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

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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

Procedure for Leak testing of strips / Enter your email address:

blisters
1.0 OBJECTIVE
To lay down a procedure for leak testing of strips / blisters. Subscribe
2.0 SCOPE
Delivered by FeedBurner
All packing areas.
3.0 RESPONSIBILITY
Production officer. Great Lakes Vacuum
4.0 ACCOUNTABILITY We rebuild & repair vac uum
pumps, blowers & also stock oil
Production executive
and parts!
5.0 PROCEDURE www.gre atlak e svacuum .com

5.1 Take the required number of strips / blisters as mentioned Portable Vacuum Pump
Economical,Cool & Quite, Long
in the Annexure – I. Check the quality of strips/ blisters for any Life Versatile, Tough, Light
damages. weight
Cole Pa rm e r.in/Vacuum _Pum ps
5.2 Tie the collected strips / blisters with a rubber band. Water Sensor Switch
5.3 Ensure that all strips / blisters are dipped in water and close Detec t water leaks from 1/16
inch. Alarm or control based on
the lid.
detec tion
5.4 Connect opening of the desiccator to the vacuum pump. www.antx .com

5.5 Apply a vacuum of 300 mm of Hg and close the knob of the

desiccator.
5.6 Keep the vacuum for 30sec. FeedBurner FeedCount
5.7 Release the vacuum by opening the knob of the desiccator
slowly and open the lid remove the strips / blisters.
5.8 Wipe out the traces of water from the strips / blisters by
Blog Archive
using lint free duster .
5.9 Open the pocket of strips by using scissors to remove the ► 2010 (18)

tablets / capsules. ► 2009 (165)

5.10 Open the blisters manually. ▼ 2008 (376)
► December (43)
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5/3/2010 cGMP and Regulatory Updates: Procedu…
5.11 Check for any traces of water inside the strips / blisters. ► December (43)
5.12 Number of tablets or capsules, which have become wet, ► November (84)
should not be more than 1%. If the leakage is more than the ▼ October (105)
above percentage repeat the leak test. Procedure for Cleaning of
Production areas after B...
5.13 Record it in the respective batch packing record, with
signature and date. M aintenance of dies and
punches.
ANNEXURE -I
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

Note: Procedure for handling of

finished goods
1. Perform leak test at the starting of blistering / strip sealing,
Returning of unused Raw and
operation.
Packing materials
2. If there is machine break down more than 1/2 hour perform
Destruction of old, torn
leak test immediately after starting the operation. rejected FBD and FEM
3. Whenever leakage observed during leak test, ensure that bags...
rectification is done. Transferring of Materials
4. If leak test failure is occurring repeatedly, bring to the notice from Dispensing to M odul...
of Executive / Sr. Executive for corrective action. Cleaning procedure for New
at 8:05 PM Equipment
Transferring of machine
under major break downs
1 comments:
Procedure for Inventory of
Sieves
vicky said...
M aintenance of Dies and
Punches stock card.
But mention about the amount of water to be
Returning of on-line rejected
taken,also.
packing material
November 3, 2008 11:55 AM Packing line start up and
closing procedure
Post a Comment Handling of New M achines
Procedure for Indenting of
Stereos
RTD Calibration Guide Returning of on-line rejected
How to Calibrate a PT100 or RTD Fluke raw M aterial
Application Note Download
www.HartScientific.com Procedure for Disposal of
Materials
Torque tester
quality control devices online & laboratory Exit Procedure - Annexure Y
www.at2e.com
Entry Procedure - Annexure Y

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5/3/2010 cGMP and Regulatory Updates: Procedu…
Oil Field Tubulars Procedure for cleaning of
Pup Joints, X & R Nipples Tubular Production Aids
Accessories,Flow Coupling
www.petroquip.com Procedure for Maintaining
Vacuum Technology Environmental Conditions...
In manufacturing equipment at low Gowning room Exit
cost.Welcome:086 024-23820832!
www.ulvac-usy.com Procedure
Gowning room Entry
Procedure
Newer Post Home Older Post Exit Procedure - Annexure X
HVAC SYSTEM - BASIS OF
Subscribe to: Post Comments (Atom) 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: Procedu…
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

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5/3/2010 cGMP and Regulatory Updates: Procedu…
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: Procedu…
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)
► August (38)
► July (25)

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