5/3/2010 cGMP and Regulatory Updates: Returnin…

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cGMP and Regulatory Updates

This Blog is created for the updation of knowledge on current Good Manufacturing Practices (cGMP) and current
Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs) for any
Pharma plant.

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FRIDAY, OCTOBER 31, 2008 Subscribe via email

Returning of unused Raw and Packing Enter your email address:

materials
1.0 OBJECTIVE
To lay down a procedure for returning of unused raw and Subscribe
packing materials.
Delivered by FeedBurner
2.0 SCOPE
Module 1,2,3,4,5 and packing areas.
3.0 RESPONSIBILITY
Vacuum Packing Machine
Production officer / Executive. Manufacturer Vacuum Packing
4.0 ACCOUNTABILITY Machine We design, manufac turer
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Production manager.
5.0 PROCEDURE Egg Cartons
Egg Cartons & Poultry Supplies
5.1 Returning of unused Raw materials. Incubators, Shipping Boxes &
5.1.1 Return unused materials along with stock return note as More
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5.1.2 Ensure all unused raw materials are tied in separate poly UK based European supplier
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return note or through system generated stock return note.
5 .2 Returning of unused packing materials.
5.2.1 Return unused packing material along with SRN as per FeedBurner FeedCount
(Annexure-I).
5.2.2 Ensure that all the packing materials are properly labelled.
5.2.3 Place them in a trolley / crates and send to stores with an
Blog Archive
authorized stock return note duly approved by production
Officer. ► 2010 (18)

Annexure-I ► 2009 (165)

STOCK RETURN NOTE ▼ 2008 (376)
► December (43)
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5/3/2010
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Returned by with date:
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cGMP and Regulatory Updates: Returnin…
► December (43)
► November (84)
▼ October (105)
Procedure for Cleaning of
Production areas after B...
M aintenance of dies and
punches.
Procedure for cleaning of
HDPE pallets.
Cleaning procedure for
Inprocess container
Correction of wrong entry in
BMR / BPR
Procedure for Leak testing of
strips / blisters
Recording and monitoring of
differential air press...
Procedure for defoiling of
blisters / strips
Procedure for handling of
finished goods
Returning of unused Raw and
Packing materials
Destruction of old, torn
rejected FBD and FEM
bags...
Transferring of Materials
from Dispensing to M odul...
Cleaning procedure for New
Equipment
Transferring of machine
under major break downs
Procedure for Inventory of
Sieves
M aintenance of Dies and
Punches stock card.
Returning of on-line rejected
packing material
Packing line start up and
closing procedure
Handling of New M achines
Procedure for Indenting of
Home Older Post Stereos
Returning of on-line rejected
raw M aterial
Procedure for Disposal of
Materials
Exit Procedure - Annexure Y
Entry Procedure - Annexure Y
2/7
5/3/2010 cGMP and Regulatory Updates: Returnin…
Procedure for cleaning of
Production Aids
Procedure for Maintaining
Environmental Conditions...
Gowning room Exit
Procedure
Gowning room Entry
Procedure
Exit Procedure - Annexure X
HVAC SYSTEM - BASIS OF
DESIGN PARAMETERS &
EQUIPME...
Qualification Protocol of
Heating, Ventilation and...
SOP - PAINTING OF THE
FACILITY
INSTRUMENT OPERATION
PROCEDURE DISSOLUTION
APPARAT...
INSTRUMENT CALIBRATION
DISINTEGRATION TEST
APPARA...
INSTRUMENT OPERATION
PROCEDURE
DISINTEGRATION TEST...
INSTRUMENT OPERATING
PROCEDURE UV-
SPECTROPHOTOMETE...
OPERATION OF HIGH
PRESSURE LIQUID
CHROMATOGRAPHY
INSTRUMENT CALIBRATION
PROCEDURE GAS
CHROMATOGRAPH...
CALIBRATION OF FLUID BED
DRIER TEM P GUAGE
CALIBRATION OF 6- STATION
DISSOLUTION APPARATUS
CALIBRATION OF DRIER
TEMPERATURE GUAGE
CALIBRATION OF DRY AND
WET BULB THERMOM ETER
CALIBRATION OF FLAME
PHOTOMETER
CALIBRATION OF
FLUORIMETER
CALIBRATION OF HPLC
CALIBRATION OF INFRA RED
SPECTROPHOTOMETER
CALIBRATION OF M IXING

