2. Introduction
Food quality management is an important aspect of food service as it prevents
infectious disease outbreaks, maintains customer trust, and improves profits.
For example, if Zane does not follow food quality management standards and
does not keep products adequately refrigerated, they may grow disease
causing bacteria, which would harm customers and hurt revenue.
3. Need for Food Quality:
• Major challenge for food industry is to maintain the food
quality; the reason being well consumers.
• For this reason, food industry has to adopt certain
techniques in order to meet the growing need of
maintaining food quality; this is known as quality control.
• The main issue which is considered while quality control
process is to deteriorate the level of microbes and other
contaminants in food.
4. Consumer Requirements:
• “ The 21st century customer had become
demanding, curious, comparative, branded,
flexible and opting for THE BEST WITH IN
CHEAP RATES”.
• Hence the brand providing consistent QUALITY,
OPTIMUM and CHEAP
products/services can survive in the competition.
5. Food quality management is the process of directing and controlling the raw material
handling, production, packaging and distribution of food products in order to ensure
effectiveness and efficiency.
To be considered safe for consumption, a food must meet: legislative requirements;
technological criteria; hygiene requirements; transport and handling requirements; trading
conditions and satisfy its intended use.
Conti….
6. Conti….
The relation between quality and safety is intricate and although safety cannot be
viewed as a totally independent aspect from quality, recognising the complexity of
both concepts brought the need of managing them separately.
In fact the reasoning behind separating food safety from quality was the need to place
the concept of safety first and above all the other quality aspects.
7. Common Food Quality Management System Applied In Each Section
are:
1. GMP (Good Manufacturing Practices)
2. ISO (International Organisation for Standardization)
3. HACCP (Hazard Analysis Critical Control Points)
4. TACCP (Threat Assessment Critical Control Points)
5. VACCP (Vulnerability Assessment Critical Control Points).
6. GHP (Good Hygienic Practices).
8. ⚫Good Manufacturing Practices (GMP) is a system
(Practice, set of regulations, codes, and
guidelines)that ensures manufacturing products
such as food, cosmetics, and pharmaceutical goods
which are consistently produced and controlled
according to set quality standards. .
1. Good Manufacturing Practice
9. Aim of GMP
The basic aim of GMP is concerned with the precautions needed to ensure adherence to
all quality and safety basic requirements, like:
elimination, prevention, minimisation of all product failures in the broadest sense;
consistently yields safe, ensuring a certain quality uniformity.
11. Avoid risks and possibilities of mix-up at all stages of Mfg, labeling Pkg and testing
Air Handling Unit (AHUs), comfort of the personnel working and regular
monitoring of temp & humidity, Particle Count, DOP testing etc.
Proper drainage system which prevents backflow.
Avoid open channels and if must be able to clean and disinfect
General Requirements for GMPs
12. Building & Facilities
1. Design and construction features.
2. Lighting.
3. Ventilation, air filtration, air heating and cooling.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toilet facilities.
7. Sanitation.
8. Maintenance.
13. Good Manufacturing Practices
⚫A basic principle of GMP is that quality cannot be tested into a batch of
product but must be built into each batch of product during all stages of the
manufacturing process.
⚫It is designed to minimize the risks involved in any food production that cannot
be eliminated through testing the final product.
14. Ten Principles of GMP
1. Design and construct the facilities and equipment's properly
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on instructions
7. Design ,develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits
16. Sale
⚫No distributor … and no importer shall sell a drug unless it has been
fabricated, packaged/labeled, tested, and stored .
Premises & Equipment
⚫Permits effective cleaning
⚫Prevents contamination
⚫Orderly conditions
⚫Good state of repair
17. Personnel
⚫Appropriate education, training and experience
⚫Sufficient number of people
⚫Receive GMP training
Sanitation
Sanitation Program to prevent contamination Limit the sources and types of
contamination
⚫ Cleaning procedures for facilities & equipment
⚫ Pest control
⚫ Environmental monitoring
18. Raw Material, Packaging Material and Finished Product
Testing
⚫Each lot or batch of raw material is tested
⚫Confirm the identity of the raw materials
⚫Provide assurance that quality of the drug in dosage
⚫Samples of incoming materials are collected and tested before use
⚫Approved test methods and specifications are used
⚫Results must conform to specifications for release for use or sale
⚫Transportation and storage records
19. Manufacturing Control
⚫Written procedures are established and followed
⚫Master formulae, manufacturing order and packaging order
⚫Critical processes are validated
⚫2nd person verification of activities
⚫Self-Inspection Programmed
20. Quality Control Department
⚫Quality Control Responsibilities
⚫Testing of bulk components prior to use by production
⚫Testing of finished product prior to release for sale
⚫Stability program
⚫Review batch records, labels
⚫Release product, based on QC test results
⚫Training, auditing
⚫Customer complaints
21. Records
⚫Document all GMP activities
⚫Use Good Documentation Practices (GDP)
⚫Records must be readily available
Good Documentation Practices
⚫Documentation must be:
⚫permanent (black or blue ink)
⚫legible, clear, concise
⚫accurate
⚫Timely, complete
22. Samples
⚫Retain samples of each lot of raw material and finished product
for specified period of time
Stability
⚫Establish the length of time in which the product
meets all specifications
⚫Monitor the drug for this period of time
Sterile Products
⚫Packaged in separate enclosed area by trained personnel using
method to ensure sterility
23. Why GMP is important
⚫A poor quality medicine may contain toxic substances that have been
unintentionally added.
⚫A medicine that contains little or none of the claimed ingredient will not have
the intended therapeutic effect.
24. GMP IN……
⚫GMP in solid dosage forms
⚫GMP in semisolid dosage forms
⚫GMP in Liquid orals
⚫GMP in Parenterals Production
⚫GMP in Ayurvedic medicines
⚫GMP in Bio technological products
⚫GMP in Nutraceuticals and cosmeceuticals
⚫GMP in Homeopathic medicines
25. Some of the main risks are….
⚫unexpected contamination of products, causing damage to health
or even death.
⚫incorrect labels on containers, which could mean that patients
receive the wrong medicine.
⚫insufficient or too much active ingredient, resulting in ineffective
treatment or adverse effects.
