In-process control of oral drug product during manufacturing & Packing

In-process control of oral drug product during manufacturing & Packing

Test

Description

VIRTUAL INSPECTION

About Pharmaceutical Guidanace

Check Also

About Pharmaceutical Guidanace

Related Articles

Check Also

Do Not Sell My Personal Information

Reason for Revision

Pharmaceutical Guidanace May 4, 2020 QA & QC, Quality Assurance Comments Off on In-process control of oral drug product during manufacturing & Packing 5,351 Views

Objective

To lay down the procedure for in-process control of oral drug products during manufacturing & Packing.

Scope

This procedure is applicable for in-process sampling, analysis, and reporting to be carried out during manufacturing and packing of drug products at the formulation Plant.

Responsibility
- Quality Assurance and production personnel shall responsible to follow the procedure mentioned in this SOP.

Accountability
- Head Production & Head QA shall be accountable for the implementation of this SOP.
Abbreviations and Definitions

QA	:	Quality Assurance
SOP	:	Standard Operating Procedure
QC	:	Quality Control
LOD	:	Loss on drying
DT	:	Disintegration Test
BFR		Blister forming Roller
CSR		Counter sealing Roller
PHR		Peripheral Heating Roller
PSR		Pressure sealing Roller
BCP		Batch Coding and Printing
PRC		Print Registration control

Procedure
- In-process tests carried out during routine manufacturing of oral dosage forms by Production & QA.
- The in-process tests including the procedure and action are taken if any discrepancy is found shall be mentioned under individual headings & annexures.
- If the processing time for the batch is less than 2 hours, then the in-process checks shall be carried out during the initial, middle, and end of the operation.
- The in-process test shall be carried out at different stages such as:
  - For tablet following stage shall be considered in-process – drying, lubrication, compression, coating, Inspection, and packaging operations as per the requirements.
  - For Capsule following stage shall be considered in-process -blending, capsules powder filling, packaging operations as per the requirements.
  - For Liquid following stage shall be considered in-process -Washing, Bottle filling & sealing, and packaging operations as per the requirements.
  - For Ointment following stage shall be considered in-process -tube filling & sealing and packaging operations as per the requirements.
- All the in-process tests conducted during the above-mentioned processes shall be recorded in the respective formats (from Annexure III to IX).
- In-process test parameters shall be considered during routine production i.e. as follows:
  - Tablets

S. No.	Stage	In-process Test	Sample Qty.	Test Frequency
1.	Drying	Description	10 gm.	After completion of drying
		LOD
2.	Compression	Description	32 Tablets	For Production Initial, every 1 hour and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.
		Average weight
		Uniformity of weight
		Disintegration Test
		Hardness
		Thickness
		Friability
3.	Coating	Description	20 Tab.	For Production & QA After completion of coating of the composite sample
		Average weight
		Uniformity of weight
		Disintegration Test
		Thickness
		Weight Gain	200 Tab. For each lot	For Production After completion of each lot

4.	Inspection	Challenge test from Metal	–	For Production Initial, every 1 hour and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.
		Inspection for defects	20 Tab.
5.	Packing	Sealing & forming temp.	–	For Production Initial, every 2 hours, after every breakdown, and at the end of the batch.
		Batch coding details		For Production Initial, every 1 hour and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.
		Defective Tablets, cut pockets, and overprinting
		Leak Test	Strips from 1 rotation of CSR /blisters from sealing plate sealed per stroke/2 bottles (in case of induction sealing)	For Production Initial, every 2 hours and at the end of the batch. For QA Initial, every 4 hours and at the end of the batch.

Capsules

S. No.	Stage	In-process Test	Sample Qty.	Test Frequency
1.	Capsule filling	Description	20 Capsules	For Production Initial, every 1 hours and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.
		Fill weight
		Average weight
		Uniformity of weight
		DT
		Locking length
2.	Inspection	Optical Defects	–
3.	Packing	Sealing & forming temp.	–	For Production Initial, every 2 hours, after every breakdown, and at the end of the batch.
		Batch coding details	–	For Production Initial, every 1 hours and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.
		Defective Capsules, cut pockets, and overprinting	–
		Leak Test	Strips from 1 rotation of CSR / blisters from sealing plate sealed per stroke sealing.	For Production Initial, every 2 hours and at the end of the batch. For QA Initial, every 4 hours and at the end of the batch.

Liquid

S. No.	Stage	In-process Test	Sample Qty.	Test Frequency
1.	Bottle washing	The volume of water per nozzle per station	6 nos. of bottles	Initially by production
1.	Bottle washing	Visual examination of washed bottles	6 nos. of bottles	For Production Initial, every 1 hour and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.
1.	Bottle filling & sealing	Description	08 Bottles
		Filled volume
		Leak Test
2.	Inspection	Optical Defects	–
3.	Packing	Batch coding & overprinting details	–	For Production Initial, every 1 hours and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.

