Procedure for Line Clearance Before Production

Department	Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/082
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a standardized procedure for performing line clearance before the start of production in the ointment manufacturing process. Line clearance ensures that the production area and equipment are free from any materials, documents, or residues from the previous batch, preventing cross-contamination and mix-ups.

2. Scope

This SOP applies to all personnel in the Production and Quality Assurance (QA) departments responsible for performing and verifying line clearance before the initiation of a new batch in ointment manufacturing.

3. Responsibilities

• Production Operator: Performs physical cleaning and removes unnecessary items from the production area.
• Production Supervisor: Ensures that line clearance activities are completed and documented properly.
• Quality Assurance (QA) Officer: Verifies the effectiveness of line clearance and provides final approval.
• Quality Assurance (QA) Manager: Reviews and ensures compliance with GMP guidelines before approving production startup.

4. Accountability

The QA and Production Managers are accountable for ensuring that line clearance is performed according to GMP standards and documented properly.

5. Procedure

5.1 Pre-Clearance Checks

• Ensure that the previous batch has been completed and all leftover materials have been removed.
• Verify that any rejected, quarantined, or unused materials are stored properly.
• Ensure that used equipment is cleaned and documented as per the cleaning SOP.
• Check that the production area is free from unwanted documents, tags, or labels.

5.2 Equipment Inspection

• Confirm that all machines are clean and in operational condition.
• Check calibration records of critical equipment (e.g., mixers, filling machines).
• Verify that all required tools and accessories are available.

5.3 Raw Material and Packaging Material Verification

• Confirm that only QA-approved raw materials and packaging components are present.
• Ensure that the correct labels and batch records are available.
• Verify that packaging material is not mixed with previous batches.

5.4 Environmental Conditions

• Ensure temperature and humidity levels are within specified limits.
• Check air filtration systems and ensure proper airflow.
• Verify that the production area meets cleanliness requirements.

5.5 Documentation and Approval

• Record all line clearance checks in the Line Clearance Log.
• QA personnel must verify and approve the line clearance checklist.
• Only after QA approval can the production process be initiated.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• BMR – Batch Manufacturing Record

7. Documents

• Line Clearance Log (Annexure-1)
• Line Clearance Approval Form (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• USP <1072> – Disinfection and Cleaning of Equipment

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Line Clearance Log

Date	Batch Number	Production Area	Equipment Status	Material Check	Environmental Check	Verified By
01/02/2025	OINT-101	Mixing Room	Clean	Approved	Within Limits	QA Officer
02/02/2025	OINT-102	Filling Room	Clean	Approved	Within Limits	QA Officer

Annexure-2: Line Clearance Approval Form

Date	Batch Number	Area Clearance Completed	Final Approval Status	Approved By
01/02/2025	OINT-101	Yes	Approved	QA Head
02/02/2025	OINT-102	Yes	Approved	QA Head

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head