Questions & Answers for PIC/S GDP Guide Q&A Document

premises. In practice
the application of MKT
fails where a complete
chain of temperature
recording cannot be
allocated to a specific
consignment of a
product. Attempts to
apply MKT have been
proposed by
wholesalers as an
alternative to having
adequate temperature
control within their
warehouses as well
as attempting to
downgrade the impact
of temperature
excursions. The use
of MKT in the
wholesale
environment without
robust supporting
information and
methodology is
therefore discouraged.
Chapter 4, 4.2.1 What is readily Documents including
Documentation, General available/retrievable? procedures and
records should be
available or easily
accessible to the
personnel doing the
operation described in
the document.
Chapter 4, 4.2.4 Who is a designated The authority to
Documentation, General person? approve documents
should be authorized
by management and
documented as such.
Where these
authorisations pertain
to Responsible Person
(RP) functions, this
should be
appropriately
documented.
Chapter 4, 4.2.5 What is “where The reason should be
Documentation, General appropriate “? clearly stated, unless
obvious. Inspectors
should refer to the
PIC/S “Good Practices
for Data Management
and Integrity in
Regulated GMP/GDP
Environments”
(PI 041-1)

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Chapter 4, 4.2.8 What is meant by kept up SOP should reflect

Documentation, General to date? current regulatory
requirements, local
practices, and
company specific
operations.
Chapter 5, Operations, 5.2.3 What is meant by Periodic assessments
Qualification of Suppliers periodically rechecked? of bona fides should
be undertaken on a
risk basis. This may
include but is not
limited to: functions
undertaken by the
company, reliability of
the organisation, any
history of regulatory
action, length of time
in business and types
of medicines offered.
Where additional
guidance may be
published, such as
regulatory suspension
or revocation notice,
these should be
examined on the
frequency published
by the Licencing or
Competent Authority.
Chapter 5, Operations, 5.3.2 Does authorization for Yes, however, it may
Qualification of distribution mean holding also include other
Customers a licence? authorisations or
entitlements. Relevant
national legislation
should be reviewed to
ascertain entitlements.
Chapter 5, Operations, 5.3.3 Are there any best It is recommended to
Qualification of practices for the check for unusual
Customers investigation of “unusual repetition of orders,
sales patterns”? sudden increases of
orders, and unusually
low prices.
Chapter 5, Operations, 5.5.1 What are “healthcare Wholesalers should
Storage products “? refer to relevant
national legislation.
Chapter 5, Operations, 5.5.3 What are “appropriate As defined on the
Storage storage conditions”? outer packaging of the
product. Where no
conditions are cited,
the company should
ascertain storage
conditions from
Licencing or
Competent
Authorities. Where no
guidance exists, the
manufacturer should

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be consulted for
further guidance.
Chapter 5, Operations, 5.5.7 What is meant by stock Unexplained stock
Storage irregularities? anomalies.
Chapter 5, Operations, 5.5.6 and What is “near expiry date” There is sufficient
Picking shelf life left that
5.7 or based on the time of
supply to the
“ appropriate remaining pharmacy/retailer and
shelf life”? then the patient, the
product will still be
within shelf life when it
is consumed.
Chapter 6, Complaints, 6.3.2 Must all conditions be met Yes
Returns, Suspected in this section to return to
Falsified Medicinal saleable stock?
Products and Medicinal
Product Recalls,
Returned Medicinal
Products
Chapter 6, Complaints, 6.3.2 ii What is acceptable time 10 days, or in
Returns, Suspected limit for return to saleable accordance with the
Falsified Medicinal stock? relevant national
Products and Medicinal legislation.
Product Recalls,
Returned Medicinal
Products
Chapter 7, Outsourced 7.2.2 Is the audit required to be Most initial audits
Activities, Contract Giver physical on-site audit? should be conducted
on site, with any
consideration of
ongoing remote or
physical assessments
considered because of
the audit and on a risk
basis. However, it is
recognised there are
some circumstances
where this is not
possible to conduct
on-site audits
immediately, such as
during the Covid-19
pandemic. In this
instance, risk-based
principles and
justifications should be
applied and a physical
audit should be
completed as soon as
practicable.
Chapter 7, Outsourced 7.2.2 What is the requirement of The person should
Activities, Contract Giver the person who conduct have knowledge and
the on-site audit? expertise in the
contracted operation.
Chapter 8, Self- 8.2.2 Are their circumstances No, a self-inspection
Inspections where external audits are must always be

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acceptable as a substitute undertaken by the

to self-inspection? company and external
audits, or regulatory
inspections are not
acceptable
replacements for this
function, however, a
company may take
into consideration any
external audits
conducted by subject
matter experts when
assessing the scope
of their self-
inspections.
Chapter 9, 9.2.1 Do set temperature or Whereas GDP does
Transportation humidity limits/values as not specifically cite
required by the products’ continuous monitoring
labelling have to be as a requirement, a
continuously monitored company must be able
during transportation and to demonstrate that
the data be available for storage conditions as
review, if so, required by defined on the product
the MAH, and/or inspector have been maintained.
or any other relevant party Practically, it is
challenging to
demonstrate goods
have been transported
in label conditions
without continuous
monitoring for longer
journeys, however,
may be practical for
short journeys outside
of climatic extremes.

Local legislative
requirements
pertaining to the
monitoring or
management of
relative humidity
where applicable
should also be
considered.
Chapter 9, 9.2.2 Who is responsible to The MAH or
Transportation inform the Manufacturer manufacturer does not
Authorisation Holder need to be made
(MAH) or the aware by default; for
manufacturer in case of example, if goods are
any significant deviations to be destroyed
(e.g. temperature following an excursion,
excursions)? there is no need to
report this unless local
legislative provisions
to do so are in place.
However, when

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investigating
temperature
deviations, MAHs or
manufacturers may be
consulted to assess
the impact on product
quality. Where such
deviations are
identified, this is the
responsibility of the
distributing
wholesaler. It is
important to note that
stability data in itself
does not justify the
use of medicines
subject to temperature
excursions due to lack
of accumulative data
and the impact of such
excursions must be
considered
proportionately

Local legislative
requirements
pertaining to the
monitoring or
management of
relative humidity
where applicable
should also be
considered.
Chapter 9, 9.2.9 Should the transportation Where required by the
Transportation company hold a national legislation.
wholesaler’s licence?
Chapter 9, 9.2.9 When the products are As required by the
Transportation stored by the national legislation.
transportation company,
during transportation, how An organisation
long can they be stored should ensure that
before a wholesaler’s appropriate
licence is necessary? assurances are in
place to ensure the
quality of medicinal
products is maintained
from point of dispatch
regardless of localised
licencing requirements
of entities, such as
transport companies.
Chapter 9, 9.4.5 What is the definition of The recipient of the
Transportation, Products the customer? product, e.g.,
requiring controlled wholesaler, pharmacy.
conditions

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