ARCHIVED - Standard Operational Procedure for the Determination of Equivalency of Inspection Methods

Table of Contents:

1. Scope
2. Introduction
3. Vocabulary/Definitions
4. Choice of Sites
5. Team
6. Planning
7. Interpretation
8. Performing the Inspection
9. Confidentiality
10. Reports
11. Roles and Responsibilities
12. 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

11. Roles and Responsibilities

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.

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.