Ointment

S. No.	Stage	In-process Test	Sample Qty.	Test Frequency
1.	Tube filling & sealing	Description	06 tubes	For Production Initial, every 1 hour and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.
		Net Content	06 tubes
		Average fill mass	20 tubes
		Individual fill mass
		Batch coding on crimping
		Loose Capping
		Crimping
2.	Packing	Batch coding & overprinting details	–	For Production Initial, every 1 hours and at the end of the batch. For QA Initial, every 2 hours and at the end of the batch.

Records
- All the tests conducted during the in-processes shall be recorded in the respective formats. ‘Forms and records’
- Discrepancies during IPQA with their Recommended Action.
- In-Process Tests Including the procedure of Testing is summarized in Annexure

Forms and Records
- Discrepancies during In-process with their Recommended Action
- In-Process Tests Including the Frequency of Testing
- In Process Control: Tablets
- In-Process Control: Capsules
- In-Process Control: Liquid Filling & Sealing
- In-Process Control: Liquid Packing
- In Process Control: Capsule packing
- In-Process Control: Ointment Filling & Sealing
- In-Process Control: Ointment Packing
- In-Process Control: Tablet packing
Distribution
- Master Copy – Documentation Cell (QA)
- Controlled Copies – Quality Assurance and Production

History

Date	Revision Number	Reason for Revision
–	–	New SOP

Annexure-I

In case of any deviation follow the SOP on Handling of Deviation

Discrepancies during In-process with their Recommended Action Following are the in-process tests and actions to be taken in case of any discrepancy observed.

Stage	In-process Test	Action to be taken
Drying/ Blending/ Lubrication	LOD	QA to investigate. Isolate the container and label it “Under Hold” Withdraw more samples and check. If the results are not satisfactory, perform trials in consultation with Head QA. If the trials meet the specification, continue further processing. The investigation shall be extended to the steps already completed.
Compression	Appearance, Weight variation, Hardness, Thickness, DT, Friability	Stop the operation Isolate the container and label it “Under Hold” Investigation by quality assurance by withdrawing samples from various positions from the container. Trials on the existing / next container i.e. in-process testing for all physical parameters. If the samples meet the requirement, continue the processing. The remaining tablets during trial and under hold container will be kept as “Non-recoverable” The investigation shall be extended to the already compressed tablets and if required random sampling shall be carried out from these containers.
Coating	Appearance, % Weight gain, Thickness, DT, Average Wt., Uniformity of weight	Stop the operation Isolate the lot or batch and label it “Under Hold” Investigation by quality assurance by withdrawing samples from various positions from the container. Trials on the existing / next lot or batch i.e. in-process testing for all physical parameters. If the samples meet the requirement, continue the processing. The investigation shall be extended to the steps already completed. The remaining tablets during trial and under hold container will be kept as “Non-recoverable”.
Capsule Filling	Lock Length of filled capsule; fill content, average weight, weight variation, moisture content, DT.	Stop the machine Inform production officer and QA officer. Investigate. Corrective actions e.g. machine settings to rectify the problem. If required take trials on fresh containers. After setting, perform complete in-process analysis for physical parameters. Reject the trial and in-process test samples. The investigation shall be extended to the steps already completed. Continue the processing.
Packing	Leak Test	Stop machine. Inform production. QA shall investigate. Corrective actions to rectify the problem. Recheck for leak test from the already packed strips/ blisters at random. If found satisfactory, packing to be continued. If not, then analyze the strips/ blisters for the pack quality and reject. Perform the leak test and if find OK then start the operation. The investigation shall be extended to the steps already completed and if required the random sampling from already packed shippers shall be carried out for leak test.
	Overprinting Details	Stop the machine. Inform production officer. QA shall investigate. Corrective actions to rectify the problems. Rejection and destruction of all overprinted material. Line clearance by QA. Rechecking of overprinting details after rectification by production officer and QA officer. If required, recheck the packed product if any with random sampling for overprinting details. Continue the packing activity.
	Bottle inspection, induction sealing, Measuring cup placement labeling, weight of the carton and shipper, shipper number.	Stop the machine. Inform production officer. QA shall investigate. Corrective actions to rectify the problems. Line clearance by QA. Rechecking after rectification by production officer and QA officer. If required, recheck the packed product if any with random sampling. Continue the packing activity.
Bottle filling	Bottle washing, fill weight, cap/closure placement,	Stop the operation Isolate the bottles and label it “Under Hold”, QA shall investigate. Corrective actions to rectify the problems. Line clearance by QA. Rechecking after rectification by production officer and QA officer. Continue the filling activity.

