Procedure For Equipment Log Book

Procedure For Equipment Log Book

 

1.0 Objective
To keep control and check on the use of Sophisticated Laboratory equipment and also to know the

details of the test performed on the Instrument.
2.0 Scope
Standard Operating Procedure is to provide procedures for Specifications and test method to

be followed for raw materials, in process and finish products 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 Frequency of maintaining the equipment log book will be as and when a particular instrument is used and operated.
5.2 Following procedure is to be adopted for HPLC, Dissolution Apparatus, UV- Spectrophotometer,

pH Meter, Conductivity Meter, Polarimeter, Viscometer, Refractometer, DT Apparatus, Friability and to

all the equipments used in the Lab.
5.3 Before using Laboratory equipments the Officer concerned should heck and confirm that the

equipment is calibrated as per the SOP meant for that particular equipment.
5.4 Enter the sample details, method details, date and the Officers Signature as

specified in the individual equipment log book.
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

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 BATCH MANUFACTURING

sop for placebo batch

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

sop for Sanitization of Seals

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 equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

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

 

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