Receipt of Batch from Production to Packing Department
1.0 OBJECTIVE:
1.1 To lay down a procedure for Receipt of Batch from Production to Packing Department.
2.0 SCOPE:
2.1 This SOP is applicable for Receipt of Batch from Production to Packing Department in Injection Parenteral
3.0 RESPONSIBILITY:
3.1 Officer / Executive Production
4.0 ACCOUNTABILITY:
4.1 Head Production
5.0 PROCEDURE:
5.1 Before taking a Product on Packing Line, Officer /Executive of Packing area shall take the “Line Clearance” for Secondary Packing material and ensures that the BMR is Complete in all respect up to Production Stage.
5.2 At the time of Batch Receipt from Production Officer / Executive of Packing Area shall check and verify the Transfer Quantity as per the BMR and Status Label on each container.
5.3 The Complete Batch along with BMR shall be transferred / handed over by the Production Area Officer / Executive to the Packing Area Officer / Executive.
5.4 The Status Label on each Container shall bear all necessary information for proper identification.
6.0 ABBREVIATIONS:
Sr.No. Abbreviation used Full form of abbreviation used
a) SOP Standard Operation Procedure
b) QA Quality Assurance
c). BPR Batch Packing Record
d) BMR Batch Manufacturing Record
7.0 ATTACHMENTS (ANNEXES) : Nil
Not Applicable
8.0 REFERENCES:
In-House
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area