Rework Residue , Purpose:
Rework Residue , To lay down a procedure for Handling of Rework Residues from Batch Processed Material /Intermediate product.
Rework Residue , Scope:
This SOP is applicable for the Production Area of XX Pharmaceuticals Limited.
Definition / Abbreviation:
[][]N/A
Responsibilities:
[][]The Roles and Responsibilities are as follows :
Operator
[][]To follow the laid down procedure.
Executive, Production
[][]To monitor and check the laid down procedure.
Manager, Production
[][]To implement this correctly.
Manager, Quality Assurance
[][]To approve the Document.
Procedure:
Precaution:
[][]Do not add any rework unless it is authorized beforehand by Head of Quality Assurance.
[][]Do not add the rework of a batch to other batch (es) until packing of the batch is completed.
[][]Ensure that rework of different products is not stored in the same container.
[][]Do not store any rework which is less than 0.25 % of the actual batch size.
Rework Residue :
[][]Following stated defects can be considered for storage and addition as rework in a batch leftover granules, chipping / capping defects, lamination, tablets with variations in physical parameters like weight, hardness, thickness, friability or edge broken tablets at the time of compression, coating and inspection. Residue after compression, encapsulation & PFS is also be considered as rework.
[][]Prepare a ‘Rework Residue Addition Note’ as per format (Annexure-I). The rework addition note shall be approved beforehand by Head of Production or his designate and authorized by Head of Quality Assurance.
[][]Process the rework as per Batch Manufacturing Record (BMR) of the specific product from the declared necessary step(s).
[][]Maximum allowable amount for addition of rework in a fresh batch is 5 % of actual batch size.
[][]Rework bulk shall be free from any foreign matter, objectionable color and / or odor.
[][]First batch of any product in which rework is added shall be kept for stability study.
Non-Rework :
[][]Any amount of tablets / capsule(s) which is collected as ‘Rework’ but is less than 0.25 % of the actual batch size shall be considered as ‘non-rework’.
[][]‘Non-rework’ shall be destroyed as per Quality Assurance SOP.
Storage of Rework :
[][]Store the rework in tightly closed double lined polybag with “REWORK’ Label in a container on a pallet in WIP Tablet/Capsule store.
[][]Rework of more than one batch of the same product can be stored in one container with proper status label.
[][]Record the rework generated from the batch(es) and their addition history in ‘Rework Residue
[][]Register’ as per (Annexure II). The register shall be kept in production Executive.
[][]Issue rework residues for use only in the presence of Production Executive.
[][]Rework generated from a batch shall be added to the batch(es) which are manufactured within the next three months. For example, rework generated from a batch manufactured in January shall be added to only the fresh batch manufactured within April, not to be added to the batch manufactured in May and so on. But in that case expiry of the fresh batch where rework is added shall be same as expiry of rework batch. In such cases rework shall not be stored for more than 90 days. If any rework amount is left after the said period, destroy the left over with prior approval of Quality Assurance (QA).
Annexure:
Annexure I – Rework Reside Addition Note.
Annexure II – Rework Residue Register.