SOP For Sampling of In-Process Product

SOP For sampling of inprocess product is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This SOP has been established to provide the guidelines to be followed to take homogeneous and representative samples of in-process products (Final Mix, Compressed / Coated Tablets, Filled Vials / Capsules & Bottles).

SCOPE

This procedure is applicable to Quality Assurance and Production Department.

RESPONSIBILTY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE

Upon receiving BMR from Production Department Q.A.I collects the samples against the respective BMR.

Before sampling make sure that the area where sampling is to be carried out is properly clean, which will not adversely affect the quality of the product (by ingress of dust, moisture or by cross contamination)

Check required RH and Temperature required for the product to be sampled.

Check the identification label on the container from the production which includes product name, B. No. Batch size. Mfg. Date, Status etc.

Products which are moisture sensitive must be sampled under the controlled conditions of RH and Temperature.

Container, which does not bear the identification label, should be "Hold".

Use gloves and mask and ensure that sampling tool like scoop, spatula etc, used to draw the sample are clean and dry,

Take out specified quantities of the sample in a suitable clean and dry container (polythene bag, glass bottle etc.) sealed and identify the sample by labeling/writing with product name, strength, and sample status duly signed by concerned personnel.

After sampling, the parent container should be sealed effectively to avoid any contamination. It must be ensured the presence of Silica Gel Bags in the containers containing RH sensitive products.  

Bring sample into QC Laboratory and after physical inspection enter the sample in BMR receiving record file and hand over sample to QC along with BMR for testing purposes.