https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP Good Practice in the Life Science industry

1. GxP for life science
companies
Step by step training guide for
beginners

2. What is GxP?
GxP is the general abbreviation for the
good practice quality guidelines and
regulations

3. Why is quality important in the life
science industry?

5. Quality is essential
• Can’t check the quality before buying or
trying
• Prescriber and patient must be confident no
harm is going to occur, and that the product
does what it says it does
• The right product is prescribed, at the right
strength
• Accurate labelling
• Free from contamination
• Correct packaging
• Product is fit for purpose
• Risks are understood and effectively treated
GxP in EQMS: www.qualsys.co.uk

6. GxP aids compliance with global regulations
• GxP regulations refer to underlying international pharmaceutical requirements such as those outlined in:
• US FD&C Act
• US PHS Act
• FDA regulations
• EU Directives
• Japanese regulations
• Other applicable national legislation / regulations:
• Good Manufacturing Practice (GMP)
• Good Clinical Practice (GCP)
• Good Distribution Practice (GDP)
• Good Quality Practice (GQP)
• Good Pharmacovigilance Practice (GVP)
• Medical Device Regulations (MedDev)
• Prescription Drug Marketing Act (PDMA)

7. Five Ps of GxP
People
• Have clear roles and responsibilities
• Follow all procedures
• Fully trained and assessed for the work
they do
Procedures
• Documented and recorded
• Cover all critical processes
• Ensure deviations are fully
investigated
and reported
Products
• Specifications for raw materials,
components, intermediate and finished
product
• Methods for manufacture and packing,
testing, sampling, status control,
stability testing and records
Premises and
equipment
• Designed to allow effective cleaning
and prevent cross-contamination
• Validated and calibrated, have
procedures, schedules and records
Processes
• Clearly defined, consistent and
documented
• Critical steps identified
• Any required changes must follow the
change control procedures
GxP with EQMS: www.qualsys.co.uk

8. Things can still go wrong…
1. Investigation of anomalies
2. Supplier and contractor Audit
3. Design and Maintenance of equipment
4. CAPA
5. Line Clearance and Segregation
6. Design and Maintenance of Facilities
7. Quality Management – Change control
8. Quality Management
9. Contamination – chemical / physical

9. Typical FDA findings:
• Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications,
whether or not the batch has already been distributed (21 CFR 211.192).
• Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR
820.198(a).
• Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
• Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned
responsibilities. Training shall be documented, as required by 21 CFR 820.25(b).

10. Quality management challenges
Consistency
•Same standards
all the time
across the
business
Controls
•Good security,
documentation,
risk and data
management
Compliance
•Alignment of
regulated and
non-regulated
information,
transparency
and policy
control

11. GxP Computerised systems are subject
to GxP regulations

12. Computerised systems
• Organisations are rapidly transforming
• Outsourcing, mergers and acquisitions and rationalise portfolios
• Regulatory fines are on the rise, legal exposure and loses in revenue without
effective risk management and information governance
• This has meant GxP organsiations have not been able to move their content
to the cloud as aggressively as they would like
• Many have legacy systems which are inflexible to user needs, time
consuming to maintain and validate and have inefficient silos between
regulated and unregulated information – slowing collaboration and innovation

13. Why businesses choose EQMS by Qualsys
• The EQMS suite is an integrated, easy-to-use
GxP process management software system
• Configurable applications address the challenges
of competing in a regulated market according to
GLP, GCP, GMP and GDP regulations.
• The EQMS suite connects applications for
automating, streamlining, and effectively
managing document control, change control,
training control, audits, CAPA, customer
complaints, and more.
• Unlike other companies, Qualsys provides a
thorough Validation Master Plan support service
GxP with EQMS: www.qualsys.co.uk

14. 48% of Qualsys customers work
to GxP standards

15. Quality management system implementation
• Multiple layers of security and governance technology
• Operational practices
• Compliance policies
• World-class implementation service
• Guided validation
• Experience and training implementing GxP systems, ISO 13485, ISO
17025, & more

16. 700+ successful
implementations

17. Key considerations when choosing software
1.Ensuring the confidentiality,
integrity and availability of data
stored in the cloud
2.Controls are maintained
3.Re-validation is manageable
when there is a change

18. Aizlewood’s Mill,
Nursery Street,
Sheffield
S3 8GG
+44 114 282 3338
info@qualsys.co.uk
Get in touch