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SCHEDULE B

SCHEDULE B - I

SCHEDULE B - I - A

SCHEDULE B - II

SCHEDULE B - III

SCHEDULE B
CONDITIONS FOR GRANT OF A LICENSE TO MANUFACTURE BY WAY OF FORMULATION
SECTION-I
PREMISES

SECTION--2
EQUIPMENT FOR PRODUCTION

SECTION--3
QUALITY CONTROL DEPARTMENT

SECTION--4
DOCUMENTATION

SECTION--5
SANITATION AND HYGIENE

SCHEDULE B-I
[See rule 16 (6) (b)]

REQUIREMENTS OF PLANT AND EQUIPMENT

(A) The following equipment is required for the manufacture of drugs for external appliances or suspense:
(1) Mixing tanks where applicable:
(2) Kettles, steam, gas or electrically heated.
(3) A suitable power driven mixer.
(4) Storage tanks or pots.
(5) A calloid mill or a suitable emulsifier or homogeniser, where applicable.
(6) A triple-roller mill or an ointment mill, where applicable.
(7) Liquid filling equipment.
(8) Jar or tube filling equipment, where applicable.
Area of minimum of 200 square feet is required for the basic installation.

(B) The following equipment is required for manufacture of Syrups, Exlixirs and Solutions :--
(1) Mixing and storage tanks.
(2) Mixer.
(3) Filter press or other suitable filtering equipment such as metafilter or sparklet filter or Also-pad filter.
(4) Water still or Deioniser.
(5) Various liquid measures and weighing scale.
An area of maximum 300 square feet is required for the basic installations.

(C) Equipment for the manufacture of Pills and Compressed Tablets including Hypodermic Tablets. For efficient operation, the tablet production department shall be divided into the following three distinct and separate sections situated in different rooms,
(i) Granulating Section;
(ii) Tableting Section;
(iii) Coating Section.
The following equipment is required in each of the three sections :-

1. Granulating Section: (1) Disintegrator, where applicable.
(2) Power Mixer or granulation mixer with stainless steel cabinet
(3} Granular
(4) Oven thermostatically controlled.

2. Tableting Section:
(1) Tablet machine, single punch or rotary.
(2) Pill machine, where applicable.
(3) Punch and dyes storages cabinet.

The Tableting Section shall be free from dust and floating particles. For this purpose, it is desirable that each tablet machine is connected either to an exhaust system or isolated into cubicles.

3. Coating Section:
(1) Jacketed kettle, or equivalent steam, gas or dect£1cally heated for preparing solution.
(2) Coating pan.
(3) Polishing pan, where applicable,
{4) Heater and exhaust system, where applicable.

The coating section shall be made dust-free and suitable exhaust provided to remove excess powder and the fumes resulting from solvent evaporation.

A total area of not less than 900 square feet for the three Sections is required for basic installations.

The manufacture of Hypodermic Tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. The granulation, tableting and packing shall be done in this room.

(D) The following equipment is required for the manufacture of Powders :--
(1) Disintegrator, where applicable.
(2) Mixer.
(3) Sifter or sieve.
(4) Stainless steel vessels and scoops of suitable material,
(5) Filling equipment,

In the case of operations involving floating particles of fine powder or dust a suitable exhaust system shall be provided, Workers shall be provided with suitable marks during operation.

If a manufacturer has e tablet section where the powder of the granules can be manufactured, provided that such granules or powder or non toxic, no separate equipment will be required for manufacture of such powder as granules.

(E) The following equipment is required for filling of Hard Gelatin Capsules:-

(1) Mixing and blending equipment.

(2) Capsule filling units.
An area of minimum of 200 square feet is required for the basic installations. The room shall be air-conditioned and also dehumidified wherever necessary.

(F) The following equipment is required for ,the manufacture of Surgical Dressings other than Absorbent Cotton Wool
(1) Rolling machine.
(2) Trimming machine.
(3) Cutting equipment.
(4) Folding and pressing machine for gauze.
(5) Mixing tanks for processing medicated dressings.
(6) Hot air drying ovens.
(7) Steam steriliser or dry heat steriliser.

An area of minimum of 300 square feet is required for the basic installations. In case medicated dressings are to be manufactured, room with an area of minimum of 300 square feet shall be provided.

(G) The following equipment is required for the manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-Lotions and other use :-

(1) Hot air oven electrically heated with thermostatic control.
(2) Kettle, gas or electrically heated with suitable mixing arrangement.
(3) Colloid mill or homogeniser.
(4) Tube filling equipment.
(5) Mixing and storage tanks of stainless steel or of other suitable material.
(6) Sintered glass funnel, seitz filter or filter candle.
(7) Liquid filling equipment.
(8) Autoclave.

An area of minimum of 250 square feet is required for the basic installation. The manufacture and filling shall be carried out in art air-conditioned room under aseptic conditions. The room shall be further dehumidified if preparations containing antibiotics are manufactured.

