sop for Procedure for Reprocessing
1.0 Objective
To lay down a procedure for reprocessing.
2.0 Scope
This Standard Operating Procedure is applicable for procedure for reprocessing
to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive Production shall be responsible for the reprocessing activity.
3.2 Officer / Executive QA shall be responsible for verification of reprocessing.
3.3 Concerned department head / his designee responsible for implementation of this SOP.
3.4 Head QA / his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
Reprocessing : The working of all or parts of a batch of product of an
Unacceptable quality from a defined stage of production so that
Its quality may be rendered acceptable by one or more additional
operation.
SOP : Standard Operating Procedure
BPCR : Batch Production & Control Record
QA : Quality Assurance
QC : Quality Control
TAC : Tablet & Capsule Block
R : Reprocessing
No. : Number
% : Percentage
5.0 Procedure
5.1 Deviations in the following parameters of different dosage forms shall be treated for reprocessing
5.1.1 Assay % below the specified limit.
5.1.2 Product is not complying with the dissolution test.
5.1.3 Uniformity of content is below the specified limit.
5.1.4 Disintegration time is more than the specified limit.
5.1.5 pH does not comply with the specified limit.
5.2 QA shall do thorough investigation to the deviation along with production and give
report covering corrective action for the batch and preventive measures for the future to Head QA.
5.3 During investigation if cause and impact of deviation is found to be physical as
explained above, the batch shall be permitted for reprocessing.
5.4 The Head QA shall authorize the method of Reprocessing.
5.5 Head QA shall approve if any extra quantity of raw material is required.
5.6 If new batch number is allotted to Reprocessed batch, a new BPCR shall be issued by QA Department.
5.7 Reprocessed batch shall be allotted a modified batch number with suffix “R” with the original batch number.
5.8 The batch number with suffix “R” denotes that this batch is a Reprocessed batch.
5.9 The Reprocessed batch shall be closely monitored for quality and stability studies throughout the shelf life of the product.
5.10 Reprocessing shall not be allowed in sterile products.
5.11 Reprocess due to return of goods from market shall be allowed only after investigation by QA and approval by Head QA.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Production, Quality Assurance and Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
-
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
-
Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
Cleaning Validation of Equipment
Measurement and Recording of Temperature and Relative Humid
Sampling of Product at Intermediate Stages