Levy GxP QA Auditing Services provides auditing services to ensure compliance with Good Practice standards including GCP, GMP, GLP, GDP, and more. They have a global team of experienced auditors who can audit pharmaceutical companies, clinical trials, laboratories, and more. Their services include regulatory inspections, mock inspections, SOP writing assistance, training, and guidance on compliance with standards.

1. Levy GxP QA Auditing Services
Levy GxP QA Auditing Services are a professional Quality
Consultancy.
 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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

7. 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

8. Levy GxP QA Auditing Services
GCP 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

9. 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

10. 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.

11. 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

12. 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

13. Levy GxP QA Auditing Services
Mock 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

14. 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.