In-process Checks During the Manufacturing of all Capsule in Pharmaceuticals

Standard Operating Procedure of In-process Checks During the Manufacturing of all Capsule in Pharmaceuticals is describe in this post.

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1. Purpose:

1.1. To establish a procedure for the In-process checks during the manufacturing of all products.

2. Scope:

2.1. It is applicable to all the products being manufactured or Packed at Pharmaceuticals

3. Responsibilities:

3.1. QA Manager

3.2. QC Officer

3.3. Production Pharmacist

3.4. Q.A Officer

4. Procedure:

4.1. Issuance of Raw Material & Packaging Components

4.1.1. Check the product name, strength, printing quality and quantity of Packaging components as assigned on B.P.O.
4.1.2. Weigh accurately the Raw Materials and attach identification slips with each material as per B.M.O.
4.1.3. Weighing Activity should be performed under the supervision of three persons i.e. one from warehouse, one from production & one from Q.A.

4.2. Disintegration:

4.2.1. Perform the Disintegration test of the required product as mentioned in the individual monograph and calculate the results accordingly.
Frequency: At Start

4.3. Dissolution:

4.3.1. Perform the Dissolution test of the required product as mentioned in the individual monograph and calculate the results accordingly.

Frequency: At Start

4.4. Average Weight:

4.4.1. Take 20 tablets and weight them, then note the weight of a single tablet according to the specification
Frequency: At Start and after each 30 minutes