1.0 Purpose: This SOP describes the method for the control of various critical steps during the manufacturing processes and to ensure that the variation of these parameters does not affect the quality of product.

2.0 Scope: This SOP applies to Production Staff and Quality Control Staff.

3.0 Responsibility: Production Chemists and Quality Control Chemists to follow this procedure.

4.0 Materials and Equipment: As required

5.0 Procedure: To assure batch uniformity and integrity of drug products, tests or examinations are conducted on appropriate samples of in-process materials of each batch at different time intervals during the processing of a batch. Such control procedures establish the manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures include but are not limited to the following –

5.1.1 Monitor the Environmental conditions i.e.temperature, relative humidity (as per SOP# FAC-08) and microbial control (as per SOP# – QC-14).

5.1.2 In case of any product changeover in manufacturing stage, check the wash water analysis report / line clearance form before starting the new product or batch.

5.2.1 Sampling of materials at intermediate stage and finished product is done as per SOP# QC-20 to ensure sample tested in Quality Control Laboratory is true representative sample of a batch.

Appearance, average weight, uniformity of weight, friability, hardness, disintegration time, moisture content of granules, dissolution, leak test.

Appearance, uniformity of colour (suspensions / emulsions), clarity of solution, pH, uniformity of volume.

Appearance, average weight, uniformity of weight, disintegration time, relative humidity / temperature of room, moisture content, leak test, visual examination of filled and empty capsules.

For empty capsules – brittleness, pinholes, disintegration, weight variation, colour variation, & proper locking.

Appearance, uniformity of colour, pH of prepared suspension, humidity / temperature of room, moisture content, sealing of bottles

5.4.1 Prior to start of any overprinting operation, check and verify for correctness the first coded label/carton/foil.

5.4.2 Before start of packing operations, check and certify for line / area clearance.

5.4.3 Ensure that bulk material container(s) received for packing are of the same batch and approved for packing.

5.4.4 During packing, the packed containers are frequently checked for defects like packing error, quantity packed, identity in packed container, overprinting quality with regards to batch no., mfg. date, exp. date, MRP & supply etc.

6.0 Recording: All the observations are recorded in batch production records.