Annexure-II

In-Process Tests Including the Frequency of Testing

S. No.	Test parameters	Sample quantity	Procedure
1.	Appearance / Description for tablets	20 tablets	Check for defects like surface finish, lamination, mottling, chipping and swelling powder on the tablets embossing (if any), picking, capping and sticking. The appearance of the tablets should comply with that mentioned in the individual specification.
2.	Average Weight	20 tablets	Weigh individually all tablets, calculate the average weight.
	Weight variation (For tablets)	20 tablets	Weigh one by one 20 tablets and determine the weight variation by subtracting the individual weight of tablets with average weight of each tablets.
3.	Disintegration time testing for tablets	6 tablets	Operate the disintegration tester as per SOP. Place 1 dosage unit in each of the six tube of the basket and, if prescribed add a disk. Operate the apparatus, using water or the specified medium as the immersion fluid, maintain temperature at 37+2ºC or given in specification. At the end of the time limit specified, lift the basket from the fluid, and observed the tablets. All of the tablets have disintegrated completely. If 1or 2 tablets fail to disintegrate completely, repeat the test on 12 additional tablets. The requirement is met if not less than 16 of the total of 18 tablets are disintegrated.
4.	Hardness Testing	6 tablets	Hardness test shall be performed with the help of tablet hardness tester as per SOP number _____________
5.	Thickness testing for compressed/ coated tablets	6 tablets	Thickness shall be determined using vernier caliper/ digital tablet hardness tester as per SOP number _________.
6.	Friability test	Tablets with a unit mass equal to or less than 650 mg, take a sample of Whole Tablets Corresponding to 6.5 g. For Tablets with a Unit mass of More Than 650 mg, take a sample of 10 Whole Tablets.	The tablets should be Carefully de-dusted prior to testing. Accurately weigh the tablets sample, and place the tablets in the drum. Rotate the drum 100 times, and remove the tablets. Remove any loose dust from the tablets and accurately weigh. Operate friability test apparatus as per SOP number __________
7.	Weight gain of coated tablets	100 tablets	Take weight of 100 pre warmed tablets and Weigh the 100 coated tablets. Calculate the weight gain.
8.	Appearance / Description for capsules	20 capsules	Take about 20 capsules at random check for defects like dented capsules, telescopic capsules, empty capsules, capsules with notch, printing quality, crust / lump formation in the blend, improper colour distribution of the blend, powder leaking from the locking end and powder on capsules. The appearance of the capsules should comply with that mentioned in the individual Specification.
9.	Disintegration time testing for capsules	6 capsules	Introduce 1 capsule in to each tube and operate the disintegration tester as per SOP number _______. Insert disk over each capsule. Operate the apparatus, using water or the specified medium as the immersion fluid, maintain at 37+2ºC. At the end of the time limit specified Capsules pass the test if all of them disintegrate completely. Result reporting is same as for tablets.
10.	Weight variation (For capsules)	20 capsules	a) Weigh 20 intact capsules individually and determine the average weight. b) Remove the contents of each capsule with the aid of small brush or plug of cotton. Weigh the emptied shells individually and calculate for each capsule the net weight of its content by subtracting the weight of the shell from respective gross weight, determine the average net content from the sum of the individual net weights.
11.	Appearance / Description for Syrup & suspension	Bottle from every head	Examine for lump formation, caking, quality of suspension odour. The appearance should comply with that mentioned in the individual specification.
12.	Lock length of the capsules	6 capsules	Lock length of the capsules shall be determined using vernier caliper
13.	Loss on drying (Powders / Granules)	Approximately 2 g or as per specification	Determine the loss on drying with the help of IR moisture analyzer as per respective SOP
14.	Fill weight of syrups	No. of bottles filled while single rotation of dosing wheel	Take Bottles directly from the syrup filling machine and check the fill weight of powder
15.	Leak Test	Strips from 1 rotation of CSR /blisters from sealing plate sealed per stroke/2 bottles (in case of induction sealing)/ Bottles equal to no. of sealing head.	Leak test shall be performed as per SOP number ____
16.	Bottle Cleanliness	Two bottles/Jar	Visually check the bottles/Jar for their cleanliness
17.	Overprinting details	Random sampling	Visually check the blister, strips, carton, label for batch details, wrinkles, proper pasting, appearance, etc.
18.	Labeling	Random sampling	Visually check the labeling for any defects like Wrinkles/ crumpled/ slanted/ stained or any other abnormal observations.
19.	Leaflet Placement	Two bottles/jars	Visually check whether the leaflet is placed correctly on the bottle cap/ inside the cartons.(as applicable)
20.	Measuring Cup Placement	Two bottles	Visually check whether the Measuring Cup is placed correctly on the bottle.
21.	Tests to be conducted during blister and strip packing	Random sampling	Visually check for any punctures, empty pocket, overprinting details, sealing quality, knurling quality, forming quality, sealing and forming plate and roller temperature.
22.	Carton packing	Random sampling	Visually check for the correct coding, Product details, and weight of the Carton.
23.	Tests to be conducted during shipper packing	Random sampling	Visually check for the correct coding, number of unit packed, proper BOPP taping, shipper number and weight of the shipper.
24.	Metal detector challenge test	Ferrous non-ferrous and S.S. blocks.	Pass ferrous non-ferrous and S.S. blocks through metal detector. Check the blocks whether it is rejected.

