Darlynn's is a food manufacturing business located at the University Food Square in DLSU-D. It is owned by Raelita C. Villena and produces various food products. During an inspection on September 21, 2012, some issues were found regarding ventilation, space between equipment, hand washing facilities, pest control, and employee training on food handling and sanitation. Overall improvements were needed to fully comply with good manufacturing practices.
This document discusses biosafety and containment procedures in laboratories working with genetically engineered organisms (GEOs). It defines biosafety as precautions to reduce exposure to infectious materials and limit contamination. Containment includes both physical measures, like air filtration and waste disposal, and biological measures, like disabling organism survival outside the lab. Biosafety levels 1-4 are outlined based on pathogen risk, with higher levels requiring more stringent controls and facilities to isolate dangerous biological agents. Biosafety cabinets are also described as primary containment equipment.
Unit 1 introductionto industrial biotechnologyTsegaye Mekuria
This document provides an overview of industrial biotechnology and fermentation technology. It defines industrial biotechnology as using living cells or their components like enzymes to generate industrial products. The basic principles of fermentation technology include selecting microorganisms, preparing growth media, developing inoculum, controlling fermentation conditions in bioreactors, and recovering products. The document outlines factors for each step like selecting microbes that metabolize substrates and give desired products, using defined or complex media, and extracting cell-bound or free products. It also discusses properly disposing of waste from fermentation processes.
This document provides information on different types of bioreactors. It begins by defining a bioreactor as a vessel that enables microbial growth while preventing contamination and providing necessary conditions. It then describes six main types of bioreactors: stirred tank, bubble column, airlift, fluidized bed, packed bed, and photobioreactor. Each type is discussed in 1-2 paragraphs, outlining its mixing method, applications, and basic design. Key parts of bioreactors like temperature control, pH control, and foam control systems are also summarized. The document concludes by stating that bioreactors must carefully control factors like oxygen delivery, agitation, temperature, pH, and foam to optimize microbial production.
The material describes components of industrial fermentation media with their respective metabolic importance for the industrial microbes. it also addresses industrial scale sterilization methods.
The document describes different biosafety levels and types of biosafety cabinets. It outlines 4 biosafety levels (BSL 1-4) with increasing containment requirements based on the risk of the pathogens handled. BSL1 requires standard practices while BSL4 requires the highest level of containment for dangerous exotic agents. It also describes 3 classes of biosafety cabinets (Class I-III). Class I provides personnel and environmental protection while Class II (types A1, A2, B1, B2) provides product, personnel and environmental protection. Class III provides the highest level of containment suitable for BSL3 and BSL4 work.
This document discusses biosafety levels for working with microorganisms. It describes the four biosafety levels from BSL-1 to BSL-4, providing more stringent safety protocols for higher levels that involve more dangerous pathogens. BSL-1 involves well-characterized microbes and requires standard practices like handwashing. BSL-2 adds personal protective equipment, waste decontamination, and controlled access. BSL-3 further restricts access and requires respiratory protection due to airborne risks. BSL-4 is for dangerous exotic pathogens and requires the most stringent containment and protective equipment, including full body isolation suits.
This document defines various microbiology terms related to sterilization and disinfection. It discusses sterilization techniques like heat, filtration, and radiation. It also covers chemical disinfectants including phenols, bisphenols, biguanides, halogens, and chlorine. Physical methods like heat, filtration, refrigeration, and radiation can kill microbes. Chemical disinfectants have varying mechanisms of action, with phenols and halogens damaging cell membranes and bisphenols inhibiting fatty acid synthesis. Proper evaluation of disinfectant efficacy involves tests against standard microbes.
This document discusses biosafety and containment procedures in laboratories working with genetically engineered organisms (GEOs). It defines biosafety as precautions to reduce exposure to infectious materials and limit contamination. Containment includes both physical measures, like air filtration and waste disposal, and biological measures, like disabling organism survival outside the lab. Biosafety levels 1-4 are outlined based on pathogen risk, with higher levels requiring more stringent controls and facilities to isolate dangerous biological agents. Biosafety cabinets are also described as primary containment equipment.
