Procedure For Approval of in process bulk and Finish product
1.0 Objective
The purpose of this SOP is to provide written procedures for Approval of in process bulk and Finish product.
2.0 Scope
Standard Operating Procedure is to provide procedures for Approval of in process bulk and Finish Product at abc Pvt. Ltd.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 On intimation by production vide their intimation slip; Quality Control Officer In
charge of sampling shall collect the sample of In process, Bulk and Finished product
as per the sampling procedure. Refer sampling SOP for Bulk, In process and Finished Product.
Frequency of Sampling will be as and when intimated by Production Department.
5.2 The samples of In process, Bulk will be tested as per the requirement of production Department.
5.3 Finished product samples will be tested as per the prescribed Pharmacopoeia / Co. Specification.
5.4 Once the In process / Bulk testing is complete intimation slip with the results of test carried out,
duly signed and approved label shall be issued to the production Department.
5.5 Once the Finished product analysis is completed, a complete analytical report in the prescribed
protocol duly signed by the analyst, counter signed by group In charge / Executive Quality Control
and finally Approved by QC/QA Manager will be issued to the production.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
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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
Cleaning And Assembly Of Tube Filling Machine
Proper Handling of Non Recoverable Residues
sop for Handling Of Off Line Packing
Air Washing Of Collapsible Tube
Handling Of Dispensed Material
Procedure for House Keeping in quality Control Department
Procedure For Rounding off procedure for analytical numeric values
Procedure For Stability product handling and testing
Procedure For Sampling and Testing of Purified Raw and R O Water
Procedure For Sampling of Finish Product
Procedure For Approval of in process bulk and Finish product
