GLP Organization and Personnel
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1 G L P T O PIC S GLP Organization and Personnel Cindy Green BBS UNITED, ALEX HAYDEN/GETTY IMAGES GLP Topics addresses topics associated with good laboratory practice requirements. We intend this column to be a useful resource for daily work applications. The key objective for the column: Useful information. Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Suggestions for future discussion topics or questions to be addressed are requested. Manuscripts or case studies submitted by readers illustrating compliance strategy and planning are also most welcome. Please send your comments and suggestions to column coordinator Cindy Green at cindynwrs@seanet.com or to coordinating editor Susan Haigney at shaigney@advanstar.com. ORGANIZATION OF THE TEST FACILITY Management of test facilities engaged in the conduct of studies regulated under good laboratory practice (GLP) (21 CFR 58) is required to clearly define the organizational structure and responsibilities of the assigned personnel (1, 2). This includes, but is not limited to, the requirement to designate a study director, establish a quality assurance unit (QAU), and ensure study personnel are knowledgeable and trained prior to initiating the GLP study. The use of a current organization chart and job descriptions provides an immediate mechanism for describing the test facility operations. Compliance history has demonstrated that without full management commitment and the formal involvement of personnel, GLP systems lack credibility and will not function as they should. Management and organizational systems therefore are a critical element of setting up GLP in a laboratory (1). Further details on the roles and responsibilities of these individuals are provided in this article. The role of the sponsor is also described. PERSONNEL RESPONSIBILITIES The following sections detail the GLP responsibilities of personnel. Test Facility Management Test facility management has the overall responsibility for implementation of both good science and good organization, including compliance with GLP. Good science can be defined as the accurate and complete definition of experimental design and acceptance criteria, basing studies on sound scientific 30 Journal of GXP Compliance
2 C i n d y G r e e n procedures, controlling and documenting experimental variables, thorough evaluation of study results, and accurate conclusions based on scientific fact. Good organization can be defined as providing for adequate physical facilities and qualified staff, appropriate identification and assignment of staff, clear definition of the responsibilities for study personnel, good recordkeeping, and compliance with GLP (1, 2). During a US Food and Drug Administration audit, FDA expects to see that the organizational structure is appropriate to ensure that studies are conducted in compliance with GLP regulations, and that management, study directors, study personnel, and sponsors are satisfying their assigned responsibilities. In addition, FDA expects to see objective evidence of involvement of testing facility management in the operations at the testing facility (2) and adequate oversight by sponsors. When the testing facility contracts work to other facilities, the oversight of those assigned responsibilities must be clearly defined and evident on the organization chart. Procedures should be in place describing the selection of a study director. When selecting a study director, it is the responsibility of testing facility management to be aware of that person s workload for both current and planned studies. Using the master schedule, resource loading can be effectively managed. Test facility management should assure that the test facility is compliant with applicable GLP regulations by ensuring that the following are performed: Assignment of individuals to the study is documented A study director is assigned prior to initiating a study When required, a study director is replaced during the conduct of a study and the replacement is documented A QAU is established, supported, and operates in compliance with applicable regulations For multi-site studies, a principle investigator, if necessary, is designated, qualified, properly trained, and experienced to fulfill his responsibilities for the assigned study and there are clear communication lines between all study participants Standard operating procedures (SOPs) are established describing responsibilities and operation of the test facility New and revised SOPs are adequately reviewed and approved by testing facility management prior to implementation, and historical versions are maintained by a designated individual The study protocols are reviewed and approved by testing facility management and the study director; the approval of the study protocol is documented; and the study protocol is available to the QAU A master schedule is maintained and workloads managed appropriately; the master schedule must list all nonclinical studies conducted on FDA-regulated products intended to support an application for a research or marketing permit Personnel, facilities, equipment, supplies, etc. are available for timely execution of scheduled studies Facilities, equipment, and supplies meet requirements and are appropriate for their intended use There is a sufficient number of personnel assigned to the study Appropriate technical training is provided Personnel are properly educated and trained for study participation, including documented evidence that personnel understand the functions that they have been