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5/3/2010 cGMP and Regulatory Updates: Returnin…
TANK (GRADUATED)
CALIBRATION OF pH METER
INSTRUMENT OPERATION
PROCEDURE - KARL FISHER
TITRA...
CALIBRATION OF FLAME
PHOTOMETER
CALIBRATION OF UV-VISIBLE
SPECTROPHOTOMETER
CALIBRATION OF
VISCOMETER
WATER SAMPLING &
ANALYSIS FOR VALIDATION
VISUAL INSPECTION OF
CONTROL SAMPLES
PROCEDURE FOR VIABLE
PARTICLE COUNT BY AIR
SAMPLIN...
AUTOCLAVE VALIDATION
PROTOCOL
B12 Assay Method
PROCEDURE FOR ASSAY OF
ANTIBIOTICS BY DIFFUSION
ME...
BIOLOAD IN PRIMARY
PACKING M ATERIALS
FUNCTIONS OF
MICROBIOLOGY
DEPARTMENT
Growth Promotion Test
IDENTIFICATION TESTS FOR
PURE CULTURES
PROCEDURE FOR
FUMIGATION and DE-
FUMIGATION
RECEIPT AND MAINTAINANCE
OF CONTROL SAMPLE
ART WORK
ANALYSIS AT PUBLIC
LABORATORY
Rejection of non-confirming
product
Personnel Validation
Out of Specification Results
LABELLING PROCEDURE AND
CONTROL
LABELING PROCEDURE FOR
REAGENTS AND SOLVENTS
Corrective and Preventive

…vinvarun.biz/…/returning-of-unused-ra… 4/7
5/3/2010 cGMP and Regulatory Updates: Returnin…
action SOP
BIOLOAD IN STEAM
PROCEDURE FOR SAMPLING
& ANALYSIS OF
COMPRESSED AI...
PROCEDURE FOR
MONITORING THE
BACTERIALOGICAL QUALI...
INSTRUMENT OPERATION
B.O.D. INCUBATOR
PROCEDURE FOR
CALIBRATION OF B.O.D.
INCUBATOR
PROCEDURE FOR
DESTRUCTION OF USED
MEDIA
DISINFECTANT EFFICACY
TEST (BY SWABING
METHOD)
PROCEDURE FOR
MONITORING
BACTERIOLOGICAL
QUALITY O...
M ETHOD FOR THE
ANTIM ICROBIAL EFFICACY
TEST
PROCEDURE FOR
ENVIRONM ENTAL
MONITORING BY SETTLE
P...
PROCEDURE FOR FINGER
DAB TEST - SOP
PROCEDURE FOR
CALIBRATION OF
AUTOCLAVE -SOP
INSTRUMENT OPERATION
REFRIGERATOR
INSTRUMENT
OPERATION,CLEANING &
CALIBRATION OF MIC...
Instrument Operation Of
Digital Colony Counter
PROCEDURE FOR OPERATION
AND CLEANING OF
AUTOCLAVE
Instrument Operation of
Antibiotic Zone reader
BATCH RECORD REVIEW SOP
ISSUE, ENTRY, REVIEW AND
CONTROL OF BATCH
RECORDS

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5/3/2010 cGMP and Regulatory Updates: Returnin…
DOCUM ENT CONTROL SOP
STANDARD OPERATING
PROCEDURE FOR SOP
ROLE OF QUALITY
ASSURANCE MANAGER
ROLE OF QUALITY
ASSURANCE
WATER SYSTEM VALIDATION
INSTRUMENT CALIBRATION -
THERMOM ETER
INSTRUMENT CALIBRATION
UV LIGHT VIEW CHAMBER
INSTRUMENT OPERATION UV
LIGHT VIEW CHAMBER -
SOP
INSTRUMENT OPERATION
VACUUM OVEN -SOP
INSTRUMENT CALIBRATION
BROOKFEILD VISCOM ETER
INSTRUMENT OPERATION
BROOKFEILD VISCOM ETER
CLEANING OF SAM PLING
EQUIPMENT
HANDLING OF HAZARDOUS
CHEM ICALS - SOP
CALIBRATION OF
VOLUMETRIC GLASS
WARES

► September (81)
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