This document discusses the requirements for manufacturing cosmetic products under Schedule MII in India. It provides an introduction to Schedule MII and its importance given the increasing popularity of cosmetics. The general requirements for factory premises, buildings, and equipment are outlined. Specific requirements for plant and equipment are defined for different types of cosmetic products based on the manufacturing area needed. The document also discusses labelling, packaging, and quality standards that must be followed. Offences and penalties for non-compliance with the act are mentioned.
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.
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.
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/
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Regulatory provision related to manufacture of cosmeticManish Rajput
cosmetic, regulatory provision, schedule M, condition of licence, schedule U, prohibition of certain cosmetics, misbranded and spurious cosmetics, loan licence, offences and penalties,
Import, manufacture, sale or distribution of cosmetics were not being regulated in India prior to year 1962. In early sixties, it became necessary to regulate import, manufacture and sale distribution of cosmetics due to prevalence of misbranded and/or spurious cosmetics. Cosmetic was brought within the purview of the Drugs Act and the name of the Act was changed to the Drugs & Cosmetics Act, 1940 (hereinafter referred to as the Act) by Act 21 of 1962. However, the implementation of these provisions came into effect only in mid sixties when rules relating to import and manufacture of cosmetics were framed by the Government of India in 1964. Thereafter, rules have been amended time to time to achieve the intended purpose. Salient regulatory provisions will form the subject matter of this chapter
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/
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
Regulatory provision related to manufacture of cosmeticManish Rajput
cosmetic, regulatory provision, schedule M, condition of licence, schedule U, prohibition of certain cosmetics, misbranded and spurious cosmetics, loan licence, offences and penalties,
Import, manufacture, sale or distribution of cosmetics were not being regulated in India prior to year 1962. In early sixties, it became necessary to regulate import, manufacture and sale distribution of cosmetics due to prevalence of misbranded and/or spurious cosmetics. Cosmetic was brought within the purview of the Drugs Act and the name of the Act was changed to the Drugs & Cosmetics Act, 1940 (hereinafter referred to as the Act) by Act 21 of 1962. However, the implementation of these provisions came into effect only in mid sixties when rules relating to import and manufacture of cosmetics were framed by the Government of India in 1964. Thereafter, rules have been amended time to time to achieve the intended purpose. Salient regulatory provisions will form the subject matter of this chapter
cosmetics - regulatory : Regulatory provisions related to cosmetics PV. Viji
REGULATORY PROVISIONS RELATED TO COSMETICS , REGULATORY PROVISIONS RELATING TO IMPORT OF COSMETICS , Application for registration certification for import cosmetics , Grant of registration certificate , Standards for imported cosmetics , REGULATORY PROVISIONS RELATING TO MANUFACTURE OF COSMETICS , REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS , LOAN LICENCE
Definition of cosmetic products as per Indian regulation. Indian regulatory requirements for labeling of cosmetics .Regulatory provisions relating to import of cosmetics ,Misbranded and spurious cosmetics. Regulatory provisions relating to manufacture of cosmetics – Conditions for obtaining license, prohibition of manufacture and sale of certain cosmetics, loan license, offences and penalties.
Definition of cosmetics.
Regulation provision relating to manufacture of cosmetics
a. How to obtain license
b. Conditions of license
c. Regulatory provision on sale of cosmetics
d. Loan license
Offences and Penalties
Cosmetics regulatory: includes Regulatory provision relating to manufacture of cosmetics, Schedule M (II) of D & C rule 1945 deals with requirements for the factory premises for the manufacture of cosmetic, requirement of plant & equipment, conditions of licencing, regulatory provision on sale of cosmetics, loan licence, Regulatory provision relating to import of cosmetics, offences & penalties, List of amending Act and adaptation orders.
This presentation will give General overview about Indian Regulatory Requirements for cosmetics.
This ppt contains information about latest cosmetics rules 2020 and D& C Act 1940
M Pharm Pharmacognosy Semester 2, HERBAL COSMETICS UNIT 1, Herbal/natural cosmetics, Classification &
Economic aspects. Regulatory Provisions relation to manufacture of cosmetics: -
License, GMP, offences & Penalties, Import & Export of
Herbal/natural cosmetics, Industries involved in the production of
Herbal/natural cosmetics.
pharmacy, cosmetics, regulatory provisions related to manufacturing, import, sell and distribution of cosmetics as per drug and cosmetics act and rules 1940&1945
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2. CONTENTS
What is Schedule M?
Schedule MII
Introduction
General requirements
Location and surrounding
Buildings and permises
Plant and equipment
Sale
Labelling,packaging and standards
3. What exactly schedule M is?
It is requirement of factory and premises ,plant and
equipment for manufacturing drugs and pharmaceutical
product.
M-1: Requirement of factory premises for the manufacture
of Homeopathic preparations.
M-2: Requirement of factory premises for the manufacture
of cosmetics.
