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Check List for Lay out Plan Approval for ManufacturingAllopathic Drugs

Sr.No.

ManufacturingSection

AreaProvided

RequiredArea (As per

New Sch MReq.)

Other Requirement

1 ExternalPreparation(Ointments,Emulsion ,Creams,Lotions, Paste,Dusting Powderetc.)

30 sq.mt+

10 sq. mtAncillary Area

Air handling system,Airlock, AirConditioning & AirSupply through 20Micron filler & Exhaustsystem

2 Liquid Orals

(Syrups, Elixirs,Suspensions etc.)

30 sq. mt

+10 sq. mt

Ancillary Area

Air handling system,

Airlock, In primarypackaging area 5-micron air supply &temp .below 30degree Celsius.

3 Oral Powder 30 sq. mt Air handling system,Exhaust system, andSeparate Section. ForBlending.

4 Tablets.A. Granulation

B. CompressionC. Packing

D. Coating

60 sq. mt

20 sq. mtAnc. Area

30 sq. mt+10 sq. mt anc.

Air handling system,Dehumidifier & Air

Conditioning asrequired and SuitableExhaust systemCubicle for each tabletmachine.

E. Beta Lactum Separatemanufacturing &packing Section

Area as requiredfor general tabletsection

Suitable Measures toavoid crosscontamination, Airhanding System

F. HypodermicTablets

Separatemanufacturing &PackingSection

Area as required

5 Capsule SectionA General (Non

25 sq. mt+

Air handling system,Airlock Exhaust

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Penicillin) 10 sq. mtancillary.

Dehumidifier & A/C

E. Beta LactumGroup

25 sq. mt+

10 sq. mt

ancillary.

Air handling system,Provisions to avoidCross contamination

C. Soft GelatinCapsule

30 sq. mt Air handling system,A/C, Dehumidifier

6 Surgical DressingsA. Surgical

Bandages(ExcludingCotton wool)

B. MedicatedDressings

30 sq. mt

30 sq. mt

) Air handling) System

7 Opthalmic

Preparation (Eyeointments, EyeLotions etc.)

25. sq. mt

+10 sq. mt. anc.

Sterile, Air conditioned

Dehumidifier & AirLock

8 Pesseries &Suppositories(if manufacturedby Granulation &compressionarea required is asper tablet section)

30 sq. mt Other requirement asper Tablet section

9 Inhalers, Vitroli 20 sq.mt Air handling system

9 a Metered Doseinhalers

As required Air handling systemWith followingsubsectionsChange room,Container preparationbulk preparation &fillingQuarantine spraytesting

10 Basic drugs

A General 30 sq. mt a .Construction abovethis is not allowed

Air handling system 5micron air supply

b Sterile 30 sq. mt All provisions requiredfor manufacture of

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sterile formulation

11 Disinfectant /PhenylPowder repacking

30 sq. mt30 sq. mt Air lock

12 Liquid repacking 30 sq. mt Air handling system

14 Medicinal gases 30 sq. mt15 Cotton Wool 100 sq. mt

16 Hard gelatincapsule

75 sq. mt Air handling system

17 Mechanicalcontraceptivesa. Condomsb. copper Tc. Tubal rings

30 sq. mt25 sq. mt25 sq. mt

Air handling SystemAseptic area

18 Bottle washingCleaning

15 sq. mt Air handing system

19 ParenteralPreparations( Following Sub-sections arerequired for Glasscontainers )a Water

managementarea

b Containers &closures prep.

c Solution prepd Filling capping

sealinge Sterilizationf Quarantineg Visualinspectionh Packing area

150 sq. mt

Air handling systemEnvironmentalMonitoring & otherSpecial Provisions asper Sch M Part l A

100 sq. mtancillary areafor small volumeparenteral

150 sq.mt. ancillaryarea

100 sq. mt for packingmaterial store for largevolume parietals

20 For parenteral preparation in plastic container Mfgd by FFS/BFS Technologyfor metered dose required

Water managementAreaSolution preparation

AreaContainer moulding,filling & sealing AreaSterilization AreaQuarantine Area

250 sq. mt

As per Sch M Part I Air

handling unit,Environmentmonitoring& Special Provision

150 Ancillary Area150 Packing materialstores for LVP

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Visual inspectionArea

Packing Area

20 Quality Control

A Chemical Testing 20 sq. mt

B Instrument room 10 sq. mt Air conditionedC Microbiology 10 sq. mt Air Lock Air handling

unit LAF

D Pyrogen Testing 15 sq. mt Air conditioned

E Sterility testing 10 sq. mt Air Lock, Air handingunit LAF

F Animal house 15 sq. mt Air conditioned

21 Office 10 sq. mt

22 Workers room 8 sq. mtfor Gents

8 sq. mt

for Ladies23

abcd

Raw materialSection

One/two sectionThree/four sectionMore than FoursectionReceiving bay

30 sq. mt40 sq. mt50 sq. mt

As required &covered

A/C forthermolabile drugs

Separate samplingarea

Separate area forSampling/Dispensing &storing of Beta-lactum,cytotoxic & sex

hormones24 Quarantine Raw

Material10 sq. mt A/C for the

thermolabile drugs

25 Finished Goods Store A/C for thethermolabile drugs

a One section 20 sq. mt

b Each additionalSection

10 sq. mt

26 Quarantine forfinished product

10 sq. mt

27 Packing & labeling Air handling system for primary packing section

a one section 20 sq. mtb Two section 30 sq. mt

c Three or more 50 sq. mt

28 Packing Materials 75% of the arearequired for rawmaterial section

Air conditioned or airhandling system asrequired.