SOP for repacking of online recovery after De-foiling of Product

Objective

The Objective of this SOP is to provide detailed instructions on checking strips and repacking online recovery after de-foiling.

Scope

The scope of this SOP is to lay down the detailed procedure to check the strip/blister before packing those in inner cartons, the rejected strips/blisters are then de-foiled to recover good tablets/capsules, and those are then inspected and packed to complete the packing. This also provides the precautions to be taken while doing the process.

Responsibility

Performance: Worker, Operator, and Technician Responsible to perform the activity.

Checking: Production Supervisor, Technical Staff and above to counter-test the activity.

Accountability

HOD: Production/Assigned Designee for Overall Implementation in System with powerful Procedural management to compliance.

Procedure

Checking:

Take the strips from the conveyer belt and check for the following parameters: (Pockets: Strips should not have empty pockets.
Strips should not have punctured or ruptured pockets.
Strips should not have any broken tablets.

Sealing: Strips should have proper sealing.

Cutting: Strips should have proper cutting.

Overprinting: Printing should be neat & clean, with clear & completely readable batch details.

Pack the strips if strips are found well in the above checks.
Collect the rejected strips in the ‘To be recovered’ container.
Recovery of Product from strips: –

Aluminum strips:

Cut the strip near pockets carefully avoiding damage to the product.
Remove the product from opened pockets.
Collect the product in s.s. container and paste the “To be inspected” label.
Sort out a good product and collect the good product in S.S. Container and rejected product in polybags.
Re-pack the good product immediately online and destroy the rejected product.

Blister strips:

Insert the rejected blisters into the de blistering machine and set accordingly with the size of blister.
The product will be collected in the S.S container provided in the machine.
Inspect the tablets to separate the good ones.
Collect the good product in S.S. Container and rejected products in polybags.
Re-pack the good product immediately online and destroyed rejected product in presence of QA. Officer.

Precaution

Wear hand gloves, nose mask at the time of de-foiling and recovery of the product
Prevent the product from damage at the time of de-foiling and recovery of the product
This SOP is applicable to Blister strips and Aluminum strips.
Necessary precaution for safety concerns and others if applicable as required.

Acceptance Criteria: Only good intact, properly sealed, and over-printed strips should go for packing.

Frequency: As and when strip/blister sealing operation is online.

Annexure

Nil

Abbreviations

SOP: Standard Operating Procedure

BMR: Batch Manufacturing Record

QC: Quality Control

Q.A: Quality Assurance

HOD: Head of the Department

Revision History

Nil