Standard Operational Procedure for the Determination of Equivalency
of Inspection Methods
Table of Contents:
- Scope
- Introduction
- Vocabulary/Definitions
- Choice of Sites
- Team
- Planning
- Interpretation
- Performing the Inspection
- Confidentiality
- Reports
- Roles and Responsibilities
- Follow-up
1. Scope
This SOP describes the items normally necessary to initiate, plan, decide,
operate, report upon and follow-up an inspection together with an inspectorate
included in an MRA. It identifies the key steps involved during an inspection
in order to determine the equivalency of the inspection process of the
participating regulatory agencies. It is understood that equivalency does
not mean identical but it does mean leading to the same result.
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2. Introduction
An inspection to determine equivalency of inspection methods is initiated
primarily to evaluate the system used by the host on routine inspections
when inspecting a relevant firm. The team members must respect the scope
of such an inspection and the fact that it also is a regular event for
the firm and licence holder and, in most cases, is one of a series of
routine inspections. Furthermore it is an important part of a confidence
building programme and team members should act accordingly. Any major
disagreement therefore must be discussed or solved and recorded amongst
the team and not in front of the inspected firm.
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3. Vocabulary/Definitions
Establishment report
The inspection report issued by the host.
Evaluation report
The report issued by the visiting inspector
Host
Any person (inspector or expert) performing their duties within their
own territory together with visitor(s).
JSG
Joint Sectoral Group as described in the MRA.
Relevant firms
The firms, making products listed in Section 4.3 (a) of the MRA.
Visitor/Visiting inspector
Any person (inspector or expert) visiting the other party's territory.
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4. Choice of Sites
The visiting inspectors should be offered inspection sites in principle
from any of the relevant firms. The choice should be made from relevant
firms included. As the MRA will mean a general possibility for all licensed
firms to export to the other party, not only licensed firms currently
exporting to the other party should be inspected. In practice the selection
should be made from firms which are scheduled for a routine inspection
in order not to burden firms. Visiting inspector may request inspection
of firms outside this interval for a special reason like a legal requirement
to inspect a particular firm.
(During the transition period a confidence building programme including
inspections will be elaborated by the JSG. It is expected that besides
those inspections, regular GMP inspections will be made as usual during
the transition period. However such inspections must not interfere with
the inspections initiated to determine equivalency but may occasionally
be scheduled in close connection to such inspections in order to save
resources for the visitor and unnecessary burden to the firm. Such extended
inspections must be notified to the JSG co-chairs.)
4.1 Host inspectorate should on request from the visiting inspectorate
list all relevant firms planned to be inspected during next 2 to 6 months.
4.2 The list should state:
- Company name and its location (city or full street address);
- Product range (cf. product types as stated in manufacturing authorizations);
- Size of site (approx. number of employees at site);
- In case a full inspection is not planned for, an indication of
the scope and products;
- Expected inspection duration (days);
- Scheduled preliminary date (month) for the inspection;
- The language to be used by the inspector.
4.3 The list to be sent to JSG co-chairs.
4.4 Visitor to make preliminary selections from the lists of planned
inspections. Notify host and discuss suitability to determine equivalency
of inspection methods.
4.5 Notify host about final selection and planned inspection dates.
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5. Team
An inspection team should not include more than 4 to 5 people who all
must have a clear role. Preferred maximum size is 3 persons.
The host inspector will always plan and lead the inspection. Visiting
inspector may give any suggestion in order to facilitate planning and
execution of the inspection.
Visitor may include 1-2 persons (inspector and/or an expert) plus an
interpreter when necessary.
Visiting inspector should be experienced to be able to evaluate the performance
of the host team. Host inspector should be representative of the normal
allocation of inspectors.
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6. Planning
Host inspectorate is responsible for planning in close cooperation with
visitor and firm. All final decisions should be taken by host. Host should
assist visitor in travel planning but visitor must pay all of own expenses.
Parties are responsible for their respective costs when entering this
programme.
Host should make proper agreements with firms including informing the
firm about the scope and purpose of the inspection. The inspection should
be confirmed in writing at least a week before the inspection. Names of
team leader and all visiting inspectors should be given.
Any area where the firm may suggest exclusion of the visitor in accordance
with a MRA confidentiality clause should be notified to visitor. Host
should make proper arrangements with firm and visitor regarding entering
requirements, e.g. protective clothing, vaccination or microbiological
tests.
A Site Master File / Reference File should be requested and copied to
the visitor.
A pre-inspection meeting should be arranged for the team. It takes place
immediately before the inspection and the scope is to present the inspection
environment for the visitor. Such a meeting is expected to last half to
one day.
The agenda for such a meeting should include:
- Introduction to the host inspectorate and normal inspection practice
for the scheduled inspection;
- Introduction to the firm to be inspected (past inspection history,
products licensed, recalls etc.);
- Discussion of the proposed plan for the inspection exercise.
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7. Interpretation
The host team will decide language to be used during the inspection.
Another language than the official language(s) may be used if a written
consent from the firm is obtained in advance. Arrangements for interpretation
should be planned for as necessary. Visitor is responsible for including
any interpreter and within the maximum number of team members.
