QMS-185 Batch Review and Release for Supply – Non-Sterile Products

 1. PURPOSE 

This standard Operating Procedure (SOP) describes the process of release for supply of non-sterile finished goods and bulk product manufactured at a GMP site.

 2. SCOPE

This procedure describes processes which need to be followed when conducting release for supply. The release covers:

 2.1. Finished product release for supply

 2.2. Releasing part of a batch for supply (Partial release for supply)

 3. RESPONSIBILITY 

 3.1. Quality Assurance

It is the responsibility of the QA Manager (Dispositions) to ensure that this SOP is followed by the personnel in charge of conducting release for supply. 

It is the responsibility of the QA Associate (authorized QA person) conducting release for supply to follow the directions outlined in this procedure and to ensure the released product meets both regulatory and marketing authorization requirements.

 3.2. Production Department

It is the responsibility of the Production Site Manager to ensure that the manufacturing and packaging operators have completed all sections of the M/FBRs (Batch Record) or that appropriate comments and actions are taken and documented. Site Production Manager is also responsible for making sure that all QC physical analysis were conducted prior to filling and packing the bulk product.

 3.3. Approved Laboratory:

 It is the responsibility of Approved Laboratory to carry out Quality Control Analysis. 

 3.4. Warehouse

It is the responsibility of the warehouse personnel to organize shipping of the product once it has been released by QA.

 4. MATERIALS REQUIRED/REFERENCES

 4.1. Appendix A: Form 935 – Finished Product Audit Record – Blending, Tableting, Packaging and QC

 4.2. Appendix B: Form 940 – Visual Inspection of Final Finished Product

5. DEFINITIONS

 5.1. M/FBR : Batch Record sheet that contains all manufacturing and packing process details (such as instructions from dispensing, amount of actives dispensed, moisture content in granulation and blending, compressed tablet information, etc).

 5.2. Designate: A Designate is a suitably qualified Person, nominated by management to perform a defined task.

 5.3. OOS: Out of Specification

 5.4. ERP: Enterprise Resource Planning

6. PROCEDURE

The products manufactured at the GMP site are sampled and tested for physical and chemical properties either in house (QC laboratory) or in external approved contract laboratories.

All batch Documents including batch analytical results are reviewed and approved before release for supply.

 6.1. Visual Inspection of Final Finished Pack

 6.1.1. QA Associate should visually inspect all finished products prior to release to market.

 6.1.2. Visual inspection should include details such as batch number, expiry date, packaging codes with revision numbers, MO number and general condition of the goods.

 6.1.3. If releasing bulk product to contractors for filling and/or packing then the bulk product needs to be inspected for batch number, date of manufacturing and quantity.

 6.1.4. Details should be recorded in “Form 940: Visual Inspection of Final Finished Products.”

 6.2. Manufacturing/Packing Process Records/QC testing

 6.2.1. All products are manufactured according to the product MBR (Manufacturing Batch Record) and samples of the bulk are taken for analysis. The bulk is analyzed at the manufacturing facility for physical properties according to Product Specifications. Two bulk samples (if possible bulk top and bulk bottom) are sent to the QC Laboratory or Approved External Contract Laboratory for chemical properties.

 6.2.2. Any product with an unsatisfactory assay history is held at the bulk stage awaiting active assay analysis before transferring to packaging. All other products proceed to packaging without the bulk actives assay analysis, on the basis of, their compliance to the physical specifications for the product, and no manufacturing deviations were encountered during the bulk manufacturing stage. 

 6.2.3. Once the bulk product has passed the quality control requirements, then it is transferred to packaging and packed according to the FBR (Finished Batch Record). 

Whenever deviations occur in manufacturing and/or testing, the QA Manager or designate must be informed immediately and a deviation must be raised. Appropriate actions will be taken as a result of the investigation. 

