SOP for Visual Inspection of Filled Vials and Ampoules

OBJECTIVE

To lay down the procedure for Visual Inspection of Parenteral Products.

SCOPE

This SOP is applicable for Visual Inspection of filled vials and ampoules.

RESPONSIBILITY

Officer / Executive – Production

ACCOUNTABILITY

Head – Production

PROCEDURE

Before packing each & every parenteral product undergoes strict naked eye visual inspection for the presence of any particulate matter and other things which can term them as rejected. Container is thoroughly checked by keeping in front of black & white back ground and gently shacking . Put green slip in inspected goods, red slips in rejected goods & yellow slips in to be inspected goods.

Containers with following characters should rejected.

1. Black/ white or any colour particle.
2. Fibres.
3. Crystals.
4. Ampoules / vials with defective seals
5. Cracked ampoules / vials
6. Glass.
7. Change in colour of solution.
8. Volume less or more than nominal volume
9. Deformed ampoule/ vial.
10. Empty ampoule/ vial.
11. Any objectionable matter not described in the description of the product.
12. Coagulated powder in case of dry injections.

• Check the cleanliness of the Visual Inspection / Area Booth and take line clearance from QA department before operation.
• Update the status board of Visual Inspection, as Product Name, Batch No., Mfg. Date, Exp. Date, Stage, sign, Date.
• Unload the parenteral products after Leak Test / Terminal Sterilization and further transfer into plastic trays/carets for visual inspection.
• Visual inspectors shall collect the trays / carets of filled of parenteral products and hold the specific quantity of specific size as mentioned in Annexure-I at a time in hand for visual inspection and inspect the filled parenteral product in white and black background for NLT 5 seconds each. (In case of Respules, five-five/single-single/lose to be inspected).

1. All individual Parenteral Products of Ampoules will be checked for sealing defects, Glass particle, Less volume, High volume, Black particles, Fiber, White particle and charring.
2. All individual Parenteral Products of Dry powder injection vials will be checked for Air Bubble, Moulded Vial, Sealing defects, cracked vial, Less fill weight, High fill weight, Broken Flip off Seal and Empty vial.
3. All individual Parenteral Products of Three Piece vials will be checked for Dirty Vial, Vial Without Cap, Mould defect, Broken Ratchet, Improper Sealing, Leaked vial, Surface Particle, Improper Fixing of Cap.
4. In case of Respules Inspect for Less Volume, High volume, Rough surface, De- shaped, foreign particles, Extra plastic, Leakages and Empty. (For all type of defects of Parenteral Products, referred SOP).

• Visual Inspection shall be performed under Black and White background separately for NLT five second each to detect the defective of Filled & Sealed Ampoules & Respules.
• Visual Inspection shall be performed on the Roller rail of Visual Inspection machine each to detect the defective of Dry powder products.
• Visual Inspection shall be performed of physically check the Individual vial each to detect the defective of Three piece Vial.
• Rejected of Parenteral Products shall be kept in respective compartment of Visual Inspection Rejection Pigeon Box with lock & key system/Respective crates.
• Good Parenteral Products to be collect in trays/carets with status label as “INSPECTED” and that particular are ready for labeling.

• After completion of visual inspection activity, the lock of Rejection Pigeon Box will be opened in presence of IPQA personnel & counts the different type of rejections (or from Respective carets) record in Annexure-II & Annexure-III for Respective Line (For Ampoule and Respules product, rejection data shall be filled in respective BMR only).
• After Every hour of visual inspection, 05 minutes eye rest to be given to all visual inspectors.
• Visual Inspection Defects of Parenteral products as per Annexure-II.
• Annexure – III “Visual Inspectors Rotation Record” can be used on need basis.

ABBREVIATIONS

NLT: Not Less Than

No.: Number

QA: Quality Assurance

SOP: Standard Operating Procedure

ANNEXURES

Annexure-I: Sufficient visual quantity

Annexure-II: List of Defected Parenteral Products

Annexure-III: Visual Inspectors Rotation Record

REFERENCES

Nil

REVISION HISTORY

Nil