Unit 1 introductionto industrial biotechnologyTsegaye Mekuria
This document provides an overview of industrial biotechnology and fermentation technology. It defines industrial biotechnology as using living cells or their components like enzymes to generate industrial products. The basic principles of fermentation technology include selecting microorganisms, preparing growth media, developing inoculum, controlling fermentation conditions in bioreactors, and recovering products. The document outlines factors for each step like selecting microbes that metabolize substrates and give desired products, using defined or complex media, and extracting cell-bound or free products. It also discusses properly disposing of waste from fermentation processes.
This document provides information on different types of bioreactors. It begins by defining a bioreactor as a vessel that enables microbial growth while preventing contamination and providing necessary conditions. It then describes six main types of bioreactors: stirred tank, bubble column, airlift, fluidized bed, packed bed, and photobioreactor. Each type is discussed in 1-2 paragraphs, outlining its mixing method, applications, and basic design. Key parts of bioreactors like temperature control, pH control, and foam control systems are also summarized. The document concludes by stating that bioreactors must carefully control factors like oxygen delivery, agitation, temperature, pH, and foam to optimize microbial production.
The material describes components of industrial fermentation media with their respective metabolic importance for the industrial microbes. it also addresses industrial scale sterilization methods.
The document describes different biosafety levels and types of biosafety cabinets. It outlines 4 biosafety levels (BSL 1-4) with increasing containment requirements based on the risk of the pathogens handled. BSL1 requires standard practices while BSL4 requires the highest level of containment for dangerous exotic agents. It also describes 3 classes of biosafety cabinets (Class I-III). Class I provides personnel and environmental protection while Class II (types A1, A2, B1, B2) provides product, personnel and environmental protection. Class III provides the highest level of containment suitable for BSL3 and BSL4 work.
This document discusses biosafety levels for working with microorganisms. It describes the four biosafety levels from BSL-1 to BSL-4, providing more stringent safety protocols for higher levels that involve more dangerous pathogens. BSL-1 involves well-characterized microbes and requires standard practices like handwashing. BSL-2 adds personal protective equipment, waste decontamination, and controlled access. BSL-3 further restricts access and requires respiratory protection due to airborne risks. BSL-4 is for dangerous exotic pathogens and requires the most stringent containment and protective equipment, including full body isolation suits.
This document defines various microbiology terms related to sterilization and disinfection. It discusses sterilization techniques like heat, filtration, and radiation. It also covers chemical disinfectants including phenols, bisphenols, biguanides, halogens, and chlorine. Physical methods like heat, filtration, refrigeration, and radiation can kill microbes. Chemical disinfectants have varying mechanisms of action, with phenols and halogens damaging cell membranes and bisphenols inhibiting fatty acid synthesis. Proper evaluation of disinfectant efficacy involves tests against standard microbes.
Air microbiology is a scientific discipline that concerns the microorganisms, including bacteria, archaea, fungi and viruses, in the atmospheric air. It is a subdiscipline of environmental microbiology.
This document discusses biosafety levels and biosafety cabinets. It describes the four biosafety levels based on the hazard level of the pathogens being used. It also explains different types of biosafety cabinets including class I, II and III cabinets and how they provide varying levels of protection for personnel, products and the environment. Air filtration using HEPA and ULPA filters in biosafety cabinets is also summarized. Finally, it provides an overview of international standards for biosafety cabinets.
The document discusses microbial control through various physical and chemical methods. It begins with a brief history of bubonic plague in Europe during the Middle Ages caused by the Yersinia pestis bacterium. It then defines key terms like sterilization, disinfection, bactericidal and bacteriostatic. The document outlines several conditions that influence the effectiveness of antimicrobial agents and describes various physical methods of microbial control including heat, filtration and radiation. It provides details on how these methods kill microbes and examples of their applications.