(H) The following equipment is required for the manufacture of Pessaries and Suppositories :-
(1) Mixing and pouring equipment.
(2) Moulding equipment.
An area of minimum of 200, square feet required far the basic installation,

In case of pessaries manufactured by granulation compression, if the licence does not have a tablet section, a separate area of minimum of 300 squared feet and the following equipment is necessary :--
(1) Mixer.
(2) Granulator.
(3) Drier.
(4) Compressing machine.
(5) Pessary and tablet counter.

(I) The following equipment is required for the manufacture of inhalers end Vitrallae:
(1) Mixing equipment.
(2) Graduated delivery equipment for measurement of the medicament.
(3) Sealing equipment,
An area of minimum of 200 square feet is required for the basic installations.

(J) The following equipment is required for the repacking installation of drugs and Pharmaceutical Chemicals
(1) Sifter.
(2) Stainless steel scoops end vessels.
(3) Weighing and measuring equipment.
(4) Filling equipment.
An area of minimum of 300 square feet is required for basic packing operations. In the case of operations involving floating particles of fine powder or dust, a suitable exhaust system should be provided.

(K) Requirements for the manufacture of Parenteral Preparations: The whole process of the manufacture of parenteral preparations may be divided into the following separate operations:

(a) Preparations of the container: This includes, cutting. washing, drying sterilisation of ampoules or vials prior to
(b) Preparation of solution: This includes preparation and filteration of solution.
(c) Filling and sealing: This includes filling and sealing of ampoules or filling and capping of vials.
(d) Sterilisation.
(e) Testing,
The following basic hygienic requirement shall be complied with

(1) Strict sanitation shall be maintained throughout the entire plant in order to prevent contamination and to keep out pyrogens, Masks end overalls shall be worn wherever necessary.

(2) The preparation room where the solution ate prepared shall be of such a nature that may be kept scrupulously clean. This room shall be air-conditioned.

(3) The filling and sealing rooms shall likewise be air-conditioned under positive pressure with air locks provided to. prevent, the entry of air from outside. The walls and floor shall be such as may permit their being sprayed and washed with an antiseptic solution. The benches shall preferably have stainless steel or laminated plastic tops capable of being washed.

(4) In the room provided for aseptic filling and sealing, necessary measures for maintaining sterility and to preventing contamination shall be adopted.

(5) A separate room shall be provided .for sterilisation, testing (for leaks and floating particles) and dryin

(6) Finished products shall be stored in a suitable separate place.

The following equipment required :-

Manufacturing Area :
(1) Storage equipment for ampoules and vials
(2) Ampoule washing and drying equipment.
(3) Dust proof storage Cabinets.
(4) Water still.
(5) Mixing and preparation tanks or other containers. The tanks or containers shall be made of either glass or such material which will not react with the liquid
(6) Filtering equipments such as filter press or sintered glass funnel.
(7) Autoclave,
(8) Hot Air Steriliser,

Filling and Sealing Room:
(9) Benches for filling and sealing.
(10) Filling and sealing unit

Aseptic Filling and sealing room:
(11) Bacteriological filters such as Seitz filter, candles or sintered glass filters,
(12} Filling and. sealing unit,

General Room:
(13) Inspection table with draft and light background
(14) Leak tasting equipment.
(15) Labelling and packing benches,
(16) Storage equipment including cold storage and refrigerators, if necessary

Note /: The above requirements of this schedule are subject to modifications, at the discretion of the Central Licensing Board if it is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter in the circumstances of a particular case:

Provided that such variation shall be recorded in writing with reasons therefor and also communicated in writing to the manufacturer for his record,

Note//: This Schedule gives equipment and space required for certain categories of drugs only. There are, in addition, other categories such as drugs miscellaneous pharmaceuticals such as Ferries Ammonii Citras. Potassium Citras, Glycerin, Paraffin, Oxygen gas, Disinfectant fluids, mechanical contraceptives, surgical cotton and tinctures which are not listed in this Schedule. The Central Licensing Board shall, in respect of such categories of drugs, have the discretion to examine the adequacy or otherwise of factory premises, space, plant, machinery and other requirements having regard to the nature and extent of the manufacture to carry out necessary modifications in them and, on the modification. having been made, approve of the manufacture of such categories of drugs. Any drug so permitted to be manufactured by the Central Licensing. Board shall be deemed to be an additional category of drug for the purpose of this Schedule.

