CLEANING, OPERATION, MONITORING & PRECAUTIONS OF MANUAL VISUAL INSPECTION TABLE & PROCESS FOR MANUAL INSPECTION OF SVP CONTAINERS.
To lay down the procedure for cleaning, operation, monitoring & precautions of visual Inspection table & process for manual visual inspection of filled & sealed SVP containers.
This SOP is applicable for manual visual inspection of filled & sealed SVP containers of SVP manufacturing facility
|Equipment Name||Equipment ID||Location|
3.0 REFERENCE(S) & ATTACHMENTS
3.1.1. USP <1790> Visual Inspection of Injection products
3.1.2. USP<790> Visible Particulate in injection
3.2 CROSS REFERENCE DOCUMENTS
3.2.1. Training of new visual Inspector
3.2.2. Operation & calibration of Lux Meter
|S.No.||Attachments No.||Attachment Title|
|126.96.36.199||Attachment-I||:||Visual Checker “Eyes rest” Record|
|188.8.131.52||Attachment-II||:||Visual Inspection Board Light Intensity Record|
|184.108.40.206||Attachment-III||Visual Defects Pictorial|
4.0 DEFINITION & ABBREVIATION(S)
4.1.1 Visual Inspection: Visual Inspection of medicinal products for parenteral use should detect any readily identifiable visible container defect and ensure constant quality of products in terms of absence of particulate matter and/or turbidity, correct or uniform appearance of containers.
This is the process of sorting unacceptable units from acceptable units by human visual inspector and/or through qualified equipment.
SOP: Standard Operating Procedure
QA :Quality Assurance
PROD. : Production
C.C. No. :Change Control Number
SS : Stainless Steel.
WFI :Water for Injection
IPA : Iso Propyl Alcohol
BMR : Batch Manufacturing Record
cGMP :Current Good Manufacturing Practice
BPR : Batch Packing Record
IPQA : In-Process Quality Assurance
USP : United States Pharmacopeia
5.1 Originating department shall be responsible:
5.1.1. Preparation of the SOPs.
5.1.2. To provide the final draft copy to Quality Assurance.
5.1.3. To follow the described here in.
5.1.4. To perform the operation/activity as per respective SOP.
5.1.5. To impart the training to concerned personal as well as operators before effective date of SOPs.
5.1.6. Co-ordinate with engineering person for maintenance/breakdown.
5.1.7. To maintain online documentation, records & log books.
5.1.8. Initiation of change control to revise or modify the SOPs.
5.2 Head of Originating department/designee shall be responsible for:
- Ensure that sub-ordinate, operators are trained before performing any task or operation.
- To check the SOP for proper contents/technical parameter as per the equipment.
- To get the SOP approval from Quality Assurance or designee.
- To provide the training of SOP to the concerned personnel before effective date of the SOP.
- To ensure implementation of the SOP on effective date.
- To maintain the controlled copies of the SOPs at required location.
- To ensure the compliance of SOP.
5.3 Quality Assurance department shall be responsible for:
5.3.1. To verify that all content of SOP are relevant to the concern equipment & process.
5.3.2. To maintain the approved master copy of the SOP of all department for document control.
5.3.3. To issue the required number of controlled copies to the departments and document the same.
5.3.4. To verify that all the instructions are followed properly as per the given SOP.
5.3.5. To ensure implementation of SOP.
5.3.6. To verify that records/log books are maintained as per defined system.
5.3.7. To verify instrument is calibrated before operation.
5.4 Engineering person shall be responsible for:
5.4.1. Co-ordinate with production person for schedule preventive maintenance or breakdown maintenance of equipment.
5.4.2. Perform maintenance of equipment or system as per schedule.
5.5 Head QA Shall be responsible for:
5.5.1. Review of draft SOP regulatory and cGMP compliance.
5.5.2. Final approval of new or revised SOP by signing off as approved by.
5.5.3. To ensure the implementation of the defined system.
5.6 Plant head shall be responsible for:
5.6.1. To approve new or revised SOP.
5.6.2 To ensure the implementation of defined system.
6.1.1. Visual inspection should not to be perform until visual board light is switch “ON”.
6.1.2. Don’t touch the electrical part of visual table.
6.1.3. Any weak eye side visual inspector should not perform visual inspection.
6.1.4. If during visual inspection any inspector feel stress on eye or headache should not continue visual inspection.
6.2.1. Switch ‘OFF’ from mains.
6.2.2 Clean the visual inspection table with IPA 70% solution before start process & whenever necessary in between or end of the process.
6.2.3. All the rejection box/container should be clean with IPA 70% v/v solution.
6.2.4. Clean the conveyor belt from up & down side with clean lint free cloth.
6.2.5. After completion of the shift, switch off electrical supply remove all checked and unchecked ampoules from the table & keep appropriate place.