Environmental conditions for plant tissue culture laboratorySandhyaUpadhyay9
The document discusses the environmental conditions required for successful plant tissue culture. It outlines five key areas: 1) laboratory design and management, 2) environmental conditions, 3) sterilization techniques, 4) conditions in the inoculation area, and 5) conditions inside growth chambers. Specific requirements include maintaining temperature between 24-26°C, controlling air movement, using sterile culture vessels and media, and employing sterilization methods like autoclaving. The inoculation area must be inside a laminar flow hood with positive pressure and UV sterilization. Growth chambers need temperature control, lighting of 3000-8000 lux for 16 hours, and 40-60% humidity. Proper environmental protocols are necessary for contaminant-free culture and
This document discusses biosafety and biosafety cabinets. It defines biosafety as safety precautions that reduce risk of exposure to infectious materials. There are 4 biosafety levels depending on the risk of the microbe, with level 4 being the highest risk. Biosafety cabinets provide protection to personnel, environment, and products being handled. There are 3 classes of biosafety cabinets - Class I provides personnel and environmental protection; Class II provides personnel, environmental, and product protection; Class III provides highest level of containment for dangerous pathogens. The document outlines practices for different biosafety levels and cabinet classes.
This document outlines regulations for safety in biological plants regarding biohazards and biosecurity. It defines key terms like biohazard, biosecurity, and biosafety. It discusses safety basics in biological plants including biosafety in the lab and personal biosafety. It covers national regulations in India for biological safety as well as international regulations. Guidelines are provided for risk assessment, pathogen assessment, biosafety levels, good manufacturing practices, and the roles of various containment barriers.
Biological safety cabinets and its Use In Culturing Ragya Bharadwaj
This document provides an overview of biosafety cabinets, including their definition, biosafety levels, types of cabinets, mechanics, safe work practices, and certification. It defines biosafety cabinets as containment devices that protect the user and environment from biological agents. The types of cabinets described are Class I, II (types A, B1, B2, B3), and Class III. Class II cabinets provide protection to the user, product, and environment. The document outlines the biosafety levels from 1 to 4 and lists representative agents for each. It also discusses the mechanics, selection criteria, and safe operation of various cabinet types.
Good Manufacturing Practices (GMP) ensure that products are consistently produced and controlled according to quality standards for their intended use. GMP requirements include clearly defined and validated manufacturing processes, qualified personnel, suitable premises and equipment, approved procedures and instructions, and record keeping. Facilities, equipment, and operations must be designed and maintained to minimize risks of contamination and ensure quality.
The document discusses good manufacturing practices (GMP) for neutraceuticals. It outlines the general requirements for premises where neutraceuticals are manufactured, including ensuring premises are designed for easy cleaning and maintenance. Facilities must be provided for ventilation, lighting, water supply and drainage. Equipment must be designed to prevent contamination and ensure products are consistently produced according to quality standards. Personnel hygiene facilities like hand wash basins must also be provided and kept clean. The document provides details on cleaning procedures, waste disposal, pest control, and water supply requirements to ensure neutraceuticals are manufactured under hygienic conditions.
The document provides guidelines for hygienic and sanitary practices for food catering businesses. It discusses appropriate locations away from pollution, proper facility layout with forward material flow, and equipment requirements. Facilities must have potable water, cleaning areas, hand washing stations, ventilation, and proper lighting. The layout and facilities are designed to prevent contamination and allow for effective cleaning.
This document outlines good manufacturing practices and requirements for pharmaceutical manufacturing facilities. It discusses requirements for premises, buildings, warehousing, production, quality control, personnel, and operations. Specifically, it addresses the following key points:
1. Facilities must be designed and maintained to ensure hygienic manufacturing conditions and prevent contamination.
2. Separate dedicated areas are required for sensitive products like antibiotics and hazardous materials.
3. Production, quality control, and ancillary areas like personnel facilities must be separated.
4. Strict personnel hygiene practices and medical monitoring are required.
5. Manufacturing operations must be well-controlled and supervised to prevent mix-ups or
Section III of the Codex Alimentarius focuses on primary food production and aims to ensure food is safe for intended use by avoiding environmental threats and controlling contaminants. It provides guidelines for hygienic production, handling, storage, transport, cleaning and personnel hygiene.
