A GUIDE

TO GxP
COMPLIANCE
 CONTENTS
1. WHAT IS GxP? 3

2. WHAT IS GMP? - GOOD MANUFACTURING PRACTICE 10

3. WHAT IS GAMP - GOOD AUTOMATED MANUFACTURING PRACTICE? 13

4. WHAT IS CSV FOR GXP? 16

5. WHAT IS GCP? - GOOD CLINICAL PRACTICE 17

6. WHAT IS GOOD PHARMACOVIGILANCE PRACTICE (GPVP) 18

7. WHAT IS GLP? - GOOD LABORATORY PRACTICE 20

8. WHAT IS GDP? - GOOD DISTRIBUTION PRACTICE 21

9. WHAT IS GACP? - GOOD AGRICULTURAL AND COLLECTION 23

PRACTICE FOR MEDICINAL PLANTS

10. WHAT IS GDOCP? - GOOD DOCUMENTATION PRACTICE 24

11. WHAT IS ALCOA+? 25

12. GxP AND QUALITY MANAGEMENT SYSTEMS 26

13. WHAT DOES IT TAKE TO BE GxP COMPLIANT? 27

2 The Guide to GxP ComplianceCOGNIDOX.COM

 1. WHAT IS GxP?
GxP refers to the ‘good practice’ guidelines and regulations created to
ensure that food, medical devices, drugs and other life science products are
safe, effective and usable.

The ‘X’ in GxP can refer to a number of disciplines - GMP (Good Manufacturing Practice),
GDP (Good Distribution Practice),GLP (Good Laboratory Practice) and many more.

Together they define the various ways companies in regulated industries are required
to control their processes, procedures, people and premises to ensure consistency and
quality in their products and services

Who defines and oversees GxP compliance in the

Life Sciences industry?
The Food and Drug Administration (FDA), the European Medicines Agency (EMA), the
UK Medicines and Healthcare Products Regulatory Agency (MHRA), as well as the
International Organization for Standardization (ISO) all define and refer to GxP in their
publications. These organisations, among others, promote, oversee and enforce their
observation around the world.

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 Which sectors and companies need to adhere to GxP?
This guide will concentrate on GxP as it relates to:

• Medical Device Manufacturers

• In Vitro Medical Devices (IVD)
• Pharmaceuticals
• Life sciences
• And those working across these industries in other capacities:
• Subcontracting suppliers
• Importers and distributors

The disciplines of GxP can also be relevant for those working in the
following sectors:

• Agritech
• Food production
• Novel food production
• Medicinal Cannabis Producers
• Cosmetics

GxP is all about control

The GxP requirements outlined by the regulating bodies, ask businesses to formally
define the protocol and controlled processes vital to the safety of their end products.

For example:

• How products are consistently manufactured

• How new technologies are researched
• How product designs are tested and challenged
• How laboratory and manufacturing equipment is calibrated and maintained
• How their processes are traced from start to finish through controlled documentation
• How different kinds of products are stored and transported
• How their workers are trained
• How records of all these processes are captured and maintained to monitor the
ongoing effectiveness of these systems

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 So, no matter what sector you operate in and the specific GxP standards that
apply to you, you need the tools and quality systems to:

Document Manage risk

publish and regularly review assess severity,
your GxP (e.g, Standard document and mitigate
Operating Procedures) risk of product failure

Record Control
evidence that these tasks processes to achieve
have been performed required standards in
end products

Because these are the methods by which you will:

• Create high performing products of consistent quality in the most efficient way
• Minimise risk of product failure - proportional to its potential to harm
• Provide evidence that regulated products are in conformity with
regulatory requirements
• Ensure knowledge is maintained in your organisation
• Establish a mechanism for communication in all levels of your company
• Achieve accountability across an organisation for regulated activity

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 Why is GxP compliance so important?
Due to the potential risk to human health of the products they oversee, the
powers of the regulators in these sectors are far-reaching.

GxP compliance is monitored and enforced by agencies and government bodies through
certification requirements, regular inspections and unannounced auditing.

In many cases the scope of the regulator’s remit continues to widen taking in new sectors
and product categories. This reflects the extent of innovation in these industries, as well
as cross-sector dependencies in the production techniques they use.

For this reason, regulators often require companies to verify and vouch for the GxP
compliance of their partners throughout the supply chain.

As a result more and more companies are finding they need to adopt GxP - and prove
they have adopted them - to protect their markets, supplier status and future business.

