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  • Regulatory NewsRegulatory News

    Pathology Peer Review in Toxicology Studies: FDA Offers Q&A

    The US Food and Drug Administration (FDA) on Wednesday released nine draft questions and answers to help sponsors and nonclinical laboratory staff manage and conduct pathology peer review during good laboratory practice (GLP)-compliant toxicology studies. “When conducted, pathology peer review should be well-documented. However, documentation practices during pathology peer review have not been clearly defined and vary among nonclinical testing facilities. This question...
  • Regulatory NewsRegulatory News

    EC Explains Brexit’s Impact on GLP

    Beginning 1 November, the UK will likely not be a member of the EU. As that date approaches, the European Commission has outlined the consequences of how EU rules in the field of Good Laboratory Practice (GLP) will no longer apply to the UK, although an EU-wide “Mutual Acceptance of Data” (MAD) system will apply. The MAD system, established under the Organisation for Economic Co-operation and Development (OECD), will apply as of the UK’s withdrawal date, and all member ...
  • Regulatory NewsRegulatory News

    FDA Cites GMP, GLP Violations at Two Sites

    The US Food and Drug Administration (FDA) posted two warning letters on Monday that flagged a total of nine violations of good manufacturing practice (GMP) at California-based Total Thermal Imaging (TTI) and four violations of good laboratory practice (GLP) at an American Preclinical Services (APS) facility in Minneapolis. TTI’s warning letter comes after an FDA inspection of its website and brochures concluded that its Thermographic Business Package lacked the approv...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: No Manufacturers Have Complied With India's GMP Request (15 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Nine Months After Deadline Passed, No Manufacturers Have Complied With DCGI GMP Request The Drug Controller General of India (DCGI) has repeated his demand for manufacturers to assess the quality of their facilities and submit the resulting reports. DCGI Dr. GN Singh made the original request one year ago, but is yet to receive good manufacturing or laboratory practice...
  • Regulatory NewsRegulatory News

    Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

    A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies. The proposed rule, unveiled in August , would require a complete quality system approach for these safety ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Orders Manufacturers to Assess Their Compliance with GMPs, GLPs The Drug Controller General of India (DCGI) has ordered companies to self-assess their compliance with good manufacturing and laboratory practices (GMPs/GLPs). DCGI is demanding manufacturers carry out the self-assessment, award themselves a quality rating and submit the resulting report to the relev...
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

    The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies. The 142-page proposed rule outlines what’s referred to as a “GLP Quality System,” which will involve additional management responsibilities and standard operating procedures (SOPs), as well as a more nuanced approach for multi-site ...
  • Regulatory NewsRegulatory News

    WHO: 'Critical' Data Integrity Issues Found at Indian CRO

    Quest Life Sciences, an Indian contract research organization is under fire after World Health Organization (WHO) inspectors uncovered 'critical' data integrity issues during an inspection last October. Background As part of its Prequalification of Medicines Programme , WHO carries out inspections of companies involved with clinical research and manufacturing to ensure prequalified medicines are of "acceptable quality, safety and efficacy." The program focuses on prod...
  • FDA Issues Draft Guidance on Application of GLP Regulation to Devices

    A new draft guidance document released by the US Food and Drug Administration (FDA) explains that good laboratory practice (GLP) regulations under 21 CFR 58 generally-but not always-apply to medical device premarket and research applications. Background Just as good clinical practices (GCPs) are intended to govern the proper conduct of clinical trials to ensure the collection of adequate data and good manufacturing practices (GMPs) are intended to ensure the adequate pr...
  • Feature ArticlesFeature Articles

    Seeing the Bigger Audit Picture with an Enterprise Quality Management System

    If you ever want to watch a lively debate, bring together three groups-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) auditors-and tell them to find common ground for their processes so they can coexist in the same system. They will look at one another's processes and find things that are totally foreign, and conclude that they cannot do it. You know what? They are right. GLP auditors are responsible for assuring the qu...
  • FDA Looks to Support Animal Rule With New GLP Training Program

    • 15 June 2012
    How do you ensure regulatory compliance in the world's most dangerous laboratory environments? The US Food and Drug Administration (FDA) wants to know, and is proposing to put money behind an initiative it says is aimed at supporting its 'Animal Rule' by developing an academic-based training program to educate pharmaceutical professionals working in high containment environments on good laboratory practices (GLPs). In an advanced posting of an 18 June Federal Register ...
  • EMA Adopts Reflection Paper on Evaluating Clinical Trial Samples

    The European Medicines Agency (EMA) adopted a reflection paper that aims to provide quality systems guidance for laboratories in charge of analyzing and evaluating samples generated from clinical trials. Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples , adopted 28 February and released 20 March, intends to provide clinical laboratories "with information that will help them develop and maintain quality systems" that com...