Procedure for Checking Weight of Filled Capsules

1) Purpose

The purpose of this SOP is to establish a procedure for periodically checking the weight of filled capsules to ensure consistency within specified limits and maintain product quality.

2) Scope

This SOP applies to the weight control of all filled capsules produced within the pharmaceutical manufacturing facility.

3) Responsibilities

The Production department is responsible for performing weight checks. The Quality Control (QC) department is responsible for verifying and documenting the results.

4) Procedure

1. Preparation for Weight Checking:
   1. Ensure all weighing equipment is calibrated and clean before use.
   2. Prepare the capsules to be checked, ensuring they are representative of the batch.
2. Weight Checking Process:
   1. Select a random sample of capsules from the batch.
   2. Weigh each capsule individually and record the weights.
   3. Compare the weights to the specified limits to determine compliance.
3. Review and Documentation:
   1. Document all weight check results in the weight variation logbook.
   2. Review the results to ensure they fall within acceptable limits.
   3. If any weights are outside the limits, follow the procedure for addressing weight variation issues.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Weight Variation Logbook, Calibration Records, and Weight Check Forms

7) Reference, if any

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

8) SOP Version

Version 1.0