M-3: Requirement of factory premises for the manufacture
of medical devices.
4. SCHEDULE M II
It is requirement of factory and
permises ,plant and equipment for
manufacturing of cosmetic
products.
5. INTRODUCTION
Due to increasing popularity of the cosmetics the
government of india has shown its serious concern
in their manufacture as evident from the
introduction of the schedule M II in august 1992
laying down the requirements of factory
premises,plants and equipment for the
manufacture of cosmetics.
6. GENERAL REQUIREMENTS
1.Location and surroundings:
The factory building(s) for manufacture of drugs shall
be so situated that it avoid risk of contamination from
external environmental including open sewage, drain,
public lavatory.
2. Building and premises :
• Buildings shall be designed, constructed, adapted
and maintained to permit production of drugs under
hygienic conditions
• They shall conform to the conditions laid down in the
Factories Act, 1948
7. GENERAL REQUIREMENTS
The premises used for manufacturing, processing,
warehousing, packaging, labeling and testing purposes
shall be
a) compatible with other drug manufacturing
operations
b) adequate working space to avoid the risk of mix-up
between different materials & avoid the possibilities
of contamination and cross contamination
c) designed / constructed / maintained to prevent
entry of insects, pests, birds, and rodents
d)Well illuminated, effectively ventilated, with proper
Air Handling Units .
8. PLANT AND EQUIPMENT
Part II of schedule M II recommends the requirement of plant ,
equipment and area for the manufacture of cosmetics under the
following sections.( recommended area given in bracket)
A. Powders- Face powder,cake make-up,compacts,face
packs,masks,and rogues etc. (15 sq meters )
B. Creams,lotion,emulsion,pastes,cleansing milks, shampoo, pomade,
brilliantine, shaving creams and hair oils etc. (25 sq.meters)
C. Nail polishers and nail lacquers. (15 sq meters)
D. Lipsticks and lipgloss etc. (15 sq meters)
E. Depilatories ( 10 sq meters)
F. Preparations used for eye-
i) Eyebrows,eye lashes, eye liners etc. (10 sq meters)
ii) Kajal and surma ( 15 sq meters)
9. PLANT AND EQUIPMENT
G. Tiolet soaps ( 100 sq meters)
H. Aerosols (15 sq meters)
I. Alcoholic fragnance solutions (15 sq meters)
J. Hair dyes( 15 sq meters)
Tooth powders and tooth pastes-
i. Tooth powders in general (15 sq meters)
ii. Tooth pastes (15 sq meters)
iii. Tooth powder,black ( 15 sq meters)
10. OFFENCES AND PENALITIES
Adoption of the above good manufacturing practices to
the manufacture of cosmetics shall go a long way ensuring
better quality cosmetics to the consumers.
Manufacture of any cosmetic in contravention of this act
and the rules is punishable with imprisionment upto one
year or fine upto RS 2000 or with both on first convicton
and three years and with fine .The penality for subsequent
offences in both the cases is imprisionment upto 1 year or
fine upto Rs 2000 or with both.
11. SALE OF COSMETICS
Cosmetics which do not contravene the provision of the act
and the rules may be sold without a licence . Dealers are
bound to disclose on demand the name and other
particulars of the persons from whom they obtain
cosmetics . penality for the sale or distribution of cosmetics
contravening the provision of the Act and the rules as same
as applicable for their manufacture.
• Following classes of cosmetics are prohibited to be
stocked, sold or exhibited for sale:
12. SALE OF COSMETICS
1. Any cosmetic which is either misbranded,spurious or not
of standard quality.
2. Any cosmetic containing any ingredient which may
render it unsafe or harmful for use under the directions
indicated or recommended.
3. Any cosmetic which is imported or manufactured or
otherwise in contravention of the provision of the Act
and the rules.
13. LABELLING,PACKING AND STANDARDS
• Cosmetics whether imported or manufactured in india
must be labelled in accordance with the following
provisions:
• Labelling of cosmetics in general
On both the inner and outer labels
a) The name of the cosmetic.
b) The name and the principal place of business of the
manufacturer.
14. LABELLING,PACKING AND STANDARDS
On the outer label
a) A deceleration of the net contents expressed in terms of
weight for the solids, fluid measures for liquids,weights
for semi-solids,combined with numerical count if the is
sub-divided.
On the inner label where a hazards exists.
a) Adequate direction for safe use.
b) Any warning, caution or special direction required to be
observed by the consumer.
c) Batch number preceded by the letter “B”(not necessary if
the cosmetic is 10g or less; or 25 ml or less)
15. LABELLING,PACKING AND STANDARDS
d) A statement of the names and quanties of the poisions
ingredients.
e) Manufacturing licence number preceded by the letter
“M”. If the package has only one label all the information
required on the inner and outer label should appear on
such label only.
• Tooth paste containing fluoride
On tube and carton
a) Fluoride content in ppm (not more than 1000 ppm) and
the date of expiry.