This document provides guidelines for effective area and line clearance procedures during production changeovers to ensure patient and customer safety. It defines key terms and outlines control measures for reject materials, equipment design considerations, documentation requirements, and investigation of line clearance failures. The purpose is to minimize risks from foreign materials contaminating product batches during changeovers.

1. PRODUCTION/
PACKAGING
CHANGEOVER & LINE
CLEARANCE

2. Rationale
This is a serious GMP violation & can
have potentially devastating
consequences for patient & customer
safety,& the company’s commercial
activities
Purpose
To describe necessary measures to
ensure effective area/line clearance
procedures

3. Definitions
 Area/Line Clearance:The whole process
including clearing,cleaning & checking.
 Clearing:Removal of any item which could
compromise quality if found in the
subsequent batch.
 Cleaning:Removal of product & cleaning
residues.
 Checking:An independent confirmation that
the area/line is indeed clear & clean
 Rogue:Any item which could compromise
quality if found in the subsequent batch that is
detected after the line clearance has been
signed off.

4. Control of Reject Material
 Should not accidentally get into acceptable
quality material.
 If any reject material is to be reworked,then
an SOP should clearly describe how the
status of the material is to be controlled &
identified.
 Reject materials should be appropriately
labelled or containers should be designed to
minimise the risk of materials escaping it.

5. Other important Areas:
 Areas used for off-line printing or
electronic verification
 Areas used to collate or store QC
samples,rejects or waste materials
 Wash-Bays.

6. Equipment Design
 Design should be assessed for potential
rogue traps & these should be minimised.
 Design should be easy to disassemble &
reassemble
 Clear guards should be used wherever
possible to aid visibility.
 Use of torch light/mirrors etc can help in
making all areas visible
 Process area should have no excess
furniture.

7. Guides For Line
clearance
 Checklists/SOPs
 Photographs/Diagrams
 Production operator’s familiarity of the
area & equipment.

8. Other important Points……
 During checking, a sign should be posted at
the end of the line or the production area that
line checking is in progress & there should be
no interruption .
 Where a large area is divided into zones,clear
identification of the boundaries should be
made & should be stated in The SOP
 Materials once brought off line must not be
brought back to the line after line-checking is
completed .

9. Other important
Points……(cont’d)
 Only personnel involved in cleaning,clearing
& checking operations should be on-line
when these operations are progressing.
 Equipment/change parts should not be
stored within an area/line.If they are to be
stored,then they should be clearly labelled.
 If a break occurs during the procedure,the
completion must be made after the break for
all areas not signed in the record.

10. Area/Line clearance
Documentation
 SOPs covering cleaning,clearing & checking
should include instructions on actions to be
taken on discovery of rogue/line clearance
failure.
 A deviation report should be prepared &
investigated to find out the root cause.
 Rogues & line clearance failure should be
trended to identify problem areas.
 Records must be kept of line
clearance,cleaning & checks made.

11. “Measles Chart”
A cluster of dots can identify a potential problem area where
attention can be focussed.