- OBJECTIVE:
- To lay down a procedure that ensures and demonstrates system suitability requirement of chromatographic methods used in the quality control laboratory. The procedure shall apply for HPLC tests of content uniformity, assay, dissolution, related substances, and gas chromatographic methods.
- SCOPE:
This SOP is applicable to procedure that ensures and demonstrates system suitability requirement of chromatographic methods used in the quality control laboratory. The procedure shall apply for HPLC tests of content uniformity, assay, dissolution, related substances, and gas chromatographic methods at {Company Name} {Location}.
- RESPONSIBILITY:
- Officer/Executive/Designee Quality Control – Shall be responsible for operation as per SOP.
- Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
- PROCEDURE:
- Samples for analysis shall be run on chromatography systems with pre-programmed injection sequences.
- A single injection of the standard preparation shall be injected intermittently for each injection sequence.
- The area response of the first set of injections of standard preparations and the area response of the intermittent standard (or bracketing standard) shall comply with the precision requirements of system suitability of the analytical method, i.e. % RSD of the area responses of the first set of injections and the intermittent standard shall comply with the requirement of the analytical method.
- All samples shall be prepared and injected as per the standard test procedure.
- The following table shall describe the frequency of injection of the intermittent standard.
| Test | Number of batches |
| Assay | 5 |
| Related Substances | 5 |
| Residual Solvents | 5 |
| Content Uniformity | 1 |
| Dissolution | 3 |
| Dissolution profile | 1 |
- A single injection of the standard preparation should be injected at the end of each injection sequence.
- REFERENCES:
Not Applicable
- ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Quality Control
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| RSD | : | Relative Standard Deviation |
| QC | : | Quality Control |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |