We wish to emphasize that the sixth edition of bmbl remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective. Each company is responsible for implementing their own safety injuryillness prevention program and should. Pharmaceutical researchers use the principles of chemistry and biotechnology to design and synthesize new molecules used to treat or prevent disease. This quality manual template is based on internationallyaccepted standards, and provides guidance for public health and clinical laboratories on writing policies and procedures that support a quality. Safety glasses must be worn when in laboratories involved with accessuse of chemicals. When these policies and procedures are followed, the. The environment, health and safety manual provides university employees with written health and safety policies and procedures for promoting a safe and healthy work environment. Laboratory operations involving hazardous substances are sometimes carried out continuously or overnight unattended. For pharmaceutical companies, for example, glp compliance is extremely important. Laboratory safety manual november 2020edition environmental health and safety department university of washington box 354400 seattle, wa 981954400 phone. Dea controlled substances and pharmaceutical products. Aphl how to write a laboratory quality manual 5 components of a laboratory quality manual while the structure of a quality manual allows for flexibility, the content should include a description of the laboratory s goals, policies, procedures, roles, responsibilities and monitoring process for each of the qses. They work with a variety of chemicals and biological agents, putting themselves at risk for serious injuries.
Department of transportation dot procedures for transportation workplace drug and. This handbook is provided to owners, proprietors and managers of small businesses by the occupational safety and health administration osha, an agency of the u. Table of contents hazards overview dermal exposure case studies handling and personal protective equipment postexposure treatment incompatibles. Of course, safety rules are only effective when they are enforced. This safety manual has been prepared as an educational resource for students, staff, and faculty. Staff in uw laboratories using hazardous chemicals must have access to a copy of the. This can include computers, processors, sorters and anything else in which the drug comes in contact. Process hazards analysis documentation for pharmaceutical. Laboratory safety manual shall be updated annually to reflect any changes in regulations, university standard operating procedures or ehs policies. The general laboratory safety manual provides control measures essential for. Similar apparatus is present in pharmaceutical and biological applications. We have taught courses to more than 100,000 people in 30 countries, spanning different industries, including research, hightech. Information provided in this writ ten material should not be considered as all encompassing, or suitable for all situations, conditions or environments. Laboratory safety manual environment, health and safety.
Duke university is committed to providing a safe work environment for learning, teaching and research. Analytical methods for pharmaceutical analysis a training manual by a. The laboratory environment can be a hazardous place to work. These operating procedures may be supplemented or amended as new guidelines and standards are developed or legislated. Dec 28, 2017 pharmaceutical lab safety of the equipment equipment refers to any instrument used in the manufacturing of a drug product. Lab safety institute courses, osha training for chemical. All staff and students must have read and abide by the health and safety guidance manual issued by the school of pharmacy and pharmaceutical sciences. Occupational safety in the pharmaceutical industry begins with the same kind of basics all manufacturers use. Use a hood if the tlv available on the sds of a substance is laboratory safety rules is essential to avoiding disasters in the lab. Jul, 2016 pharmaceutical safety with the latest research and manufacturing occurring within the pharmaceutical industry it is important to provide a general overview of laboratory safety requirements in order to keep your employees informed of safety measures and prevent injury or harm. They also have a positive influence on the quality of the result. Pharmaceutical manufacturing safety challenges and solutions.
Fda requirements on pharmaceutical lab safety proficientrx. The lab safety institute is a nonprofit organization providing laboratory safety education and consultation worldwide. Layloff2 division of drug analysis, food and drug administration fda, 1114 market street, st. Staff in uw laboratories using hazardous chemicals must have access to a copy of the manual and the supplemental laboratory specific information. Biol1414 introduction to biotechnology laboratory manual.
Quality management pharmaceutical manufacturing systems. Safe handling, storage, use and disposal of the chemical waste in the laboratory require policies for the safety of users and the environment. It is the responsibility of each laboratory manager and principal investigator to assure that updates are made to hisher copy of the laboratory safety manual as distributed by the laboratory safety. Safety glasses must be worn when in laboratories involved. Pharmaceutical manufacturing safety challenges and. Laboratory safety manual ehs university of washington. Laboratory coat and safety glasses laboratory manual this book small hardback notebook labelled with your name, course and student id number. Pharmaceutical safety with the latest research and manufacturing occurring within the pharmaceutical industry it is important to provide a general overview of laboratory safety requirements in order to keep your employees informed of safety measures and prevent injury or harm. Lab manager recently scoured the safety policies of several laboratories to determine some of the most common lab safety rules out there, to help you whether youre developing or updating a set of policies for your own lab. The experiments cover a wide range of preparations found in u. Marko n a rhi, helsinki university of technology, helsinki, finland, national gmp regulations and codes and international gmp guides and guidelines. Environmental health and safety page 1 of 20 sections.
Please bookmark this page electronically or print a copy of the complete lsm and make it available to laboratory staff. If youre looking for a safety manual template, a good place to start is with oshas small business handbook. Research, has developed this laboratory safety manual to minimize the risks associated with. This laboratory safety manual serves as your chemical hygiene plan chp, it belongs to. This manual applies to federal agency drug testing programs that come under executive order 12564 dated september 15, 1986, section 503 of public law 10071, 5 u. Having a strong set of overall laboratory safety rules is essential to avoiding disasters in the lab. Good laboratory practice training manual for the trainer. So that safety has real significance in the workplace, it is. Wash your hands with disinfectant soap when you arrive at the lab and again before you leave. This faculty specific laboratory safety handbook has been prepared as a result of these extensive efforts.