Annexure-III

In-Process Control: Tablet

Stage: Compression

1.0 Description:

Frequency for Description:

For Production: Initial, every 1 hours and at the end of the batch.

For QA: Initial, every 2 hours and at the end of the batch. Every 2 hours)

Test	Date/ Time	Observations	Done by
Description

2.0 Tablets Size Verification:

Frequency for Tablets Size Verification (By Production & QA): Initial Machine setting

SNo.	Length	Width	Diameter
1
2
3
4
5
6
7
8
9
10
Average
Maximum
Minimum
Limit

3.0 AVERAGE WEIGHT AND UNIFORMITY OF WEIGHT RECORD:

Date : Location : Equipment ID No. :

Product Name : B. No. :

Size :

Temperature °C : RH : %

Frequency:

For Production: Initial, every 1 hours and at the end of the batch.

For QA: Initial, every 2 hours and at the end of the batch. Every 2 hours).

Sample size=20 tablets Analytical Weighing Balance ID No.:………………

Date
Time
Wt. of 20 Tab.
Av. Wt. (mg)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Max. Wt. (mg)
Min. Wt. (mg)
Variation + %
Variation–– %
Checked By

4.0 Hardness & Friability:

5.0Thickness

Tablets	Thickness
	Time

1
2
3
4
5
6
7
8
9
10
Average
Maximum
Minimum
Limit

6.0 Disintegration time

Tablets	Disintegration Time
	Time

1
2
3
4
5
6
Maximum
Minimum
Checked By
Limit	Not More Than 30 minutes

Frequency for Hardness, Friability, thickness & Disintegration test:

For Production: Initial, every 1 hours and at the end of the batch.

For QA: Initial, every 2 hours and at the end of the batch. Every 2 hours

Stage: Coating

Date : Location : Equipment ID No. :

Product Name : B. No. :

Size :

Temperature °C : RH : %

Frequency:

For Production: Initial, every 1 hours and at the end of the batch.

For QA :Initial, every 2 hours and at the end of the batch. Every 2 hours)

1.0 Description

Test	Date/ Time	Lot No.	Observations	Done by
Description (At the end of each lot)

2.0 Disintegration Test:

Test	Date/ Time	Lot No.	Observations	Done by
Disintegration Test (At the end of each lot)

3.0 Weight gain of coated tablets:

Weight gain of coated tablets (At the end of each lot)

Weight gain in % = B – A x 100 = ……… % (Limit……………..)

Limit :

Lot number →

Date/ Time →

Actual Weight of 100 pre-warmed Tablets in g (A)

Actual Weight of 100 coated tablets in g (B)

Actual % weight gain of 100 coated tablets

Thickness in mm (At the end of each lot)

Limit (mm):

Lot number

Date/ Time

Minimum (mm)

Maximum (mm)

Done by/ date

4.0 AVERAGE WEIGHT AND UNIFORMITY OF WEIGHT RECORD:

Sample size=20 tablets

Date
Time
Wt. of 20 Tab.
Av. Wt. (mg)
1	6	11	16
2	7	12	17
3	8	13	18
4	9	14	19
5	10	15	20
Max. Wt. (mg)
Min. Wt. (mg)
Variation + %
Variation–– %
Checked By

