Why working practices in a laboratory are regulated

First, GLP is a quality management system, not a scientific management system. Or, in other words, GLP defines a set of quality standards for study conduct, data collection, and results reporting. GLP does not define scientific standards. If a study follows GLP, then you can be reasonably sure that the reported results were collected as outlined in the study protocol; however, you cannot be sure that the study actually addresses the scientific hypothesis. In the world of cooking, GLP would ensure that someone follows the recipe exactly as written; however, it does not assure you that the recipe was good or that the resulting item will be tasty!

This QA unit is intended to be an independent group or individual that monitors the entire study conduct, analysis, and reporting. The purpose of QA is to verify that all written procedures are followed throughout the study.

As an example, perhaps there is an SOP that says that a senior pharmacokineticist must review the results prior to finalization. The QA auditor will verify that this review occurred. Verification could be done by reviewing a signed document, reviewing an electronic signature, or even speaking directly with the reviewer. The QA auditor will ensure that the senior pharmacokineticist has adequate training as defined by SOPs in the organization to perform his or her duties.

As a precaution against the wrong regulator being connected, the cylinder outlet threads for fuel gases for example, hydrogen and propane have a left-handed thread, whereas oxygen and inert gases have a right-handed thread. A laser produces an intense, highly directional beam of light, and exposure to this beam can result in damage to the eye and skin. Safe exposure limits for nearly all types of laser radiation have now been established and these are referred to as maximum permissible exposures MPEs by professionals in the field.

However, based on experience, a more general system of laser hazard categories or classifications has been developed; basically, lasers are assigned to one of four general classes 1—4, where 4 is the highest class. The higher the class of a laser, the more stringent are the control measures required.

An He—Ne laser, for example, is a Class 2 laser. A brief description of this category of laser taken from information published by the Laser Institute of America is as follows:. A Class 2 laser or laser system must emit a visible laser beam. Because of its brightness, Class 2 laser light will be too dazzling to stare into for extended periods.

Momentary viewing is not considered hazardous since the upper radiant power limit of this type of device is less than the MPE for momentary exposure of 0. Intentional extended viewing, however, is considered hazardous.

It follows from this description that you should avoid looking into a direct Class 2 laser beam and also make sure that the beam cannot be reflected by material inadvertently placed in its path. If the laser beam does enter your eye, say by an unintended reflection, you should move your head away immediately.

Do not re-sheath needles or sharps unless unavoidable due to the nature of the work. Dispose of all solid waste in autoclave bins by autoclaving and then via the clinical waste route.

Hazards are caused by incorrect balancing of tubes, leakage from a broken or collapsed tube within the rotor or aerosol production from the tubes themselves. Sealed buckets should be used for hazardous material in a centrifuge without an airflow check the manual.

Allow 2 minutes after a rotor comes to rest before opening the lid of the centrifuge, to allow any aerosol to settle. Dispose of all solid waste in autoclave bags in the grey bins provided and then by autoclaving and then via the clinical waste route. Spillage must be contained by absorbent material and disinfected appropriately, based on the GM Risk Assessment form. Field-work covers a wide spectrum of outdoor activities and takes place in almost every environment present both in the UK and abroad.

It is acknowledged that there is an element of risk in much of this work. The Health and Safety at Work Act recognises that risk is inherent in some occupations and seeks to ensure that systems of work are in place to reduce risks to an acceptable level. There has been increasing concern about the safety of field trips in the light of recent court cases involving fatalities of schoolchildren on organised field trips.

What has been emphasised is the need for well-written risk assessments. Indeed, one education authority was prosecuted for not having produced written risk assessments.

One may start up a mountain in bright sunshine, but the weather can quickly change to a blizzard; this can result in a dangerous situation because of loss of visibility and cold, which may lead to hypothermia. In arid areas there can be a problem with flash floods. People have decided to camp in a dried-up river valley which suddenly becomes a torrent.

At the other extreme, when working in summer or hot, dry regions, there is the danger of sunstroke, sunburn and dehydration. Plan your work to avoid the hottest time of the day, put suntan lotion on, wear a hat and take plenty of water with you.

If you are working in any area that is tidal then you must be aware of the tide times to avoid being cut off or drowned. When planning field trips it is important to be aware of the weather, in addition to weather forecasts. Information about potential local flooding can be obtained from the Environment Agency.

It is important to be able to communicate in an emergency, so a mobile phone or a VHF radio is important. Check the reception, however, because it can vary in remote areas. Alternatively, for very remote areas, a satellite phone can be used.

