Check List for Lay out Plan Approval for Manufacturing Allopathic Drugs

Sr. No. Manufacturing Section Area Required Provided Area (As per New Sch M Req.) 30 sq.mt + 10 sq. mt Ancillary Area Other Requirement

External Preparation (Ointments, Emulsion , Creams, Lotions, Paste, Dusting Powder etc.) Liquid Orals (Syrups, Elixirs, Suspensions etc.)

Air handling system, Airlock, Air Conditioning & Air Supply through 20 Micron filler & Exhaust system

30 sq. mt + 10 sq. mt Ancillary Area

Oral Powder

Tablets. A. Granulation B. Compression C. Packing D. Coating E. Beta Lactum

Air handling system, Airlock, In primary packaging area 5micron air supply & temp .below 30 degree Celsius. 30 sq. mt Air handling system, Exhaust system, and Separate Section. For Blending. Air handling system, 60 sq. mt Dehumidifier & Air 20 sq. mt Conditioning as Anc. Area required and Suitable Exhaust system 30 sq. mt+ Cubicle for each tablet 10 sq. mt anc. machine. Separate Suitable Measures to manufacturing & avoid cross packing Section contamination, Air Area as required handing System for general tablet section Separate manufacturing & Packing Section Area as required 25 sq. mt +

F. Hypodermic Tablets

Capsule Section A General (Non

Air handling system, Airlock Exhaust

1

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Penicillin) E. Beta Lactum Group

9 9a

C. Soft Gelatin Capsule Surgical Dressings A. Surgical Bandages (Excluding Cotton wool) B. Medicated Dressings Opthalmic Preparation (Eye ointments, Eye Lotions etc.) Pesseries & Suppositories (if manufactured by Granulation & compression area required is as per tablet section) Inhalers, Vitroli Metered inhalers Dose

10 sq. mt ancillary. 25 sq. mt + 10 sq. ancillary. 30 sq. mt

Dehumidifier & A/C Air handling system, Provisions to avoid mt Cross contamination Air handling system, A/C, Dehumidifier

30 sq. mt ) Air handling ) System 30 sq. mt 25. sq. mt + 10 sq. mt. anc. 30 sq. mt Sterile, Air conditioned Dehumidifier & Air Lock Other requirement as per Tablet section

20 sq.mt As required

Air handling system Air handling system With following subsections Change room, Container preparation bulk preparation & filling Quarantine spray testing a .Construction above this is not allowed Air handling system 5 micron air supply

10 A

Basic drugs General

30 sq. mt

Sterile

30 sq. mt

All provisions required for manufacture of

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sterile formulation 11 Disinfectant / 30 sq. mt Phenyl 30 sq. mt Air lock Powder repacking 12 Liquid repacking 30 sq. mt Air handling system 14 Medicinal gases 30 sq. mt 15 Cotton Wool 100 sq. mt 16 Hard gelatin 75 sq. mt Air handling system capsule 17 Mechanical contraceptives a. Condoms 30 sq. mt Air handling System b. copper T 25 sq. mt Aseptic area c. Tubal rings 25 sq. mt 18 Bottle washing 15 sq. mt Air handing system Cleaning 19 Parenteral Preparations Air handling system ( Following SubEnvironmental sections are Monitoring & other required for Glass Special Provisions as containers ) per Sch M Part l A a Water management 100 sq. mt area ancillary area b Containers & 150 sq. mt for small volume closures prep. parenteral c Solution prep 150 sq.mt. ancillary d Filling capping sealing area e Sterilization f Quarantine g Visual 100 sq. mt for packing inspection material store for large h Packing area volume parietals 20 For parenteral preparation in plastic container Mfgd by FFS/BFS Technology for metered dose required As per Sch M Part I Air handling unit, Water management Environment Area monitoring Solution preparation & Special Provision Area 250 sq. mt Container moulding, 150 Ancillary Area filling & sealing Area 150 Packing material Sterilization Area stores for LVP Quarantine Area

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20 A B C D E F 21 22

Visual inspection Area Packing Area Quality Control Chemical Testing Instrument room Microbiology Pyrogen Testing Sterility testing Animal house Office Workers room

20 sq. mt 10 sq. mt 10 sq. mt 15 sq. mt 10 sq. mt 15 sq. mt 10 sq. mt 8 sq. mt for Gents 8 sq. mt for Ladies

Air conditioned Air Lock Air handling unit LAF Air conditioned Air Lock, Air handing unit LAF Air conditioned

23

Raw material Section One/two section Three/four section More than Four section Receiving bay

a b c d

24 25 a b 26 27 a b c 28

Quarantine Raw Material Finished Goods Store

One section Each additional Section Quarantine for 10 sq. mt finished product Packing & labeling Air handling system for primary packing section one section 20 sq. mt Two section 30 sq. mt Three or more 50 sq. mt Packing Materials 75% of the area Air conditioned or air required for raw handling system as material section required.

A/C for thermolabile drugs Separate sampling 30 sq. mt area 40 sq. mt Separate area for 50 sq. mt Sampling/ As required & Dispensing & covered storing of Betalactum, cytotoxic & sex hormones 10 sq. mt A/C for the thermolabile drugs A/C for the thermolabile drugs 20 sq. mt 10 sq. mt

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