SCHEDULE B I-A.
[See rule 16 (bb)-7]
CONDITIONS OF FACTORY PREMISES

1. Location and surrounding: The premises should be away from drinking water sources and an area liable to flooding.

2. (a) Building: Building should be provided with both good general ventilation and protection against direct sunlight, with easy access for fire-fighting equipment including fire-extinguishers, fire-blankets, .hose, reels and fire-alarm, etc. Sufficient water must be available for fire-fighting.
(b) Wells: Walls as far as possible should be protected by non-flammable or slow burning material.
(c) Doors; Doors must be fire resistant preferably with self-closing system,
(d) Floors: Floors should be impermeable to liquids, smooth and free from cracks. There should be no drains at all in plants and in warehouse. If drains are absolutely necessary they must not contract directly with waterways or public sewers,
(e) Signs: Signs indicating smoking restrictions, location of emergency kits, fire-fighting equipment, telephone end escape routes must be prominently displayed. Local exhaust system must be effective,.

3. Personnel: To void intoxication by skin contact, inhalation of fumes, vapours and dust, accidental ingestion, the protected clothing and equipments, e.g., protective helmet or cloth cap, eye protection (safety spectacles, goggles or face shield) dust or light fume masks, one piece worksuit with closely fitting trouser bottoms, rubber or plastic gloves Or gauntlets, rubber or plastic apron, and workboots with protective toecaps, must be provided.

Staff must not be allowed to go home wearing the same clothing they wore at work; emergency showers and eye washing facilities must be provided in the premises. Safety instructions should be strategically displayed in local language. All emergency and safety equipment must be frequently and regularly checked and maintained to ensure its conditions satisfactory.

4. Medical Services: There must be pre-employment medical; , examination for all staff members whether working permanently or on contract basis. When organophosphates or carbamates are handled, pre-exposure baseline blood cholinesterase level must be determined for all operational staff. Staff regularly engaged in formulation and packing procedures and maintenances must have their cholinesterase levels checked regularly and detailed records must be kept. The checks should be carried .out by a properly equipped hospital or laboratory under qualified expert.

"Levels of cholinesterase activity should be interpreted by a doctor, but the following guide might be helpful :--

(i) A decease of more than 20% in blood cholinesterase activity,. from the pre-exposure value indicates that the cause should be investigated.

(ii) A decrease of more than 40% in blood cholinesterase activity from the pre-exposure value indicates that the worker concerned should be removed from further exposure to organophosphates or carbamates.

Workers should not be exposed again to cholinesterase inhibiting compounds until further tests show a blood cholinesterase activity within 20% of the pre-exposure value.

SCHEDULE B-II

GOOD MANUFACTURING PRACTICES (GMPs) FOR LICENCE TO
MANUFACTURE BY WAY OF FORMULATION

PART-I
GENERAL CONDITIONS

SECTION-1

SECTION-2

SECTION-3

SECTION--4

SECTION -- 5
GOOD PRACTICES IN MANUFACTURING PROCESSING

SECTION--6
MATERIALS

SECTION -- 7

SECTION -- 8

SECTION -- 9

SECTION -- 10

PART - II
ADDITIONAL CONDITIONS FOR MANUFACTURE OF STERILE PRODUCT

SECTION -1

SECTION--2

SECTION -- 3

SECTION -- 4

SECTION -- 5

SECTION -- 6

SECTION -- 7

A. Substances Parenteral preparation in general:
1. Serial Number.
2. Name of the drug.
3, Batch Size,
4. Batch number.
5. Date of commencement of manufacture and date when manufecture was completed,
6. Name of all ingredients, quantities required for the batch size, quantities actually used. (All weighings and measurements shall be checked initiated b¥ the competent person in the section).
7. Control reference numbers in respect of raw materials used in formulation.
8. Date of mixing in case of dry products, e.g., powder, powder mixture for capsule products, etc.
9. Date of granulation wherever applicable.
10. Weight of granules.
11. Date of compression in case of tablets/date of filling in case of capsules.
12. Dates of coating wherever applicable.
13. Records of test to be carried out in case of tablets as under
(a) Average weight every thirty minutes.
(b) Disintegration time as often as practicable.
14. Records of readings taken to check weight variation in case of capsules,
15. Reference to Analytical Report number stating whether of standard quality or otherwise.
16, Records on the disposal of rejected batches and batches with-drawn from the market.
17, Actual production and packing particulars indicating the size and quantity of finished packings,
18. Date of release of finished packings for distribution or sale,
19. in case of Hypodermic tablets and ophthalmic preparations which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained,
20. Signature of the expert staff responsible for the manufacture,

B. Parenteral preparation:
1. Serial Number,
2. Name of the drug,
3. Batch Size,
4. Batch number (if bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch),

5. Date of commencement of manufacture and date of completion.

6. Name of all ingredients, quantities required for the lot size, quantities actually used. (All weighings and measurements shall be checked and initialled by the competent person in the section).