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 So, what are the specific areas of best practice which
GxP cover?
GxP defines the best practices that cover every part of the life sciences
industry and value chain.

But all GxP can be seen as subsets of Good Manufacturing Practice (GMP) - because
they all feed into and support the safe production and delivery of regulated life
science products.

GxP is about controlling the processes by which these products are developed,
manufactured and handled in defined ways throughout the supply chain - ensuring they
are of consistent quality and can be used as intended by consumers:

GMP - Good Manufacturing Practice

GAMP - Good Automated Manufacturing Practice

GCP - Good Clinical Practice

GLP - Good Laboratory Practice

GPvP - Good Pharmacovigilance Practice

GDP - Good Distribution Practice

GACP - Good Agricultural and Collection Practice

GdocP - Good Documentation Practice

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 The central pillars of GxP
Documentation, Communication, Traceability and Accountability

To demonstrate that required controls have been observed and ensure potential
non-conformance in end products can be identified and corrected - there must be
accountability and traceability in data and documentation throughout the
product lifecycle.

Data integrity is key

Knowing that data and documentation is accurate, up-to-date and accessible (and that
they cannot be changed or tampered with) gives a high level of confidence to companies
and regulators. It tells regulators that required activity has been undertaken and
faithfully recorded by the right people at the right time.

Good Documentation Practices (GDocP) are central to all GxP

Underpinning all GxP, therefore, are the record-keeping and documentation requirements
that keep processes trackable and companies fully accountable for the integrity of their
data and the quality of their end products. This is referred to by the FDA and others as:

GdocP - Good Documentation Practice

It should be noted that GDocP is not a ‘standard’ in its own right, but is a key part of all the
practices described above.

GXP: If it isn’t documented - it didn’t happen

To be compliant with GxP organisations need to specify, document and log every critical
action made by every employee in the development, manufacture and delivery of a
product or project by every employee. But they should do this in a way commensurate
with the risk that non-conformance poses. And in a way that is ultimately auditable.

Quality Systems are needed to implement and validate GXP

To ensure all these required actions are understood and observed across an organisation,
companies need Quality Management Systems to be in place. These Quality
Management Systems need to:

Qualify, Control, Record

All the key GxP processes, systems and procedures

that ensure the safety of their end products.

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 Who needs a QMS?
Quality Management Systems are a ubiquitous requirement for operators in every part
of the life science industry and supply chain. From farmers cultivating raw ingredients
and researchers testing their safety in laboratory settings - to the manufacturers and
distributors responsible for turning them into products and delivering them to end users.

The risks of non-compliance in GxP

The risks of non-compliance in life sciences GxP are many and varied, which is why these
standards are codified and harmonised in regulated sectors as much as possible around
the world.

Consequences of the breakdown of best practice include product failure, wasted time
and resource. But at the more serious end of the scale they include serious physical harm
to end users resulting in the revocation of licenses, major fines and even imprisonment
for those with liability.

Inadequate documentation: a major factor in GxP

non-compliance
Many of the fines and sanctions issued around non-compliance in GxP are as a result of
inadequate and incomplete documentation. Data shows the FDA Observation Form 483
is most commonly issued because there is an absence of written procedures and CAPA
processes are not adequately defined or followed. At the same time the MHRA in the
UK cite insufficient or incomplete validation of computer systems and processes as a
common reason for failed inspections.

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 2. WHAT IS GMP? - GOOD
MANUFACTURING PRACTICE
GMP, also known as cGMP (Current Good Manufacturing Practice) ensures
pharmaceutical products, medical devices and other regulated items are
consistently manufactured and controlled according to quality standards -
thus reducing the risk of harm to consumers.

Rules and interpretations differ from country to country (and change frequently) but all
GMP require that products

• are of consistently high quality;

• are appropriate for their intended use;
• meet the requirements of the marketing authorisation or clinical trial authorisation.

The US FDA inspects manufacturing facilities producing drugs, medical devices

and In Vitro Diagnostics, for the US market, to ensure cGMP are in place. These
include facilities around the world that manufacture active ingredients and finished
products. Inspections follow a standard approach and are conducted by highly
trained FDA staff.

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 What’s different about life science manufacturing?
The kind of items these regulations cover are difficult to dismantle (or individually check)
for quality testing purposes after they have been assembled in a production process.
And their failure could represent a substantial risk to human health. Think of a strip
of pills or a complex software-controlled medical device. Although batch testing is
an important part of QC, GMP instead, seeks to ensure quality is ‘built into’ a product,
through the effective and consistent control of the processes used to create it.

