1) SOP for QA/QC Communication

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for effective communication between the Quality Assurance (QA) and Quality Control (QC) departments to ensure timely reporting, investigation, and resolution of deviations and quality issues.

3) Scope

This SOP applies to all QA and QC personnel involved in the communication and coordination of quality-related activities within the pharmaceutical manufacturing facility.

4) Responsibilities

• QA personnel are responsible for overseeing the quality systems and ensuring compliance with regulatory standards.
• QC personnel are responsible for conducting tests and inspections to verify product quality.
• Both QA and QC personnel are responsible for timely and accurate communication of deviations and quality issues.
• Supervisors are responsible for facilitating communication between departments and resolving any communication barriers.

5) Procedure

1. Initial Communication of Deviations
   1. QC personnel identify and document any deviations or non-conformances during testing or inspections.
   2. Immediately report the identified deviations to the QA department using the designated communication channels (e.g., email, deviation report form).
   3. Ensure that all relevant details, including the nature of the deviation, date, time, and involved personnel, are included in the report.
2. Review and Preliminary Investigation by QA
   1. QA personnel review the deviation report upon receipt to assess the severity and potential impact on product quality.
   2. If necessary, QA initiates a preliminary investigation to gather additional information and determine the root cause of the deviation.
   3. Document the findings of the preliminary investigation in the deviation report.
3. Coordination of Full Investigation
   1. QA and QC personnel collaborate to plan and conduct a full investigation if the deviation warrants further examination.
   2. Assign specific tasks and responsibilities to relevant personnel from both departments to ensure a thorough investigation.
   3. Maintain open communication throughout the investigation to share progress, findings, and any required corrective actions.
4. Corrective and Preventive Actions (CAPA)
   1. Based on the investigation findings, QA and QC jointly develop and implement corrective and preventive actions to address the root cause of the deviation.
   2. Document the CAPA plan, including timelines, responsibilities, and verification methods.
   3. Ensure that the CAPA plan is communicated to all relevant personnel and departments.
5. Follow-up and Verification
   1. QA and QC personnel monitor the implementation of the CAPA plan to ensure timely and effective completion of corrective actions.
   2. Verify the effectiveness of the corrective actions by conducting follow-up tests and inspections as needed.
   3. Document the verification results and update the deviation report accordingly.
6. Documentation and Reporting
   1. Maintain detailed records of all communication, investigation activities, and CAPA actions related to the deviation.
   2. Ensure that deviation reports are accurately completed and filed in the designated location for future reference and audits.
   3. Prepare summary reports of deviation trends and CAPA effectiveness for periodic review by QA management.
7. Periodic Meetings and Communication
   1. Conduct regular meetings between QA and QC departments to discuss ongoing quality issues, deviations, and CAPA progress.
   2. Establish a clear agenda for each meeting and document the minutes, including action items and responsible personnel.
   3. Encourage open communication and feedback to continuously improve the QA/QC communication process.

6) Abbreviations, if any

• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• SOP: Standard Operating Procedure

7) Documents, if any

• Deviation Report Forms
• CAPA Plans
• Investigation Reports
• Meeting Minutes
• Summary Reports

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Company-specific quality management policies

9) SOP Version

Version 1.0