- OBJECTIVE:
To lay down the procedure for action plan in case of stopping a stability study.
- SCOPE:
This SOP is applicable to the procedure for action plan in case of stopping a stability study at {Company Name} {Location}.
- RESPONSIBILITY:
- Officer/Executive/Designee Quality Control – Shall be Responsible for discontinuation and follow the procedure 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:
- An ongoing stability study shall be terminated subject to any one of the following conditions.
- When a project is terminated by scientific or management decision.
- When the active material source is no longer available on the commercial market.
- When there is a significant change in the physicochemical specifications of the approved active material.
- When the container-closure system is no longer available on the commercial market.
- When the resin for a plastic component of a container-closure system is no longer available on the commercial market.
- When results for any analytical parameter for a particular product remains out-of-specification (OOS) after an appropriate full investigation according to the SOP with a final decision to discontinue the further stability study.
- The stability study will be terminated by giving appropriate reasons for stopping the study by Manager-QC (Stability) in the format as per Annexure-I after approval from QA-Head.
- The discontinuation activity will be initiated which will be finally verified Manager-QC (Stability) and approved by QA Head.
- REFERENCES:
Not Applicable
- ANNEXURES:
| ANNEXURE NO. | TITLE OF ANNEXURE |
| Annexure-I | Discontinuation of stability studies |
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 |
| OOS | : | Out of specification |
| 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 |
Annexure-I
DISCONTINUATION OF STABILITY STUDY
Frequently Asked Question?
1. Under what circumstances might a stability study be terminated due to a scientific or management decision?
Answer: This could occur if the planned study design becomes irrelevant (e.g., changes in formulation or dosage), funding limitations arise, or the target product is no longer commercially viable.
2. Why would a stability study be terminated if the active material is no longer commercially available?
Answer: Without access to the material, testing wouldn’t be possible, rendering the study pointless.
3. What kind of changes in the active material’s specifications would warrant termination?
Answer: Significant changes in potency, purity, or other physico-chemical properties could impact the product’s stability and render the original study data irrelevant.
4. Under what circumstances would the container-closure system being unavailable necessitate termination?
Answer: If the packaging can’t be obtained, the product’s stability under a different system would need evaluation, requiring a new study.
5. How does the unavailability of a plastic component resin trigger termination?
Answer: Similar to the full closure system, an alternative resin might affect stability, necessitating a new study.
6. What happens if an out-of-specification (OOS) result can’t be resolved after investigation?
Answer: In such cases, the continued safety and efficacy of the product are questionable, making further stability testing potentially irrelevant.
7. Who is responsible for approving stability study termination and how is it documented?
Answer: The Manager-QC (Stability) proposes termination with justifications in a specific format (Annexure-I), requiring approval from the QA Head.
8. What steps are involved in “discontinuation activity” after termination?
Answer: The specific steps aren’t detailed, but they likely involve closing out the study, reporting final data, and archiving study materials.
9. Who is responsible for verifying and approving discontinuation activities?
Answer: Again, the Manager-QC (Stability) leads the process, requiring final approval from the QA Head.