SAMPLING OF BLEND AND BULK FINISHED PRODUCT -SOP

1.0 PURPOSE:
To provide a written procedure for sampling of Blend and Bulk finished product.
2.0 SCOPE:
Applicable to In process sampling.
3.0 RESPONSIBILITY:
Executive Manufacturing , Executive QA and Assistant Manager QA.
4.0 ACCOUNTABILITY:
Manager Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 SAMPLING OF BLEND:
6.1.1 Sampling of Blend is done after unloading the blend in to IPC, Sample is collected from all IPC, Composite sample is made by mixing samples collected from all IPC in sample bag, Label the sample with proper information.
6.2 SAMPLING OF BULK FINISHED TABLET / CAPSULE:
6.2.1 Collect about 10 tablet / capsule in a sample bag at each time during individual weight variation checking. At the end of batch pooled composite sample from the same is sent to Quality control analysis.
6.3 PROCESS VALIDATION SAMPLING:
6.3.1
During Process validation, sampling is done as per the protocol
6.3.2
In process validation samples are collected in triplicate from each point as per protocol
• First sample for analysis
• Second sample for conformation / repetition if any disturbance occurs in first sample analysis.
• Third sample should be kept until analysis report is completed.
7.0
REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATION:
9.1 IPC: Intermediate Product Container
9.2 QA : Quality Assurance