, Certified
 
 Organic, Kosher or Halal products will be stored separately. Materials that are
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Receiving Process for Raw Materials & Packaging E-204 14 Page 5 of 5 
 Components 
 
 Gluten or may contain gluten will be stored separately. 
 
 6.7 Should raw material or packaging components be received in an environmentally
 
 controlled transport truck, and a data logger is provided, the data logger will be
 delivered immediately to the QC lab. The data will be promptly download and placed in
 
 the raw material release packet. In the event a data logger is not provided the
 
 temperature will be checked by the designated warehouse associate with a calibrated
 thermometer and the temperature will be recorded onto Form E-901-F1 Trailer
 
 Inspection Log. Refer to SOP E-901 Shipping and Receiving Transport Inspection.
 
 6.8 Storage Conditions must be as reflected in the CofA. Product received with no
 
 temperature referenced on CoA will not require special storage conditions. Should an
 
 excursion occur, it is at the discretion of the customer and QC Laboratory to decide if
 the material is to be received and used. 
 
 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 04/13/11 | New - - | - | - |
| 1 | 04/04/13 | Changed the SOP format and number. Updated SOP format. - - | - | - |
| 2 | 08/01/13 | Added form E-204-F2. Added in section 5.12 “Expiration Date”. - - | - | - |
| 3 | 12/13/13 | Added sections 5.2.2 and 5.2.3. Added purchasing to section 5.2. Added ID# to section 5.11.1 and Form E-204-F1 | 13-1168 | M. Wienke |
| 4 | 04/16/14 | Added section for allergen materials. Updated SOP format. | 14-0332 | M. Wienke |
| 5 | 09/10/14 | Added step for the request of technical drawings and specifications. | 14-0729 | S. Millar |
| 6 | 09/08/16 | Biennial review: Reworded for clarity. | 16-0791 | W. Asbell |
| 7 | 11/29/16 | Added reference to nonprescription drugs and cosmetics | 16-1091 | E. Hasanbasic |
| 8 | 01/09/19 | Remove R-card requirements. Updated to reflect Batchmaster processes. | 19-0032 | J. Murphy |
| 9 | 10/01/20 | Procedure Rewrite to include label control receiving process. CC- Removed incoming log. Added Non GMO Project Verified comments to section 6.1, 6.4 ‘ uw Be) and 6.6. Added temperature information in section 6.7 COziUhe? C. Mitchell Added CFR reference. Added comments in reference to bulk , 08/10/21 finished product received for packaging. COA21-0220 ©. Mitenell | 20-0699 | J. Murphy |
| 2 | 11/02/21 | Added references to Certified Organic, Kosher and Halal in CC- sections 6.4 and 6.6 Added packaging components to scope of procedure. Changed SOP 49. bi eee title. Clarified procedure throughout. ic aaibilid J Nuieny | 21-0424 | C. Mitchell |
| 14 | 08/15/23 | Added materials that are Gluten or may contain gluten to be store CC- separately to Section 6.6 notes. | 23-0415 | ¢ Horelle |