SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS

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Note: – External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting powders and identical products used for external applications).

In addition to these requirements, following Specific Requirements shall also be followed;
(1). The entrance to the area where topical products are manufactured should be through a suitable airlock. Outside the airlock, insectocutors shall be installed.
(2). The air to this manufacturing area shall be filtered through at least 20µ air filters and shall be air-conditioned. The area shall be ventilated.
(3). The area shall be fitted with an exhaust system of suitable capacity to effectively remove vapours, fumes, smoke, floating dust particles.
(4). The equipment used shall be designed and maintained to prevent the product from being accidentally contaminated with any foreign matter or lubricant.
(5). No rags or dusters shall be used in the process of cleaning or drying the process equipment or accessories used.
(6). Water used in compounding shall be Purified Water IP.
(7). Powders, wherever used, shall be suitably sieved before use.
(8). Heating vehicles and a base like petroleum jelly shall be done in separate mixing area in suitable stainless steel vessels, using steam, gas, electricity, solar energy, etc.
(9). A separate packing section may be provided for primary packaging of the products.

Please find all articles related to SCHEDULE M below-

SCHEDULE M-III-REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES

SCHEDULE M-II-REQUIREMENT OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS

SCHEDULE M-I-Requirements of factory premises for manufacture of Homoeopathic preparations

[SCHEDULE- M] REQUIREMENTS OF PLANT AND EQUIPMENT,PART- II      

[SCHEDULE- M] SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR MANUFACTURE OF ACTIVE PHARMACEUTICAL INGREDIENTS (BULK DRUGS), PART I-F      

[SCHEDULE- M] SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED-DOSE-INHALERS(MDI),PART I-E

[SCHEDULE – M ] SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS),PART I-C

[SCHEDULE – M] SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES), PART I-B

[SCHEDULE M] SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES & LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS,PART – 1 A   

[SCHEDULE M] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS, PART 1       

Reference Link:

  1. http://www.cdsco.nic.in/writereaddata/ScheduleM(GMP)6.pdf.
  2. http://www.rajswasthya.nic.in/Drug%20Website%2021.01.11/Revised%20Schedule%20%20M%204.pdf
  3. https://pdfs.semanticscholar.org/presentation/c576/ddc26d53b12a9124a45933b9279023c0fbb5.pdf.
  4. https://www.slideshare.net/BiNduXtrEiy/good-manufacturing-practices-schedule-m
  5. https://www.idma-assn.org/pdf/GMP-workshop-sme-schedule-circular.pdf

 

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