Good Manufacturing Practice (GMP)

Date: 25 April & 26 April 2011 Presenter: Ms. Kohilavani Ramalingam

Good Manufacturing Practices Apply to all stages of manufacture, processing and distribution

Minimizing RISK

The basics of food quality and safety.

Hazard Inventory

Management Responsibility
Top management shall appoint qualified persons responsible for implementing and maintaining the GMP and quality assurance system

Document control and Complaint Handling

Quality Manual (Link to ISO 9001) The quality control system shall include monitoring of the implementation and achievement of GMP Identify measures to correct any failure to achieve GMP. Such corrective measures shall be implemented without delay and made available to the competent authorities for inspections Identifying and analyze the root causes of complaints. Subsequent actions shall be taken to eliminate the causes.

Specification
Product trade name Product name Product code Description Country of origin Storage condition Physical & chemical parameters Microbiological analysis Organoleptic Properties

Product Recall

Traceability
Written procedures for identification and tracing of all products. This shall cover every stage from receipt of incoming raw materials to delivery of product. The effectiveness of the traceability system shall be demonstrated either by an audit of existing recall records or by a simulation of a recall.

Example

Traceability Information

Advantages of Traceability
Traceability can be used to improve stock control. Traceability can be used to monitor the effect the quality the suppliers goods have on your finished goods. Traceability can be used to optimize both internal and external logistics with respect to timeliness, transport distance, storage time, etc.

Site and Premises

Basic environmental safety requirements that should be considered: Building are not close to any source of pollution Amenities, shower rooms and change rooms with personal lockers for employees shall be provided Factory is designed for easy cleaning and doors with non absorbent surfaces Floors, walls and ceiling ae contructed with material that is cleanable and suitable fro safe quality food production. Any short comings (such as flaking paint, oil and water leakages and etc) must be fixed.

Processing Environment

Effective drainage system and effectively remove wastewater from the floor Ensure wastewater and sewage system are not to be cross connected Adequate lighting is provided in the operational area Light bulbs are protected Microbiological sensitive area must be provided with filtered air that is free from pathogens or spoilage organism

External areas
All external areas belonging to the company and close to the premises shall be tidy and in good condition. Potential sources of contamination shall be minimized. A clean and unobstructed area should be provided along the external walls of buildings used for production and storage. External pathways should be suitably maintained to avoid contamination to raw materials, unfinished and finished products during transportation.

 All the external openings for auxiliary devices and equipment shall be suitably protected. When stored outside, all raw materials and products shall be protected from contamination. External drainage systems shall be constructed to prevent the access of pests. The organization shall have in place measures to prevent the access of non-authorized persons.

Buildings
Construction and layout shall permit adequate maintenance and cleaning. In production and storage areas an appropriate gap along the walls shall be provided. Protection against pest access shall be effective. The organization shall provide appropriate and cleanable bins and containers for regular disposal of waste. Surfaces of walls, partitions and floors shall permit appropriate cleaning. To minimize the accumulation of dust and to prevent the possibility of condensation contaminating the product, ceilings and overhead fixtures should allow access for cleaning.

Buildings
Windows, sills and doors shall be maintained and cleanable. They shall be properly fitted. Other constructions such as stairs, steps, platforms, etc. shall be maintained and cleanable. Adequate lighting shall be provided in all areas. Where necessary, separate storage areas shall be available to prevent contamination of incoming materials, products, cleaning agents etc. Windows in production and storage areas intended to be opened shall be equipped with screens

Supplier Monitoring
Monitoring suppliers performance is necessary for a department to assess whether it is receiving value for money
Product Quality Percentage of incoming rejects (delivery accuracy) Warranty claims Service Quality Call-out time Customer service response time Performance against agreed delivery lead times Relationship/Account Management Costs are maintained or reduced

Internal Audits
The company shall have regular internal audits to confirm the compliance to GMP. The company shall extend its GMP management system to relevant outsourced processes. There shall be a written contract. Outsourcing (sub-contracting) and suppliers shall be audited, evaluated, approved and monitored by the company. Records shall be maintained.

Glass and Lighting

Equipment
Objectives
To review the requirements for equipment

selection design use maintenance

To discuss problems related to issues around selected items of equipment

Equipment
Principle
Equipment must be

located designed constructed adapted maintained

to suit the operations to be carried out

Equipment
What does

location design construction adaptation maintenance cleaning calibration mean in practice?