The quality manual template is a supplement to the laboratory quality management system training toolkit, module 16 documents and records. This manual does not apply to specimens submitted for testing under u. Viii, graded from the simple preparation of waters, solutions and infusions to more. Laboratory manual of pharmaceutical enggineering 2e 2018 and a great selection of related books, art and collectibles available now at. Sop for sampling, testing and release of raw materials. This manual addresses many of mandated requirements. Clean and decontaminate work areas before and after each activity involving hazardous drugs. Workplace drug testing programs using urine 82 fr 7920 dated january 23, 2017 effective october 1, 2017. Every single piece of equipment must be inspected to ensure consumer safety. You simply cannot s ay that no employee has ever violated a safety rule, policy or procedure. Unused drug and drug vials should be collected as hazardous waste.
The lab and chemical safety program is responsible for safety and environmental compliance within research and teaching labs throughout uf facilities. Laboratory safety manual university of california, san diego. Unfortunately, this key aspect of the life cycle of products in this sector is a poor cousin to other issues. Aphl how to write a laboratory quality manual 4 purpose of this manual public health laboratories work is highly complex and requires high levels of accuracy, precision, reliability and confidentiality provided in a timely and costefficient manner. Pharmaceutical laboratory manual jama jama network. The following must be brought to all pharmaceutical chemistry laboratory practicals. Health and safety features in a forensic laboratory. Employee safety in the pharmaceutical discovery laboratory. If any employee has questions regarding these policies, please contact environment, health and safety at 9199625507 or by using the contact form.
Protect the environment from hazardous chemicals and wastes. Requests for this manuscript should be sent to this author. Safety is the responsibility of all food and drug fda employees. Jan 26, 2021 the uc san diego webbased laboratory safety manual, which includes the chemical hygiene plan, must be readily available to laboratory personnel.
Jan 19, 2016 in the pharmaceutical industry, psi must include chemical reaction hazard information as well as the flammability and toxicity of all reactants, intermediates and products. The manual is intended to be a concise breakdown of the site policies, so that contractors can determine if a policy, or program, applies to their particular work. The present laboratory safety manual describes policies, procedures, equipment, personal protective equipment, and work practices that are capable of protecting students and all users including visitors of dry laboratories concrete, fluid. The ehs laboratory safety staff support compliance with the use of dea controlled substance and pharmaceutical products through training sessions, guidelines, consultations and inspections. For the last seven years, he has served as the laboratory safety officer for sentara healthcare, a multihospital system in virginia and. The three main elements of safe containment of microorganisms are 1 good laboratory practices and technique, 2 safety equipment, and 3 facility design. Jan 03, 2020 other lab safety hazards sharp glass, etc hazard control and risk mitigation strategies for the pharmaceutical manufacturing industry. Safety glasses with a rating of z87 and closetoed shoes. Remove shoe covers, gown and outer gloves and dispose of in a cytotoxic container before leaving room. Dan scungio, mt ascp, sls, cqa asq, has more than 20 years of experience as a certified medical laboratory scientist, more than 10 of which were spent in the management of clinical labs, anatomical pathology labs, and collection sites. This handbook provides policies and guidelines for safe laboratory work practices, and it applies to all laboratories at su.
Biosafety in microbiological and biomedical laboratories. We have taught courses to more than 100,000 people in 30 countries, spanning different industries, including research, hightech, government, medicine, and academia stem educators. The laboratory safety and chemical hygiene plan chp is a written program for ensuring the safe use of chemicals in laboratories at indiana university. General and specific safety instructions reflecting identified risk, should be made available to each staff member and supplemented regularly as appropriate e. A suitable laboratory coat must be worn while in the laboratories.
The complete guide to laboratory safety, fifth edition. Section 3 safety in lecture theatres and teaching laboratories. Laboratory personnel at algoma, all individuals who perform procedures in a laboratory. Lab safety staff will escort the dea inspectors during their audits and act as a liaison for the institution. Laboratory safety office has developed this manual as a guidance document to familiarize uf faculty, staff, students, volunteers, and visitors with the institutionwide policies and procedures for the safe use of hazardous chemical and other material at the university and its affiliates. Taking all reasonable precautions in the circumstance to protect the health and safety of a worker.
Pharma lab safety staff orientation initiafy gocontractor. The occupational and environmental safety office oeso promotes workplace safety through various. The objective of this manual is to provide information on health and safety policies and procedures and to define minimum standards for safe practices in the universitys research and teaching laboratories. Describe potential laboratory safety hazards and protective mechanisms associated with each of the following categories. Students will not be allowed to attend a practical if they do not have a laboratory coat. It is the responsibility of the people who design these experiments to ensure safety precautions are taken, particularly in the.
Safety management systems and efforts risk management hazard identification and control. General safety rules for quality control laboratory. Guidelines for the safe handling of hazardous materials and other common laboratory hazards. The authorities and laboratory organizations say that these practices help ensure safety. Biosafety in microbiological and biomedical laboratories bmbl has served as the cornerstone of biosafety practice in the united states since its initial release in 1984. This compilation of one hundred and forty experiments in pharmaceutic compounding is intended for teaching pharmacy students.
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