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Schedule ‘M’
DETAILED STUDY
Rahul Pal
B. Pharm (5th Sem)
Schedule “M”
“Goods Manufacturing Practices (GMP)” are minimum standards used in the
manufacturing process that assure that the product meets requirements of safety, identity,
strength, quality, and purity.
 The FDA attempts to inspect manufacturers every 2 years.
 The Schedule M has again been amended in a major way by the Drugs and Cosmetics (8th
Amendment) Rules, 2001 w.e.f. 11th December 2001.
 These rules shall not apply to the manufacturers who are presently licensed to
manufacture drugs for the period up to the 31st Dec. 2003.
 The manufacturing premises shall be used exclusively for production of drugs and not for
any other manufacturing.
• It is defined as “the part of quality assurance which is aimed to ensure that the product is
consistently manufactured to the quality appropriate to their intended use”.
• It prescribes the requirements of premises, plant and equipment needed for setting up
manufacturing unit.
Part: 01. Requirements for Premises & Materials:
Part: 02.
Requirements for
Plant & Equipments:
 Area.
 Equipments.
Parts of
Schedule “M”:
 Part 1.
 Part 1A.
 Part 1B.
 Part 1C.
 Part 1D.
 Part 1E.
1) Location & surrounding.
2) Buildings & Premises.
3) Water Supply.
4) Disposable of Waste.
5) Storage.
6) Working Space.
7) Sterile Products.
8) Container’s Cleaning.
9) Machinery.
10) Raw materials.
11) Equipments.
12) Batch manufacturing Record.
13) Health Clothing, Sanitation &
Hygiene of Workers.
14) Medical Services.
15) Distribution Record.
16) Record of Marketing Complaints.
17) Quality Control.
Part-1: Requirements for Premises and
Materials
01). Locations and Surroundings*: The factory building shall be situated and
constructed to avoid contamination from sewerage, drain, disagreeable, dust and smoke etc.
02). Buildings and Premises*:
Manufacturing shall permit work under hygienic conditions. It should be free from any insects.
Light and ventilation facility should be adequate. Walls and floor should be free from cracks
and damp. It shall be located so as to be:
a) The flooring shall be smooth.
b) Building should have a proper drainage system.
c) Proper fire safety measures and proper exists should be there.
• Drying space for raw material, in process medicines should be separate and measures
should be done to prevent it from flies/insects/dust etc.
03. Water Supply*: Water supply should be pure and of potable quality. Adequate
provision of water for wasting the premises shall be made.
04. Disposable of Waste*:
(i) Disposal of sewage and effluents from the factory should be as per “Environment
Pollution Control Board’’.
(ii) All bio-medical wastes should be destroyed as per “Biomedical Waste
management rules-1996”.
05. Stores*: Store should have adequate space for independently and separately
store raw material, packaging material and finished products.
06. Working Space*: Manufacturing area should be adequate for orderly
placement of equipment, machinery and material used during manufacturing
operations and quality control to facilitate easy and safe working.
07. Sterile Products*: Sterile products separate enclosed areas shall be provided
with the air lock system for the entry and shall be essentially dust free and has to be
carried out.
• Air supply shall be filtered through bacteria proof filter (HEPA filter). Access to
manufacturing area shall be restricted to minimum number of authorized personal.
• Special procedure to be followed for entering and leaving the manufacturing area
shall be written down and displayed.
08. Container’s Cleaning*: Washing, cleaning and drying section of
containers such as bottles and jars should have adequate arrangement.
09. Machinery*: To carry out manufacturing process, adequate machinery and
equipment require. These machineries could be manually operated or semi-
automatic or fully automatic based upon your need and investment.
10. Raw-Materials*: The licensee shall keep on inventory of all raw material to be
used at any stage of manufacture of drugs and maintain the record as per schedule U. All
such raw material be:
(a) Identified and their container examined for damage and assigned control number.
