QC laboratory. It includes physical access, restricted area guidelines, and authorization protocols for sensitive zones.

3. Responsibilities

• QC Head: Ensure access privileges are assigned appropriately and reviewed periodically.
• Security Officer: Monitor entry and exit using access control systems and visitor logs.
• QA Officer: Conduct periodic audits to verify access compliance.
• IT Department: Manage and maintain electronic access control systems.

4. Accountability

The Head of Quality Control is accountable for ensuring that all access to the laboratory is managed securely and in line with GMP expectations.

5. Procedure

5.1 Access Authorization

1. Only trained, qualified, and authorized personnel are permitted to access the QC lab.
2. Access shall be granted through a formal request using the Lab Access Request Form (Annexure-1).
3. The QC Head must approve access based on the individual’s job role and training status.
4. Each authorized individual will receive an access badge or biometric entry rights, as per the lab’s security protocol.

5.2 Categorization of Access

1. Level 1 – Full Access: For QC Analysts, Reviewers, Supervisors.
2. Level 2 – Restricted Access: For QA, Production staff, and maintenance teams during scheduled visits.
3. Level 3 – Temporary Access: For auditors, visitors, and trainees. Must be escorted and logged.

5.3 Visitor and Auditor Entry

1. Visitors must be escorted by an authorized employee at all times.
2. Before entry, they must sign the Visitor Logbook (Annexure-2) and receive safety instructions.
3. Auditors must receive temporary access badges and follow the same registration protocol.

5.4 Access Monitoring and Revocation

1. Electronic logs must be reviewed monthly to track access violations or anomalies.
2. Access must be revoked immediately if:
   • The employee leaves the organization
   • Job responsibilities change
   • A disciplinary action is pending
3. Records of revoked access shall be maintained in the Access Termination Log (Annexure-3).

5.5 Unauthorized Entry Handling

1. Any individual found in the QC lab without authorization shall be reported to the QA Head and Security immediately.
2. Incident report must be raised and root cause investigation initiated within 24 hours.
3. Corrective and preventive actions (CAPA) shall be documented and closed within 7 days.

5.6 Compliance with GMP and Data Integrity

1. Personnel must not share access credentials or allow tailgating into restricted zones.
2. All activities within the QC lab must comply with ALCOA+ principles of data integrity.
3. Any deviation observed must be immediately logged and reviewed by QA.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available

7. Documents

1. Lab Access Request Form (Annexure-1)
2. Visitor Logbook (Annexure-2)
3. Access Termination Log (Annexure-3)
4. Lab Access Register

8. References

• 21 CFR Part 11 – Electronic Records and Signatures
• EU GMP Annex 11 – Computerized Systems
• WHO TRS No. 1019 – Annex 4: Good Data and Record Management Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Lab Access Request Form

Name	Employee ID	Department	Access Level	Approval Date
Rajesh Kumar	EMP123	QC	Level 1	14/04/2025

Annexure-2: Visitor Logbook

Date	Name	Purpose	Escorted By	Exit Time
14/04/2025	Anita Sharma	Regulatory Audit	Sunita Reddy	12:30 PM

Annexure-3: Access Termination Log

Employee Name	Employee ID	Date of Termination	Reason
Suresh Mehta	EMP088	01/04/2025	Resignation

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	Implementation of access control system	QA Head
14/04/2025	2.0	Added biometric and ALCOA+ integration	Audit Recommendation	QA Head