Tags Aberdeen Aberdeenshire Abu Dhabi Abu Dhalouf Abu Hamour Abu Samra ABUJA ACCRA Acre Ad Dawhah al Jadidah ADDIS ABABA Adelaide AFGHANISTAN Agra Agrigento Ahmedabad Aïn Beïda Ain Khaled Ain Sinan Ajman Ajman and Ra’s al-Khaimah Ajmer Al Ain Al Aziziya Al Bidda Al Daayen Al Dafna Al Ebb Al Egla Al Gharrafa Al Ghuwariyah Al Hilal Al Jasrah Al Jeryan Al Karaana Al Kharaitiyat Al Kharayej Al Kharrara Al Kheesa Al Khor Al Khulaifat Al Luqta Al Mamoura Al Mansoura Al Markhiyah Al Mashaf Al Masrouhiya Al Mearad Al Messila Al Mirqab Al Najada Al Nasraniya Al Qassar Al Rufaa Al Sadd Al Sailiya Al Sakhama Al Seej Al Shagub Al Souq Al Tarfa Al Thakhira Al Themaid Al Thumama (Al Wakrah) Al Thumama (Doha) Al Utouriya Al Waab Al Wajba Al Wakrah Al Wukair Al Zubarah Al-Shahaniya Alagoas ALBANIA Alberta Alessandria ALGERIA Algiers Aligarh Allahabad Allerdale Amapa Amazonas Amber Valley Amersham AMMAN Ampthill Amravati Amritsar Amsterdam Amur Ancona and Craigavon and Down ANDORRA ANDORRA LA VELLA ANGOLA Angus ANKARA Annaba ANTANANARIVO ANTIGUA & BARBUDA Antrim and Newtownabbey Antwerp Aosta APIA Ar Ru'ays Ards and North Down ARGENTINA Argyll and Bute Arkhangelsk Arlington Armagh ARMENIA As Salatah Ascoli Piceno Ashbourne ASHGABAT ashington Ashland Ashmore and Cartier Islands ASMARA Asti Astrakhan ASUNCIÓN Athens Auckland Aurangabad australia Australian Antarctic Territory Australian Capital Territory Austria Avellino Aylesbury Aylesbury Vale AZERBAIJAN Baaya BAGHDAD BAHAMAS Bahia BAHRAIN BAKU BAMAKO Banbridge BANDAR SERI BEGAWAN Bangalore BANGKOK Bangladesh Bangor BANGUI Bani Hajer BANJUL Barahat Al Jufairi BARBADOS Barcelona Bareilly Bari Barletta-Andria-Trani Barrow-in-Furness BASSETERRE Bath Batna Bavaria Beaconsfield Béchar Bedford BEIJING BEIRUT Béjaïa Belarus Belfast Belgium Belgorod Belgrade BELIZE Belluno BELMOPAN Belper Benevento BENIN Bergamo Berlin BERN Bhavnagar Bhilai Nagar Bhiwandi Bhopal Bhubaneswar Salem BHUTAN Biella Bikaner Birmingham Birmingham (West Midlands) BISHKEK Biskra BISSAU Blackburn with Darwen Blackpool Blaenau Gwent Blida BLOEMFONTEIN Bloomsbury Bodmin BOGOTÁ BOLIVIA Bologna Bolsover Bordj Bou Arreridj BOSNIA & HERZEGOVINA BOTSWANA Bou Saâda Bournemouth Bracknell Forest Bradford BRASILIA BRATISLAVA brazil BRAZZAVILLE Bremen Brescia Bridgend BRIDGETOWN Brighton Brighton and Hove Brindisi Brisbane Bristol British Columbia BRUNEI BRUSSELS Brussels-Capital Region Bryansk Bu Fasseela Bu Samra Bu Sidra Bucharest Buckinghamshire Budapest BUENOS AIRES BUJUMBURA Bulgaria BURKINA FASO Burlington BURUNDI Buxton CABO VERDE Caerphilly Cagliari CAIRO Caltanissetta CAMBODIA Cambridge Cambridgeshire Camden CAMEROON Campobasso canada Canberra Canterbury CAPE TOWN Cardiff Carlisle Carmarthenshire Caserta CASTRIES Catania Catanzaro Causeway Coast and Glens Ceara Centerville CENTRAL AFRICAN REPUBLIC Central Bedfordshire Ceredigion CHAD Chalfont St. Giles Chandigarh Charlottetown Chelmsford Chelyabinsk Chennai Cheshire East Cheshire West and Chester Chester Chesterfield Chichester Chieti CHILE Chiltern China Chlef Christmas Island City of London Clackmannanshire Clayton Cleveland Clinton Clydebank Coatbridge Cockermouth Cocos (Keeling) Islands Coimbatore Coldstream colombia COLOMBO Como COMOROS CONAKRY Congleton CONGO Constantine Conwy Copeland