Good laboratory practice

Introduction

Good laboratory practice have principles which give structure to the studies of which they are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers including the environment, can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides.

Purpose

Good laboratory practice provides results from the study which are reliable and can be used for making risk/safety assessments.

The Good laboratory practice regulations provide an interpretation of the terminology used in defining the elements of GLP. Here are few examples

Study plan – this is a document which shows why an experiment is being carried out and how it should be performed in order to comply with Good laboratory practice.

Study Director- dealing with Good laboratory compliant

Study personnel- all the people that carry out the experiments

Study initiation Date – Date that the study first signs the study plan

Study Plan Amendment – an intended change to study plan after the initial study date

Standard operating procedures – sufficiently detailed work instructions to allow the procedure to be repeated exactly the same way each time by any operator.

Findings

Raw materials

• Raw materials are reagents used in processing. They are classified regarding identification of samples for example
• Enzymes which are used in the study.
• Storage instructions
• Expiry date
• Quality e.g. purity of a chemical
• Source of the material, preparation date and stability
• Cell culture

Equipment maintenance and calibration

All the equipment must be clean to function reliably.

For each piece of equipment there should be:

• A number for identification of the apparatus.
• A calibration check (should be traceable to national or international standards)
• Validation that equipment fir for purpose
• Staff should be trained to use equipment
• Operating and parameters
• Clean equipment
• Data logging and tracking

Transport

Delivering chemicals by roads or by train have the possibilities of accidents. If there is a leak it could cause a spillage which can cause cars to slide and hit each other which could potentially lead to an explosion which could cause fatalities as well as damage to the nearby surroundings.

Customer services

The aim is to build up a trust between clients and the company. Any reported problem from any client should be followed up and dealt with to the highest standard possible.

Labelling, storage, packing

All the reagents must be fully labelled with:

• Name of reagent
• Who made it?
• Date the item was prepared
• Expiry date
• Storage conditions
• Hazard labels
• Name of the company or institution
• If the reagent is not labelled there is no evince of what it is!

Storing/Packing of data

Materials required to be stored include:

• The study plan, raw data, samples of test and reference items, specimens and final report of each study
• The records of all inspection performed by the quality assurance
• Personal records
• Records and reports of the maintenance and calibration of equipment
• Validation documentation for computerise systems
• SOPs
• Environmental monitoring records

The materials retained should be properly indexed and movement of information should be noted.

Training

For high quality GLP training, you need experienced Course Directors. Each Course Directors have to be from senior level scientific, regulatory and management positions in a variety of organisations and industries.

Procedures

SOPs stands for Standard operating producers

SOPs is a factor which in the production of products fit for their intended use. All the operators must be aware of all the relevant SOPs and implement them correctly.

If there is a failure carrying them out correctly it means that it can lead to the production of products harmful, and potentially lethal to customers.

Implementing of quality standards for example what must happen in a work place to ensure compliance?

Everyone in the lab should know what they are doing. In implementing Good Lab Practice the study director is the single point of control for a given study and has the responsibility for its overall conduct and finial report.

Standard Operating procedures

A key aspect of the study personnel’s role in ensuring good lab practice compliance in their work is the writing and implementation of standard operating procedures. These are work instruction, which are accurately detailed to allow the procedure to be repeated exactly the same way each time by any operator

Internal mentoring

Those who have been in long term employment would be expected to encourage and support new and younger staff members. Giving guidance where it is needed.

Quality assurance (QA)

Quality assurance refers to all actions necessary to provide confidence that the product or service will satisfy the prescribed requirement for quality. QA involves the setting up of a quality system, and overseeing that this system is being implemented correctly.

In short, quality assurance does exactly what it says. By considering all the aspects of the business process it ensures that the work being done will meet the required standard.

The responsibilities of the Quality Assurance:

• maintain copies of all approved study plans and Standard Operating Procedures in use in the test facility and have access to an up-to-date copy of the master schedule
• Verify that the study plan contains the information required for compliance with these Principles of Good Laboratory Practice.

Recording of primary data

Log Book is a primary source of raw data in any process. It provides evidence which may be used in a court law it might also be sued in patent applications or used as a cross reference in auditing work.

Monitoring temperatures in incubators or fridges

Monitoring temperature is very important in lab.

For the operation of fridges and freezers we need to consider what temperature should it run at ?

The required limit e.g. 4oC +/- -2oC

All fridges used for the storage of medicines must have the temperature monitored daily to ensure the correct storage of those medicines.

Maintenance of log book:

• Bound note book should only be used.
• The hand writing should be clear so that operators can understand it.
• Blue or black ink must be used in order to prevent fading and allow documents to be photocopied easily.
• All pages should be numbered to prevent pages being removed.
• All data should be recorded.
• All data should be verified through the use of signatures and witnesses.
• Correction should be verified by being signed and dated.
• Blank lines or pages should be crossed out with a diagonal line signed and dated.
• All detailed information about instruments, samples, materials, and equipment should be included.
• The logbook should be stored in a secure location.

Regulator Bodies which are involved in ensuring compliance with the chosen standard are the governments and the trade association.

Inspectors carry out biennial inspections of all labs within the UK that perform regulatory studies that require to be conducted to Good Lab Practice

After a satisfactory inspection by GLPMA, be issued with a statement of GLP compliance.

The GLPMA provides information to trade association and other Governments departments on aspects of GLP.

Regulators:

Governments

The Governments are responsible for enforcing the regulations in GLP on the behalf of the UK Monitoring Authority

• MHRA Medicines and Healthcare products Regulatory
• Veterinary Medicines Directorate (DEFRA)
• Pesticides safety Directorate (DEFRA)
• Food standard Agency for example feed addictives, novel and foods, food additives and food contaminants )
• Health and safety executive
• Environment Agency

Trade associations

Monitoring compliance;

• Association of British pharmaceutical industry
• Association of consultant bioscience industry
• Crop protection association
• British Association of research quality Assurance
• Chemical aspects of Toxicology Discussion Group.
• Association of independent research testing organisations
• United Kingdom accreditation service.