7. Control reference numbers in respect of raw materials used.
8. PH of the solution wherever applicable.
9. Date and methods of filtration.
10. Sterility test reference on bulk batch wherever applicable. (If bulk lot is divided into various batches and processed separately, a batch number distinctly different from that of the bulk lot should be assigned to each of the processed batch.
11. Date of filling.
12. Records of tests employed :--
(a) To ensure that sealed ampules are leak-proof,
(b) To check the presence of foreign particles.
(c) For pyrogens wherever applicable.

13. Records of sterilisation in case of parenteral preparation which are heat sterilised including particulars of time temperature and pressure employed.
14. Number and size of containers filed and number rejected.
15, Reference to Analytical Report numbers stating whether of standard quality or otherwise.
16. Records of the disposal of rejected batch and batches with-drawn from the market.
17. Actual production and packing particulars.
18. Date of release finished packings for distribution or sale.
19. Particulars regarding the precautions taken during manufacture to ensure that aseptic conditions are maintained.
20. Control reference numbers in respect of the lot of glass containers used for filling.
21. Signature of the expert staff responsible for manufacture.

II. RECORDS OF RAW MATERIALS
Records in respect of each raw material shall be maintained indicating the quantity received, control reference numbers, the quantities issued from time to time, the names and batch Nos. of the products for the manufacture of which the quantities have been issued and the particulars relating to the proper disposal of the stocks.

III. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS
A. Tablets and capsules:
1. Analytical report number.
2. Name of the sample.
3. Date of receipt of sample,
4. Batch number.
5. Protocols of tests applied:
(a) Description.
(b) Identification.
(c) Uniformity of weight.
(d) Uniformity of diameter (if applicable).
(e) Disintegration test (time in minutes).
(f) Any other tests.
(g) Results of assay.

Note: Records racer, cling various tests applied (including reading and calculation) should be maintained and necessary reference to these records should .be entered in serial No. 5 whenever necessary.
6. Signature of the Analyst.
7. Opinion and signature of the approved Analyst.

B. Parenteral Preparations
1. Analytical report number.
2. Name of the sample.
3. Batch number.
4, Date of receipt of sample.
5. Number of containers filled.
6. Number of container packed
7. Protocols of tests applied
(a) Clarity,
(b) PH wherever applicable,
(c) Identification.
(d) Volume in container,
(e) Sterility--(/) Bulk sample wherever applicable (ii) container sample.
(f) Pyrogen test, wherever applicable.
(g) Toxicity test, wherever applicable.
(h) Any other teats.
(i) Results of assay.

Note: Records regarding various tests applied (including readings and calculations)should be maintained and necessary reference to these records should be entered in Serial No.7. wherever necessary
8. Signature of the Analyst.
9, Opinion and signature of the approved Analyst Pyrogen Tests:-
1. Test Report number.
2. Name of the sample.
3. Batch number.
4. Number of rabbits used.

5. Weight of each rabbit.
6. Normal temperature of each rabbit.
7. Mean initial temperature of each rabbit,
8. Dose and volume of solution injected into each rabbit and time of injection.
9. Temperature of each rabbit noted at suitable intervals,
10. Maximum temperature.
11. Response.
12. Summed response,
13. Signature of the Analyst,
14. Opinion and signature of the approved Analyst

Toxicity Test:
1. Test Report number.
2. Name of the Sample
3, Batch number
4. Number of mice used and weight of each mouse, Strength and volume of the drug injected,
6, Date of injection,
7. Results and remarks,
8. Signature of Analyst,
9. Opinion and signature of the approved Analyst.

C. For other drugs:
1.Analytical report number
2. Name of the sample
3. Batch number.
4, Date of receipt of sample
5. Protocols of tests applied:
(a) Description.
(b) Identification.
(c) Any other tests
(d). Results of assay.

Note: Particulars regarding various tests applied (including reading and calculations) shall be maintained and necessary reference to these records shall be entered in serial No. 5 wherever necessary.

6. Signature of the Analyst.
7. Opinion and signature of the approved Analyst.

D. Raw materials:
1. Serial number
2. Name of the material

3. Name of the manufacturer/supplier.
4. Quantity received.
5. Invoice/Challan number and date.
6. Protocols of tests applied.
Note: Particular regarding various tests applied (including reading and calculations) shall be maintained and necessary reference these records shall be entered in serial No. 6 wherever necessary.
E. Container, packing material, etc.:
1. Serial number.
2. Name of the item.
3. Name of the manufacturer/supplier.
4. Quantity received.
5. Invoice/Challan number and date.
6, Results of tests applied.

Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered serial No. 6 wherever necessary.

7. Remarks.
8. Signature of the examiner.

Note I: The foregoing provisions represent the minimum requirements to be complied with by the licensee. The Central Licensing Board may, however, direct the nature of records to be maintained by the licensee for such drugs as are not covered by the categories described in this Schedule.

Note 2: The Central Licensing Board may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down in the Schedule are complied with.

Note 3: The Central Licensing Board may as its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case.

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