Section IV addresses secondary food production. It provides recommendations for facility location, design, premises, equipment, facilities for water, drainage, cleaning, personnel hygiene, temperature control, ventilation and storage. The guidelines aim to minimize contamination and ensure establishments can properly control food safety hazards.
This document provides guidelines for food hygiene inspections. It defines key terms like food hygiene, food safety, contamination, and cleaning. It describes how food establishments should be designed, located, and equipped to minimize contamination and allow for effective cleaning. Facilities for handwashing, cleaning/sanitizing equipment, temperature control, and waste disposal should be provided.
Design and Construction of plant as per the GMP Guidelines.pdfMohiniTawade
GMP is that part of Quality assurance which ensures that the products are consistently
manufactured and controlled to the Quality standards appropriate to their intended use
GMP, Goods manufacturer Practices, Drug and Cosmetic actDrSampuranSuahg
GMP (good manufacturing practices) regulations ensure that pharmaceutical products are consistently manufactured and controlled according to quality standards. Key aspects of GMP include maintaining high standards for facilities, equipment, production processes, packaging and labeling, quality control testing, record keeping, and personnel qualifications. GMP helps to minimize risks of contamination and ensures that products meet specifications for identity, strength, quality, purity and safety.
This document outlines good manufacturing practices (GMP) for Ayurvedic, Siddha, and Unani medicines. It discusses infrastructure requirements for manufacturing facilities, including adequate space for receiving raw materials, manufacturing, quality control, finished goods storage, and offices. It also covers requirements for buildings, water supply, waste disposal, cleaning of containers, storage, and machinery/equipment. Worker health, clothing, sanitation, and medical services are also addressed. The objective is to ensure raw materials are authentic and contamination-free, manufacturing follows the proper process, quality control measures are in place, and the finished drug is of acceptable quality.
This document outlines Good Manufacturing Practices (GMP) for the production of phytomedicines according to Ayurveda, Siddha, and Unani systems of medicine in India. It discusses requirements for facilities, equipment, personnel, documentation, raw materials storage, and quality control. The key points are:
- Facilities must be designed and maintained to allow hygienic production and prevent contamination. Equipment must be suitable for operations and cleaned regularly.
- Personnel involved in production and quality control must be qualified and receive training. Sanitary practices like health checks and protective clothing are required.
- Comprehensive documentation includes specifications, manufacturing processes, training records, and methods to investigate defective
This document outlines Good Manufacturing Practices (GMP) guidelines for drug manufacturing facilities. It addresses requirements for facility premises, materials, production areas, quality control, personnel, and sanitation. Key requirements include preventing contamination risks through proper building/area design, segregation of incompatible operations, control of air handling systems, cleaning procedures, personnel training, and health/hygiene practices. The guidelines are intended to ensure consistent high quality drug production under hygienic conditions.
PRP are steps or procedures including GMP & SSOP that control conditions within a food establishment to promote safe food production. They establish basic hygienic requirements including facility location and construction, equipment cleaning, utilities like water and air, cleaning and sanitation programs, personal hygiene facilities, and more. Requirements include proper drainage, separation of raw and processed areas, smooth cleanable surfaces, pest control, and documented cleaning procedures.
Air microbiology is a scientific discipline that concerns the microorganisms, including bacteria, archaea, fungi and viruses, in the atmospheric air. It is a subdiscipline of environmental microbiology.
This document discusses biosafety levels and biosafety cabinets. It describes the four biosafety levels based on the hazard level of the pathogens being used. It also explains different types of biosafety cabinets including class I, II and III cabinets and how they provide varying levels of protection for personnel, products and the environment. Air filtration using HEPA and ULPA filters in biosafety cabinets is also summarized. Finally, it provides an overview of international standards for biosafety cabinets.
The document discusses microbial control through various physical and chemical methods. It begins with a brief history of bubonic plague in Europe during the Middle Ages caused by the Yersinia pestis bacterium. It then defines key terms like sterilization, disinfection, bactericidal and bacteriostatic. The document outlines several conditions that influence the effectiveness of antimicrobial agents and describes various physical methods of microbial control including heat, filtration and radiation. It provides details on how these methods kill microbes and examples of their applications.
