Batch Production Record Review and Release of Finished Product

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1.0 Purpose 
 
 The purpose of this procedure is to define the process for the review of batch production
 records and to specify the manner in which finished products are released for shipment.
 
 2.0 Scope 
 
 This procedure applies to all products manufactured and/or packaged at Jon Nutritional Labs.
 
 3.0 Responsibility 
 
 3.1. ‘It is the responsibility of Quality to follow this procedure. 
 
 3.2 It is the responsibility of Quality Management to implement this procedure and to
 
 ensure that the procedure is being followed. 
 
 4.0 Definitions 
 
 4.1 BPR — Batch Production Record; an accurate reproduction of the MBR and is a
 
 compilation of documents and forms issued to production that contains/identifies all of
 the pertinent instructions/process steps/specifications necessary to manufacture a batch
 
 of product 
 
 42 MBR — Master Batch Record; a compilation of documents and forms that
 contains/identifies all of the pertinent instructions/process steps/specifications necessary
 
 to manufacture a product 
 
 4.3 Product Profile — a document with the details of the finished product specifications,
 
 unique for each approved product 
 
 
 

[SOP 

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 4.4 Product SKU — Stock Keeping Unit; the unique identification number assigned to a
 product/customer 
 
 4.5 OOS — Out of Specification 
 
 4.6 QC-— Quality Control 
 
 4.7. DC-— Document Control 
 
 48 COA-— Certificate of Analysis 
 
 49 COC -— Certificate of Compliance 
 
 410 COM- Certificate of Manufacture 
 
 5.0 References 
 
 5.1 C-201, SOP, Deviation and Investigation Procedure 
 
 5.2 C-104, SOP, Master Batch Record and Issuance of Batch Production Record
 
 6.0 Procedure 
 
 6.1 Quality will perform a review of the BPR to ensure that all critical control points of the
 
 processes have been documented and have met the specified ranges and yields.
 
 6.2 Each page will be reviewed for data integrity. 
 
 6.2.1 Ensure that all components and raw materials used in the batch have been
 
 released. 
 
 6.2.1.1 A release report must be generated for each batch of product, which
 outlines all raw material and packaging component lots used to create
 
 the batch, and the release status of each lot. The batch may not be
 
 
 

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 released unless all raw materials/components display a status of
 Released. 
 
 6.2.2 Ensure there are no outstanding investigations. 
 
 6.2.2.1 Should the batch be the subject of an investigation, the investigation
 
 must be closed and added to the BPR prior to release. 
 
 6.3 Verify that all calculations are correct and all signatures/initials/dates are present and
 
 legible. 
 
 6.4 Ensure that all results, yields, and reconciliations fall within the acceptance criteria
 stated in the BPR. 
 
 Note: If a reconciliation yield is out of specification but a justified explanation is
 
 evident, indicate in the Comments section of the yield page the information
 
 regarding the adjustment and justification for release. If a justified explanation is
 not evident, a deviation will be opened and an investigation will be performed
 
 per SOP C-201 Deviation and Investigation Procedure. 
 
 6.5 Verify that all corrections have been documented properly. 
 
 Ensure that all labeled/cartoned/pouched/blistered products have a representative
6.6 sample of the printed packaging component affixed in the BPR for traceability.

 Ensure that there is a master case label and pallet label (if applicable) affixed in the
6.7 BPR for traceability.

 Ensure that all batches contain a copy of the product coding printed or stamped onto the
6.8 primary packaging container placed in the BPR for traceability. Verify the batch

 number and shelf life is consistent with the information provided in BPR.
 
 Review the entire BPR to ensure that it is complete, all required information is entered
6.9 or attached, and all signatures/initials/dates/times are present.

 
 

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 6.10 Complete the Final QC Yield to verify that the order has been fulfilled and falls within
 
 the allowable range. If outside of the specified range, forward this information to
 
 Production for review. 
 
 6.11 All released batches require a COA. A copy of the COA will be sent to the customer or
 
 with the shipment unless another method has been requested by the customer.
 
 6.11.1 Quality will create a COA from the approved analytical testing results for each
 
 batch. 
 
 6.11.2 The COA will be based on the product’s testing and specifications.
 
 6.12 Quality will sign the COA and place it in the BPR. 
 
 6.13 A COC/COM/additional release reports may be generated upon customer request.
 
 Indicate the release or rejection of the batch and complete the relevant Batch Release
6.14 and Reconciliation Form per SOP C-104 Master Batch Record and Issuance of Batch

 Production Record. 
 
 A Release Letter will be generated and provided to the customer upon release.
6.15 The batch status will be changed to released in the ERP system, which will allow for

6.16 the generation of a delivery note.

 Once the product is released, the In-Process/Pending Release tag will be removed from
6.17 the pallets. The Shipping Department will be made aware that the batch is released and

 the product is now approved for shipment. 
 
 If the product is rejected, replace the In-Process/Pending Release tag with a Hold tag
6.18 and move the pallet to the designated holding area until an investigation is completed

 and a disposition has been obtained. 
 
 
 

[SOP 

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 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/20/10 | New - : | - | - |
| 1 | 07/26/10 | Added Sections 5.9 and 5.10 - - | - | - |
| 2 | 09/13/12 | Clarified and reorganized SOP. Changed format and title. Added details regarding label standard requirements. Updated SOP format. Added instructions for Ion Stock | 12-138 | V. Iltcheva |
| 3 | 09/12/14 | Formulations/Packaged per Customer orders. Made some minor changes to reflect current practices. Biennial review — add reference to CFR and SQF, updated orders of | 14-0696 | M. Wienke |
| 4 | 08/24/16 | steps for batch release, changed process when packaging Ion Stock orders for customer | 16-0777 | E. Hasanbasic |
| 5 | 09/23/19 | Scheduled review: updated procedure to reflect current processes. Scheduled review: changed logo and footer. Added release report requirements. Added investigation requirements. Added blisters | 19-0695 | K. Burris |
| 6 | 09/18/23 | and pouches to scope of required samples. Added initials to scope CC- of review requirements. Added release requirements in the ERP and subsequent activities. | 23-0468 | K. Burris |