SOP : Good Manufacturing  Practices (GMP)

1. PURPOSE:

To provide guidelines on maintaining a safe and hygienic environment and healthy working habits and conditions are essential for food Industry.

2. SCOPE:

Applies to all people (Employees, Contractors & Visitors) who are involved in production, handling and distribution of the products manufactured at Food Plant & all materials (including ingredients, packages &products) handled, stored & produced in sanitary manner.

3. RESPONSIBILITIES:

4. PROCEDURE:

Food Industry, GMP implementation plan divided into two segments, viz., Employee Practices & Production Practices. A broad classification of the activities comes under these categories given below:

Further to the same the following practices adopted and mandated at site.

1. Personal hygiene and sanitation: 

Employees must maintain a high degree of personal cleanliness.

1.1 Prohibited Acts:

• To help prevent product contamination, the following actions are not allowed in GMP areas:
• Eating and/or drinking, including product taste testing. (Permitted only in authorized areas of the facility or as authorized by the facility Quality Manager or designated manager at the facility).
• Chewing gum, candies, throat candies, throat lozenges and tobacco.
• Holding toothpicks, matchsticks or other objects in the mouth.
• Placing pens or cigarettes behind the ears.
• Wearing false eyelashes or fingernails.
• Carrying objects above the belt or waistline (e.g., pens, flashlights, thermometers).
• Expectorating (spitting) in production areas.
• Carrying pills or medication in clothing pockets.
• Smoking in GMP areas.
• Use of hands for unsightly practices are avoided, which may result to contamination of food products such as:

                     a) Touching face

                     b) Wiping forehead, 

                     c) Placing fingers on or in the mouth, nose or ears, 

                     d) Adjusting glasses, 

                     e) Scratching head or back, 

                     f) Handling product/product samples for testing in unsanitary manner

1.2 Badges & ID Cards: Use of badges and clip-on identification (ID) cards are permitted according to local security policy and must be worn below

the waist. Visitor identification badges are permitted but must not be a source of contamination at the plant.

1.3 Buttons, service pins or similar articles are not permitted on uniforms, smocks, bump caps, or hard hats.

1.4 Jewelery: Rings, watches, earrings, necklaces, or other jewelry must not be worn in GMP areas.

1.5 All plant personnel shall undergo annual physical examination as required by. health department.

1.6 Personnel with a communicable disease or a carrier thereof or with boils, core, infected wound or other abnormal source of microbiological contamination are not allowed to work in areas where contamination of food, food contact surfaces, equipment, packaging and raw materials or personnel may occur.

1.7 Personnel wash their hands thoroughly with Soap and Water followed by disinfectant. Hand washing should be done before starting work, after each absence from work station (e.g. visiting the toilets), or any other time when hands becomes soiled and contaminated.

 1.7.1 Hand Sanitizers & dryers are provided at all hand washing stations and it is mandatory to sanitize the hands completely before entering to the workstations.

      Hand Washing and Sanitizing Methods: The steps listed below are required when washing and sanitizing hands.

• Wet hands with warm water.
• Apply soap. Lather the soap by thoroughly rubbing the hands together taking care to apply both rubbing action and soap to the entire surface area of the hands.
• Rinse hands completely.
• Dry hands by wiping with tissue paper.
• Sanitize hands with a sanitizer after the hands have been washed and dried.

1.7.2  Keep hands and fingernails clean and properly trimmed. The following are not allowed:

•  Fingernails with nail polish
•  Perfumed hand lotion and creams
•  False fingernails and eyelashes

1.8 Exposed (unwrapped) products, packaging materials and equipment as food contact surfaces are not allowed to touch with:

•  Injured or bondage hands unless protected by gloves.
•  Gloves are maintained intact, clean and sanitary.
•  Cut and open sores in fingers unless covered and dressed by companyMedical Officer.
•  Coughing or sneezing in the manufacturing area are avoided.
•  No person are allowed to spit, use tobacco, chew gum, eat food and drink beverage or store clothing as personal belongings in any room where food products are manufactured or stored nor in which utensils, packaging materials or ingredients are stored.
•  Housekeeping: Littering and other poor housekeeping practices are not allowed. All refuse must be placed in properly identified containers.
•  Lunch boxes are stored in designated areas; Lunches must be completely enclosed in cleanable and/or reusable containers, or in single-use packaging.
•  Lockers: Personal lockers must be maintained free of trash and soiled clothing. Inspection and cleaning of lockers would be ensured. Foods and direct product contact tools must not be stored in employee lockers.