The 5ps of GMP - are the best practice areas of focus for life science manufacturers.
They prioritise reducing the risk of non-conformities in end products by ensuring the
consistent implementation of processes and procedures, equipment and personnel
training, across the product lifecycle.

P People
P
Premises & Equipment

P
Need to have clear roles and Are validated and calibrated for
responsibilities expected performance
Need to follow all procedures Have procedures, schedules and
records associated with them
Be fully trained and assessed
for the work they do Designed for effective cleaning
Products Designed to prevent cross
contamination
Have specifications for raw materials,
components, intermediate and
finished products

P P
Have repeatable methods for:
research, development, processing,
manufacture and packing, testing,
sampling, status control, stability
testing and record keeping

Processes Procedures
All critical steps identified Should be documented and recorded
All processes defined, consistent Cover all critical processes
and documented
Ensure all non-conformities are
Robust change controls are in place investigated and reported

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 Through proper SOP documentation, implementation and record
keeping GMP ensures:

• Standard operating procedures are defined and well-documented.

• Manufacturing processes are defined and controlled. Any changes to processes are
evaluated and validated.
• The manufacturing process is recorded to prove that all required procedures and
instructions are properly followed.
• Manufacturing occurs in a controlled environment that prevents cross-contamination.
• The causes of any quality defects are investigated and action taken to ensure that the
defect does not occur again.

GMP also sets out best practice methods for manufacturers to ensure their products are
packaged and labelled correctly, and that they have the ingredients and strength they
claim to have.

GMP is a crucial element of end to end quality management. Together with

quality control and quality risk management, it needs to form part of an overall
QMS, designed to reduce the risk of contamination, errors and deviations
in production.

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 3. WHAT IS GAMP - GOOD
AUTOMATED MANUFACTURING
PRACTICE?
Good Automated Manufacturing Practice (GAMP) are the guidelines for companies
involved in the development and implementation of automated systems for the
Pharmaceutical and Food Industries.

Increasing automation, presents huge opportunities for Pharmaceutical manufacturers,

particularly, as they seek to produce drugs more quickly, efficiently and cost-effectively.
But more automation inevitably means more complexity and an increasing risk of failure
and non-conformance in end products.

For a pharma production line controlled by computer systems much of the focus on
regulating quality of output shifts to the development and maintenance of the
software itself.

What is Computerised System Validation?

Computerised Systems Validation (CSV) is a way of proactively guarding against the
failure of such automation, and it has become a key feature of the regulatory landscape.

A CSV process establishes documentary evidence that a specific computerised system

will consistently produce a product meeting its predetermined specifications and
quality attributes.

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 This V model of software validation ensures quality is ‘built into’ your
product development and management processes rather than simply
‘tested for’ and corrected retrospectively in an end Product.

Validation Master Maintain state of

Plan (VMP) Validation

User Requirement Performance

Specification (URS) Qualification (PQ)

Functional Requirement Operation

Specification (FRS) Qualification (OQ)

Technical Requirement Installation

Specification (TRS) Qualification (IQ)

Construction
Factory Acceptance Test (FAT) & Site
Acceptance Test (SAT)

The V-model provides a logical sequence that helps to organise the complex activities of
defining a project scope, executing it, and qualifying it at every stage.

The V model provides an excellent basis for design control and tracking changes as a
project proceeds. And the right document management system can help companies
organise and generate the documentation required to execute and record this process
of specification, qualification and validation - with all the relevant files indexed and stored
for future auditing purposes.

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 But there is a logistical problem with this. This kind of validation can be a time consuming
and expensive process to execute. Where end products are complex and product
updates are frequent, these validation requirements can overwhelm a business resource
and undermine their agility. In fact, when a company is using other manufacturers
software to automate their systems, it might be impossible to achieve. That’s where the
GAMP5 guidelines are intended to help.

What is GAMP5?
GAMP5® refers to the ISPE‘s best practice guidance (Version 5) which has been adopted
by the industry as a framework for companies to successfully validate their computerised
systems using a risk-based approach.

