Packaging procedures

Well controlled manufacturing environment (trained personnel, formalized line clearance, adequate documentation, and verification practices) Customized and study-specific labeling and packaging procedures Sponsor-controlled relabeling and product retrieval operations Limit investigator site manipulation of CTM and labeling... 

Name and address of drug product manufacturer ° Description of manufacturing and packaging procedures ° Limits and analytical methods identity, strength, quality, and purity... 

E. Method of Manufacture, Packaging Procedure, and In-Process Control... 

MIL-F-83670 QJSAV) Foam-in-Place Packaging, Procedures for Use, cancelled 13 April 1986 and replaced by MIL-F-45216A, issued 15 July 1984. 

Packaging procedure, including description of packaging stages and quality control. 

The containers must correspond to those reflected in Annexure 1 (presentation), 10 (stability data) and 11, the description of the packaging procedure, except that the description given under the presentation in Annexure 1 need not include the specific type of material of the container (e.g., Bottles of 100 should suffice). Recently applicants have sometimes been requested to specify the con-... 

For materials destroyed during analysis, it is not possible to measure all individual samples. If the trend in preparation is continuous and known, an extrapolation on the uncertainty of the certified value can be attempted but this would also decrease the analytical value of the CRM. In the majority of situations drifts or trends are not foreseen and known. Therefore, it will be necessary to measure samples all over the packaging procedure. The between-vial homogeneity study has the objective to verify that no difference exists in the parameter of interest (concentration of the element or substance) between sets. It may also verify that the matrix composition remains similar. The objective of the within-vial study was to verify the homogenisation procedure and estimate the minimum sample intake if necessary. The between-vial homogeneity assesses that the material is suitable for comparability between laboratories. 

Sometimes a trend is detected between the vials a systematic increase or decrease in the content of an element or substance appears between vials. Two explanations are possible. Either the production of the material has suffered from a drift or the measurement method has itself drifted. To differentiate between both reasons, the analyst must perform the measurements between samples in a non chronological manner. As samples should be taken regularly during the packaging procedure and are labelled it is possible to arrange their analysis in a randomised way. If a random selection is performed for the between bottles test the drift in production may be overlooked. Figure 4.8 illustrates the differences in conclusion in case of production and method drift. It indicates that in addition to the dispersion of the results, the analyst must also identify the evolution of the results in terms of absolute quantity. 

Microfabrication techniques can be used effectively in manufacturing thick-and thin-film electrochemical sensors. However, a well planned package procedure for the sensor is essential in rendering the sensor practical. The selection of the packaging material to protect the sensor s integrity in a testing environment is a key to its functioning properly. 

Changes in the packaging material, e.g., replacing plastics by glass, may require changes in the packaging procedure and therefore affect product stability. 

A formally authorized Master Packaging Procedure should exist for each dosage form, package size and type of container. 

All packaging operations should proceed in accordance with the instructions given and using the specified materials in the Master Packaging Procedure. Details of the operation should be recorded on the Batch Packaging Record. 

On completion of the packaging operation, the last production package should be carefully checked to confirm that it fully agrees with the Master Packaging Procedure. 

The quality control unit should participate in the development of the master processing procedures and master packaging procedures for each batch size of a product in order to assure batch-to-batch uniformity. 

An accurate reproduction of the appropriate master packaging procedures which is checked for accuracy, dated and signed by the Production Manager and the Quality Control Manager or their designated delegates. 

Is the vendor willing to let the customer s representatives inspect their product packaging procedure ... 

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