implementing corrective actions to resolve any equipment failures that contribute to deviations.

Maintenance Team: Responsible for addressing maintenance-related deviations and ensuring that equipment is functioning according to specifications to prevent further issues.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all deviations are documented and that appropriate corrective actions are implemented. The overall compliance with this SOP is monitored by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Deviations

1. During the manufacturing process, deviations from standard operating procedures (SOPs) or process parameters should be immediately identified by production personnel. Deviations may include, but are not limited to:
   • Failure to meet specified process parameters (e.g., temperature, pressure, filling volume)
   • Out-of-specification raw materials or ingredients
   • Equipment malfunctions or failures
   • Personnel errors or non-compliance with procedures
   • Environmental conditions outside the acceptable range (e.g., humidity, airflow)
2. Once a deviation is identified, production personnel should immediately notify the supervisor or quality control staff, and the deviation must be documented in the Deviation Report (Annexure-1).

5.2. Documenting the Deviation

1. The Deviation Report should include the following information:
   • Deviation ID (unique identification number)
   • Description of the deviation (e.g., the nature of the issue, how it was identified, and the equipment or process affected)
   • Date and time of the deviation
   • Personnel involved in the deviation
   • Immediate actions taken to mitigate or contain the deviation (e.g., stopping production, adjusting process parameters)
   • Root cause investigation (if applicable)
2. Ensure that the Deviation Report is signed and dated by the responsible personnel who identified and documented the deviation.

5.3. Investigating the Deviation

1. The Quality Assurance (QA) team is responsible for investigating all deviations. The investigation should include:
   • Reviewing the batch manufacturing record (BMR) and other relevant documentation (e.g., equipment logs, environmental monitoring records)
   • Conducting interviews with the personnel involved in the deviation to understand the cause
   • Examining the equipment used in the process to identify potential issues (e.g., malfunctioning equipment, incorrect settings)
   • Assessing the impact of the deviation on product quality and compliance with specifications
2. Once the root cause is determined, document the findings in the Deviation Report and outline any corrective actions required to address the issue.

5.4. Implementing Corrective and Preventive Actions (CAPA)

1. Based on the investigation, the QA team should determine appropriate corrective and preventive actions (CAPA) to resolve the deviation and prevent recurrence. CAPA should include:
   • Immediate corrective actions to resolve the deviation (e.g., adjusting equipment settings, replacing raw materials, retraining personnel)
   • Long-term preventive actions to prevent similar deviations from occurring in the future (e.g., revising SOPs, upgrading equipment, implementing more stringent monitoring procedures)
2. Ensure that the CAPA plan is documented in the Deviation Report and that all actions are tracked to completion. The responsible personnel should sign off on the actions taken.

5.5. Reviewing and Approving the Deviation Report

1. Once the deviation investigation is complete and corrective actions are implemented, the Deviation Report should be reviewed by the QA team to ensure that all relevant details are included, and that corrective actions are appropriate.
2. If the deviation is resolved and no further issues are identified, the QA team should approve the Deviation Report and close the case.
3. If additional actions are needed, the QA team should request further investigation and corrective actions until the deviation is fully resolved.

5.6. Archiving the Deviation Report

1. Once approved, the Deviation Report should be archived for future reference. All deviation reports should be retained for the required duration according to company policy and regulatory requirements.
2. Ensure that archived deviation reports are accessible to authorized personnel and can be retrieved for audits, inspections, or further investigations.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record
• PCR: Product Control Record
• QC: Quality Control

7. Documents

1. Deviation Report (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Root Cause Analysis Report (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation ID	Deviation Description	Corrective Action	Root Cause	Investigation Date	Responsible Person
DEV-12345	Pressure deviation in filling machine	Recalibrated pressure gauge	Equipment malfunction	06/02/2025	Rajesh Patel

Annexure-2: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Recalibrated pressure gauge and inspected equipment	Rajesh Patel	06/02/2025

Annexure-3: Root Cause Analysis Report

Root Cause ID	Root Cause Description	Investigation Findings	Corrective Action	Responsible Person
RC-12345	Incorrect calibration of pressure gauge	Pressure gauge was improperly calibrated during maintenance	Recalibrated and tested pressure gauge	Rajesh Patel

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated deviation documentation procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures