Guidelines for In-Process Control During Blending Operations

1) Purpose

The purpose of this SOP is to provide guidelines for in-process control during blending operations to ensure consistent quality and content uniformity of capsules.

2) Scope

This SOP applies to all blending operations performed within the pharmaceutical manufacturing facility.

3) Responsibilities

The Production department is responsible for performing in-process control during blending. The Quality Control (QC) department is responsible for verifying the results.

4) Procedure

1. Preparation for In-Process Control:
   1. Ensure all in-process control equipment is calibrated and clean.
   2. Prepare the sampling plan and ensure all necessary materials are available.
2. In-Process Control:
   1. During blending, periodically take samples according to the sampling plan.
   2. Conduct in-process tests to verify content uniformity and other critical parameters.
   3. Record the results of in-process tests in the in-process control logbook.
3. Handling Deviations:
   1. If any in-process test results fall outside the acceptable range, document the deviation and investigate the cause.
   2. Implement corrective actions to address the deviation and prevent recurrence.
   3. Re-test the samples after corrective actions to ensure compliance with the in-process control criteria.
4. Post-Blending Actions:
   1. Ensure all in-process control results are documented in the batch record.
   2. Review the in-process control results to confirm that the blending operation meets all quality criteria before proceeding to the next stage.
5. Documentation and Review:
   1. Maintain records of all in-process control activities in the in-process control logbook and batch record.
   2. Periodically review in-process control procedures and criteria to ensure ongoing compliance and quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

In-Process Control Logbook, Batch Record, and Deviation Reports

7) Reference, if any

Relevant regulatory guidelines such as ICH Q7 and FDA Guidance for Industry

8) SOP Version

Version 1.0