Equipment
Equipment layout and design must aim: to minimize risks of error to permit effective cleaning and maintenance To avoid: cross-contamination, dust and dirt build-up any adverse effect on the quality of products Equipment must be installed to: minimize risks of error minimize risks of contamination

Pipes Pipes
Fixed pipe work clearly labelled indicate contents and direction of flow Service piping's and devices adequately marked non-interchangeable connections or adaptors for dangerous gases and liquids Contents and direction of flow indicated e.g. water lines, equipment components, air-handling systems

Production Equipment
Appropriate design

easily and thoroughly cleaned on a scheduled basis procedures and records

No hazard to the products

contact parts of suitable non-reactive materials non additive and not absorptive
Defective equipment

removed, or labelled to prevent use

Production Equipment
Closed equipment used when possible Open equipment, or when equipment opened, precautions taken to prevent contamination Non-dedicated equipment cleaned according to validated cleaning procedures between different products Current drawings of critical equipment and support systems maintained

Production Equipment
Current drawings of critical equipment Verify against qualification protocol and report, as well as supplier's manual

Check if in accordance with drawing, or changes (change control)

Verify critical components installed, e.g. filters, control and monitoring devices

 What are some of the key questions you can ask about the blender?

Washing, cleaning and drying

Equipment used for washing and drying not the source of contamination Equipment design should promote easy cleaning Cleaning on scheduled basis, procedures and records Washing and cleaning manual automated (Clean in place (CIP), Steam in place (SIP)

Heating, Ventilation and AirConditioning (HVAC)

Weather louvre
Silencer

Flow rate controller

Control damper

To prevent insects, leaves, dirt and rain from entering To reduce noise caused by air circulation Automated adjustment of volume of air (night and day, pressure control) Fixed adjustment of volume of air

Humidifier

Silencer

Heating and cooling units

Preventive Maintenance
Long-term benefits of preventive maintenance include: Improved system reliability. Decreased cost of replacement. Decreased system downtime. Better spares inventory management.

Breakdown Maintenance
It means that people waits until equipment fails and repair it. Such a thing could be used when the equipment failure does not significantly affect the operation or production or generate any significant loss other than repair cost.

Preventive maintenance
It is a daily maintenance ( cleaning, inspection, oiling and re-tightening ), design to retain the healthy condition of equipment and prevent failure through the prevention of deterioration, periodic inspection or equipment condition diagnosis, to measure deterioration. It is further divided into periodic maintenance and predictive maintenance. Just like human life is extended by preventive medicine, the equipment service life can be prolonged by doing preventive maintenance.

Periodic maintenance ( Time based maintenance - TBM)

Time based maintenance consists of periodically inspecting, servicing and cleaning equipment and replacing parts to prevent sudden failure and process problems.

Corrective Maintenance
It improves equipment and its components so that preventive maintenance can be carried out reliably. Equipment with design weakness must be redesigned to improve reliability or improving maintainability

Maintenance Prevention
It indicates the design of a new equipment. Weakness of current machines are sufficiently studied ( on site information leading to failure prevention, easier maintenance and prevents of defects, safety and ease of manufacturing ) and are incorporated before commissioning a new equipment.

Contamination control
Identify the potential cross contamination? Chemical Biological Physical

Pest control

Always prevent the presence of pets inside the plant

Pest control
Poisoned bait Poisoned bait is a common method for controlling rat populations, however is not as effective when there are other food sources around Traps Traps have been used for killing off mice found in houses Poison spray Spraying poisons by planes, hand held units, or trucks that carry the spraying equipment, is a common method of pest control.

Have you seen this man ?

Metal detecting
Product safety Equipment protection Contract (customer) requirement Regulatory compliance

What can be detected All metals are either ferrous, nonferrous or stainless steel. The ease of detection will depend on their magnetic permeability and electrical conductivity. The size, shape and orientation (with respect to the detector coils) of the metal particle also is important. Since size, shape and orientation of metal contaminants is not possible to control, it is best to operate a metal detector at the highest possible sensitivity setting.

Rework
Identify the rework material.
Apply tags with product identification information, which may include name of the product, lot code and date of production. You can also use color-coded containers to identify rework material. Store rework in a way that prevents contamination with potential food hazards and growth of microorganisms Store rework in an appropriate environment that prevents or minimizes food

Rework
General good storage practices. For example:
store rework materials off the floor and away from walls to minimize contamination cover and protect rework materials use clean containers ensure storage room is adequate for storing food products (ex: avoid pest access, permit maintenance and cleaning)

Rework
Prevent cross-contamination with allergens. Inappropriate use of rework materials
may result in the presence of undeclared ingredients in final products. specify designated uses for rework materials. For example, use rework materials only with products that already have the same ingredients. identify ingredients and ensure that rework containing different ingredients is not used in those products

Rework
Develop a rework tracking system to be able to identify the final products containing rework materials. A rework tracking system will be necessary if a food product is recalled because it or any of its ingredients is identified as a health risk

Rework
Monitor the use of rework. To ensure rework material is used and handled properly, you should:
confirm that rework material is properly identified confirm that rework material is stored under conditions that protect the safety of your products (ex: correct temperature) observe employees handling rework to ensure they follow proper procedures monitor your rework tracking system by reviewing records

Waste Control

Lab / Maintenance Waste

How do we define industrial waste?

