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Standard Operating Procedures (SOPs) in clinical laboratories are even one of the requirements for the formation of a Laboratory, Good Laboratory Practice (GLP) in accordance with applicable legislation. In Indonesia, SOP violations related to officer compliance in the use of PPE occurred in the Ibnu Suwito Baturaja Hospital clinical laboratory. Lack of readiness for the implementation of SOPs in the pre-analytical area also occurred in the medical record process at the Parahita Laboratory in 2020. In implementing the SOP, Kimia Farma Laboratories and Clinics implement Viona (Visibility Of Routine Activities) in the form of CCTV which is directly connected to the IT and quality headquarters in Jakarta, one of the programs launched to monitor the implementation of the SOP in the laboratory branch offices and Kimia Farma Clinics throughout Indonesia. Laboratories and clinics of Kimia Farma Sumatra Business Unit 3, consisting of 3 Primary Clinics and 3 Medical Laboratories spread across Palembang, Lubuk Linggau and Jambi. This study aims to evaluate the implementation of SOPs in the Laboratories and Clinics of Kimia Farma Business Unit Sumatera 3, and analyze the compliance of officers in following related SOPs, especially in the aspects of greeting and grooming. In this study, it was found that Greeting and grooming violations were still the highest violation findings during 2022, the knowledge of officers of the SOP was good, more than 50% of the Clinical Laboratory officers and 78% of the Kimia Farma clinic officers of the Sumatra 3 Business Unit, but this knowledge did not describe the application of the SOP at the outlet as evidenced by. Punishment received by 2 outlets of Kimia Farma Sumatera Business Unit 3 for Viona's violations. Based on the results of observations, the researcher suggests that it should further improve the evaluation of follow-up findings and be used as a KPI parameter in determining outstanding Business Managers. [ABSTRACT FROM AUTHOR]

In December 2021, the United States Food and Drug Administration (FDA) issued the final guidance for industry titled Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers. The stated purpose of the FDA guidance is to provide information to sponsors, applicants, and nonclinical laboratory personnel regarding the management and conduct of histopathology peer review as part of nonclinical toxicology studies conducted in compliance with good laboratory practice (GLP) regulations. On behalf of and in collaboration with global societies of toxicologic pathology and the Society of Quality Assurance, the Scientific and Regulatory Policy Committee (SRPC) of the Society of Toxicologic Pathology (STP) initiated a review of this FDA guidance. The STP has previously published multiple papers related to the scientific conduct of a pathology peer review of nonclinical toxicology studies and appropriate documentation practices. The objectives of this review are to provide an in-depth analysis and summary interpretation of the FDA recommendations and share considerations for the conduct of pathology peer review in nonclinical toxicology studies that claim compliance to GLP regulations. In general, this working group is in agreement with the recommendations from the FDA guidance that has added clear expectations for pathology peer review preparation, conduct, and documentation. [ABSTRACT FROM AUTHOR]

Clinical embryology is a dynamic and ever-evolving field, and as such clinical practice guidelines must be regularly reviewed and updated. Accordingly, this document supersedes previous good clinical practice in clinical embryology guidance, developing, and updating where necessary, existing good practice guidelines. The Association of Reproductive and Clinical Scientists (ARCS) suggests this Good Laboratory Practice framework as appropriate and effective to ensure the best possible care for all individuals undertaking fertility treatment. Efforts have been made to ensure that the language used is inclusive and reflective of the wide range of patients who seek treatment. The guidance provided within this document aims to be relevant within an international context and to consider the range of regulatory considerations affecting clinical embryology laboratories. This guideline was written to guide best practice but is not intended as a tool to judge the practice of centres within the UK or beyond., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: siRNA is a promising therapeutic modality highlighted by several US FDA approvals since 2018, with many more oligonucleotide assets in clinical development. To support siRNA discovery and development, robust and sensitive quantitative platforms for bioanalysis must be established to assess pharmacokinetic/pharmacodynamic relationships and toxicology. Droplet digital PCR offers improved sensitivity and throughput, as well as reduced susceptibility to matrix effects, compared with other analytical platforms. Methodology: The authors developed a stem-loop reverse transcription droplet digital PCR method to measure siRNA in mouse plasma and liver extract using bioanalytical method qualification guidelines. Conclusion: This newly developed assay has been demonstrated to be a superior alternative to other platforms, with the added benefit of greater sensitivity, with dynamic range from 390 to 400,000 copies/reaction and readiness for FDA investigational new drug-enabling applications.