SCHEDULE M II

There is detail introduction about schedule M II which lies on schedule m

1. PRESENTED BY: AMIT KUMAR KUSHWAHA I.D NO:-17BPH088 B.PHARM (5 th SEM) SHUATS/SIHAS SCHEDULE M II

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- Eyebrows,eye lashes, eye liners etc. (10 sq meters) 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- Tooth powders in general (15 sq meters) Tooth pastes (15 sq meters) 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 Any cosmetic which is either misbranded,spurious or not of standard quality. Any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended. 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 The name of the cosmetic. The name and the principal place of business of the manufacturer.

14. LABELLING,PACKING AND STANDARDS On the outer label 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. Adequate direction for safe use. Any warning, caution or special direction required to be observed by the consumer. 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. 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 Fluoride content in ppm (not more than 1000 ppm ) and the date of expiry.

16. THANK YOU !