Note! All costs for interpretation which is a consequence of the inspection
should be carried by the visitor. Firms should only be required to provide
interpreter if the inspection is a substitute for a regular inspection
scheduled also by the visitor. This may be the case where a firm is exporting
to the other party.
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8. Performing the Inspection
Host team leader should inspect in accordance with normal practice.
For Canada this is procedure # SOP-0006 on "GMP Inspection of Drug
Establishments".
For (other Party) this is (identification of procedure/SoP).
Host team must evaluate deficiencies in accordance with their respective
GMP.
For Canada this is "GMP, Health Canada" most recent edition.
For (other Party) this is (identification of standard(s)).
With the agreement from the host lead inspector the visiting inspector
may during the inspection ask questions related to observations made or
not made by the host. The purpose of such questions should be to evaluate
the inspection process rather than to further evaluate the firm. The host
lead inspector may at his/her own discretion refer other questions to
other occasions for example, to the daily follow up meeting.
Use of cameras, video, tape recording etc. should be with the host's
normal practice.
Host team leader must report to the respective JSG co-chair that an inspection
has been performed. The establishment report should not be sent to the
JSG unless specially requested. This is to respects firm's right
of confidentiality.
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9. Confidentiality
The confidence building programme including inspections to determine
equivalency of inspection methods is a part of an agreement signed by
Canada and (name of other Party) at high level and in conformance with
requests from industry. Full cooperation from selected firms is therefore
expected.
All inspectors entering into the inspection programme must obey legal
requirements such as not to disclose any proprietary information obtained
during an inspection. Reference is also made to the MRA, Section XX,
Confidentiality.
Host and visitor must be aware of firm's rights regarding proprietary
rights and trade secrets. Firm may in exceptional cases and in limited
parts of an inspection suggest to exclude visitor from inspecting special
areas. Such exceptions should be explained to the visitor during the planning
and the scope of the inspection must not be lost. This paragraph would
not apply to an area in a firm used for manufacture of products (or influencing
products) to be exported to the territory of the visitor.
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10. Reports
Two sets of reports should be issued. An establishment report
from the inspection and an evaluation report (by the visiting inspector).
The establishment report should be written and issued as for an ordinary
inspection by the host. Visitor should not take part in writing of this
report, only comment upon it in the evaluation report. The report may
include a statement about the scope of the inspection. Visitor team members
must be mentioned. This report should be issued within 30 days after the
last inspection day (or the longer time accepted as routine by that inspection
service) with a copy to the visitor.
Reports should avoid disclosing any secret information if not necessary
to meet the scope of an inspection. Such information should be annexed
to the main report to facilitate confidentiality.
The establishment report should be written in the host's language. If
both host and firm accept it, the report may be issued in a language more
suitable for the visitor. Otherwise, visitor is responsible for translations
of reports to own language. Firms should only be required to provide translation
if the inspection is a substitute for a regular inspection scheduled also
by the visitor. This may be the case where a firm is exporting to the
other party.
The evaluation report is issued by the visiting inspector in English or
translated to English by the visitor.
A draft evaluation report should be sent to the lead inspector within
15 days after receiving the establishment report. Comments should be made
within 7 days and the completed evaluation report should be issued within
further 15 days and sent to the JSG co-chairs with a copy to the lead
inspector. Any delays must be communicated to the JSG co-chair representing
the visitor. When the host inspector has serious concerns about the evaluation
report which are not resolved in discussion with the visiting inspector,
he /she may attach a comment to the evaluation report.
Several individual evaluation reports will be amalgamated to assist in
the evaluation of equivalency.
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11. Roles and Responsibilities
Host responsibility
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Shared responsibility
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Visitor responsibility
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Planning
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Information to firm
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Confirmation of participating visitor
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Inspection
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Pre-inspection meeting
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Every day follow-up
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Exit meeting
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Evaluate host inspection
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Write inspection report
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Write evaluation report
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Planning includes previous reports and communication with firm.
Complaint and recall file. Updated SMF/SRF.
Pre-inspection meeting takes places immediately before the inspection
and the scope is to present the inspection environment for the visitor.
Such a meeting is expected to last half to one day.
Every day follow-up is a short meeting for the team only, where
inspection matters can be discussed in confidence within the team.
Exit meeting with the firm should be held according to host procedure.
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12. Follow-up
Where follow-up is a normal procedure by the inspectorate or a consequence
of the inspection result, the visitor should be informed about such activities
as they proceed. Visitor should be copied with relevant communication.
Based on follow-up activities the visitor can amend the initial evaluation
report as necessary. Procedures and time frames given in § 10 Reports
should be followed (e.g. information to the lead inspector). Visitor should
not be obliged to consider follow-up activities longer than 3 months after
the inspection.
The JSG should be informed of any other consequent action by the regulatory
authority, for example action against an authorization as a result of
findings during the inspection.
When host take the decision to re-inspect a firm within the transition
period, visitor must be invited to this inspection but has no obligation
to participate.
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