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Good Laboratory Practices

Development – To define detail, scope and purpose.

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Training participants will gain a basic understanding of Good Laboratory Practices and their applications within food safety and quality systems. Basic knowledge competency will be verified through successful completion of the accompanying Good Laboratory Practices assessment activity. Basic skill competency can be verified through the Good Laboratory Practices competency checklist available as a resource for this training activity.

Key Definitions For Good Laboratory Practices
- Good Laboratory Practices or GMP: Good Laboratory Practice include the developed, documented and implemented processes and conditions under which analytical laboratory activities are planned, performed, monitored, recorded, and reported.
- Proficiency Testing: An evaluation of the ability of a laboratory to achieve a correct test result when compared with at least 1 other laboratory in which more than 1 similar sample is periodically sent to more than 1 laboratory for analysis. Outcomes of each laboratory’s testing results are compared with those of other laboratories in the group.
- Reagent: A reagent is a substance or compound that is added to a system in order to bring about a chemical reaction or is added to see if a reaction occurs. Such a reaction is used to confirm the presence of another substance.
- Standard Operating Procedures or SOP: Established procedure or set of procedures to be followed in carrying out a given operation or in a given situation.
- Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.

Good Laboratory Practices Development
When considering the development, documentation and implementation of Good Laboratory Practices within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

About Good Laboratory Practices
It is not uncommon for food businesses to conduct their own testing of raw ingredients, work in progress or finished products, particularly for testing against microbiological or chemical criteria. It is important that these and other related activities do not have an impact upon the safety of the foods being produced onsite, and that the results are accurate. It is also important to ensure that any contracted laboratory services are also operating within the confines of established Good Laboratory Practices.

Good Laboratory Practices commonly include requirements for:
- Organization Structure and Personnel;
- Laboratory Quality Assurance Program;
- Facilities and Amenities;
- Laboratory Testing Equipment and Materials;
- Test Systems;
- Test and Reference Items;
- Standard Operating Procedures;
- Reporting of Testing Results;
- Storage of Testing Records and Reports.

Organizational Structure and Personnel
Systems should be developed, documented and implemented to ensure appropriate outcomes regarding the organisational structure covering the scope and purpose of the laboratory facility. This should ideally include a defined organisational structure showing reporting channels and clear definition of requirements for the covering of absences within key positions. Position descriptions should also be developed, displaying clear nominations for the qualifications and experience of key personnel participating within laboratory activities.

Management responsibilities should be defined to include requirements for:
- Ensuring that qualified personnel, appropriate facilities, equipment, and materials are available;
- Maintaining a record of the qualifications, training, experience and job description for each professional and technical individual;
- Ensuring that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;
- Ensuring that health and safety precautions are applied according to relevant regulations;
- Ensuring that appropriate Standard Operating Procedures are developed, documented, implemented and followed;
- Ensuring that there is a Quality Assurance Program with designated personnel;
- Maintaining copies of all laboratory testing plans;
- Maintaining a historical file of all Standard Operating Procedures;
- Ensuring for each test conducted that a sufficient number of personnel is available for its timely and proper conduct.

Laboratory Quality Assurance Program
A quality assurance program should be developed, documented and implemented to include requirements for:
- Quality assurance program elements to ensure that all tests performed are in compliance with Good Laboratory Practices;
- Providing resources for application of the quality assurance program through interactions by an individual or by individuals who are familiar with the testing procedures conducted within the laboratory;
- Proficiency testing to ensure the accuracy of testing outcomes conducted under the established testing methods with the available equipment and materials. Proficiency testing commonly involves taking at least 2 identical samples; One of which is tested within the food business laboratory; the other of which is sent to an accredited testing laboratory. The testing methods employed by the food business laboratory are duplicated by the accredited laboratory, and testing outcomes are compared to ensure results are within a suitable range of variance. Proficiency testing activities are commonly coordinated with an accredited testing laboratory to ensure the most accurate outcomes. This may include decisions to hold sample under agreed temperatures and storage conditions and begin testing at a pre-determined time.

The responsibilities of the quality assurance personnel should include, but not be limited to, the following functions:
- Ascertain that the testing plans and Standard Operating Procedures are available to personnel conducting testing and laboratory functions;
- Ensure that the testing plan and Standard Operating Procedures are followed through scheduled inspections of the laboratory and by auditing examples of tests in progress. Records of such procedures should be retained.
- Ongoing reports to management regarding conformance and unauthorised deviations from the established testing plans and Standard Operating Procedures;
- Review and authorize the final testing outcomes and reports to confirm that the methods, procedures, and observations are accurately described, and that the reported results accurately reflect the actual outcome of testing conducted.