GAMP5 provides guidelines for required validation processes that take into account the
following concepts:

• A holistic understanding of product and process

• The way products can be managed and validated using a QMS
• The way lifecycle management can be levered for more scalable validation processes
• Encouraging a scientific approach to risk management that focuses on the systems that
pose the most potential risk to end-users
• Levering the involvement of suppliers in the validation process to avoid duplication of
effort and speed up compliance

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 4. WHAT IS CSV FOR GXP?
Computerised Systems Validation is a requirement in many different parts of life
science regulation including around the systems used to support GLP and GCP.

Adopting a Document Management System that functions as part of your QMS, can help
a business verify and validate the operation of its required functionality while creating
software systems. They can trigger validation processes to take place when new features
are added, which are automatically documented as part of your change control process.

Defining and setting up these systems early on will help companies more successfully
pass audits and inspections that increasingly focus on validation as a proactive measure
against systems and product failure.

In the UK, the MHRA inspectorate have explained how inadequate CSV documentation
frequently contributes to companies failing their audits:

“Many of these specific accounts point to a failure of systems and training when it
comes to documentation, with processes of validation being sketchily defined or
left half complete - pointing to a kind of process fatigue setting in at key moments
in a company’s evolution of best practice.”

Inspecting and certifying bodies around the world have echoed these issues.

Validation for electronic Quality

Management Systems
It should be noted that electronic Quality Management Systems themselves are
‘computerised systems’ that require validation.

ISO 13485 Clause 4.1.6, for example states that “software applications shall be validated
prior to initial use and, as appropriate, after changes to such software or its application”

A good supplier will be able to supply ‘validation packs’ to assist you in meeting these
application validation requirements.

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 5. WHAT IS GCP? - GOOD
CLINICAL PRACTICE
Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific
quality requirements that must be followed when designing, conducting, recording and
reporting clinical trials that involve human beings.

Guidance on good clinical practice has been produced by the International Conference
on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH).

The GCP guidelines require the following:

• All clinical trials should be conducted in accordance with ethical principles, sound
scientific evidence and clear detailed protocols.
• The benefits of conducting trials should always outweigh the risks.
• The rights, safety and well-being of trial participants are of primary importance
and these should be preserved by obtaining informed consent and maintaining
confidentiality.
• Care must be given by appropriately qualified personnel with adequate experience.
• Records should be easily accessible for accurate reporting, verification and
interpretation.
• Investigational products should be manufactured according to Good Manufacturing
Practice (2).

The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of
human subjects in clinical trials. It seeks to minimise human exposure to investigational
products. In doing so it improves the quality of available data while speeding up the
marketing of new drugs and reducing costs for sponsors and end users alike.

Adopting a Quality Management System is part and parcel of establishing a robust,

compliant and reproducible approach to clinical testing.

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 6. WHAT IS GOOD
PHARMACOVIGILANCE
PRACTICE (GPvP)
GPvP refers to a minimum set of standards defined by the EMA which ensures
companies continue to monitor the safety of the medicines they have developed after
they have been launched in the market.

What is Pharmacovigilance? (PV)

Pharmacovigilance refers to the scientific process of data collection, analysis, monitoring
and prevention of any adverse effects in drugs and therapies.

It is a set of ongoing requirements intended to determine which adverse events are

acceptable side effects of a drug or therapy, given their overall benefit to human health -
and which are not.

The proper administration of PV within a business authorized to market and sell drugs
is vital to prevent the catastrophic failures of oversight experienced in the past, where
medicines such as Thalidomide continued to be licensed and sold, despite strong
evidence appearing of its horrifying side effects.

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 What is GPvP compliance?
GPvP entails constructing and maintaining a Quality Management System capable of
storing and allowing access to vast quantities of safety data, which, in turn, is used to
monitor and report on the safety of all the drugs a company has authorisation to market.

The QMS describes and defines all the measures, processes and procedures necessary
to ensure that suspected adverse reactions to medicinal products are collected,
processed and acted upon.

There are many requirements for the effective and auditable administration of this
system including:

• The appointment of a Qualified Person Responsible For Pharmacovigilance (QPPV) - an

individual who is personally responsible for the safety of the human pharmaceutical
products marketed by that company

• The creation and maintenance of a Pharmacovigilance System Master File. A PSMF

is a document describing the pharmacovigilance system used by the marketing
authorisation holder (MAH) with respect to one or more authorized medicinal products.

• The preparation for the attention of the authorities of notification of serious adverse
effects (ICSRs), periodic safety reports (PSURs) and reports on studies of post-
authorisation safety (PASS);

In the UK the MHRA inspects Marketing Authorisation Holders (MAH) to determine

that they comply with these obligations.