# Personal hygiene verification will be done on randomly, shift wise.

2. Uniform Policy

•  Employees who work in GMP areas will wear only company-approved clothing. Whenever any non-production employees, contractors are entering a GMP area then they must wear company provided uniforms/clothing, which is kept at cleaned locker.
•  Plant uniforms are always be in good repair and shall not be worn outside the plant. No pockets on the shirt.
•  Safety shoes for all the personal who are working in the GMP areas.
•  Sweaters must be short haired, close knit and must be worn inside an
• outer garment.
•  Hair must be neatly groomed (not extending over the ears or beyond the shirt collar) and covered with hairnets and must be worn at all times in the GMP areas.
•  Product handling employees must be cleanly shaven. No beard or long facial hair of any kind is permitted. Mustache/Beard must be completely covered using a facial mask in GMP areas.
•  Shoes must be made of leather, vinyl outer layer and kept clean (in good condition at all times). Slippers and open-heel/toe footwear are not allowed in the plant area.
•  Use of sneeze mask is required at dusty areas such as mixing and dumping.
•  Lockers must be kept clean and free of soiled clothing and food items.

3. Extraneous Matter Control

3.1 Carrying pens, pencils, thermometers, glasses, tools, etc. above the belt or waistline is strictly prohibited to prevent these articles from accidentally

falling into the product.

3.2 Do not sit nor stand on raw and packaging materials and their containers (e.g. bags, drums, carboys, pails). All packaging materials must be used only for their intended use.

3.3 A minimum clearance of 30 cm between walls and product storage is maintained in raw material and product storage areas to allow for pest surveillance. Any signs of pest activity within the facility to be reported to Quality In-charge or designated person for pest control.

3.4 All doors are self-closing door.

3.5 Traffic patterns between raw, semi-finished and finished product zones must be established.

3.6 The use of any glass articles in processing should be numbered and to be checked as per frequency defined in the Glass policy.

3.7 Bags being tipped into mixer, hopper or tote bins should always be kept off-floors to avoid contamination coming from the floor from being introduced to the product.

3.8 Pails, drums, containers of materials and equipment always must be covered during breaks and production interruptions.

3.9 Cleaning equipment with wooden handles such as brooms, brushes, squeegees are not allowed in the processing area.

3.10 Equipment must not be dragged across the floor. During clean up, all cleaning equipment is placed on clean plastic pallets specially designated for such purpose, wash pails may be placed directly on the floor.

3.11 All garbage containers should be labeled and covered. Black poly bags to be used for waste material storage.

3.12 Walls and floors are kept clean and litter free. Spilled product or broken packages are cleaned immediately.

3.13 The affected equipment and surroundings is cleaned, sanitized and in good repair prior to use in production.

4. Plant Visitor Control

•  Plant visitors, whether transient or on official business such as project contractors, suppliers and service providers, are allowed to plant in
• compliance with plant Safety and sanitation requirements.
•  Visitors of the facility are provided with appropriate identification. (Visitor badge, Cleaned & visitor aprons, hair & Beard net).
•  All visitors who are entering into the company have to fill the personal wellbeing declaration. Accompanied employee should verify and counter sign on the well-being form and the form should be handed over to security stationed at shop-floor entrance.
•  Visitors are accompanied by a person at the management level or a management designates who ensures compliance.
•  Visitors are not allowed to take photographs or videos inside the shop floor.
•  Regulatory Visits: The regulatory visit procedures ensure that facility complies with
• local and/or national laws governing regulatory visits. Expectations are: Instructions to ensure proper communication and procedural interface between management and the regulatory body are in place.
• Organizationally, these are handled by the following functions: Product registration related matters through Quality, Manufacturing and Human Resources departments
•  Sanitary Operations compliance through Quality Assurance Department.
•  Safety compliance through EHS Manager.
•  Information is provided to Quality In-charge, which include regulatory report findings and plant responses. Report distribution and controls are in place to ensure that management level receive information.
•  Any information or documents provided to regulatory visitors e.g. photograph/diagrams of the plant areas, process flow, or equipment design and layout must be marked “Confidential”.

5. Handling & Storage:

5.1 The handling practices must protect and maintain the safety, integrity and quality of materials and products.

5.2 Containers used to measure raw materials are dedicated, color coded, clean and stored off the floor to prevent contamination.

