sop for Qualification of Visual Inspector
1.0 OBJECTIVE:
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
3.0 RESPONSIBILITY:
3.1 Officer / Executive QA and Production
4.0 ACCOUNTABILITY:
4.1 Head – QA
5.0 PROCEDURE:
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.
6.0 ABBREVIATION:
| 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 |
7.0 ATTACHMENTS (ANNEXES) :
7.1 Annexure-I: List of Qualified Visual Inspector
8.0 REFERENCE :
| 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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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