Good laboratory practice in the pharmaceutical sector
With so many risks and hazards present, pharma lab work needs to adhere to good laboratory practice. But what does that entail?
Laboratories are an essential element of the work undertaken by pharmaceutical companies. They’re the location for preclinical and non-clinical studies. This makes them the source of initial data on the efficacy, toxicology, pharmacology, biocompatibility, and safety of drugs, biologics, and medical devices. However, laboratories are also the source of many risks and hazards for those who work in them and the environment.
In this article, we’ll look at some of the legislation governing laboratory practice and safety, and how you can ensure you’re following good laboratory practice.
Why is good laboratory practice important?
Laboratories are working environments full of potential occupational risks. Those working in them often spend long hours there, and may be exposed to various chemicals, biological agents, hazardous waste, and even radioactive substances. Many of these agents can have long-term effects on both individuals’ health and the environment. It’s therefore essential to follow good practice when it comes to laboratory management to ensure employees remain safe, and to prevent any contamination or leakage outside the lab.
Labs are also the places that test potential manufacturing processes to monitor and manage product effectiveness. Lab safety is therefore also closely related to product effectiveness and quality management for the manufacturing process.
There are two important aspects of lab safety:
- Lab safety requirements define the data companies must track and report on to maintain safety compliance.
- Good laboratory practice is considered essential for ensuring the quality and integrity of safety data.
Which government agencies are responsible for laboratory safety?
Many international bodies have a hand (or say) in laboratory safety and good laboratory practice, including:
The Organization for Economic Cooperation and Development (OECD)
The OECD has set out principles for good laboratory practice, which it describes as a managerial quality control system. The system covers the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, and reported — and how data from them are retained. These principles must be followed by any test facility that carries out studies to be used by authorities to assess the health and environmental safety of chemicals or chemical products. Compliance is checked by national monitoring programs in countries that use the OECD principles.
The European Union (EU)
The European Union Directive 2004/9/EC sets out the requirements for Member States about good laboratory practice, in line with the OECD guidance. It imposes a duty on designated authorities to supervise the implementation of good laboratory practice. Those authorities also have to inspect and audit compliance for all chemicals, including cosmetics, industrial chemicals, medicinal products, food additives, animal feed additives, and pesticides. Directive 2004/10/EC incorporates the Annex of the OECD guidance. It describes the following requirements for the organization and personnel:
- Quality assurance program.
- Facilities apparatus.
- Materials and reagents.
- Test and reference items.
- Performance of studies.
- Recordkeeping and reporting.
US Food and Drug Administration (FDA)
The FDA has published Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58). This sets out a management system to assure the quality and integrity of safety data from non-clinical laboratory studies that are used to obtain marketing permission for:
- Food and color additives.
- Animal food.
- Human and animal drugs.
- Medical devices for human use.
- Biological products.
- Electronic products.
In other words, approval to market these products is dependent on complying with the FDA’s guidelines on good laboratory practice.
US Environmental Protection Agency (EPA)
The US EPA has established a Good Laboratory Practices Standards Compliance Monitoring Program. It requires good laboratory practice in any facilities that carry out non-clinical studies to submit data to the agency to obtain approval to market pesticide products (40 CFR part 160, Federal Insecticide, Fungicide and Rodenticide Act “FIFRA”) or industrial chemicals (40 CFR part 792, Toxic Substances Control Act “TSCA”). The program defines the criteria to ensure data quality and integrity. Here again, approval to market any of these products will depend on compliance with the standards set out by the agency.
International Labor Organization (ILO)
The ILO publishes International Hazard Datasheets on Occupations to protect workers from dangers inherent in their occupation or profession. Laboratory workers are exposed to physical, chemical, and biological hazards, as well as ergonomic, psychosocial, and organizational factors.
The ILO hazard datasheet sets out requirements for basic prevention measures, such as:
- Wearing personal protection equipment, such as shoes, gloves, and eye protection.
- Using chemical safety measures like labeling and safety data sheets.
- Establishing biohazard safety rules for handling hazardous substances, biological agents, or laboratory animals.
- Offering safety training to workers so that they can identify hazards and react appropriately.
In June 2022, the ILO issued technical guidelines on biological hazards in the working environment. This sets out employers’ obligations to ensure the safety of laboratory workers by:
- Providing personal protective equipment and occupational health services.
- Implementing biological hazard identification and risk assessment systems.
- Carrying out health surveillance for workers.
- Offering hazard information and training.
- Preparing emergency responses.
- Inspecting and ensuring regulatory compliance.
US Occupational Health and Safety Administration (OSHA)
There are also health and safety standards that apply to laboratories. In the US, these are issued by OSHA (29 CFR1910). They include requirements about personal protective equipment (1910 Subpart I), such as eye, face, and respiratory protection.
The standards cover general principles of selecting, providing training on, and ensuring the safe use of this equipment. There are also standards on general environmental controls (1910 Subpart J), including the lockout and tag-out process for hazardous energy sources, and toxic and hazardous substances (1910 Subpart Z).
This covers the monitoring of permissible hazardous chemical exposure to employees, ensuring chemical hazards labeling and safety data sheets communication, as well as special controls on exposure to formaldehyde and blood-borne pathogens.
How to implement, manage, and maintain good laboratory practice
Many of the guidelines set out above are nominally voluntary. However, compliance is essential to obtain authorization to market a product that comes under the scope of the guidelines. Others — such as health and safety requirements — are mandatory. They include aspects such as signage, training, protective equipment, and processes for handling hazardous substances. Good laboratory practice therefore starts with complying with regulations about lab safety. Pharmaceutical companies will need to go beyond this to comply with the requirements set out by agencies in any jurisdiction in which they operate and wish to market products.
Going beyond lab safety regulations takes a comprehensive understanding and implementation of the compliance requirements for every type of facility in any jurisdiction you may operate in. To stay on top of such broad and evolving regulations needs ongoing expert insight — which is why our solutions are designed to be highly customizable and readily accessible. With the up-to-date information provided by our team of experts, you can ensure your teams have all the necessary information to adhere to the protocols and practices that will keep them safe, while assuring your products will be authorized to go to market.