MAN-060 Reconciliation Procedure of Component and Product

1. General

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. Procedure

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 2^nd 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