| Department | Manufacturing | Document no | MAN-060 | ||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Document Owner
Operations Manager
Affected Parties
All operation’s colleagues
Purpose
This SOP describes how to reconcile finished goods and determine the allowable discrepancies of components and products when reconciled.
Scope
To be followed by Authorised Persons (Operators trained in Process Documentation).
Definition
| Reconciliation | A process to measure efficiency of use for raw material or components |
Related Documents
| Form-125 | Example- Batch Reconciliation Sheet for Tablet Packing |
| VD-005 | Tablet Packing Components and Finished Goods Reconciliation Limit |
| QMS-035 | Deviation Report System |
| QMS-090 | Evaluation of Batch Documentation for Tablet Packing |
| NOTE: Any changes to reconciliation limits must be also be updated in SOP QMS-090 | |
EHS Statement
There is no EHS implication.
Procedure
1.1. Recording of numbers used in the reconciliation must occur in real time. Reconciliation must occur immediately on completion of a step. The practice of reconciling the components with delay should not be allowed.
1.2. The purpose of reconciliation is to ensure that all materials have been accounted for and no mix-up occurred. Reconciliation is carried out on printed and/or coded components and the finished product. The limits outlined in this procedure should help detect errors at the time of manufacture and avoid release of a non‑conforming product.
1.3. Reconciliation should be performed at the end of each stage, especially if the goods are moved from one location to another. Final reconciliation should cover the whole process.
1.4. The reconciliation calculation should be based on real figures. Estimate is allowed in relation to materials that can be “lost” during the process,
1.5. It is of prime importance that all products are correctly identified (labelled). A series of systems – defined by batch documents and SOP’s – exist to ensure components are correctly labelled, e.g.
Unique component Material and version number
Bar code checks
Reconciliations after pre-coding
Line Clearance/Opening/Cleaning Procedures
Security storage
Sampling of all printed and/or coded materials
2.1. At the end of each specific packing of a batch or part-batch, the printed components and product will be tallied by the Machine Operator, e.g. labels, cartons, leaflets, tablets, etc.
2.2. These components will be reconciled as a % yield, comparing the number at the start with the number at the end of the process including all waste that occurred during the process.
2.3. % yield =
No. of Goods produced at the end of process + Rejects + Samples + Returned x100
No. of goods received at the start of process
2.4. All components and products should reconcile 100%, however, allowances are made (Tolerance limits) to allow for counting error and/or minor inconsistencies.
ANY UNUSUAL situation and out-of-tolerance tally must be investigated immediately on checking the reconciliation.
In the case of the out of the range result a recount must be done and the entries corrected. If the % yield is still outside the allowable limits a thorough investigation must take place to ensure the cause of such a deviation to establish that no mix up has occurred.
2.5. Yields outside the set tolerances must be explained in a Deviation Report (DR).
See SOP QMS-035.
3. Example-Allowable Tolerances for Printed Components
| Batch Size (Packs) | 0 – 50,000 Packs | Over 50,000 Packs |
| Cartons used on packs | 99 -101% | 99.5 – 100.5% |
| Leaflets used on units | 99 -101% | 99.5 – 100.5% |
| Labels used on units | 99 – 101% | 99.5 – 100.5% |
Note:
The number of leaflets received on the line should be taken as the amount specified on the manufacturer’s label, or in the case of partial boxes, the number written on the partial sticker.
On completion of the BPN all partial boxes of leaflets must be counted, the amount will be written on the ‘Partial’ sticker and the box will be sealed before return to the warehouse.
3.1. Possible causes of unsatisfactory reconciliation:
3.1.1. Mixed or rogue labels or cartons
3.1.2. Error in initial counts of labels or cartons.
3.1.3. Error in final packed count.
3.1.4. Wrong or incomplete packing of shipper.
3.1.5. Incorrectly counted samples, rejects and returns.
3.1.6. Wrong number of labels/bottle, i.e. label missing or 2 labels instead of one/bottle.
3.1.7. Lost or mangled labels/cartons/leaflets.
4. Example-Allowable Tolerances for Filled Product
Batch Size (Units Produced *)
| 0 – 50,000 Units | Over 50,000 | |
| Tablets | 98 – 102 % | 99 – 101 % |
* Units refers to a single item i.e. 1 Tablet.
4.1. Possible causes of unsatisfactory product reconciliation:
4.1.1. Poor counts on containers filled.
4.1.2. Wrong quantity of contents added.
4.1.3. Wrong or incomplete packing of shipper.
4.1.4. Mix-up of components from a 2nd batch.
4.1.5. Inadequate check of rejected material.
4.1.6. Laboratory/Stability samples not included in calculation.
4.1.7. Loss of Bulk Product or inadequate determination of residual.
5. Summary of Changes
| Version # | Revision History |
| MAN-060 | New |