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.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
THIS IS ABOUT SCHEDULES AND RULES IMPLEMENTED FOR MANUFACTURING, IMPORT, EXPORT, PRESCRIPTION, STORAGE OF ALLOPATHY, AYURVEDIC AND UNANI DRUGS.THERE IS DIFFERENT SCHEDULE FOR DIFFERENT KIND OF DRUGS LIKE BIOLOGICAL PRODUCTS, NARCOTIC DRUGS ETC.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
THIS IS ABOUT SCHEDULES AND RULES IMPLEMENTED FOR MANUFACTURING, IMPORT, EXPORT, PRESCRIPTION, STORAGE OF ALLOPATHY, AYURVEDIC AND UNANI DRUGS.THERE IS DIFFERENT SCHEDULE FOR DIFFERENT KIND OF DRUGS LIKE BIOLOGICAL PRODUCTS, NARCOTIC DRUGS ETC.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
LINK FOR VIDEO LECTURES
https://youtu.be/-4nzP2vOGdg
DRUG TECHNICAL ADVISORY BOARD IS IN THE PHARMACY SYLLABUS AND THE QUESTIONS ARE ASKED IN THE PHARMACY EXAMS .
SUCH AS GPAT NIPER AND SEMSESTER EXAM/
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
LINK FOR VIDEO LECTURES
https://youtu.be/-4nzP2vOGdg
DRUG TECHNICAL ADVISORY BOARD IS IN THE PHARMACY SYLLABUS AND THE QUESTIONS ARE ASKED IN THE PHARMACY EXAMS .
SUCH AS GPAT NIPER AND SEMSESTER EXAM/
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments,
standard operating procedures, health and hygiene, documentation and records.
INTRODUCTION
Components of GMP
GMP Provisions: Under Schedule-T are grouped
Location and surroundings
Factory Premises
Buildings
Water supply
Containers cleaning
Disposal of Waste
Requirements for the sterile products
store
Working space:
Space requirement for manufacturing of Unani medicine
Health & Hygiene
Machinery and Equipments
Machinery and equipments for maufacturing of ayurveda and siddha medicine
Documentation and Records
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
Schedule M is good manufacturing practices and requirements of premises, plants and equipment for pharmaceutical products.
Schedule M is a part of drugs and cosmetics act, 1940.
Schedule M- І:Requirements of factory premises for manufacture of homoeopathic preparations.
Schedule M- ІІ: :Requirements of factory premises for manufacture of cosmetics.
Schedule M- ІІІ: :Requirements of factory premises for manufacture of medical devices.
This presentation describes Schedule M of Drugs & Cosmetic Act. It consists of Good Manufacturing Practices (GMP) for the manufacturing of drugs. Detailed guidelines about factory premises, machinery, process, quality control, etc. have been given.
pratik ghive cGMP According to schedule Mpratikghive82
Pratik Ghive Current Good Manufacturing Practices (cGMP) Guidelines According to schedule M Cover all guidelines as per Drug and cosmetic act 1940 and ICH guidelines
Schedule M for Pharmacy Students, Here from Pharmaceutical Jurisprudence 5th Sem.
Make easy in Student language.
Both Pharmacy Students (B Pharm & D Pharmacy
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The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
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• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
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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.