Environmental conditions for plant tissue culture laboratorySandhyaUpadhyay9
The document discusses the environmental conditions required for successful plant tissue culture. It outlines five key areas: 1) laboratory design and management, 2) environmental conditions, 3) sterilization techniques, 4) conditions in the inoculation area, and 5) conditions inside growth chambers. Specific requirements include maintaining temperature between 24-26°C, controlling air movement, using sterile culture vessels and media, and employing sterilization methods like autoclaving. The inoculation area must be inside a laminar flow hood with positive pressure and UV sterilization. Growth chambers need temperature control, lighting of 3000-8000 lux for 16 hours, and 40-60% humidity. Proper environmental protocols are necessary for contaminant-free culture and
This document discusses biosafety and biosafety cabinets. It defines biosafety as safety precautions that reduce risk of exposure to infectious materials. There are 4 biosafety levels depending on the risk of the microbe, with level 4 being the highest risk. Biosafety cabinets provide protection to personnel, environment, and products being handled. There are 3 classes of biosafety cabinets - Class I provides personnel and environmental protection; Class II provides personnel, environmental, and product protection; Class III provides highest level of containment for dangerous pathogens. The document outlines practices for different biosafety levels and cabinet classes.
This document outlines regulations for safety in biological plants regarding biohazards and biosecurity. It defines key terms like biohazard, biosecurity, and biosafety. It discusses safety basics in biological plants including biosafety in the lab and personal biosafety. It covers national regulations in India for biological safety as well as international regulations. Guidelines are provided for risk assessment, pathogen assessment, biosafety levels, good manufacturing practices, and the roles of various containment barriers.
Biological safety cabinets and its Use In Culturing Ragya Bharadwaj
This document provides an overview of biosafety cabinets, including their definition, biosafety levels, types of cabinets, mechanics, safe work practices, and certification. It defines biosafety cabinets as containment devices that protect the user and environment from biological agents. The types of cabinets described are Class I, II (types A, B1, B2, B3), and Class III. Class II cabinets provide protection to the user, product, and environment. The document outlines the biosafety levels from 1 to 4 and lists representative agents for each. It also discusses the mechanics, selection criteria, and safe operation of various cabinet types.
Good Manufacturing Practices (GMP) ensure that products are consistently produced and controlled according to quality standards for their intended use. GMP requirements include clearly defined and validated manufacturing processes, qualified personnel, suitable premises and equipment, approved procedures and instructions, and record keeping. Facilities, equipment, and operations must be designed and maintained to minimize risks of contamination and ensure quality.
The document discusses good manufacturing practices (GMP) for neutraceuticals. It outlines the general requirements for premises where neutraceuticals are manufactured, including ensuring premises are designed for easy cleaning and maintenance. Facilities must be provided for ventilation, lighting, water supply and drainage. Equipment must be designed to prevent contamination and ensure products are consistently produced according to quality standards. Personnel hygiene facilities like hand wash basins must also be provided and kept clean. The document provides details on cleaning procedures, waste disposal, pest control, and water supply requirements to ensure neutraceuticals are manufactured under hygienic conditions.
The document provides guidelines for hygienic and sanitary practices for food catering businesses. It discusses appropriate locations away from pollution, proper facility layout with forward material flow, and equipment requirements. Facilities must have potable water, cleaning areas, hand washing stations, ventilation, and proper lighting. The layout and facilities are designed to prevent contamination and allow for effective cleaning.
This document outlines good manufacturing practices and requirements for pharmaceutical manufacturing facilities. It discusses requirements for premises, buildings, warehousing, production, quality control, personnel, and operations. Specifically, it addresses the following key points:
1. Facilities must be designed and maintained to ensure hygienic manufacturing conditions and prevent contamination.
2. Separate dedicated areas are required for sensitive products like antibiotics and hazardous materials.
3. Production, quality control, and ancillary areas like personnel facilities must be separated.
4. Strict personnel hygiene practices and medical monitoring are required.
5. Manufacturing operations must be well-controlled and supervised to prevent mix-ups or
Section III of the Codex Alimentarius focuses on primary food production and aims to ensure food is safe for intended use by avoiding environmental threats and controlling contaminants. It provides guidelines for hygienic production, handling, storage, transport, cleaning and personnel hygiene.
