Why did the testing firm skip the required steps in the code of conduct?
The regulatory system requires that
the testing is carried out by an approved testing contractor
(or its authorised representatives) who has been
established and supplied by the Testing Agency (a
national regulatory body). A,b,c, d, or e of the
T/A Codes of Conduct: Testing and Licensing should
be carried out for each testing batch by each approved
testing contractor recognised under the relevant code.
e of the T/A Codes of Conduct: Testing and Licensing should be carried out by a certified testing laboratory approved by the Testing Agency. F (and c) of the T/A Codes of Conduct: Testing and Licensing should not be carried out by a person not registered with the Testing Agency.
There is no written guidance on site visits.
Please check the relevant relevant codes of conduct on
the relevant website and make your own enquiries and
If the operator’s sample test is not approved by
the Testing Agency then the sampling facility could be
unsafe as there is no third party inspections of the facility by the authority responsible for the safety of the sampling area. The Testing Agency:
• Assesses the qualification and competence of the
test site personnel, including the testing equipment
procurement process, environmental management systems
and safety certifications.
• Updates its operating policies to ensure
that chemicals are safely maintained and
answering questions relating to the authorisation of the
supplier of samples.
• Enforces compliance and conduct an investigation into issues brought to its attention and has the powers to seek prosecution and licence revocation in respect of non-compliance. The Testing Agency:
• Review test facility risk management and
• Enforces standards and complies with the relevant
safety codes of practice.
• Ensures the licensees submit all data in a
form requested by the regulator.
• Urges drug manufacturers to:
• Proactively understand the process and attitude of other pharmaceutical customers and to ensure that suppliers meet their
standards of customer service
• Ensure that sensitive information is stored
(and redacted from the use of disk images) to avoid
misuse or loss by other third parties.
– Source: Thetrapreneur.co.uk
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