SOP on Charge-In of Components
1.0 Purpose: This SOP describes the procedure for Charge-In of a product batch.
2.0 Scope: This SOP applies to Production Staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required
5.0 Procedure:
5.1.0 The batch is formulated with the intent to provide not less than 100% of labeled or established amount of active ingredient.
5.1.1 Most active ingredients show assay results that are not exactly 100%.
5.1.2 With inherent errors in analytical methodology in the order of 1 – 2% it is not possible to precisely determine “True” assay value.
5.1.3 Consequently it is acceptable to use material that is within acceptable specification without specific adjustment to accommodate batch analytical variations.
5.1.4 When it is necessary to calculate a specific quantity, materials with significant and variable e.g. loss on drying / water, potency etc., requirement is specified by quality Control.
5.1.5 For a product that is known to show some inherent loss of potency during production process, assay values are taken into account for each batch. Whenever necessary, an overage is added to allow for potency loss.
5.2.0 Dispensing of materials is a critical stage of the manufacturing operation.
5.2.1 It ensures that right amounts of correct material, released by Quality Control, are allocated to specified batch of product.
5.2.2 Proper labeling of component containers makes the checking at production usage more effective.
5.2.3 Dispensing also allows to visually examine containers for damage, and contents for atypical appearance or foreign matter.
5.2.4 A single check is performed in raw material store and second check is being done on receipt by production.
5.2.5 Materials are individually checked for identification and quantity at production stage.
5.2.6 Second person verify addition of components to a process and reconciliation is done.
5.2.7 In the event that a raw material being weighed did not correlate with records, component is hold, investigated and remaining quantity is drawn from raw materials stores.