Levy GxP QA Auditing ServicesLevy GxP QA Auditing Services are a professional QualityConsultancy. We have a global team of highly experienced auditors, providing full GPvP, GCP, GMP, GLP, GCLP and GDP auditing capabilities. GPvP - Good Vigilance Practice It assesses pharmaceutical companies’ compliance with UK and EU legislation relating to the monitoring of the safety of medicines given to patients. GCP – Good Clinical Practice It assesses the compliance of organizations conducting clinical trials using investigational medicinal products with UK and EU legislation.
Levy GxP QA Auditing Services GMP - Good Manufacturing Practice Concerned with both production and quality control. Ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization (MA) or product specification. GLP Good Laboratory Practice GLP inspectors verify that test facilities which conduct non- clinical safety studies on pharmaceuticals, agrochemicals, industrial chemicals, food and cosmetics meet GLP requirements to the standards necessary for regulatory purposes.
Levy GxP QA Auditing Services GCLP - Good Clinical Practice for Clinical Laboratories A set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. GDP - Good Distribution Practice Part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification.
Levy GxP QA Auditing Services Levy Associates People Our Associates accurately interpret and apply the current standards, directives , guidance documents and industry practices to your projects and activities. Audits medical device facilities and clinical investigations in line with the following requirements; ISO 13485, 21 CFR Part 820 ISO 14155 We audit suppliers and contractors to pharmaceutical and medical device manufacturers in line to the ISO 9001 standard, also ensuring those not required to comply with the GxPs that their quality system is both effective and capable.
Levy GxP QA Auditing Services GPvP - Good Vigilance Practice Audits Regulatory authorities are increasing their demands on industry for robust safety monitoring systems. Many organisations are preparing themselves for GCP and Pharmacovigilance inspections. Our team have the skills and the experience to conduct Mock GCP and Pharmacovigilance Inspections according to your needs. Our people can help you to optimise your systems to meet regulatory expectations. Pre and post marketing pharmacovigilance systems audits Audits of on-going risk management procedures Pharmacovigilance systems audits of global functions, affiliates, marketing partners and distributors worldwide Mock inspections to ensure your pharmacovigilance teams are well prepared.
Levy GxP QA Auditing Services Pharmacovigilance Audit - Areas assessed The quality management system in place for the collection, processing (i.e. data entry into the adverse event database), coding, classification, medical review and regulatory reporting of ICSRs Training and qualifications of personnel employed to perform pharmacovigilance activities Confirming the role and responsibilities of the European Qualified Person for Pharmacovigilance Determining whether the database used for the collection and subsequent reporting of adverse events to regulatory authorities and other concerned parties is in compliance with international regulatory requirements i.e. a fully validated system Evaluating the systems in place for on-going safety surveillance, including signal detection and risk management and/or risk mitigation strategies
Pharmacovigilance Audit - Areas assessed (Cont’d) Assessing procedures for pharmacovigilance activities and worldwide literature review for product related adverse events Processes for the generation and review of periodic aggregate reports Procedures for the collection, assessment and evaluation of adverse events related to product quality complaints Assessment of procedures in call centres/medical information for identification and reporting of queries related to adverse events Ensuring systems are in place for urgent safety restrictions and product crises Ensuring contractual arrangements and oversight processes are in place for business partners and third party service providers Disaster recovery and business continuity plans
Levy GxP QA Auditing ServicesGCP Auditing Services Independent GCP audits provide an insight into the quality of your clinical research at a point in time. They facilitate the monitoring of how well your quality management system is working and whether your SOPs are adequate and meet regulatory authority expectations. Levy People have; Conducted thousands of GCP audits Conducted GCP audits in over 60 countries Conducted GCP audits in many therapeutic areas e.g. Oncology, CVS, immunology, CNS, Rheumatology, anti-infectives etc
Types of GCP Quality Audits (either in part or overall audit strategy) Audits of a sample of investigator sites participating in a specific clinical trial: Allow site-specific problems to be identified and corrected Highlight systematic issues that can impact on the quality of the trial as a whole. Prompt corrective and preventative actions by the responsible clinical study teams can significantly improve the overall quality of the trial Audits of third party service providers: Sponsor organisations frequently outsource clinical trial activities as they might not have the necessary resource or expertise internally. The sponsor is ultimately responsible for the quality of the clinical trial, and therefore has to ensure that its service providers produce deliverables of the required standard. Sponsors therefore conduct independent audits of service providers at regular intervals to ensure that their systems continue to meet the necessary regulatory standards
Types of GCP Quality Audits (Cont’d) Audits of specific systems: Systems audits may be conducted to assess whether a particular activity is in compliance with regulations. For example, the procedures for data management and statistical analysis might be reviewed in detail, and process improvements identified. Systems audits involve a review of the standard operating procedures in use, interviews of personnel implementing the procedures and a review of sample data to assess whether the procedures are effective and being complied with.Audit Follow-Up Following the conduct of an audit, a detailed audit report is written with all of the observations made during the audit. The auditees are then required to develop a corrective and preventative action plan (CAPA), with timelines and responsibilities allocated. The completion of the CAPA may be tracked by the auditor, but the responsibility for implementation of the actions is the auditee’s.
Levy GxP QA Auditing Services GCLP - Good Clinical Laboratory Practice The transposition of the EU Clinical Trials Directive 2001/20/EC into UK law (Statutory Instrument 2004 No.1031: The Medicines for Human Use (Clinical Trials) Regulations 2004 as amended) provides provision for the inspection of clinical laboratories. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has responsibility for monitoring clinical laboratories for compliance with the Clinical Trials Regulations. Compliance is assessed by inspections which on average are performed once every two years. However, it is important to note that the frequency of inspections may be increased or reduced depending on the level of compliance maintained by the laboratory and that an inspection ‘for cause’ may be performed at any time
Levy GxP QA Auditing Services Computer Systems Validation (CSV) In clinical research and development, IT systems, whether they are for clinical development, drug safety, the laboratory or manufacturing facility, need to be validated according to international regulations and guidelines. Levy People; Review the validation status of your IT systems Review the validation status of vendor IT systems Identify any gaps in the IT system validation status Advise on how best to bring your systems into compliance
Levy GxP QA Auditing ServicesMock Inspections / Inspection Readiness We have extensive experience helping companies of all sizes preparing for upcoming regulatory inspections. We can help you with all aspects of your inspection readiness planning. Gap Analysis Identifying and prioritising improvements Corrective Action Support Training - Preparing for Inspection Preparing a War Room Hosting the Inspection Inspection interview training Preparing Sites for Inspection
Levy GxP QA Auditing Services SOP Writing We offer our clients full support with any aspect of their SOP writing. Whether you are looking for help to write a new SOP, or are looking for help to review and harmonise your existing SOPs, we have the experience to support you through this process. Training & GCP Regulatory Guidance We offer both training and help in preparation for regulatory inspections or other third-party audits. Areas of training include; GPvP, GCP, GMP, GLP, GCLP and GDP, Insight into EU, US FDA, WHO or ICH guidance and regulations to meet the needs of your specific project.