Such minor accidents are always possible, especially on rough or uneven terrain. It is recommended, therefore, that boots should be worn to protect the feet and ankles, and that outer clothing should be of a suitable nature to minimise the chance of cuts, scratches, and abrasions being sustained.

Wearing gloves will minimise damage to hands. Protective headgear hard hats must be worn whenever this is advised by the party leader. Goggles or glasses should be worn when hammering or breaking rocks. Whilst no climbing requiring the use of special equipment or aids will be undertaken, it is possible that in order to view interesting geological features it may be necessary to approach the edge of a cliff, or to stand in locations where a fall could result in serious injury.

In such situations it is expected that individuals will exercise reasonable caution, and at all times will follow the instructions and advice of the party leader. Quarrying operations may involve blasting and the use of heavy earth-moving equipment. This applies to all quarries, whether working or otherwise. Similar hazards may be encountered in other industrial workings. Therefore, it is essential:. In summary, be prepared; see Appendix C below for a list of equipment that may be required for field-work.

Click to open Appendix C. The leader must be informed of any problems of mental or physical health that may affect safety during field-work. This may include, for instance, information on diabetes, asthma or epilepsy; students should also inform the leader if they require extra assistance. All work handling living organisms, soil or water may give some risk of infection, and protection in the form of gloves, masks, etc.

Supervisors should give advice concerning particular health hazards that may be encountered in the area s to be visited and, where necessary, persons planning to attend overseas field trips should contact the Occupational Health Department for appropriate first aid advice and vaccinations. If students are expected to be eating packed lunches, it may be appropriate to suggest they bring their own hand wipes if washing facilities are not available.

For further information on health issues when travelling, visit Masta Travel Health. Ticks are most common in spring and autumn in bracken and long grass. The ticks become attached to skin or clothing and migrate to moist warm areas such as the axilla armpit or groin. Tick-borne illness is increasing, even in the UK.

In North America, the following diseases are caused by tick bites: Lyme disease, human granulocytic and monocytic ehrlichiosis, babesiosis, relapsing fever, Rocky Mountain spotted fever, Colorado tick fever, tularemia, Q fever, and tick paralysis. In Europe, the list is similar, but other diseases should be considered as well; these include boutonneuse fever caused by a less virulent spotted fever rickettsial organism Rickettsia connori , and tick-borne encephalitis.

Remove ticks from body as soon as possible. Seek medical attention if necessary, or ask a field companion to help. If self-treating, use tweezers hooked under the tick's body, taking care not to pull off the tick's body and leave the head embedded. Most tick bites do not result in transmission of infection; in the case of Lyme disease for example, only about 2—3 per cent of all persons bitten by Ixodes scapularis ticks in endemic areas develop Lyme disease.

If infected, 2—6 weeks after the bite a rash and pain in the joints can develop. Untreated, this infection can lead to health problems years later. Leptospirosis is an infectious disease caused by bacteria; it occurs particularly in rodents, but also in dogs and other mammals. The greatest risk is where there is standing water, such as water and pools in streams in arid regions. Hot springs are a common source of infection. Medical attention should always be sought and the doctor informed of the recent field trip.

This can be a serious illness, and prompt diagnosis is essential. After reading this course you might like to carry out a risk assessment of your office environment or a nearby office and one of the following:. This free course provided an introduction to studying Science. This is a written plan developed by the employer e. In many large institutions, the environmental health and safety department has developed a generic Chemical Hygiene Plan, but the plan must be modified to include detailed protections that are specific to each laboratory and its workers.

This approach allows considerable flexibility in achieving the performance-based goals of the Laboratory Standard. The intention of the standard is to supersede existing OSHA health standards, but other OSHA rules on topics not specifically addressed in the standard remain applicable. The so-called "general duty" clause of the Occupational Safety and Health Act, which requires an employer to "furnish to each of his employees Other OSHA standards relating to possible eye or skin contact must continue to be observed.

There are dozens of chemicals in this category. They are listed in 29 CFR as well as in specific standards following Section Other OSHA standards setting forth permissible exposure limits PELs apply to the extent that they require limiting exposures to below the PEL and, where the PEL or "action level" is routinely exceeded, the Laboratory Standard's provisions require exposure monitoring and medical surveillance.

The requirements for exposure monitoring and medical surveillance are found in Appendix A , sections d and g of the Laboratory Standard.