Copenhagen Coral Sea Islands Cornwall Cosenza COSTA RICA CÔTE D'IVOIRE(Ivory Coast) Coventry Cremona Crewe CROATIA Cromarty Crotone CUBA Cumbernauld Cumbria Cuneo Cuttack CYPRUS Czech Republic CZECH REPUBLIC (Czechia) Dahl Al Hamam DAKAR Dalkeith DAMASCUS Darlington Darwin Dayton Dehradun Garhwali Delhi Denbighshire denmark Derby Derbyshire Derbyshire Dales Derry Derry and Strabane Devon DHAKA Djelfa DJIBOUTI DJIBOUTI (CITY) DODOMA Doha Dombivali DOMINICA DOMINICAN REPUBLIC Donetsk Dorset Dover dubai Dublin Duhail Dukhan Dumfries and Galloway Dunbar Dundee Dunkeld Duns Dunstable Durgapur Asansol Durham DUSHANBE East Ayrshire East Devon East Dunbartonshire EAST JERUSALEM East Lothian East Midlands East of England East Renfrewshire East Riding of Yorkshire East Sussex ECUADOR Eden Edinburgh Edmonton Egypt El Eulma El Oued EL SALVADOR Elgin Ely England Enna EQUATORIAL GUINEA Erewash ERITREA Espirito Santo Essex estado estados ESTONIA ESWATINI (formerly Swaziland) ETHIOPIA Exeter Fairview Falkirk Falmouth Faridabad Fenland Fereej Abdel Aziz Fereej Al Amir Fereej Al Asiri Fereej Al Asmakh Fereej Al Manaseer Fereej Al Murra Fereej Al Nasr Fereej Al Soudan Fereej Al Zaeem Fereej Bin Durham Fereej Bin Mahmoud Fereej Bin Omran Fereej Kulaib Fereej Mohammed Bin Jassim Fermanagh and Omagh Fermo Ferrara Fife FIJI Finland Firozabad Flintshire Florence Foggia Forlì-Cesena Forres Fort William Fowey france Frankfurt Rhine-Main Region Franklin Fredericton FREETOWN SINGAPORE Frosinone Fujairah FUNAFUTI Fuwayrit GABON GABORONE Galashiels GAMBIA Genoa Georgetown Georgia Germany GHANA Gharrafat Al Rayyan Ghaziabad Glasgow Gloucester Gloucestershire Goias Gorakhpur Gorizia Grasmere Greater Glasgow Greater London Greater Manchester greece Greenock Greenville GRENADA Grosseto GUATEMALA GUATEMALA CITY Guelma GUINEA GUINEA-BISSAU Gujarati Gulbarga Guntur Gurgaon Guwahati GUYANA Gwalior Gwynedd Haddington HAITI Halifax Halton Hamad Medical City Hamburg Hampshire Haora HARARE Hartlepool HAVANA Hawick Hawke's Bay Hazm Al Markhiya Heard Island and McDonald Islands Helsinki Helston Hereford Herefordshire Hertfordshire Hesse High Peak High Wycombe Highland Hobart HONDURAS HONIARA Hove Hubli and Dharwad Hudson Hungary Huntingdon Huntingdonshire hyderabad ICELAND Imperia Indonesia Indore Inverclyde Invergordon Inverness Iqaluit Iran Iraq ireland Irkutsk Irvine Isernia ISLAMABAD Isle of Anglesey Isle of Wight Isles of Scilly ISRAEL Istanbul Italy Ivanovo Izghawa (Al Rayyan) Izghawa (Umm Salal) Jabal Thuaileb Jabalpur Jackson Jaipur JAKARTA Jalandhar jamaica Jammu Jamnagar Jamshedpur japan Jelaiah JERUSALEM Jervis Bay Territory Jeryan Jenaihat Jeryan Nejaima Jhansi Jijel Jodhpur jordan JUBA KABUL Kaliningrad Kaluga Kalyan KAMPALA Kanpur KATHMANDU Katowice urban area KAZAKHSTAN Kazan Kemerovo Kendal Kent KENYA Keswick Kharkiv KHARTOUM Khawr al Udayd Kiev KIGALI Kingston Kingston upon Hull KINGSTOWN Kinross KINSHASA KIRIBATI Kirkintilloch Kirkwall Kirov Knutsford Kochi Kolkata KOSOVO Kostroma Kota Kraków KUALA LUMPUR Kurgan Kursk kuwait KUWAIT CITY KYRGYZSTAN L'Aquila La Spezia Laghouat Lancashire Lancaster LAOS Latina LATVIA Launceston Leabaib Lebanon Lebday Lecce Lecco Leeds Leicester Leicestershire Lejbailat Lekhwair Leningrad Leqtaifiya (West Bay Lagoon) LESOTHO Lexington LIBERIA