1.0 Purpose
1.1 To describe a standard procedure for visual inspection of filled bottle to identify all type of defect for delivering good quality products.
2.0 Scope
2.1 This procedure is applicable for visual inspection of all type of filled liquid bottle manufactured at "NAME" Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Operators are responsible for visual inspection.
He/ She inform the supervisor about any deviation from normal operation.
3.2
Production Officer / Sr. Officer are
responsible to ensure that the procedure is implemented properly.
3.3
Quality Assurance Officer / Sr. Officer are
responsible to verify the inspection.
3.4
Engineering department is responsible to
maintain adequate light for inspection.
4.0
Abbreviations and Definitions
4.1
Critical Defects: Turbid, dirt, big pieces of
glass, leakage, black particles and cracks.
4.2
Major Defects: Empty, visible glass, unequal
content and improper cap sealing.
4.3 Minor Defects: Spots on the inner and outer surface of Bottles, deformed bottles.
4.4 Appearance: Its visual identity and overall “elegance” which is essential for customer acceptance, for control of lot to lot uniformity.
5.0 Materials
and Equipment
5.1 None
6.0 Health and Safety Considerations
6.1 None
7.0 Procedure
7.1
Bring the filled bottles of a specific batch to
the respective workstation.
7.2
Arrange clean and dry trays with proper
labeling of respective batch.
7.3
Keep BPR beside the inspection table during visual
inspection.
7.4
Before starting inspection check the line
clearance by Production and QA Officer / Sr. Officer.
7.5
Take some filled bottles on the inspection
table.
7.6
Take 2 to 3 bottles in hand for inspection.
7.7
Shake slowly and take care not to introduce air
bubbles.
7.8
Examine each bottle at least five seconds in
fronts of black background and another five second in front of white
background.
7.9
Visual inspection team to be change after two-hour
interval.
7.10
Observe the defect category and sort out the
filled bottles having Critical, Major and Minor defect.
7.11
Packed the good bottles.
7.12
Count the defective filled bottles.
7.13
Record all observations in the respective Batch
Packaging Record.
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 None
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
|
02 |
|
|
|
11.0 Training
11.1 Head of Production
or his nominee give the training of production operator and worker.