(b) Stored at optimum temperature and relative humidity.
(c) Systematically sampled by quality control personnel.
(d) Tested for compliance with required standard of quality.
• The stock rotation is so organized that, it is on the basis of first come first out.
11. Equipment*: Equipment used for the manufacturing shall be constructed
designed, installed and maintained to:
a. Achieve operational efficiency to attain desired quality.
b. Minimize any contamination of drug and their container during manufacture.
• Equipment used for critical steps in progress shall be maintained by device capable of
recording the parameter or withdrawn systems to indicate malfunction.
12. Batch Manufacturing Record*:
Batch record should be maintained irrespective of product manufactured:
• Manufacturing records are required to provide the list of raw materials and their
quantities obtained from the store, tests conducted during the various stages of
manufacture like taste, colour, physical characteristics and chemical tests.
 Manufacturing Batch record should be signed by production chemist and analytical
chemist.
• Only after the manufactured drugs have been verified and accepted quality shall be
allowed to be cleared for sale.
13. Health Clothing, Sanitation and Hygiene of Workers*:
All workers should be healthy and should be free from contagious diseases.
 Proper uniform should be provided to workers according to nature of work.
 A uniform may include cloth or synthetic covering for hands, feet and head wherever
required.
 Adequate facilities for personal use provided like clean towel, soap etc.
 Lavatories for men and women should be separate and should be away from
processing and manufacturing area.
• Changing room facility should also be provided for changing their clothes.
14. Medical Services*: Adequate facility for first aids should be provided by
manufacturer.
Medical examination of workers at the time of employment and periodical check-up
should be conducted at least once in a year and proper record should be maintained.
15. Distribution Record*: Distribution record (Dispatch register) should be
maintained to facilitate process of prompt and complete recall of the batch. Distribution
record should be maintained till expiry of batch.
16. Record of Market Complaints*: A register should maintain to record all
reports of market complaints received regarding the products sold in the market.
• The manufacturer shall enter all data received on such market complaints;
investigations carried out by the manufacturers regarding the complaint & shall also be
recorded.
• “Once in a period of six months the manufacturer shall submit the record of such
complaints to the licensing authority.”
• Reports of any adverse reaction resulting from the use of drugs maintained in a
separate register by manufacturer.
17. Quality Control*: A manufacturer can set-up own quality control section or testing
could be done through government approved testing laboratory.
Part-2: Requirements for Plant and
Equipments
01. Area:
a) Basic Installation - Requires minimum of 30 sq. mt. (for tablets manufacturing, up
to 60 sq. mt.)
b) Ancillary Area: 10 sq. mt. (for tablets manufacturing, up to 20 sq. mt.)
02. Equipment:
Colloidal mill, mixing and storage tanks, stainless steel containers, Planetary mixer, Triple
roller, tube filling equipments, filter proof cap sealing machine, water distillation unit,
clarity testing inspection unit, disintegrator and sifter, granulator, tray or fluidized bed
driers, weighing machine, tablet compression machine, tablet inspection unit,
dissolution test apparatus, hardness tester, friability tester, disintegration test
apparatus, air conditioners, polishing pan, jacketed kettle, leakage test apparatus, capsule
filling unit, hot air ovens, Laminar air flow unit, bottle washing machines, autoclave,
transfer pumps, trimming machine, cutting machine etc.
Parts of Schedule ‘M’
• Part 1: Describes Good Manufacturing Practices for Premises and Material.
• Part 1A: Describes the specific requirement for manufacture of sterile products.
Parenteral preparations and Sterile Ophthalmic Preparations.
• Part 1B: Describes the specific requirements for manufacture of oral solid
forms (Capsule and Tablets)
• Part 1C: Describes the specific requirements for manufacture of oral liquids
(syrups, elixirs, emulsions and suspensions).