Facilities and Amenities
Requirements for laboratories and testing facilities and amenities should be defined to include:
- Suitable size, construction and location to meet the requirements of testing to be conducted and minimise disturbances that would interfere with the validity of testing outcomes;
- Design of the test facility should provide an adequate degree of segregation of different testing activities to ensure appropriate outcomes of each testing activity conducted;
- Justification of sufficient number of rooms or areas to ensure required isolation of test systems and the isolation of individual projects involving substances known or suspected of being bio-hazardous;
- Provisions for storage areas as needed for supplies and equipment. Storage areas should be segregated from areas in which testing activities are conducted, and should be adequately protected against infestation and contamination. Refrigeration should be provided for the storage of perishable items. Storage areas for the test substances should be separate from areas in which testing is conducted; These should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances;
- Space for archives for the storage and retrieval of raw data, reports, samples, and specimens where applicable;
- Handling and disposal of laboratory waste materials in a way that does not to jeopardize the integrity of testing in progress or to other activities conducted within the immediate vicinity or site in which the laboratory is located. The handling and disposal of laboratory wastes must be carried out in a manner which is meets regulatory requirements. This may include provision for appropriate collection, storage, and disposal facilities, decontamination and transportation procedures, and the maintenance of records related to waste disposal procedures;
- Location of the laboratory in relation to the production area must be given careful consideration in the planning stage with particular respect to the risk nature of the products being manufactured and the types of testing that will be carried out in the laboratory. 

Laboratory Testing Equipment and Materials
Requirements for laboratory testing equipment and materials should be defined to include:
- Suitable size, construction, condition and location of equipment used for testing and for controlling environmental conditions under which testing is conducted;
- Inspection, cleaning, sanitation and maintenance requirements for testing equipment;
- Calibration scheduled, procedures and records for relevant equipment;
- Provisions to ensure equipment and materials used in testing do not interfere with the testing procedures or outcomes;
- Identification, traceability, description and intended use information for reagents used as elements of testing conducted at the site.

Testing Systems
Requirements for testing systems should be defined to include:
- Suitable design, capacity and location of equipment used for the generation of physical or chemical testing outcomes;
- The establishment of appropriate conditions for the maintenance of the storage and handling of microbiological and chemical samples to ensure the quality of testing outcomes. In addition to standardised requirements, regulatory compliance requirements for the storage and handling of microbiological and chemical samples must be met

Test and Reference Substances
Requirements for test and reference substances should be defined to include:
- Maintenance of records including substance characterization, date of receipt, quantities received, and amounts used for testing;
- Handling, sampling, and storage procedures to ensure condition is maintained to the degree possible and contamination or mix-up are controlled;
- Identification, expiry date, storage and use instruction labelling for all test and reference substances.

Standard Operating Procedures
Standard operating procedures should be developed, documented and implemented, including the following requirements:
- Standard Operating Procedures approved by management that are intended to ensure the quality and integrity of the data and outcomes of all testing conducted. Each separate testing method facilitated should have immediately available Standard Operating Procedures relevant to the activities being performed therein. Published text books, articles or manuals may be used as supplements to these Standard Operating Procedures where applicable;
- Standard Operating Procedures should be available for all testing methods conducted within the laboratory;
- Specific Standard Operating Procedures should be documented for the documentation and reporting of testing outcomes, including requirements for the review and verification of outcomes.

Reporting of Testing Results
Reporting of testing results must be appropriately structured to include general and specific information regarding the scope and purpose of the testing conducted.

Testing results reports should include:
- An appropriate descriptive title;
- Testing facility information, including Business Name, Address, Contributing Personnel;
- Testing start and finish dates;
- Test results report number or traceability code;
- Identification of the testing method or methods used;
- Identification of materials used in the testing process;
- Identification of the substance or material tested;
- Results of testing;
- Summary of testing results against relevant standards or guidelines.

Storage of Testing Records and Reports
As with any management system, Good Laboratory Practices rely on well-developed document and record control procedures to ensure traceability and appropriate outcomes.

The following requirements should be considered regarding the storage of testing records and reports;
- Record and report archives should be designed and equipped for the accommodation and the secure storage of all relevant notes, data and outcomes of tests conducted, including final reports, quality assurance verification activities and samples and specimens where applicable. Materials stored in such archives should be appropriately indexed to facilitate orderly storage and rapid retrieval when required;
- Only personnel authorised by management should have access to storage archives;
- Movement of material in and out of the archives should be recorded to ensure traceability of items;
- All relevant records and reports should be retained for the period specified by the appropriate authorities or customers.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Laboratory Practices Development requirements in relation to their items.

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