sop for batch conversion note
To lay down a Procedure for Batch Conversion Note.
2.0. SCOPE :
This SOP is applicable for Batch Conversion Note
3.0. RESPONSIBILITY :
QA Officer/Executive: Preparation, Distribution, Revision, Retrieval and Destruction of this SOP
QA (Manager): Review, Approval, Training and effective implementation of this SOP
(To Respective Departments).
4.0. ACCOUNTABILITY :
Head QA: Authorization of this SOP & ensure Training and effective Implementation of SOP. Approval of Batch Conversion Note.
5.0. PROCEDURE :
5.1 Batch Conversion shall be given in case, where Mother Batch is converted into PS / Sale Batch of same
Composition of same or different Company.
5.2 Batch Conversion is applicable in Domestic as well as in Export Batches.
5.3 The Expiry and Manufacturing Date of Converted Batch shall be same as Mother Batch.
5.4 Expiry of Converted Batch shall not be higher than Mother Batch but shall be lower in case
of Export Batches, where Dossier are submitted with Low Expiry with proper justification.
5.5 Conversion of Batch shall be done at Packing Stage.
5.6 Batch Numbering of Conversion Batch shall be the Current Batch Number, for Sale or PS, as per Batch Numbering System.
5.7 NUMBERING SYSTEM FOR BATCH CONVERSION NOTE:
5.7.1 The Batch Conversion Note Number shall be allocated as,
YY/BC/001: YY is year, BC is batch conversion and 001 is serial no.
Example: 21/BC/001 Denotes First Batch Conversion Note
(Note: 001 is a Generation code of Batch Conversion Note Numbering System.)
5.7.2 Details of Batch Conversion Note shall be recorded in ‘Batch Conversion Note Log’ as shown in Annexure-II.
5.7.3 Finally QA Officer / Executive shall issue BPR as per BPR Requisition given by Production Department.
5.8 Original Copy of Batch Conversion Note shall be submitted in QA Documentation Cell.
5.9 Copy of Batch Conversion Note shall be attached to Mother Batch BMR as well as BPR of Converted Batch / Batches.
5.10 Copy of Bulk Analysis Report shall be attached with Mother Batch BMR as well as BPR of Converted Batch / Batches.
5.11 Stability Study shall be performed as per Frequency / Schedule for all the Converted Batches independently.
5.12 Finished Goods Report of Converted Batch can be used as a reference for other converted batch from same Mother Batch if they have identical Primary Packing Material. If different Primary Packing material is used in converted batch, analysis of individual batch shall be performed.
5.13 Control sample of each Converted Batch shall be kept as per SOP of Control Sample.
|Sr. No.||Abbreviation used||Full form of abbreviation used|
|1.||BCN||Batch Conversion Note|
|2.||BMR||Batch manufacturing Record|
|3.||BPR||Batch Packing Record|
|5.||Mfg. No.||Manufacturing Number|
|6.||MRP||Maximum Retail Price|
|7.||SOP||Standard Operating Procedure|
ATTACHMENTS (ANNEXES) :
|ANNEXURE No.||TITLE OF ANNEXURE|
|Annexure-I||Batch Conversion Note|
Batch Conversion Note Log
8.0. REFERENCE :
|Sr. No.||Reference Title|