• Part 1D: Describes the specific requirements for manufacture of topical
products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions,
Lotions, Solutions)
• Part 1E: Describes the specific requirements for manufacture of Metered Dose
Inhalers (MDI). The other associated codes such as those of Good laboratory
practice (GLP) and Good clinical practice (GCP).
THANKU!

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Schedule ‘M’ manufacturing standards

  • 1. Schedule ‘M’ DETAILED STUDY Rahul Pal B. Pharm (5th Sem)
  • 2. Schedule “M” “Goods Manufacturing Practices (GMP)” are minimum standards used in the manufacturing process that assure that the product meets requirements of safety, identity, strength, quality, and purity.  The FDA attempts to inspect manufacturers every 2 years.  The Schedule M has again been amended in a major way by the Drugs and Cosmetics (8th Amendment) Rules, 2001 w.e.f. 11th December 2001.  These rules shall not apply to the manufacturers who are presently licensed to manufacture drugs for the period up to the 31st Dec. 2003.  The manufacturing premises shall be used exclusively for production of drugs and not for any other manufacturing.
  • 3. • It is defined as “the part of quality assurance which is aimed to ensure that the product is consistently manufactured to the quality appropriate to their intended use”. • It prescribes the requirements of premises, plant and equipment needed for setting up manufacturing unit. Part: 01. Requirements for Premises & Materials: Part: 02. Requirements for Plant & Equipments:  Area.  Equipments. Parts of Schedule “M”:  Part 1.  Part 1A.  Part 1B.  Part 1C.  Part 1D.  Part 1E. 1) Location & surrounding. 2) Buildings & Premises. 3) Water Supply. 4) Disposable of Waste. 5) Storage. 6) Working Space. 7) Sterile Products. 8) Container’s Cleaning. 9) Machinery. 10) Raw materials. 11) Equipments. 12) Batch manufacturing Record. 13) Health Clothing, Sanitation & Hygiene of Workers. 14) Medical Services. 15) Distribution Record. 16) Record of Marketing Complaints. 17) Quality Control.
  • 4. Part-1: Requirements for Premises and Materials 01). Locations and Surroundings*: The factory building shall be situated and constructed to avoid contamination from sewerage, drain, disagreeable, dust and smoke etc. 02). Buildings and Premises*: Manufacturing shall permit work under hygienic conditions. It should be free from any insects. Light and ventilation facility should be adequate. Walls and floor should be free from cracks and damp. It shall be located so as to be: a) The flooring shall be smooth. b) Building should have a proper drainage system. c) Proper fire safety measures and proper exists should be there. • Drying space for raw material, in process medicines should be separate and measures should be done to prevent it from flies/insects/dust etc. 03. Water Supply*: Water supply should be pure and of potable quality. Adequate provision of water for wasting the premises shall be made.
  • 5. 04. Disposable of Waste*: (i) Disposal of sewage and effluents from the factory should be as per “Environment Pollution Control Board’’. (ii) All bio-medical wastes should be destroyed as per “Biomedical Waste management rules-1996”. 05. Stores*: Store should have adequate space for independently and separately store raw material, packaging material and finished products. 06. Working Space*: Manufacturing area should be adequate for orderly placement of equipment, machinery and material used during manufacturing operations and quality control to facilitate easy and safe working. 07. Sterile Products*: Sterile products separate enclosed areas shall be provided with the air lock system for the entry and shall be essentially dust free and has to be carried out. • Air supply shall be filtered through bacteria proof filter (HEPA filter). Access to manufacturing area shall be restricted to minimum number of authorized personal. • Special procedure to be followed for entering and leaving the manufacturing area shall be written down and displayed.
