Procedures for Addressing Deviations in Moisture Content Levels

1) Purpose

The purpose of this SOP is to outline the actions to be taken if the moisture content of capsules deviates from the acceptable limits, ensuring product quality and compliance.

2) Scope

This SOP applies to all capsules manufactured within the pharmaceutical facility, particularly those containing hygroscopic formulations.

3) Responsibilities

The Quality Control (QC) department is responsible for detecting deviations in moisture content and initiating corrective actions. The Production department is responsible for implementing the corrective actions.

4) Procedure

1. Detection of Deviations:
   1. Review the moisture content test results against the established acceptance criteria.
   2. If any result falls outside the acceptable range, document the deviation in the moisture content logbook.
2. Initial Investigation:
   1. Notify the QC manager immediately upon detection of a deviation.
   2. Conduct a preliminary investigation to identify any obvious errors in the testing process, such as instrument malfunction or operator error.
3. Root Cause Analysis:
   1. If no obvious error is found, perform a detailed root cause analysis to determine the underlying cause of the deviation.
   2. Examine factors such as raw material quality, manufacturing process parameters, and environmental conditions.
4. Corrective Actions:
   1. Based on the root cause analysis, develop and implement corrective actions to address the