LIBREVILLE LIBYA Lichfield LIECHTENSTEIN Lijmiliya Lille–Kortrijk–Tournai France/ Belgium LILONGWE LIMA Lincoln Lincolnshire Lipetsk Lisbon Lisburn Lisburn and Castlereagh LITHUANIA Liverpool Livorno LJUBLJANA LOMÉ london Loni Looe Lossiemouth Lostwithiel Luaib LUANDA Lucca Lucknow Ludhian Lusail LUSAKA Luton LUXEMBOURG M'Sila Macclesfield Macerata MADAGASCAR Madinat Al Kaaban Madinat ash Shamal Madinat Khalifa North Madinat Khalifa South Madison Madrid Madurai Magadan Moscow Maghnia MAJURO MALABO malawi Malaysia MALDIVES MALE MALI MALTA MANAGUA MANAMA Manchester MANILA Manitoba Mantua Maranhao Marlborough Marlow Marseille Mascara MASERU Massa and Carrara Matera Matlock Mato Grosso Mato Grosso do Sul MAURITANIA mauritius MBABANE Mebaireek Médéa Medway Meerut Mehairja Melbourne Merseyside Merthyr Tydfil Mesaieed Mesaimeer Messina Mexico MEXICO CITY Mid and East Antrim Mid Ulster Middlesbrough Midlothian Milan Milford Milngavie Milton Milton Keynes Minas Gerais Minsk Modena MOGADISHU Monmouthshire MONROVIA MONTEVIDEO Monza and Brianza Moradabad Moray MORONI Moscow Mostaganem Motherwell and Wishaw Mount Vernon Mourne Muaither Mumbai Muraikh Murmansk MUSCAT Mushayrib Mysore N'DJAMENA Nagpur NAIROBI Najma NAMIBIA WINDHOEK Nanded Kolapur Nantwich Naples Nashik NASSAU NAURU Navi Mumbai Neath Port Talbot Nellore Nelson Nepal Netherlands New Al Hitmi New Al Mirqab New Al Rayyan New Brunswick New Fereej Al Ghanim New Fereej Al Khulaifat New Plymouth New Salata New South Wales new Zealand Newfoundland and Labrador Newport NewportAuburn Newquay Newry NGERULMUD NIAMEY NICARAGUA NICOSIA NIGER Nigeria Nizhniy Novgorod Nizhny Noida Norfolk Norfolk Island North Ayrshire North East North East Derbyshire North East Lincolnshire NORTH KOREA North Lanarkshire North Lincolnshire NORTH MACEDONIA North Somerset North West North Yorkshire Northamptonshire Northern Ireland Northern Territory Northumberland Northwest Territories Northwich Norway Norwich Nottingham Nottinghamshire NOUAKCHOTT Nova Scotia Novara Novgorod Novosibirsk Nu`ayjah Nunavut Nuoro NUR-SULTAN Nuremberg Oakland Old Al Ghanim Old Al Hitmi Old Al Rayyan oman Omsk Onaiza OntarioToronto Oran Orenburg Oristano Orkney Islands Oryol OSLO Otago Ottawa OUAGADOUGOU Ouargla Oxford Oxfordshire Padua Paisley Pakistan PALAU Palermo PALESTINE PANAMA PANAMA CITY PAPUA NEW GUINEA Para PARAGUAY Paraiba PARAMARIBO Parana Paris Parma Patna Pavia Pembrokeshire Penrith Penryn Penza Penzance Pernambuco Perth Perth and Kinross peru Perugia Pesaro and Urbino Pescara Peterborough Philippines PHNOM PENH Piacenza Piaui Pimpri Pisa Pistoia Plymouth Poland Poole Pordenone PORT LOUIS PORT MORESBY PORT OF SPAIN PORT VILA PORT-AU-PRINCE Porto Portugal PORTO-NOVO Portsmouth portugal Potenza Powys Prague PRAIA Prato Preston PRETORIA Prince Edward Island PRISTINA Pskov Pune PYONGYANG Qatar Quebec City Queensland QUITO Ragusa Raipur Rajkot Ramsey Ranchi Ras Abu Aboud Ras Al Khaimah Ras Lafan Ravenna Rawdat Al Hamama Rawdat Al Khail Rawdat Egdaim Rawdat Rashed Reading Redcar and Cleveland Reggio Calabria Reggio Emilia Regina Relizane Renfrew Renfrewshire Repton REYKJAVIK Rhondda Cynon Taf Rieti RIGA Rimini Rio de Janeiro Rio Grande Ripon Riverside RIYADH Romania Rome ROSEAU Rostov Rotterdam Rovigo Rumeilah Russia Rutland RWANDA Ryazan