  • 6. 08. Container’s Cleaning*: Washing, cleaning and drying section of containers such as bottles and jars should have adequate arrangement. 09. Machinery*: To carry out manufacturing process, adequate machinery and equipment require. These machineries could be manually operated or semi- automatic or fully automatic based upon your need and investment. 10. Raw-Materials*: The licensee shall keep on inventory of all raw material to be used at any stage of manufacture of drugs and maintain the record as per schedule U. All such raw material be: (a) Identified and their container examined for damage and assigned control number. (b) Stored at optimum temperature and relative humidity. (c) Systematically sampled by quality control personnel. (d) Tested for compliance with required standard of quality. • The stock rotation is so organized that, it is on the basis of first come first out.
  • 7. 11. Equipment*: Equipment used for the manufacturing shall be constructed designed, installed and maintained to: a. Achieve operational efficiency to attain desired quality. b. Minimize any contamination of drug and their container during manufacture. • Equipment used for critical steps in progress shall be maintained by device capable of recording the parameter or withdrawn systems to indicate malfunction. 12. Batch Manufacturing Record*: Batch record should be maintained irrespective of product manufactured: • Manufacturing records are required to provide the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests.  Manufacturing Batch record should be signed by production chemist and analytical chemist. • Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale.
  • 8. 13. Health Clothing, Sanitation and Hygiene of Workers*: All workers should be healthy and should be free from contagious diseases.  Proper uniform should be provided to workers according to nature of work.  A uniform may include cloth or synthetic covering for hands, feet and head wherever required.  Adequate facilities for personal use provided like clean towel, soap etc.  Lavatories for men and women should be separate and should be away from processing and manufacturing area. • Changing room facility should also be provided for changing their clothes. 14. Medical Services*: Adequate facility for first aids should be provided by manufacturer. Medical examination of workers at the time of employment and periodical check-up should be conducted at least once in a year and proper record should be maintained.
  • 9. 15. Distribution Record*: Distribution record (Dispatch register) should be maintained to facilitate process of prompt and complete recall of the batch. Distribution record should be maintained till expiry of batch. 16. Record of Market Complaints*: A register should maintain to record all reports of market complaints received regarding the products sold in the market. • The manufacturer shall enter all data received on such market complaints; investigations carried out by the manufacturers regarding the complaint & shall also be recorded. • “Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing authority.” • Reports of any adverse reaction resulting from the use of drugs maintained in a separate register by manufacturer. 17. Quality Control*: A manufacturer can set-up own quality control section or testing could be done through government approved testing laboratory.
  • 10. Part-2: Requirements for Plant and Equipments 01. Area: a) Basic Installation - Requires minimum of 30 sq. mt. (for tablets manufacturing, up to 60 sq. mt.) b) Ancillary Area: 10 sq. mt. (for tablets manufacturing, up to 20 sq. mt.) 02. Equipment: Colloidal mill, mixing and storage tanks, stainless steel containers, Planetary mixer, Triple roller, tube filling equipments, filter proof cap sealing machine, water distillation unit, clarity testing inspection unit, disintegrator and sifter, granulator, tray or fluidized bed driers, weighing machine, tablet compression machine, tablet inspection unit, dissolution test apparatus, hardness tester, friability tester, disintegration test apparatus, air conditioners, polishing pan, jacketed kettle, leakage test apparatus, capsule filling unit, hot air ovens, Laminar air flow unit, bottle washing machines, autoclave, transfer pumps, trimming machine, cutting machine etc.
  • 11. Parts of Schedule ‘M’ • Part 1: Describes Good Manufacturing Practices for Premises and Material. • Part 1A: Describes the specific requirement for manufacture of sterile products. Parenteral preparations and Sterile Ophthalmic Preparations. • Part 1B: Describes the specific requirements for manufacture of oral solid forms (Capsule and Tablets) • Part 1C: Describes the specific requirements for manufacture of oral liquids (syrups, elixirs, emulsions and suspensions). • Part 1D: Describes the specific requirements for manufacture of topical products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions) • Part 1E: Describes the specific requirements for manufacture of Metered Dose Inhalers (MDI). The other associated codes such as those of Good laboratory practice (GLP) and Good clinical practice (GCP).