sop for Qualification of Visual Inspector

sop for Qualification of Visual Inspector



1.1 To lay down a procedure for Qualification of Visual Inspector.
2.0 SCOPE:
2.1 This Standard Operating Procedure is applicable for Qualification of Visual Inspector
3.1 Officer / Executive QA and Production
4.1 Head – QA
Note: Each newly joined visual inspector shall undergo a training program before going through qualification procedure.

Training shall be imparted by QA on visual inspection booth which is used for routine activity.
5.1 Qualification of Trained Visual Inspectors:

5.1.1 Officer / Executive – QA shall issue Qualification Protocol & Report to IPQA personnel for execution of qualification activity.

5.1.2 Visual inspector shall be qualified on the basis of methodology of approved protocol in the presence

of IPQA personnel by providing a kit of Filled & Sealed Glass Ampoules having known defects.
5.1.3 Personnel under qualification shall put a tick mark ‘√’ in the box of respective defects column of

qualification report. Identification of correct defects, which is ‘√’ mark by concern visual inspectors

in respective qualification report column shall be checked by production, verified by QA and reviewed

by QA from the respective visual inspector qualification Protocol.
5.1.4 All new visual inspectors shall be qualified as per respective challenge test kit and after successful

qualification, name of visual inspector shall be incorporated in visual inspector qualification

list & allowed for routine visual inspection activity.
5.1.5 Personnel shall be qualified if he / she able to detect the defect as per acceptance criteria mentioned in

protocol i.e. 100 % defect shall be identified by the visual inspectors.
5.1.6 After completion of visual inspector qualification, IPQA personnel shall hand over the qualification

report with all training records to documentation cell.
5.1.7 After successful evaluation of qualification report, QA- Documentation cell shall prepare list

of Qualified Visual Inspector and displayed in respective packing area

as per Annexure-I, Titled “List of Qualified Visual Inspector”.

5.1.8 Visual Inspector List shall be updated every six month or whenever required.
5.2 Frequency of Qualification: Visual Inspector shall be qualified in following cases
5.2.1 If a new person to be deputed as visual inspector.
5.2.2 Re-qualification of all individuals shall take place once in a year ± 30 days and eye checkup of visual

inspector should be done twice in a year.
5.2.3 Re-qualification reports shall be prepared annually on the basis of medical fitness and visual

inspection challenge test of all individual.
5.2.4 After major eye treatment i.e. eye operation.
Precaution: No personnel shall be allowed for routine visual inspection activity of Filled and Sealed Glass

Ampoules Injection in production area without training & visual inspector qualification.


S. No. Abbreviations used Full form of Abbreviation used
1. QA Quality Assurance
2. SOP Standard Operating Procedure
5. 0C Degree Centigrade
6. RH Relative Humidity

7.1 Annexure-I: List of Qualified Visual Inspector

S. No. Reference Title
1.0 As per GMP Guideline


Annexure-I: List of Qualified Visual Inspector

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel


sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area


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