Section IV addresses secondary food production. It provides recommendations for facility location, design, premises, equipment, facilities for water, drainage, cleaning, personnel hygiene, temperature control, ventilation and storage. The guidelines aim to minimize contamination and ensure establishments can properly control food safety hazards.
This document provides guidelines for food hygiene inspections. It defines key terms like food hygiene, food safety, contamination, and cleaning. It describes how food establishments should be designed, located, and equipped to minimize contamination and allow for effective cleaning. Facilities for handwashing, cleaning/sanitizing equipment, temperature control, and waste disposal should be provided.
Design and Construction of plant as per the GMP Guidelines.pdfMohiniTawade
GMP is that part of Quality assurance which ensures that the products are consistently
manufactured and controlled to the Quality standards appropriate to their intended use
GMP, Goods manufacturer Practices, Drug and Cosmetic actDrSampuranSuahg
GMP (good manufacturing practices) regulations ensure that pharmaceutical products are consistently manufactured and controlled according to quality standards. Key aspects of GMP include maintaining high standards for facilities, equipment, production processes, packaging and labeling, quality control testing, record keeping, and personnel qualifications. GMP helps to minimize risks of contamination and ensures that products meet specifications for identity, strength, quality, purity and safety.
This document outlines good manufacturing practices (GMP) for Ayurvedic, Siddha, and Unani medicines. It discusses infrastructure requirements for manufacturing facilities, including adequate space for receiving raw materials, manufacturing, quality control, finished goods storage, and offices. It also covers requirements for buildings, water supply, waste disposal, cleaning of containers, storage, and machinery/equipment. Worker health, clothing, sanitation, and medical services are also addressed. The objective is to ensure raw materials are authentic and contamination-free, manufacturing follows the proper process, quality control measures are in place, and the finished drug is of acceptable quality.
This document outlines Good Manufacturing Practices (GMP) for the production of phytomedicines according to Ayurveda, Siddha, and Unani systems of medicine in India. It discusses requirements for facilities, equipment, personnel, documentation, raw materials storage, and quality control. The key points are:
- Facilities must be designed and maintained to allow hygienic production and prevent contamination. Equipment must be suitable for operations and cleaned regularly.
- Personnel involved in production and quality control must be qualified and receive training. Sanitary practices like health checks and protective clothing are required.
- Comprehensive documentation includes specifications, manufacturing processes, training records, and methods to investigate defective
This document outlines Good Manufacturing Practices (GMP) guidelines for drug manufacturing facilities. It addresses requirements for facility premises, materials, production areas, quality control, personnel, and sanitation. Key requirements include preventing contamination risks through proper building/area design, segregation of incompatible operations, control of air handling systems, cleaning procedures, personnel training, and health/hygiene practices. The guidelines are intended to ensure consistent high quality drug production under hygienic conditions.
PRP are steps or procedures including GMP & SSOP that control conditions within a food establishment to promote safe food production. They establish basic hygienic requirements including facility location and construction, equipment cleaning, utilities like water and air, cleaning and sanitation programs, personal hygiene facilities, and more. Requirements include proper drainage, separation of raw and processed areas, smooth cleanable surfaces, pest control, and documented cleaning procedures.
The document discusses cleaning premises and equipment in the hotel industry. It covers various topics such as classifying cleaning equipment into manual, mechanical, protective and supporting categories. It describes different types of cleaning equipment like brooms, mops, vacuums etc. It also discusses cleaning agents, their classification and proper usage. The document provides guidance on cleaning various public areas of the hotel like entrance, lobby, corridors, lifts etc. It outlines the cleaning procedure and preparation required for effectively cleaning both indoor and outdoor areas of the hotel.
