GMP FOR VIT

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Good Manufacturing Practices : 

Good Manufacturing Practices Dr.C.Ramalingam

GMP : 

GMP GOOD MANUFACTURING PRACTICE WHAT IS GMP? WHY DO WE NEED IT? HOW TO GO ABOUT?

Customer Expectations : 

Customer Expectations What does your Customer expect when she buys a packaged Potato Chips No Health Hazard Crispiness , Intact with no broken pieces Taste/Flavor Thin slices Individual chip is properly coated with masala

The Customer does not expect : 

The Customer does not expect And does not tell you that it should not contain Potassium Cyanide Grease Hair Glass pieces A dead insect

GMP : 

GMP The manufacturer is not given credit if these unwanted things are not present BUT Is hanged if they are found

GMP. : 

GMP. How do we achieve this in our factory ?

GMP - Definition : 

GMP - Definition GMP can be loosely defined as : Appropriate self implemented methodology, systems and procedures covering the entire aspects of the manufacturing process to minimize or eliminate instances of contamination, mix ups and errors.

GMP : 

GMP GMP is nothing but COMMON SENSE IN AN ORGANISED MANNER Generic standards – Applicable to all food Industry

GMP – Preventing Contamination : 

GMP – Preventing Contamination The contamination could be Physical Chemical Biological

Elements of GMP : 

Elements of GMP Site selection Building Exterior Building Interior Sanitary Facilities Equipment Design, Installation and Validation Equipment sanitation

Elements of GMP : 

Elements of GMP Plant Sanitation and Personnel Hygiene Transportation and Storage Identification Manufacturing Utilities including water Waste management Pest Control programme

Elements of GMP : 

Elements of GMP Product Recall Procedure Documentation and Record keeping Internal audit and Improvement

Preparation of Check List : 

Preparation of Check List Think little negatively – as to what can go wrong at each stage from construction to manufacturing to consumption Prepare a check list under each heading with what can go wrong leading to contamination Answer honestly If contamination can take place, decide the action which will prevent its occurrence

Building Exterior : 

Building Exterior Located close to environmental Contamination ? Road around well compacted and dust proof? Any stagnation of water Any vegetation near the plant? Exterior designed, constructed and maintained to prevent pests and rodents?

Building Interior : 

Building Interior Does the layout prevent cross contamination? Walls smooth and Impervious? Does the floor has a good slope for draining? Bulbs and Fixtures provided with cover? Is the ventilation and lighting adequate? Are the openings insect entry proof? In sterile/critical areas positive air pressure is maintained ?

Sanitary Facilities : 

Sanitary Facilities Adequate Toilets and Hand washing facilities provided? Adequate running water and other hand sanitizers are provided? Are toilets separated and do not open directly into Food Processing areas

Equipment Design and Installation : 

Equipment Design and Installation Is the equipment designed, constructed and installed in such a way that it is accessible for cleaning, sanitizing, maintenance and inspection? Is the tanks and vessels well drained? Is the equipment validated? Is Food grade grease used? Is the equipment made of Food grade material? Do the pipe lines have dead ends? Key Equipment calibrated?

Equipment sanitation : 

Equipment sanitation Validation of cleaning procedures Documentation of cleaning procedures Sanitizers used are permitted and Food Grade?

Personnel Hygiene : 

Personnel Hygiene Periodic check on the work force with respect to Nails, hair, presence of wounds or any other communicable diseases. Use of protective clothing? Prevent tobacco chewing, smoking etc. Avoid rings, bangles, items in the breast pocket Is outside food consumed inside the production area .

Transportation and Storage : 

Transportation and Storage Carriers bringing and taking goods are free of contamination? Are they brought in at the appropriate temperature? Are all material labeled and their quality status identified Food and Non food chemicals segregated?

Transportation and Storage : 

Transportation and Storage Materials stored at their appropriate temperature? Are finished goods transported under conditions which will prevent Contamination?

Manufacturing : 

Manufacturing Are all food manufacturing operations conducted under such conditions and controls as are necessary to minimize/eliminate the contamination of food Effective measures in place to protect finished food from contamination by raw materials, other ingredients, or refuse

Manufacturing : 

Manufacturing Effective measures in place to protect against the inclusion of metal or other extraneous material in food   Provide adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food.

Manufacturing : 

Manufacturing Is there an adequate incoming material inspection and acceptance procedure? Are adequate in process checks in place? Is there an adequate finished product testing and release procedure?

Utilities : 

Utilities Is the water quality adequate for the purpose of use? Is the water stored outside is protected from contamination from pests etc? If steam and air comes in contact with product, are they of adequate quality?

Waste Management : 

Waste Management Drainage and sewage systems are equipped with traps to prevent pest entry? Sewage and disposal lines are designed for cleaning? Containers for waste clearly identified, leak proof and covered? Refuse handling so designed to prevent possible contamination of the plant?

Pest Control Programme : 

Pest Control Programme Written pest control programme indicating chemicals used, location, frequency and inspection. Map of trap/bait locations The pesticides used are legally permitted?

Pest Control Programme : 

Pest Control Programme The method of application does not lead to contaminants Birds and animals other than those intended for slaughter is excluded? Pest control records

Product Recall : 

Product Recall Is there a procedure addressing When to Recall? Who will decide to Recall? How to Recall? Verification of the Recall? How to deal with Government bodies? Who will be the company’s spokesperson?

Training : 

Training Training in personal hygiene and hygienic handling of food to all food handlers at the time of employment and periodically Training of personnel responsible for sanitation programme

Documentation : 

Documentation All procedures, records are documented For uniformity System and not individual oriented

REVIEW : 

REVIEW Audit Review and Improvement

GMP : 

GMP A good GMP will take care of the vast majority of contamination problems in a food industry Different GMP standards are available with minor variations – USFDA, CODEX, etc There is a proposed rule in PFA which makes establishment of GMP compulsory in Food factories prior to the grant of license.

Other Good Practices : 

Other Good Practices Good Agricultural Practices Good Hygiene Practices Good laboratory Practices Many industry specific Good Practices are available

GMP : 

GMP THANK YOU