Standard Operating Procedure for Content Uniformity Testing
1) Purpose
This SOP outlines the procedures for conducting content uniformity testing on pharmaceutical products to ensure consistency and compliance with dosage specifications.
2) Scope
This SOP applies to content uniformity testing of solid oral dosage forms, including tablets and capsules, manufactured in the pharmaceutical facility.
3) Responsibilities
The Quality Control (QC) department is responsible for performing content uniformity 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
- Review the content uniformity testing protocol and ensure all necessary materials and equipment are available (e.g., analytical balance, sample preparation tools).
- Verify the calibration and accuracy of the analytical balance.
4.2 Sample Collection and Preparation
- Collect a representative sample of solid oral dosage forms according to sampling procedures.
- Prepare individual units for testing by removing excess powder or granules (if applicable).
- Use a sample divider to obtain the required number of units for testing.
4.3 Testing Procedure
- Prepare a composite sample by combining the required number of individual units.
- Homogenize the composite sample thoroughly to ensure uniform distribution of drug substance.
- Perform content uniformity testing using a validated analytical method (e.g., HPLC, UV-Vis spectroscopy).
- Calculate the drug content for
4.4 Acceptance Criteria
- Ensure that the individual unit drug content falls within the specified range or percentage deviation from the average content.
- Document any deviations from acceptance criteria and investigate root causes if necessary.
4.5 Reporting and Documentation
- Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
- Prepare a content uniformity testing report summarizing the findings for each batch tested.
- 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
Content Uniformity Testing Protocol, Testing Records, Testing Reports, Sample Collection and Preparation Records
7) Reference, if any
Regulatory guidelines such as USP <905> Uniformity of Dosage Units, USP <711> Dissolution, European Pharmacopoeia (Ph. Eur.) 2.9.6 Uniformity of Content of Single-Dose Preparations
8) SOP Version
Version 1.0
