Procedure for Issuance of Extra Raw Material Packing Material
1.0 Objective
To lay down a procedure for issuance of extra raw material / packing material.
2.0 Scope
This Standard Operating Procedure is applicable for issuance of extra raw material / packing
material to be followed at formulation plant of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer/Executive Production shall be responsible to check and ensure the material as per issuance sheet.
3.2 Officer/Executive In-process Quality Assurance shall be responsible for verification of dispensed materials.
3.3 Officer/Executive/Manager Stores shall be responsible for dispensing of Excess materials as per the request of batch.
3.4 Concern department head shall be responsible for implementation of this SOP.
3.5 Head QA shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
5.0 Procedure
5.1 If in case extra raw / packing material is required to complete the batch
following steps should be followed.
5.1.1 Officer / Executive of concern department shall fill and sign the “Authorization
form for extra material” (Annexure–1) describing the problem observed.
5.1.2 Officer / Executive QA shall verify the Authorization form for extra material and shall
sign the same, if found satisfactory using green pen.
5.1.3 Officer / Executive of concern department shall write the suggested measure along with sign and date.
5.1.4 Officer / Executive of concern department shall calculate the quantity of Excess
material (raw / packing) required as per standard given in BPCR.
5.1.5 Officer / Executive of concern department shall sign the Quantity required.
5.1.6 Officer / Executive QA shall verify the Quantity required.
5.1.7 Manager of concerned department shall give remarks with sign and date.
5.1.8 Authorization form for extra raw / packing material shall be approved by GM Works.
5.1.9 Authorization form for extra raw / packing material shall be authorized by Head Quality.
5.1.10 Completely filled Authorization form for extra material shall be then send to
QA documentation cell for record.
5.1.11 Original copy shall be submitted to documentation cell and two photocopies of the
same shall be send to concern department and Stores respectively.
5.1.12 Each Authorization form shall be assigned a number in ten alphanumeric characters
by the Quality Assurance in the format XXX/YY/ZZZ where,
XXX : ERM or EPM (ERM for extra Raw material and EPM for Extra Packing material)
/ : for a Slash
YY : for last two characters of the current calendar year e.g. 12
for year 2012.
/ : for a slash
ZZZ : for Serial No. of the Authorization form starting from 001,
002, … … up to 999.
Thus, the first Authorization form for raw material in the year 2012 shall be numbered as ERM/12/001
And, the first Authorization form for packing material in the year 2012 shall be numbered as EPM/12/001
A new series of number shall start at beginning of every calendar year.
5.1.13 All Authorization form for Extra material shall be recorded by Quality Assurance
department in logbook titled Log book of Authorization form for Extra material as per Annexure-2.
5.1.14 Production shall then send requisition form to the warehouse Department for
issuance of authorized Extra Raw / Packing material.
5.1.15 Warehouse shall issue the material as per the authorization form.
5.1.16 Production shall check the Extra Raw / Packing material by weight
or Number or as per Authorization form.
5.1.17 Transfer the Dispensed Excess Raw / Packing material to the Manufacturing / Packing area.
5.1.18 Attach the duplicate copy of ‘Excess Material Requisition Form’ to the BPCR.
5.1.19 In case of excess packing material issued at the time of batch dispensing and
that excess quantity is required to get utilized for the completion of the operation
against the packing BOM. The same requisite quantity shall be issued/ reconcile by authorization form only.
6.0 Forms and Records
6.1 Authorization form for extra material – Annexure -1
6.2 Log Book of Authorization form for extra material – Annexure -2
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Production department , Store
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
Approval of Overprinting on Packing Material
sop for Procedure for Reprocessing
Preparation and Control of Master Batch Production and Control record
Issuance and Retrieval of Control documents
Calibration Policy for equipment
procedure for batch numbering system for products
sop for Handling of Incident during operation
Procedure for Allocation of Numbers for Machine Equipment
Validation and Qualification Facility System and Equipment
In-process Checks During Packing Operation
Procedure for Issuance of Extra Raw Material Packing Material