Residues from industry Many commercial residues Increasingly post-consumer waste is included Hazardous residues from agriculture, transport etc Above often defined industrial because urban waste is traditionally narrowly defined from a time when chemical components were not present, and because urban waste authorities and municipalities lack skills and facilities to manage special waste components. Result can be confusion and conflict of authorities

Waste Audit
1. 2. 3. 4. 5. 6. Identify plant operations Define process inputs Define process outputs Assess material balance Identify opportunities Conduct feasibility study

Transportation
(1) Names of the transporter's immediate previous source and transporter's immediate subsequent recipient; (2) Origin and destination points; (3) Date shipment received and date released; (4) Number of packages; (5) Description of freight; (6) Route of movement during the time you transported the food; and (7) Transfer point(s) through which shipment moved

Problem areas during transport

Improper refrigeration or temperature control of food products (temperature abuse). Improper management of transportation units (or storage facilities used during transport) to preclude cross-contamination, including improper sanitation, backhauling hazardous materials, not maintaining tanker wash records, improper disposal of wastewater, and aluminum phosphide fumigation methods in railcar transit;

Storage and distribution

Raw materials, packaging materials and products shall be protected from contamination (including uncharacteristic odor) during transport, storage and delivery. Raw material, unfinished products and products transferred between premises shall be suitably protected. Pallets shall be inspected before use. They shall be suitable for use with the intended products and clean, free from foreign bodies, uncharacteristic odors and pests. Pallets shall not contaminate raw materials, unfinished and finished products.

Storage and distribution

Transport vehicles shall be checked before loading and unloading. They shall be kept clean and free from foreign bodies, uncharacteristic odor and pests. All the warehouses shall be controlled to prevent any possible cross-contamination. Subcontracted warehouse facilities shall guarantee the same hygiene standard as the organizations own facilities.

Storage and distribution

Improper packing of transportation units (or storage facilities used during transport), including incorrect use of packing materials and poor pallet quality; Improper loading practices, conditions, or equipment, including improper sanitation of loading equipment, not using dedicated units where appropriate, inappropriate loading patterns, and transporting mixed loads that increase the risk for cross-contamination;

Storage and distribution

Poor pest control in transportation units (or storage facilities used during transport); Lack of driver/employee training and/or supervisor/manager/owner knowledge of food safety and/or security; Poor transportation unit design and construction; Poor employee hygiene;

Storage and distribution

Inadequate preventive maintenance for transportation units (or storage facilities used during transport), resulting in roof leaks, gaps in doors, and dripping condensation or ice accumulations; Inadequate policies for the safe and/or secure transport (or storage during transport) of foods, e.g., lack of or improper use of security seals;

Personal Hygiene

Personal Hygiene

Hand Washing
Upon arrival at work. Immediately before handling food After using the toilet After handling pets, pet cages, or other pet objects. Whenever hands are visibly dirty or after cleaning After removing gloves used for any purpose.* Before giving or applying medication or ointment to others or self. Before going home.

Clean Attire

Staff premises/ toilet facilities

Staff premises/ toilet facilities

Toilet facilities: Each plant shall provide its employees with adequate toilet and associated hand-washing facilities within the plant and furnished with toilet tissue. The facilities shall be maintained in sanitary condition; are protected from splash, dust and other contamination; Doors to toilet rooms shall be self-closing and shall not open directly into areas where food is exposed to airborne contamination, except where alternate means have been taken to prevent such contamination (such as double doors, positive air-flow systems, etc.). Signs shall be posted directing employees to wash their hands with cleaning soap or detergents after using the toilet.

Personnel and visitors

When reporting to work or on entering a production, you must: Keep hair clean and combed Keep face clean Keep apron and uniform clean Keep shoes or safety boots well covered Bathe daily Keep hair, moustache, beards and side burns short and neat

Food and drinks

Do not smoke, eat or drink in the production site or food storage area Do not eat chewing gum in production site Drinking facility need to be adequately situated

Jewellery, Smoking and Clothing

Do not wear jewelry in production Do not wipe your dirty hands on your uniform or apron Remove your aprons, mask, gloves, hairnets or hats when leaving the food preparation area or on entering a toilet

Education and training

The provision of induction training ( including code of hygiene practices and workplace health and safety) for all new recruits. The provision of on going awareness training All operators understand Good Hygiene Practice and Good Manufacturing Practices including food safety policy and objectives before they area allowed to handle food stuffs

Question & Answer

Thank You