6.2.6. Remove all broken pieces of ampoules and clean with cloth or brush.
6.3 CHECK POINTS
6.3.1. Visual inspection of filled containers should be perform after leak test.
6.3.2. The personal involve in visual inspection should be qualified person, comprising Initial qualification and periodic requalification on semiannual basis.
6.3.3. If any new visual inspector join for visual inspection trained them as per SOP.
6.3.4. The personal involve in the visual inspection should regularly undergo eye test on semiannual basis. If any visual checker doesn’t pass the eye test, replace her.
6.3.5. Every day QA & production person verify the Intensity of visual inspection board light with lux meter as per SOP. Light intensity limit of each visual board should be NLT 2000-3750 lux. Light intensity prefix determination point should be close to inspection point of operator.
6.3.6. If intensity found below the standard limit (NLT 2000-3750 lux) inform to engineering person to replace the fluorescent tubes and after replacement again verify the intensity & maintain the visual board intensity record.
6.3.7. The area where manual inspection to be performed should be suitable for carrying out this operation.
6.3.8 The visual inspector should give regular training at the end of shift under worst condition.
6.4.1. Visual inspection table is equipped with black & white board to visualize & inspect the filled & sealed containers, conveyer belt to transfer the ampoules as per figure : I.
6.4.2. To start the inspection process switch “ON” the visual inspection table & conveyer with the main panel of the machine.
6.4.3. Transfer the containers to be inspected in the packing room & get line clearance from QA.
6.4.4. Keep the plastic tray containing ampoules/respules near inspection table
6.4.5. Hold the cassette of 4/5 between thumb & four fingers as per figure : II.
6.4.6. Invert the cassettes to shake the contents & bring it to original position before observing each time in front of black and white board.
6.4.7. Each cassette should be inspected for at least 5 second against white back ground and additional 5 second against black background.
6.4.8. Following defects to be observe in containers/ampoules/respules during visual Inspection & make separate them as per their risk category.
- Solution Clarity : Solution clear/colorless (Critical)
- Particulate matter in solution : Particle present in solution (Critical)
- Leakage : Leak Container (Critical)
- Surface particle : black, white or any other colour particles (Major)
- Rough Surface : Rough surface (Minor)
- Deform Shape : Shape of container not proper (Minor)
- Volume variation : Low or high volume of solution (Major)
- Extra plastic : Extra plastic accumulated inside out side the containers (Major)
- Twisting : Twisting of neck of ampoules (Minor)
6.4.9. Acceptable quality level (AQL) table of each type of defects is as follows, to avoid greatest risk to the patient with the critical type of defects or rejection.
|Defects category||AQL range (%)|
6.4.10. If any of the deformities or rejection found, keep the rejected ampoule/container in particular rejection box identified with name. good ampoules transfer for labeling through conveyer.
6.4.11. Ampoule/ampoule cassette inspect by production chemist/officer & IPQA person alternatively as per BPR.
6.4.12. Record the rejection quantity in BPR.
6.4.13. After batch complete transfer the rejected Ampoules to scrap yard for destruction.
6.4.14. Record the equipment operation details in relevant log book.
6.4.15. Monthly basis production, QA and engineering person will verify the intensity of fluorescent tube of visual board with calibrated lux meter & make entry in visual board light intensity record.
6.4.16. Give 5 minutes break or rotate each visual inspector after every hour of continuous or uninterrupted inspection. These break or rotation allow time to rest of their eyes & mind so that visual inspector or checker doesn’t feel fatigue during inspection.
6.4.17. Visual inspector, production as well as IPQA person will check the break down & operation time by calibrated wall clock located in packing hall.
6.5 In-process check during visual inspection:
6.5.1. Every hours during visual inspection IPQA person will collect random 50 cassettes samples from already inspected ampoules, verify & record the observation in BMR as per figure : III.
6.5.2. In case of detecting rejection in inspected good ampoules, IPQA person will inform to production person to recheck the good ampoules as well as verify the particular visual inspector who is responsible for rejection & train them.
6.5.3. In case rejection detect successive three times in inspected good ampoules by particular visual inspector, shall be subjected to retrain & requalify & reappoint for inspection only after qualify by QA.
6.6.1. Engineering person will perform the schedule preventive maintenance & break down maintenance of the inspection board.
6.6.2. During operation if any of the tube light get fuse or damage, inform maintenance person to replace the same.
6.6.3. After replacing the tube production & QA person will check the intensity of the light & mention in the visual board intensity record.
6.6.4. If any other abnormalities found during operation, engineering person will rectify the same.
Figure: I (MANUAL VISUAL INSPECTION TABLE)
Figure: II (PROCESS OF VISUAL INSPECTION)
Figure: III (In process verification of ampoules by QA)
7.0 REVISION HISTORY
|Version No.||00||Effective date|
Detail of revision :New SOP