Guidelines for Acceptable Weight Variation

1) Purpose

The purpose of this SOP is to establish criteria for determining acceptable weight variation in filled capsules to ensure uniformity and quality in the final product.

2) Scope

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

3) Responsibilities

The Quality Control (QC) department is responsible for establishing and maintaining the criteria for acceptable weight variation. The Production department is responsible for adhering to these criteria during manufacturing.

4) Procedure

1. Establishing Weight Variation Criteria:
   1. Determine the acceptable weight range for each capsule based on the product specifications and regulatory guidelines.
   2. Document the weight variation criteria in the product specification sheet.
2. Weight Checking Process:
   1. Weigh a sample of capsules from each batch as outlined in the weight variation control procedure.
   2. Compare the individual capsule weights to the established weight variation criteria.
3. Handling Out-of-Specification Weights:
   1. If a capsule weight is found to be outside the acceptable range, document the deviation and investigate the cause.
   2. Implement corrective actions to address the deviation and prevent recurrence.
   3. Re-weigh the capsules after corrective actions to ensure compliance with the weight variation criteria.
4. Documentation and Review:
   1. Record all weight check results and any deviations in the weight variation logbook.
   2. Periodically review the weight variation criteria and update as necessary to ensure ongoing compliance and quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Product Specification Sheet, Weight Variation Logbook, Deviation Reports, and Corrective Action Records

7) Reference, if any

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

8) SOP Version

Version 1.0