asked to perform (i.e., evidence of competency is required) and are made aware of any special test and control article handling and storage requirements Records of personnel qualifications, job descriptions, training, and education are maintained Control and test articles are appropriately tested for identity, strength, purity, stability, and uniformity Computerized systems are validated to demonstrate they are suitable for their designated purpose and are operated according to their validated use Deviations from GLP regulations are promptly communicated to the study director Corrective and preventive actions are taken when and if deviations occur (2, 3). Study Director The study director plays a significant role in the conduct of GLP studies. The study director has the overall responsibility for the conduct of the study and its final report. The study director assumes full responsibility for GLP compliance of all activities that take place during the Winter 2009 Volume 13 Number 1 31
3 G L P T O P I C S study and for activities that support the study including the adequacy of the study protocol (4). At the end of the study, the study director must evaluate the conduct of the study and sign and date the statement that the study was conducted in compliance with GLP regulations. Therefore, the study director must be fully aware of the activities that could potentially influence the quality and integrity of the data, to evaluate their potential impact, and determine appropriate corrective and preventive actions (1, 5). Some of the responsibilities assigned to the study director can be delegated; however, the ultimate responsibility remains with the study director. As the single point of contact, the scientific, administrative, and regulatory aspects of the study must be effectively overseen by the study director (5). During an FDA inspection, FDA will assess the extent of the actual involvement and participation by the study director. If the study director is physically at a different location, communication files between the testing facility, the QAU, and the study director must be available. Objective evidence must be available that demonstrates that the study director is kept informed of any and all events that may potentially impact the quality and integrity of the data (2, 5). The study director must ensure that procedures are in place that assure the following: Protocol and amendments (if any) are reviewed and approved with a dated signature The responsibilities of the principal investigator, test facilities, and test sites for a multi-site study are defined and documented Testing facility management has committed adequate resources to conduct the study and that test materials and test systems are available Delegation of tasks to competent staff members is documented Contract facilities are qualified and suitable for conducting the parts of the GLP study contracted to them The QAU has a copy of the study protocol and amendments in a timely manner Communication between the study director and the QAU are effective throughout the conduct of the study Study personnel have access to the protocol, amendments, and applicable SOPs All raw data generated are fully documented and recorded Data are accurately recorded and verified Data are collected as specified by the protocol and amendments and associated SOPs Computerized systems are suitable for their intended use, validated, and are fit for use Personnel are familiar with and adhere to the study protocol (and amendments) and applicable SOPs Unexpected events that may potentially impact the quality and integrity of data are documented, investigated, evaluated, and corrective/preventive action assigned The final report is signed and dated indicating responsibility for the validity of the data and the level of compliance with GLPs Study protocol, raw data, related material, and final report are archived at the close of the study with reference to the location for storage of documentation, samples, and specimens If an acting or deputy study director is assigned study responsibility, that study records identify the individual assigned to this temporary role (2, 3, 5, 6). Study Personnel Each study must have an adequate number of qualified personnel assigned to assure the study is conducted in a timely and efficient manner. Study personnel include specialists, such as pathologists, statisticians, etc. The assignment of these individuals must be documented in the final study report. Each individual assigned to the study must have sufficient education, training, and experience (or the combination thereof) to enable that individual to perform their assigned tasks (6). Study personnel must take the necessary precautions to minimize the potential of contaminating test and control articles. In addition, personnel must take steps to ensure their own sanitation and health including precautions to minimize potential exposure to themselves or their co-workers to unforeseen hazards (7). Study personnel must dress appropriately including the use of protective garments such as lab coats, gloves, 32 Journal of GXP Compliance
