SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS

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SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS, AND SUSPENSIONS)

Oral Liquids are homogeneous liquid preparations, usually contains a solution, an emulsion or a suspension of one or more active ingredients in a suitable liquid base. They are prepared for oral administration either as such or after dilution. they may contain other substances such as suitable dispersing, solubilizing, wetting, emulsifying, stabilizing, suspending, thickening agents and antimicrobial substances for preservation.

Building And Equipment: –

-The premises and equipment shall be designed, constructed and maintained to suit the manufacturing of Oral Liquids. The layout and design of the manufacturing area shall strive to minimize the risk of cross-contamination and mix-ups.

-Manufacturing area shall have entry through double door air-lock facility. It shall be made fly proof by use of ‘ flycatcher‘and/or ‘air curtain‘.

-Drainage shall be of adequate size and have adequate traps, without open channels and the design shall be such as to prevent backflow. Drains shall be shallow to facilitate cleaning and disinfecting.

-The production area shall be cleaned and sanitized at the end of every production process. Tanks, containers, pipework and pumps shall be designed and installed so that they can be easily cleaned and sanitized. Equipment design shall be such as to prevent accumulation of residual microbial growth or cross-contamination.

-Stainless Steel or any other appropriate material shall be used for parts of equipment coming in direct contact with the products. The use of glass apparatus shall be minimum.

-Arrangements for cleaning of containers, closures, and droppers shall be made with the help of suitable machines/devices equipped with high-pressure air, water, and steam jets.

-The furniture used shall be smooth, washable and made of stainless steel or any other appropriate material which is scratch proof, washable and smooth.

Purified Water: –

The chemical and microbiological quality of purified water used shall be specified and monitored routinely. The microbiological evaluation shall include testing for the absence of pathogens and shall not exceed 100 CFU / ml (as per Appendix 12.5 of IP 1996). There shall be a written procedure for the operation and maintenance of the purified water system. Care shall be taken to avoid the risk of microbial proliferation with appropriate methods like recirculation, use of UV treatment, treatment with heat and sanitizing agent. After any chemical sanitization of the water system, flushing shall be done to ensure that the sanitizing agent has been effectively removed.

Manufacturing: –

-Manufacturing personnel shall wear wherever required non-fiber shedding clothing to prevent contamination of the product.

-Materials likely to shed fiber like gunny bags, or wooden pallets shall not be carried into the area where products or cleaned- containers are exposed.

-Care shall be taken to maintain the homogeneity of the emulsion by use of appropriate emulsifier and suspensions by use of appropriate stirrer during filling. Mixing and filling processes shall be specified and monitored. Special care shall be taken at the beginning of the filling process, after a stoppage due to any interruption and at the end of the process to ensure that the product is uniformly homogenous during the filling process.

-The primary packaging area shall have an air supply which is filtered through 5-micron filters. The temperature of the area shall not exceed 30 degrees centigrade.

-When the bulk product is not immediately packed, the maximum period of storage and storage conditions shall be specified in the Master Formula. The maximum period of storage time of a product in the bulk stage shall be validated.

Reference:-

Revised Schedule M4.

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