The document discusses various threats to archival materials like temperature, humidity, light, pollution, and biological agents. It emphasizes the importance of preservation by controlling the storage environment, monitoring for threats, and creating an emergency plan. A preservation plan includes conducting a survey, drafting a policy, and developing a management plan to establish procedures for regular monitoring, maintenance of stable storage conditions, and identification and treatment of at-risk materials. An emergency plan should identify potential risks and outline evacuation and recovery procedures to protect collections during incidents.
This document outlines 8 sections that define good manufacturing practices for food facilities: 1) Definitions, 2) Current food manufacturing practices, 3) Plant and grounds, 4) Equipment and utensils, 5) Sanitary facilities and controls, 6) Sanitary operations, 7) Processes and controls, and 8) Personnel. It describes requirements for facilities, equipment, hygienic practices, and training to prevent food contamination and assure food is produced safely under sanitary conditions.
Hygiene standards and procedures usually described as Good Hygienic Practices (GHP) or Good Manufacturing Practices (GMP), have been in place for many years and constituted an essential tool in traditional food control. These concepts are still essential in a modern food control system by providing the basic environmental and operating conditions for production of safe food and thus being a requisite or foundation for HACCP in an overall food safety management program. What is new is the concept of formalizing the prerequisite program alongside HACCP and the legal requirement in some countries (USA) of documented monitoring of certain sanitation areas.
Group three of the Department of Biology at the College of Science and Technology submitted an assignment on principles and practice of biosafety in microbiology laboratories and waste management. The 10-member group studied under Dr. Noël Gahamanyi and submitted the assignment on January 16, 2023. The report covered standard microbiological practices, laboratory facilities, special practices, types of laboratory waste, waste separation, and labeling. It concluded by emphasizing the responsibility of all laboratory personnel to properly manage and dispose of wastes.
This document discusses manufacturing operations and controls to prevent mix-ups and cross contamination. It outlines precautions like proper air handling, segregated areas, and status labeling. Processing of intermediates and bulk products must be documented and checks put in place to ensure quality like verifying identity and yields. Calibration records and batch production and control records are required. Contamination can occur from materials, areas, equipment or people so trained personnel and technical measures like separate production areas are important controls.
5. NO: GMP CHECKLIST
1. NAME: Darlynn’s
2. ADDRESS: University Food Square, DLSU-D
3. OWNER: Raelita C. Villena
4. TELEPHONE NUMBER: 046-8564303
5. PRODUCTS MANUFACTURED:
6. DATE/TIME OF INSPECTION: 9/21/12 ; Friday 2:50PM
7. COMPANY REPRESENTATIVE/S PRESENT
DURING INSPECTION: Raelita C. Villena
POSITION: Owner
8. LICENSE TO OPERATE: Mayor’s Permit
VALIDITY: December 2012
6. NO: PLANTS AND GROUNDS YES NO REMARKS
1. Are premises free of harborage and/or
breeding places for rodents, insects and other
pest
2. Is adequate drainage provided to avoid
contamination of facilities and products
3. Is sufficient space provided for placement of
equipment, storage of materials and for
production operations
4. Are floors, walls and ceilings constructed of
easily cleanable materials and kept clean and
in good repair
5. Are food and food contact surfaces protected
from contamination from pipes, etc., over
working areas
6. Are food processing areas effectively
separated from other operations which may
cause contamination of food being processed
7. NO: PLANTS AND GROUNDS YES NO REMARKS
7. Are food products and processing areas
protected against contamination from breakage
of light bulbs and other glass fixtures
8. Is ventilation adequate to prevent
contamination by dust and/or other airborne
substances
9. Are doors tightly fitted, smooth, non-
absorbent surfaces and where
appropriate be self-closing
10. Are windows and other openings
designed and constructed to avoid
accumulation of dirt and fitted with insect-
proof screens to prevent entry of insects,
rodents and other pests
11. Are dressing and locker rooms provided
with adequate cabinets and shelves,
hangers, adequately lighted and kept
clean. Presence of GMP posters
12. Are finished product/ dry warehouse, kept
clean, products placed in pallets,
defects/damaged products removed, lots
isolated and identified
8. NO: EQUIPMENT AND UTENSILS YES NO REMARKS
13. Are product contact surfaces of approved
material, Joints smooth and water proof
14. Are all utensils and equipment constructed of
adequately cleanable materials
15. Are equipment designed and used in a
manner that preludes contamination with
lubricants, contaminated water, metal
fragments, etc.