5.3 Strip outer bags from bagged ingredients and brush external surfaces of ingredient containers to ensure cleanliness.

5.4 Empty containers must be adequately cleaned, covered or inverted.

5.5 After the end of production and during downtimes, the product must be cleared from the processing and packaging lines.

5.6 The partially used ingredients must be stored in specific labeled container indicating lot number and identification and sealed / closed properly to avoid contamination. Partially used packaging materials must be covered when not in use.

5.7 The pipes and hoses must be kept off the floor and in designated area and capped when not in use.

5.8 Tools used for raw materials must be sanitized and dedicated.

6. Maintenance:

After completion of the maintenance activities (e.g. drilling, cutting, polishing and welding), the following points must be strictly adhered to:

•  The affected equipment and the surroundings must be properly cleaned, sanitized with 70% IPA solution and ensure good in repair prior to use.
•  All the equipment repairs must be permanent type, no temporary provision/other arrangements prohibited.
•  Rags, string, electrical wire, tapes (water proof tape, duct tape, masking tape) are not allowed for product contact equipment repairs.
•  The maintenance areas must comply with GMP standards.

7. Rework:

The rework product must be adequately covered in appropriate color coded and labeled containers stored in proper storage conditions, in neat and sanitary manner and stored on pallets in designated area.

8. Zoning:

To prevent microbial cross contamination and to assure product quality and safety. Therefore areas, where processed products are kept, shall be separated from the non-processed and/or under processed products kept areas. This separation may include personnel, personnel and materials traffic, air handling, equipment, effluent, drains and waste systems, locker rooms, or other situations that could result in transfer of microorganisms. Types of controls zoning in Food Industry:

a) Manufacturing zone (Controlled Zone):

•  Positive air inside manufacturing area.
•  Cross over benches.
•  Wearing Hair net, Moustache Mask.
•  Change of personnel dress, shoe and ware clean work-ware.
•  Hand wash before entry to manufacturing area.
•  Use of specific tools (designated).

b) Non-Manufacturing Zone:

Following procedure will be followed while going from Manufacturing to Non-Manufacturing Zone (Locker Room, Change room).

• Remove your hair net, mask safety shoe and cross roll over bench.

• Wear Personal shoes.

While going from Manufacturing (Controlled Zone) to Non-Manufacturing Zone (Adjacent to Controlled Zone i.e., Office area, AHU, HVAC Rooms

etc.) same controls will be followed as in Manufacturing (Controlled) Zone.

c) Raw/Process Zone:

•  Remove your shoe and cross roll over bench.
•  Wear slippers while going to toilet.
•  Wash hands cleanly on back from toilets.
•  Remove chapels.
•  Roll over to green zone.
•  Wear safety shoes.
•  Wash hands, wear hairnet, mask, Sanitize hands and go to manufacturing zone.

9. Sanitary Handling of Sanitation Tools & Equipment:

To prevent product contamination, certain tools and equipment must be used only for the intended purpose, dedicated to these specific uses, and handled

and/or stored separately. For example, the house keeping tools used inFood Industry is as per control & cleaning of cleaning tools program.

10. Canteen/Kitchen:

• GMP applies to all catering activities and includes good hygienic practices for food handling. The following critical points are taken into consideration in compliance with the GMP requirements:
•  Facility is constructed of suitable material and designed adequately for food handling.
•  Walls, ceilings, windows, doors, floors maintained in good condition, accessible for cleaning, and not contributing to potential source of contamination.
•  Floors are cleaned by wet mops on daily Basis.
•  Safe drinking water is provided in the plant/canteen and is analyzed for micro-contamination on a half yearly basis by an external agency.

11. Training:

All the employees are trained on GMP once in a year and evaluated for the effectiveness. All new employees mandated to undergo GMP training in their induction.

12. Maintenance Of Records

Respective departments shall keep records for two years. Disposal shall be by shredding or incineration upon approval of their respective managers.

13. GMP Audits

GMP audits are conducted by cross functional teams once in 6 months as per the standard checklist (sanitation Manual 3 and 4) and gaps addressed against the timelines specified and agreed with the area owners.

14. Corrective & Preventive Actions

Corrective and preventive actions are taken immediately based on the GMP audit findings.

15. ASSOCIATE RECORDS:

Verification record of personal hygiene