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 7. WHAT IS GLP? - GOOD
LABORATORY PRACTICE
Good laboratory practice (GLP) are principles which ensure the quality and integrity of
non-clinical laboratory studies that support research or marketing permits for products
regulated by government agencies. They are defined in FDA 21 CFR Part 58 and other
regulatory codes .

GLP should govern studies around the hazards and risks to health and the environment
posed by:

• Medicines
• Pesticides
• Cosmetics
• Veterinary drugs
• Food and feed additives
• Industrial chemicals

A key objective of GLP is securing data integrity through Good Documentation Practice
(GDocP). GDocP ensures that regulated documentation is always accessible to those
who need it - as well as data that is, Attributable, Legible, Contemporaneous, Original and
Accurate (ALCOA+).

Adherence to these and other elements of GLP ensures that published data properly
reflects the results obtained during those studies and can therefore be relied upon when
making risk/safety assessments in development projects.

Good Laboratory Practice is recognised and reproduced through a company’s Quality

Management System. A Quality Management System ensures that every study
undertaken by a laboratory is planned, performed, monitored, recorded,
archived and reported under the proper conditions
in a consistent and repeatable way.

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 8. WHAT IS GDP? - GOOD
DISTRIBUTION PRACTICE
Good Distribution Practice (GDP) governs the wholesale distribution of medicinal
products and is designed to ensure quality and integrity is maintained throughout the
supply chain.

The World Health Organisation describes GDP as:

“an essential tool to secure the distribution system from counterfeits, unapproved,
illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded
pharmaceutical products”

GDP keeps products safe and in a usable condition

for their intended consumers
Distribution is important in the life science industry because of the way sensitive or
fragile medical products are stored and transported can impact their APIs (Active Product
Ingredients) and future intended performance.

Regulators such as the EMA and the FDA have begun to increase focus on this area,
specifying the way processes and procedures should be implemented and recorded for
GDP compliance. In the UK, the MHRA certifies adherence to GDP through inspection
and auditing - and licenses businesses accordingly.

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 Anyone importing, holding, procuring, supplying or exporting medicinal products or
active substances have to adhere to these guidelines - and be able to demonstrate how
they comply.

Operators in this sector need to have auditable systems that specify and define the
measures they take to ensure:

• Medical products are always transported and stored under the right conditions
• Contamination, theft or tampering is prevented
• Recalls and complaints can be effectively managed
• Only authorised products enter the distribution network

It should be noted that the number of critical dependencies within the supply chain
means that in the EU, distributors, manufacturers and their agents are now facing ‘ joint
and several liability’ for quality failings in end products. Manufacturers need to be
confident that their suppliers and distributors are implementing GDP in a trackable and
auditable way,

For all these reasons regulators around the world are increasingly requiring
distributors to have auditable Quality Management Systems that encourage
greater accountability, traceability and co-operation throughout the supply chain.

Digital QMS are needed to define and prove the GDP processes and procedures
distributors have in place to handle and deliver products in ways that ensure their
integrity and usability.

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 9. WHAT IS GACP? - GOOD
AGRICULTURAL AND COLLECTION
PRACTICE FOR MEDICINAL PLANTS
Good Agricultural and Collection Practices (GACP) as defined by the WHO and others
to address the specific concerns of growing, collecting and primary processing of herbs
and plants that are used for medicinal purposes.

These include the QA practices, training responsibilities, and good document

management practice - including the creation of Quality Management Systems to ensure
repeatability and consistency in the standards of end products supplied to the market.

GACP - Documentation Requirements

• For cultivated medicinal plants it is essential to document the type, quantity and the
date of harvest as well as the chemicals and other substances used during production
such as fertilizers, pesticides, herbicides and growth promoters.

• All batches from each designated area should be unambiguously and unmistakably
identified by batch number.

• All processes and procedures that could affect the quality of the product must be
documented and used to promote best practice throughout the collection and storage
of the regulated materials

In recent years with the growth of interest in medicinal cannabis and as a legalised and
regulated ingredient in ‘novel foods’ - producers, distributors and manufacturers of
associated products are having to rapidly respond to new regulatory requirements.

One of the most challenging areas for these evolving companies - has been the
requirement to build the Quality Management Systems, with which they can document
and help implement best practice in an agile and auditable way.

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 10. WHAT IS GDOCP? - GOOD
DOCUMENTATION PRACTICE
GDocP (Good Documentation Practices) are the standards by which data and documents
should be created and maintained in the life sciences industry.