4 C i n d y G r e e n and masks. The garments must be changed as necessary to minimize the potential risk of contamination of test/control articles or personnel exposure to adverse conditions or agents. If an individual becomes aware of a health condition that may potentially impact the quality or integrity of the study, the individual has the responsibility to notify the area supervisor and relieve him or herself from the assigned responsibilities (3, 7). Study personnel are responsible for the following: Being knowledgeable in GLPs that are applicable to their assigned tasks Complying with the applicable GLPs, study protocol, applicable SOPs, and instructions from the study director Reporting deviations from the study protocol and associated SOPs to the study director Recording raw data promptly and accurately Recording data using established good documentation practices Taking necessary steps to minimize the potential of contamination or mix-up of test and control articles Taking necessary precautions to minimize personal health risk, risk to co-workers, and risk to the quality and integrity of study data (2, 3, 7). Quality Assurance Unit The QAU must be a separate function (i.e., independent witness) from the study director and the studies that they are assigned to audit (7). Top management must provide support to the QAU and assure that the QAU has full access to all applicable documents and procedures. A QAU individual may participate in a GLP study; however, that same individual cannot perform QAU functions on the study in which they participated (2, 6). The individuals assigned to the QAU are not required to be technical personnel; however, must be able to clearly understand their assigned responsibilities. For example, the QAU is not expected to perform a technical review of study results; however, the QAU is expected to ensure that GLPs, SOPs, and protocols are being followed as approved and that the study results accurately reflect the work completed (i.e., comparison between study results and raw data) (7). The QAU must review all phases of the study. The QAU is required to maintain copies of all protocols and amendments as well as all SOPs applicable to QAU operations. In summary, the QAU is responsible for the following: Protocol review for GLP compliance, clarity, and completeness Maintaining copies of all protocols for which the QAU is responsible SOP review to assure compliance with GLP, clarity, and consistence with other SOPs Maintaining a copy of the master schedule of all nonclinical studies indexed by test article and identifying the test system, nature of the study, study initiation date, current status, sponsor, and study director Maintaining the QAU inspection and audit schedule Conducting inspections and audits (e.g., studybased, facility/system-based, process-based, and audits of contractors and suppliers) at appropriate intervals to assure study integrity and to assure that the study is being conducted consistent with the approved protocol and applicable SOPs Maintaining records of the inspections performed including the date of the inspection, study inspected, phase of the study inspected, findings, action recommended and taken to resolve issues, and scheduled date for re-inspection, if required Notifying the study director of any findings during an inspection that may potentially impact the quality or integrity of the study Periodically submitting a study status report to management and the study director noting any problems observed Reviewing the final study report to assure that the report accurately reflects the methods and materials used and the study conducted; and that the conclusions are supported by the raw data and the reported results of the study Preparing a QAU statement for inclusion in the final study report that states that the QAU conducted inspections during the study and includes the interval or point of the inspection, the date(s) conducted, and the results of the inspection Assuring that SOPs describe the roles and responsibilities of the QAU (2, 3, 4, 6, 7). Winter 2009 Volume 13 Number 1 33
5 G L P T O P I C S The inspections that are conducted for study-based audits are pre-planned and performed at key points during the study. To assure that the study-based audit is effective, it is important for the QAU to communicate with study personnel. Prior to the inspection, the assigned individual must become familiar with the study protocol as well as the applicable SOPs. Familiarity with the SOPs is especially important to assure that all relevant policies are followed with respect to entry to the area, gowning practices, and safety regulations. The individual conducting the inspection must not negatively impact the study for the sake of conducting the inspection. Sufficient time must be allowed for the inspection to ensure that the inspection is complete and covers the key steps identified for the inspection. At the completion of the inspection, the assigned individual is responsible for preparing and issuing a factual report of the findings. The process used for the conduct of the inspection and preparation of the report must be described in SOPs (3, 4). The inspections that are conducted for system or facility-based audits are performed independently of any particular study. These audits are conducted for the test facility management rather than the study director. The following areas are typically covered during a system or facility-based audit: Study personnel qualification and training Recordkeeping Receipt and handling of test systems Facility cleaning Waste handling and waste flow Personnel hygiene, gowning, and flow Equipment maintenance and calibration Animal food handling Purchasing controls Computerized systems Test and control article identification and storage Controlled drug receipt, handling, and disposition Material receipt, handling, and labeling SOP initiation, revision, and control Archiving of records, test/control articles, and specimens (1, 4). Process-based inspections are also conducted independent of a specific study and are intended to review procedures