Quoting the TLV booklet ACGIH, , "Threshold Limit Values TLVs refer to airborne concentrations of substances and represent conditions under which it is believed that nearly all workers may be repeatedly exposed day after day without adverse health affects. The existence of a "time-weighted average TWA exposure" approach to control of airborne contaminants indicates that exposures may be somewhat higher or lower than the average at various times of the day, which is typical of work with chemicals.

ACGIH also recommends, for some compounds, a short-term exposure limit STEL , which establishes a safe exposure limit of no more than four minute periods a day. STELs are published only for compounds where toxic effects have been reported from high short-term exposures in either humans or animals. Some compounds have a "C" preceding the numerical TLV designation.

This indicates that the TLV is a ceiling level concentration that should not be exceeded during any part of the working exposure.

Ceiling limits have generally been applied to compounds that are fast acting. For compounds that include neither a STEL nor a C notation, a limit on the upper level of exposure should still be imposed. The "action level" is an OSHA regulatory term occurring in a few substance-specific regulations. It is an airborne concentration lower than the associated PEL that, when exceeded, requires certain activities, such as exposure monitoring or medical surveillance.

There are special provisions in the Laboratory Standard regarding work with "particularly hazardous substances," a term that includes "select carcinogens," "reproductive toxins," and "substances with a high degree of acute toxicity. Chemicals with a "high degree of toxicity" also require special provisions for worker health. Although "select carcinogens" are specifically identified through reference to other publications, "reproductive toxins" and chemicals with a ''high degree of acute toxicity" are not specified further, which has made it difficult to apply these categories.

It is the laboratory manager's responsibility under the Laboratory Standard and the "general duty" clause to apply scientific knowledge in safeguarding workers against risks, even though there may be no specifically applicable OSHA standard. The OSHA-mandated special provisions for work with carcinogens, reproductive toxins, and substances that have a high degree of acute toxicity include consideration of "designated areas," use of containment devices, special handling of contaminated waste, and decontamination procedures.

The OSHA requirement is for evaluation, assessment, and implementation of these special controls, when appropriate. These special provisions are to be included in the Chemical Hygiene Plan. The Laboratory Standard also requires quite detailed record-keeping, particularly with regard to records of exposure monitoring and medical surveillance, in those circumstances where exposure limits are exceeded or where work with especially hazardous substances is conducted.

OSHA standards apply only to "employees" of laboratory facilities. In many cases, students are not employees within the scope of the Occupational Safety and Health Act, but both moral and legal considerations suggest that colleges and universities provide the same protections to students as are provided to all employees regularly working in the laboratory.

Custodial and maintenance staff who service the laboratory continue to be governed by other OSHA standards, particularly the Hazard Communication Standard, which sets forth the information, training, and health and safety protections required to be provided to nonlaboratory employees. Enforcement of the Laboratory Standard, as well as other OSHA standards, may be a shared responsibility of the federal government and of state occupational safety and health programs.

Under Section 18 of the Occupational Safety and Health Act, individual states may be authorized by federal OSHA to administer the act if they adopt a plan for development and enforcement of standards that is "at least as effective as the Federal standards. In states that do not administer their own occupational health and safety programs, federal OSHA is the regulator, covering all nonpublic employers. State-plan states have generally included public employees in their regulatory approach.

What this means is that a given institution may be subject to 1 the federal Laboratory Standard, enforced by federal OSHA, 2 a state Laboratory Standard, enforced by state OSHA, or 3 if a public institution is not subject to OSHA regulation, state public institution health and safety regulations enforced by a state agency.

The environmental health and safety office at each institution should have a copy of the applicable standard. Another commonly cited violation is failure to meet the "Employee Information and Training" requirements of the Laboratory Standard.

It is likely that OSHA enforcement of the Laboratory Standard will increase in the future, as state and federal OSHA inspectors focus more on laboratory activities and the implementation of this still relatively new standard. It is important to understand the distinction between the Laboratory Standard and the Hazard Communication Standard.

As noted above, the Laboratory Standard is intended, with limited exceptions, to be the. OSHA standard governing employees who routinely work in laboratories.

The Hazard Communication Standard, on the other hand, applies to all nonlaboratory operations "where chemicals are either used, distributed or are produced for use or distribution. The requirements of the Hazard Communication Standard are, in certain respects, more demanding than those of the Laboratory Standard.

For example, the Hazard Communication Standard requires that each container of hazardous chemicals used by the employee be labeled clearly with the identity of the chemical and appropriate hazard warnings, whereas the Laboratory Standard requires only that employers "ensure that labels on incoming containers of hazardous chemicals are not removed or defaced.

