Labels reconciliation

Label usage must be reconciled to assure there are no stray labels. Whether printed on-demand or preprinted, labels should be issued to the packaging operators with a label reconciliation form. The form will indicate the label by reference identification and if the labels were printed on-demand will indicate the printed labels have been reviewed and approved by the Quality Unit or their designate. The reconciliation... 

Similar to label reconciliation, inconsistencies related to formal line clearance procedures can also result in shipping product that may later need to be recalled. It is important for QA to ensure that periodic assessments of this activity occur and that any deficiencies uncovered are immediately addressed. 

Batch Reconciliation and Label Reconciliation Theoretical Yield Actual Yield Packaged Yield... 

Packaging Records, Batch Reconciliation, and Label Reconciliation... 

The packaging and labelling of investigational products are likely to be more complex and more liable to errors (which are also harder to detect) when blinded labels are used than for licensed products. Supervisory procedures such as label reconciliation, line clearance, etc., and the independent checks by quality control staff should accordingly be intensified. 

A separate section is present to cover the label reconciliation to account for the number of labels printed, used and destroyed. The yield of labels is also discussed in Sect. 34.7. 

First of all, measures to prevent (cross-)contamination and mix-ups must be in place. These measures can be technical or organisational. Other methods to guarantee a safe process comprise adequate documentation including in-process controls and yield and label reconciliation. All processes should be controlled and supervised. 

Label reconciliation On product On secondary packaging Initials... 

SOPs must be developed for label accountability with specific tolerances spelled out. Provision must be made for label security, such as locked cabinets on operating lines. Accountability sheets for other components should be provided so that reconciliation between used and finished packages can be developed. If possible, a cleaning area and shop should be set up for the cleaning of filters and parts and the disassembly and assembly of filling machines. 

Manufacturing controls—sample batch records, list of SOPs packaging component control, raw material control, packaging and labeling control, yield accountability and reconciliation, warehousing and distribution... 

Routine established D, I, O, and P qualified15 Critical compliance and quality system QA approval Adhere to cGMPs Adhere to NDA claims Established range for reconciliation and accountability Support label claim established Formalized QA system... 

Stock Reconciliation Inspection Checks QC Sampling and Sample Labels Certificates of Analysis Variance/Defects Reporting Change Management Retest Materials... 

Where component reconciliation, in warehouse and production, requires a knowledge that labelled box quantities have been QC validated. 

The particular labelling machine chosen for any particular job must be capable of easy cleaning so that full reconciliation of the label quantities can be achieved. 

The number of units to package should be specified prior to the start of the packaging operations, considering also the number of units necessary for carrying out quality controls and the number of samples to be kept A reconciliation should take place at the end of the packaging and labelling process. 

Reconciliation of the number of labels issued with the number of unit packages and retention labels, together with the destruction of excess labels bearing lot/batch numbers. 

General operating procedures describing the receipt verification, storage, issue and reconciliation of printed packaging and labelling material should be available. 

The results of the reconciliation and any investigation should be recorded on or attached to the batch packaging and labelling records. 

Issue of known numbers of labels and reconciliation of usage. 

Labelling is the last step of the production process (see Sect. 37.3). The labelling process should be preferably performed in the preparation area, where no additional unlabelled products are present. Identity of the labels should be checked and reconciliation performed number of applied labels should to be equal to the number of produced containers. Labelling and final packaging operations in the hospital pharmacies is becoming increasingly automated. 

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