All GxP have at their heart GdocP which allows for auditable and accurate record-
keeping, good governance and quality management.

For example, compliance with the Food and Drug Administration‘s GLP as well as GMP
regulations for drugs and medical devices (21 CFR Parts 211 and 820) all speak about the
observation of Good Documentation Practices.

What types of document need to be created and maintained using Good

Documentation Practices?

• Batch Records • Quality records (including CAPAs, internal

• Bills of Materials (BOMs) inspection reports and change control)

• Certificate of Analyses (CoA) • Standard Operating Procedures

• Certificate of Compliance (CoC) • • Test Methods

• Laboratory Notebooks • Training Documentation

• Logbooks • Validation Documents (IQs, OQs and PQs)

• Policies • Product and Sample Labels

• Protocols

Good documentation practice

reflects the principles of ALCOA+

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 11. WHAT IS ALCOA+?
ALOCA+ is an acronym that defines the fundamentals for ensuring data integrity in
‘source data’. It defines the critical elements of Good Documentation Practice:

ALCOA+
Data and documents must be
Data and documents must be

A ttributable Documents must clearly identify who has created and contributed to
them, and be protected against falsification or forgery of those details

L egible Stored documentation must be legible and easy to read

C ontemporaneous Documentation should demonstrate and support

contemporaneous record-keeping

Original Storing original copies of documentation guarantees accuracy

and confidentiality.

A ccurate The processes and procedures by which companies record and keep
their documentation up to date must ensure accuracy and reliability.

+ Complete
All documentation
must have an audit
+ Consistent
Documentation must be
date and time stamped
+ Enduring
Data must be
available for as
+ Available
Data must not only exist,
they must be accessible,
trail to show no and stored in such a way long as the too, when and where
data has been to prove it has been regulation requires required for reference
deleted or lost. assembled in the and auditing purposes
expected sequence.

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 12. GxP AND QUALITY
MANAGEMENT SYSTEMS
Throughout the regulatory literature - Quality Systems are cited as the way GxPs are
expected to be defined, implemented, audited and subject to a process of continuous
improvement.

The definition and replication of all these GxPs across a business depends on the ability
to build a robust Quality Management System that is accessible to the people who need
to refer to it in their daily work.

A good digital Quality Management System can underpin a company’s ability to control
the administration and observation of GxP standards across a business.

The right digital QMS (with all its document control capabilities) gives workers the tools to
create and maintain a ‘single, accessible and definitive source of truth’ when it comes to
recording and implementing GxP in their working practices.

9 ways a digital Quality Management System (QMS)

can help you implement and demonstrate

GxP COMPLIANCE
Establishes robust Defines and
and trackable documents SOPs Offers high level of digital
change control authentication as required
procedures by FDA 21 CFR Part 11

CAPA - supports and

documents the
effective management
of corrective and
Makes preventive actions
processes,
procedures
and supporting
Digital
documents
easy for users
QMS CSV - supports
to access and validation of
contextualise computerised
systems
Supports
hierarchies of
document access
and editing
privileges Supports cycles
of continual Auditing - makes
improvement documented GxP available
for inspection and audit

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 13. WHAT DOES IT TAKE TO BE
GXP COMPLIANT?
Whether you are manufacturing a drug or medical device, warehousing
active ingredients (APIs) or carrying out laboratory testing, the demands of
GxP compliance are fundamentally the same.

GxP compliance is about having the ability to implement (and prove you have
implemented) all the controls identified as necessary for the delivery of a reliable,
safe and usable end product or service.

Compliant businesses mitigate the risk of product failure (and, therefore, harm to
consumers) through consistent process definition, training, procedural control and
record keeping around all their working practices.

And this is the proactive approach to quality and risk management through the
implementation of best practice that notified bodies and regulators around the world
need to inspect, audit and certify.

But while you need a QMS robust enough to protect consumers against the risk of
product failure, your approach to GxP needs the flexibility to keep pace with new
commercial opportunities and legislative changes.

In the end, the accessibility and agility of the digital tools you use to manage
your quality management system will be pivotal to your successful and scalable
compliance with the regulation.

COMPANY INFORMATION
Registered Office: Cognidox Limited, Eagle Labs, 28 Chesterton Rd,
Cambridge CB4 3AZ. Registered in England and Wales No. 06506232
E: [email protected] / T: +44 (0) 1223 911080

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