Careful comparison of the two standards should be made when designing an environmental health and safety program. Subtitle C of that act established a system for controlling hazardous waste from generation to disposal. This is often referred to as the "cradle to grave" system.

The cradle, however, is the point at which the hazardous material first becomes a "hazardous waste," not when it is first received in a laboratory. Under RCRA, the Environmental Protection Agency is given great responsibilities in promulgating detailed regulations governing the generation, transport, treatment, storage, and disposal of hazardous waste.

RCRA and EPA regulations were written with a focus on industrial-scale generation of hazardous waste, but, with very limited exceptions, they also apply to laboratories that use chemicals. It is important to understand who is a generator under RCRA. A generator is "any person, by site [emphasis added], whose act or process produces hazardous waste.. By this measure, most large research institutions, including the larger universities, are large-quantity generators.

Because most colleges, universities, and research institutions are located in one geographic site, they are viewed as a single generator under the definition above, and the entire facility has a single EPA generator identification number.

This means that each individual laboratory generating waste is not a "generator" within the terms of RCRA, but, as a part of the overall institutional "generator," each laboratory must comply with generator requirements. Obviously, multisite institutions are required to have separate EPA identification numbers for each site.

In determining whether a site is an "individual generation site," some EPA regional offices have been quite strict in relying on the distinction of whether the site has any public roads, the reason being RCRA's objective of not allowing unregulated transport of hazardous waste on public ways. In the definitions section of the RCRA regulations, "on-site" is defined as "the same or geographically contiguous property which may be divided by public or private right-of-way, provided the entrance and exit between the properties is at a crossroads intersection, and access is by crossing as opposed to going along [emphasis added] the right-of-way.

It cannot be moved legally to an unpermitted holding facility if such movement requires transport along a public road, even if the public road and the receiving location are within the boundaries of an institution. This has caused serious management problems for some multibuilding institutions and companies.

Generators must obtain an EPA identification number, prepare the waste for transport, follow accumulation and storage requirements, manifest hazardous waste, and adhere to detailed record-keeping and reporting requirements. Although conditionally exempt small-quantity generators are partially exempt from these requirements, they must still. Also, generators producing more than 1 kg in a calendar month of "acute hazardous waste" see below are subject to full regulation under RCRA.

While some industrial research laboratories and a few large universities have on-site EPA-permitted TSDFs, most colleges and smaller universities and research institutions do not. The process and requirements for EPA-permitting of a TSDF are very complex, involving construction of costly facilities, detailed operational plans, and specialized staff.

It is important to note that state classification of generators may be different from the classifications outlined above. Some states regulate all generators of hazardous waste with no exemptions, and some states classify generators by waste type rather than by volume. RCRA defines "hazardous waste" as solid waste that, "because of its quantity, concentration, or physical, chemical, or infectious characteristics may: 1 cause, or significantly contribute to an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness or 2 pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, or disposed of, or otherwise managed.

A "solid waste" under RCRA need not be solid! Certain otherwise hazardous wastes are excluded from regulation. These include samples sent for testing, household waste, agricultural waste not including pesticides , oil and gas production waste, and others not generally associated with laboratory activities. The RCRA regulations contain detailed provisions and testing procedures for determining if any particular chemical waste, not specifically listed in the regulations, is a "hazardous waste" within the RCRA definition.

To accumulate waste for a longer period, an EPA permit as a "storage facility" is required. Some larger institutions have a central EPA-permitted TSDF, and longer storage times are allowed in accordance with the regulations and the permit conditions applicable to that institution. One RCRA regulation of particular relevance to academic and research laboratories is the provision that. However, safe practice and the requirements of state and local regulation should guide laboratory managers in adhering to reasonable limits on accumulation volume and time.

Prudent practice is to limit accumulation time to no more than 1 year preferably less , and 55 gallons may be too large a quantity for a laboratory location, because of space limitations, fire code limitations, and potential spill or release hazards. When waste accumulates for long periods, laboratory workers tend to forget about it.

Hazardous waste, even in small quantities, should never be forgotten. Only a few years ago, it was common practice to dispose of many laboratory wastes down the drain. Good laboratory practice compliance. This content applies to human and veterinary medicines. GLP inspections The Procedure for co-ordination of GLP inspections describes the co-ordination of GLP inspections of the non-clinical safety, toxicological and pharmacological studies proposed in human and veterinary applications for marketing authorisations and various post-authorisation applications submitted to the European Medicines Agency through the centralised procedure.

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