Schedule M outlines Good Manufacturing Practices (GMP) that must be followed by pharmaceutical manufacturing units in India. It contains requirements for factory premises, plants, equipment, and quality assurance to ensure products are consistently manufactured and controlled to quality standards. Schedule M has two parts - Part 1 covers GMP for premises and materials, and Part 2 covers specific plant and material requirements. It provides detailed guidelines for facilities, equipment, sanitation, personnel, documentation, manufacturing, quality control, distribution, and more to help ensure therapeutic goods produced meet the required quality standards.
2. Schedule-M
• Schedule M is a part of Drug and Cosmetic act 1940.
• It is GMP for pharmaceuticals that should be followed by
pharmaceutical manufacturing units in India.
• It is a part of a quality assurance which ensures that the products
are consistently manufactured and controlled to the Quality
standards appropriate to their intended use.
• GMP" - A set of principles and procedures which, when followed by
manufacturers for therapeutic goods, helps ensure that the
products manufactured will have the required quality
3. • Schedule “M” Requirement of factory premises, plant and
equipments for pharmaceutical products,
• M-1 Requirement of factory premises for manufacturing of
homeopathic preparations,
• M-2 Requirement of factory premises for manufacturing of
cosmetics,
• M-3 Requirement of factory premises for manufacturing of
medical devices
4. Parts of schedule “M”
PART-1
• Good manufacturing practices
for premise and materials
PART-2
• Good manufacturing practices
for specific requirements of
plant and material
5. Part I:Good Manufacturing Practices for
premises and materials
• PART I(A) - Specific Requirements for manufacturing
sterile products, SVPs & LVPs and sterile ophthalmic
Preparations.
• PART I (B) - Specific requirement for Manufacture of
oral Solid Dosage Forms (Tablet and capsule).
• PART I (C) - special requirement for manufacture of oral
liquids (syrup, elixir, emulsion and suspension).
6. • PART I (D) - Manufacture of External Preparation
(Creams, Ointment, Paste, Emulsion, Lotion,
solution, Dusting Powder and dental Products).
• PART I (E) - Specific requirements for
manufacturing of metered dose inhalers.
• Part I (F) - Specific requirement of premises, plant
and material for manufacture of bulk drugs.
7. Part-I- GMP for premise and
materials1. General requirements:
I. Location and surrounding: Such as to avoid risk of
contamination from external environment.
II. Building and premises: should confirm to the
conditions laid down in factories act, 1948. building
should be designed in such a way to permit
production of drugs under hygienic conditions.
III. Water system: validated system to produce purified
water confirming to IP specifications. Storage tanks
shall be cleaned periodically and records
maintained by the licensee.
8. iv Disposal of waste: Disposal shall be as required under EPCB
and BMW. Hazardous toxic substances and flammable
substances should be stored in a segregated area.
2. Warehousing area: adequate area with proper racks, bins
and platforms, clean, dry and maintained with acceptable
temperature conditions., separate sampling and quarantine
areas.
9. 3. Production area: shall be designed to allow production in unit
flow and logical sequence., separate, dedicated and self
contained facilities for sensitive products like biological
preparations.
4. Ancillary areas: Rest and refreshments rooms should be
separate from other areas. Should not be directly connected to
production area.
5. Quality control area: independent of production area. separate
sections for physicochemical, biological, microbiological, radio
isotope testing. Air monitoring in microbiology are is must.
10. 6. personnel: direct supervision of competent technical staff.
adequate number of personnel; good laboratory practices and
proper training of technical staff members.
7. Health, Clothing and Sanitation of Workers: The workers
should be free from contagious diseases. It covers regular
medical check-up facilities; proper toilet facility at a distance;
personal cupboards and change room for workers.
8. Manufacturing operations and controls:
11. Competent technical staff supervision for weighing,
measuring and other operations; non sterile products free
from E. coli and Salmonella microbes; conspicuously
labeled with name, batch number, and other details; cross
contamination avoided; and all process controls checked
under master formula.
9. Precautions against mix up and cross contaminations:
manufacturing unit maintained at required level of
temperature, humidity and cleanliness. Maintenance of
proper records and SOPs to avoid mix up and
contamination.
10. Sanitation in Manufacturing Premises :
No accumulated waste; no dust particles as far as possible;
proper disinfection and cleaning of premises and no
stagnant water. The manufacturing premises should be used
for specific purpose for which it is designed.
12. 11Raw Materials:
Properly identified; analyzed; containers of raw materials inspected
for any damage; stored at optimum temperature; labeled
properly; systematically sampled by quality control personnel;
tested for compliance of required standards.
12 Equipment:
Properly installed to achieve operational efficiency; good quality
equipment to be used. The equipment used should be such to
facilitate through cleaning; prevent physical and chemical change
through contact and minimize contamination.
13. 13. Documentation and records: Important part of QA system and
as such shall be related to all aspects of GMP. Specifications for
all materials, method of manufacture, quality control.
14. Labels and Other Printed Materials :Stored properly and
separately; used as and when required and should not be inter-
mixed.
15. Quality assurance: this section collectively influence the
quality of product. Records of compliance with GMP, quality
control, sales records etc.
14. 16. Self inspection and quality audits: self inspection
should be done to evaluate compliance with GMP.Team
of independent, experienced and qualified persons for
inspection.
17. Quality Control System: Detailed instructions for quality
control of raw materials and finished product; quality
control for packaging and labeling; adequacy of storage,
quality control procedure revised as and when possible
and qualitative examination of returned products.
18. Master Formula Records (MFR): Licensee should
maintain records relating to alI manufacturing
procedures for each product and batch size to be
manufactured. It also includes patent or proprietary
status; name of formulation alongwith generic name if
any; name, quantity, and reference number of starting
materials; strength; dosage form; description;
identification
15. 19. Batch Packaging Records: It is based on relevant parts of
packaging instructions. Transcription errors to be avoided;
packaging equipment clean; planned packaging operations and
proper maintenance of packaging record.
20 Batch Processing Records (BPR): BPR for each product; clean
equipment; name of product; number and batch being
manufactured; dates and time of commencement of operation;
significant intermediate stages; initials of operator of different
steps of production; batch number;
16. 21. Standard Operating Procedures (SOPs) and Records: SOP
and records for receipts of each delivery of raw, primary and
printed packing material; sampling; instrument and
equipment; internal labeling; quarantine and storage; batch
numbering; testing, records of analysis;
22. Product Containers: Compliance with pharmacopoeia
requirements; cleaning procedures and sterilization
procedure should be properly followed. There should be
written schedule for programs for cleaning of container
23. Distribution Records: Records properly maintained; records
of complaints, adverse reactions and other reactions from
consumers are also maintained.