or processes that are repeated frequently by the testing facility. For example, process-based inspections may be assigned for the following: Receipt of test and control articles Controlled drug accountability Archiving of records Personnel training records Equipment calibration (1). The QAU is also responsible for conducting audits of contractors and suppliers. Typically, these audits are performed at external test facilities such as those used for specialized testing of specimens, metrology laboratories, etc. Major suppliers should also be audited such as the suppliers of animals and feed (1, 4). Sponsor A sponsor is defined in 21 CFR 58.3 as A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study; person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or testing facility, if it both initiates and actually conducts that study (8). A sponsor typically is the party that initiates the GLP study and submits the result of the study to the regulatory authorities. Based on these activities, the sponsor assumes the responsibility for confirming that all nonclinical studies were conducted in compliance with GLP. Therefore, it is the responsibility of the sponsor to assure there is adequate oversight of the GLP study including the identification, selection, qualification, and monitoring of the testing facility operations. This responsibility includes the validity of raw data and conclusions summarized in the test report prepared by the contract facility (8). The responsibilities of the sponsor are to assure the following: Understanding of GLP and those sections applicable to the test facility operations, by the assigned study director and designated study personnel The test facility selected is qualified and capable of conducting the study in compliance with GLP Prompt and complete disclosure of any known or potential hazards (e.g., environmental, human, or animal health) associated with the test article Adequate characterization of test articles 34 Journal of GXP Compliance
6 C i n d y G r e e n The content of the study protocol is compliant with GLP requirements Review and approval of the study protocol The content of the test report is compliant with GLP requirements and accurately reflects the conclusions from the raw data Review and approval of the test report Submission of the study results to the regulatory authorities Storage and retention of study records and material when it is necessary for the testing facility to transfer these materials (8). Personnel Training A training program must be in place to assure that there is documentation of training in all aspects of the GLP study. This training program must also assure that the study director is adequately trained and has a thorough understanding in all aspects of the planned study, including the scientific and regulatory aspects. A current summary of training, experience, and job description must be on file for all personnel. Personnel assigned to the study must have a thorough understanding of GLP, applicable regulatory requirements, and the study protocol, as well as all applicable SOPs (1). A record of all training applicable to GLP studies should be maintained in documented training records, including but not limited to the following: Work experience under the supervision of senior staff Scientific and technical meetings In-house training sessions External conferences, seminars, courses, etc. Membership in professional societies On-line training Webinars Self-taught training (e.g., reading to understand GLP topics) (6). Personal development should be continuously monitored. Additional training or retraining may be necessary, for example, when policies and procedures change or if deviations to the protocol occur. Documentation of the training program, training conducted or completed, and effectiveness of the training should be available for all personnel assigned to the study (1). REFERENCES 1. UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Handbook on Good Laboratory Practice (GLP), based on proceedings Compliance Program Guidance Manual, Good Laboratory Practice (Nonclinical Laboratories), CPGM , implemented February 21, CFR 58.29, 58.31, 58.33, Organization for Economic Co-Operation and Development (OECD), OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring: Number 4, Quality Assurance and GLP, ENV/JM/MONO(99)20, October 26, OECD, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring: Number 8 (Revised), The Role and Responsibilities of the Study Director in GLP Studies, ENV/JM/ MONO(99)24, September 15, FDA, Good Laboratory Practice Regulations, GLP Questions and Answers, OECD, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring: Number 1, OECD Principles on Good Laboratory Practice (as revised in 1997), ENV/MC/CHEM(98)17, January 26, OECD, OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring: Number 11, Advisory Document on the Panel on Good Laboratory Practice. The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP, ENV/MC/CHEM(98)16; January 22, GXP ARTICLE ACRONYM LISTING FDA US Food and Drug Administration GLP Good Laboratory Practice QAU Quality Assurance Unit SOPs Standard Operating Procedures ABOUT THE AUTHOR Cindy Green, RAC, has been working with regulated industry for nearly 35 years holding senior positions in regulatory, quality assurance, and quality control for several biotechnology and medical device companies. She has been president of her own consulting company for the past 16 years. Cindy can be reached by at cindynwrs@ seanet.com. Winter 2009 Volume 13 Number 1 35
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