6.2.4. Upon receival of final Certificates of Analysis from QC lab, the results are reviewed and results are recorded on the QA release spreadsheet. The specifications are recorded on this spreadsheet and this spreadsheet is password protected. Any change in specification is approved by a Change Control and once the change control is approved the spreadsheet is updated by a QA Associate.

 6.2.5. The QA Manager must be informed of any non compliant results for investigation and action.

 6.2.6. QA Associate must review the M/FBR in accordance with the checklist in “Form 935: Finished Product Audit Record – Blending, Tableting, Packaging and QC” and each review must be signed and dated immediately after it is checked. If a discrepancy is found it must be resolved or satisfactorily explained by the production department prior to release for supply of the product by QA. 

 6.2.7. All bulk released for packing are packed according to the FBR (Finished Batch Record). 

 6.3. Checking through Form 935 (Product Release Form)

 6.3.1. M/FBR issued by an authorized person. The ‘Authorized’ field in the M/FBR must be signed/dated by an authorized person. 

 6.3.2. BOM/Shop Traveler: Ensure BOM/Shop Traveler page is present. 

 6.3.3. Correct quantities of materials are dispensed and checked by second operator.

 6.3.4. Cleaning cards: Must be present and completed – No fields left blank. 

 6.3.5. In-process tests: Must be within specification or a deviation must be raised.  

 6.3.6. Correct packaging materials issued/used. Batch number and expiry date: Ensure that Batch number and shelf life recorded is correct on all documents and labels. The shelf life of the product is recorded on the packing document (FBR) for that product. 

 6.3.7. Line clearance: Ensure line clearance is performed. 

 6.3.8. Reconciliation page: Ensure reconciliation page is present and all reconciliation values are within limits. Any out of reconciliation limits must be explained.

 6.3.9. Deviations: Check for any open deviation reports raised for either packed or manufactured batch. Any deviation must be closed before releasing a batch for supply. 

 6.3.10. C of A: Refer to the List of Export and Third-Party Products and check if C of A / C of C need to be issued.

 6.3.11. Review the details recorded in Form 935 to be checked and verified against the batch records. Attach this to Form 940.

 6.3.12. Once the Form 935 checklist is completed, sign the field entitled ‘Final Authorization by QA’ at the bottom of the Form.

 6.3.13. Complete the electronic disposition in the ERP system. 

 6.3.14. Screen print of release transactions should be printed, initialed and dated. This need to be counter signed by second QA Associate.

 6.3.15. Print required number of “Release for Supply” disposition labels, one for each pallet and one sample to be applied to the batch records. Trained warehouse staff to apply the label, one for each pallet. 

 6.3.16. Upon completion of all release transaction, email notification is to be sent appropriate personnel, e.g. QA Managers, Logistics and, Inventory managers, Export coordinator, Product Manager.

 6.4. Releasing part of a batch for supply (Partial Release for supply)

 6.4.1. Partial release for supply is performed for finished packed stock when the batch is still packing but the portion of the batch already packed is to be released. This usually happens when the market urgently needs the product. The approval to partial release should be made by QA Manger (Disposition.)

 6.4.2. For partial release QC testing must be completed. 

 6.4.3. Complete the partial release sections of Form 935.

 6.4.4. Complete the electronic disposition at the ERP system. 

 6.4.5. Screen print of release transactions should be printed, initialed and dated. This need to be counter signed by second QA Associate.

 6.4.6. Print required number of “Release for Supply” disposition labels, one for each pallet and one sample to be applied to the batch records. Trained warehouse staff to apply the label, one for each pallet. 

 6.4.7. Upon completion of all release transactions, email notification is to be sent appropriate personnel, e.g. QA Managers, Logistics and, Inventory managers, Export coordinator, Product Manager.

APPENDIX A: Form 935 – Finished Product Audit Record – Blending, Tableting, Packaging and QC

Comments:

Final authorisation by QA

Authorised By: ___________________     Sign: ______________ Date: _____/_____/_____