16. Are equipment installed and maintained so as
to facilitate the cleaning of equipment and
adjacent areas
17. Are space provided between equipment and
the ceilings, walls, floors and other equipment
(appx. 100 cm)
18. Are the equipment/utensils properly washed
and disinfected at end of work shift
19. Are equipment regularly calibrated
9. NO: SANITARY FACILITIES AND CONTROLS YES NO REMARKS
20. Source of Water Supply:
a)MWSS
b)b) Deepwell: with Potability Test
21. Is water provided in all areas where required
for processing
22. Is there adequate protection against possible
back siphonage
23. Are water hose have not outs/leaks and not
left hanging or touching the floor
24. Are records of potability test maintained and
chlorine level monitored
25. Are the elevated tanks kept clean and
properly covered and of approved
construction
26. Is the water supply adequate in quantity and
quality for its intended use
10. NO: SANITARY FACILITIES AND CONTROLS YES NO REMARKS
27. Is the sewage disposal system adequate
28. Is waste disposal system efficient and regular
29. Is toilet room with tight fitting and self closing
door, equipped with hand washing facility,
kept
clean and in good repair
30. Are adequate hand washing and sanitizing
facilities (liquid soap, hand sanitizing dip,
paper, towels or hand drying fan) provided
where appropriate
31. Are all refuse properly stored and protected
where necessary from insects, rodents, and
other pests and disposed of in an adequate
There are a lot of
flies and
mosquitoes.
manner
11. NO: SANITARY OPERATIONS YES NO REMARKS
32. Is the facility kept clean and in good physical
repair
33. Is cleaning of facilities and equipment
conducted in such a manner as to avoid
contamination of food products
34. Are detergents, sanitizers, hazardous
materials and other supplies used in a safe
and effective manner
35. Are cleaning compounds and hazardous
materials and (insecticides and rodenticides)
kept in labeled containers, stored separate
from food products to prevent contamination
36. Are the processing areas maintained free of
insects, rodents and other pests
37. Are all utensils and equipment cleaned and
sanitized at intervals frequent enough to avoid
contamination of food products
12. NO: PERSONNEL YES NO REMARKS
38. Are personnel provided with valid health
certificates or fit to work certificate
39. Are personnel with sores, infections, etc.,
restricted from handling food products
40 Does employee wear clean outer garments,
use adequate hair restraints and remove
jewelry when handling food
41. Does employee thoroughly wash and sanitize
hands as necessary
42. Does employee refrain form eating, drinking,
and smoking and observe good food handling
techniques in processing areas
43. Does employee undergo food handling
Trainings/seminars
44. Is responsibility for overall plant sanitation
specifically assigned to an individual
Name:
Position:
13. NO: PROCESS AND CONTROLS YES NO REMARKS
45. Are raw/packaging materials and ingredients
adequately inspected, processed as
necessary and stored properly to assure that
only clean, wholesome materials are used
46. Are weighing and measuring practices
adequate to ensure the declared quantity of
contents
47. Is food processing conducted in a manner to
prevent contamination and harmful
microbiological growth
48. Are only approved food color and /or additives
used
49. Are prepackaged products provided with
consume before date on labels as per AO 16
s. 1979 “Date marking of prepackaged foods”
50. Are finished products stored and shipped
under conditions which will avoid
contamination and deterioration
14. NO: OTHERS YES NO REMARKS
51. Are cleaning and sanitizing chemicals
with shelves or cabinets, properly labeled and
stored, authorized chemical compounds
52. Are insecticides and rodenticides
authorized chemicals, handled by properly
trained personnel and properly stored in
non-food handling areas