As a responsible company, Phytopharm’s
products are developed in accordance with
recognised quality guidelines and appropriate
national and international legislation to ensure
the efficacy of the product and the safety of the
consumer. In order to achieve this, the Company
has adopted the following guidelines:

Good Agricultural Practice (GAP)

The principles of GAP are applied to the
cultivation and post-harvest processing of
botanical raw materials. The Group’s GAP
manual and associated technical documentation
have been developed with reference to
recognised codes of practice. The manual
provides a framework for cultivation protocols
that are implemented by working with local
farmers, agronomists and horticulturalists
in the countries where crops are grown.
The cultivation protocols are developed to
combine local practice with the principles of
GAP to ensure a synergy between developing
agricultural systems and western agricultural
practices. Compliance to the protocols is
assessed by the review of crop record sheets
and monitoring visits to the growing sites.

Good Laboratory Practice (GLP)

The Group requires that contractors involved in
the conduct of key non-clinical studies and the
analysis of such studies apply the appropriate
level of GLP to their facilities and the conduct
of studies therein. These requirements are
detailed in the GLP regulations Statutory
Instrument 199 No. 3106 and they have been
incorporated into the Company’s quality system.
Compliance is reviewed by routine monitoring
visits and/or audit; training may be provided
to ensure the level of compliance is acceptable.

Good Manufacturing Practice (GMP)

The Group requires that all contractors directly
managed by Phytopharm and involved in the
operational aspects of manufacture, analysis,
packing, labelling, release, storage, distribution of
its materials and products apply the appropriate
level of GMP to their facilities, as defined in
GMP regulation and guideline documents.

These practices are mandatory requirements
for products designated for use in clinical trials
conducted in accordance with competent
authorities’ regulatory requirements. Guidelines
are detailed in UK, European, US and ICH
publications and have been incorporated into
the Company’s quality system. Compliance is
routinely monitored by audit and training may
be provided to ensure the level of compliance
is acceptable.

Good Clinical Practice (GCP)

GCP is an international ethical and scientific
quality standard for designing, conducting,
recording and reporting studies that involve
the participation of human subjects. Studies
conducted in Europe and North America
must have ethical and regulatory approval
prior to initiation and compliance with the
stated protocol is independently monitored
and further assessed by audit. These actions
help to provide assurance that the rights, safety
and wellbeing of study subjects are protected,
consistent with the principles that have their
origin in the Declaration of Helsinki, and
that the clinical trial data are credible. These
requirements have been incorporated into the
Group’s standard operating procedures and
working documentation.

We are recognised by others

Phytopharm is currently approved for potential investment in selected socially and responsible investment (SRI) funds managed by both Henderson Investors and Jupiter Asset Management.

FTSE4Good

The Group has been a constituent member of the FTSE4Good index series since March 2004. The index is designed to measure the performance of companies that meet globally recognised corporate responsibility standards. More information on our approach is detailed on our website, www.phytopharm.com