Saharanpur Saïda SAINT GEORGE'S SAINT JOHN'S SAINT KITTS & NEVIS SAINT LUCIA Saint Petersburg SAINT VINCENT & THE GRENADINES Sakhalin Salem Salerno Salford Salisbury Saltash Samara SAMOA SAN JOSE SAN MARINO SAN SALVADOR Sandhurst SANTIAGO SANTO DOMINGO SÃO TOMÉ & PRÍNCIPE SÃO TOMÉ SAUDI ARABIA SARAJEVO Saratov Saskatchewan Sassari Savona Sawda Natheel Saxony Scotland Scottish Borders SENEGAL SEOUL Serbia Sétif Seville SEYCHELLES Shagra Sharjah Sheffield Shetland Islands Shropshire Sidi bel Abbès Siena SIERRA LEONE Siliguri Simaisma singular Skikda SKOPJE Slough SLOVAKIA SLOVENIA Smolensk Sofia Solapur SOLOMON ISLANDS SOMALIA Somerset Sondrio Souk Ahras SOUTH AFRICA South Australia South Ayrshire South Bucks South Cambridgeshire South Derbyshire South East South Gloucestershire SOUTH KOREA South Lakeland South Lanarkshire South Sardinia SOUTH SUDAN SOUTH TARAWA South Tyrol South West South Yorkshire Southampton Southend-on-Sea Southland spain Springfield SRI JAYAWARDENEPURA KOTTE Sri Lanka Srinagar St Albans St Asaph St Davids St. Austell St. Ives St. John's Staffordshire Stirling STOCKHOLM Stockton-on-Tees Stoke Poges Stoke-on-Trent Stuttgart SUCRE sudan Suffolk Sunderland Surat SURINAME Surrey SUVA Sverdlovsk Swansea Sweden Swindon switzerland Sydney Syracuse SYRIA TAJIKISTAN TALLINN Tambov TANZANIA Taranto TASHKENT Tasmania TBILISI Tébessa TEGUCIGALPA TEHRAN Telford Telford and Wrekin Teramo Terni Thailand Thane The Hague The Pearl THIMPHU Thiruvananthapuram Thuringia Thurrock Thurso Tiaret TIMOR-LESTE DILI Tintagel TIRANA Tiruchirappalli Tizi Ouzou Tlemcen TOGO TOKYO Tomsk TONGA NUKUʻALOFA Torbay Trapani Trento Treviso Trieste TRINIDAD & TOBAGO TRIPOLI Truro Tula TUNIS TUNISIA Turin turkey TURKMENISTAN TUVALU Tver Tyne and Wear Tyumen Udine UGANDA Ujjain Ukraine Ukraine. Dnipropetrovsk Ulhasnagar Ulyanovsk Umm al-Qaiwain Umm al-Quwain Umm Bab Umm Birka Umm Ghuwailina Umm Lekhba Umm Qarn Umm Salal Ali Umm Salal Mohammed United arab emirates UNITED ARAB EMIRATES (UAE) united Kingdom UNITED KINGDOM* (UK) United States UNITED STATES OF AMERICA (USA) URUGUAY UZBEKISTAN Vadodara VADUZ Vale of Glamorgan Valencia VALLETTA MARSHALL ISLANDS VANUATU Varanasi Varese Vasai Virar VATICAN CITY VATICAN CITY (Holy See) VENEZUELA CARACAS Venice Verbano-Cusio-Ossola Vercelli Verona Vibo Valentia Vicenza Victoria Vienna VIENTIANE VIETNAM HANOI Vijayawada VILNIUS Visakhapatnam Viterbo Vladimir Volgograd Vologda Voronezh Wadi Al Banat Wadi Al Sail Wadi Al Wasaah Wadi Lusail Wakefield Wales Warrington Warsaw Warwickshire Washington Wellington Wells West Berkshire West Dunbartonshire West Lothian West Midlands West Sussex West Yorkshire West Yorkshire (Bradford–Leeds) Western Australia Western Isles Westland Whitehaven Whitehorse Wick Wiltshire Winchester Windsor and Maidenhead Winnipeg Wisbech Wokingham Wolverhampton Worcester Worcestershire Workington Wrexham Wrexham Qatar Wycombe YAMOUSSOUKRO YAOUNDE YAREN DISTRICT Yaroslavl Yellowknife YEMEN SANA'A ZAMBIA YEREVAN York Yorkshire and the Humber Yukon ZAGREB ZIMBABWE Zürich

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

VIRTUAL INSPECTION PURPOSE: To lay down the procedure for establishing a comprehensive system of virtual …

Parameter

Parameter

Limit↓

Observation

Hardness
(Unit:____)

Friability (%)