Standard Operating Procedure for Specific Gravity Testing

1) Purpose

This SOP outlines the procedures for determining the specific gravity of pharmaceutical liquids or solids.

2) Scope

This SOP applies to specific gravity testing of raw materials, intermediate products, and finished pharmaceutical products in the manufacturing facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing specific gravity testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the specific gravity testing protocol and ensure all necessary materials and equipment are available (e.g., specific gravity bottle, balance).
2. Verify the calibration and functionality of the balance.

4.2 Sample Collection and Preparation

1. Collect representative samples of liquids or solids according to sampling procedures.
2. Ensure proper labeling and identification of samples.
3. If necessary, prepare the samples by drying or conditioning to specified conditions.

4.3 Testing Procedure

1. Weigh the empty specific gravity bottle accurately.
2. Fill the bottle with the sample and weigh it again.
3. Calculate the specific gravity using the formula:
   ( text{Specific Gravity} = frac{{text{Weight of sample in air}}}{{text{Weight of sample in air – Weight of bottle in air}}} )
4. Perform specific gravity determination in duplicate or as per protocol requirements.

4.4 Acceptance Criteria

1. Ensure that the specific gravity values of the tested samples meet the specified acceptance criteria based on compendial standards or product specifications.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a specific gravity testing report summarizing the findings for each batch tested.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

6) Documents, if any

Specific Gravity Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records

7) Reference, if any

Regulatory guidelines such as USP <841> Specific Gravity, European Pharmacopoeia (Ph. Eur.) 2.2.5 Specific Gravity

8) SOP Version

Version 1.0