1. PREPARATION FOR GMP INSPECTION
Malaysia

2. To review the activities in preparation for a GMP inspection
OBJECTIVE
To review the activities in preparation for a GMP inspection
The objectives of this module are to review the activities that need to be carried out when you are preparing for an inspection. We will look at the key issues relating to the preparation for an inspection and review the particular issues that relate to inspections in your country. 2

3. Where & How Do We Start a GMP Inspection?
GMP INSPECTION PREPARATION
Where & How Do We Start a GMP Inspection?

4. GMP INSPECTION PREPARATION
Generally the processes involve;
Planning of inspections
Formation of Inspection Team
Review of documentations
Prepare the Inspection Plan
Pre – inspection meeting
Announcement of inspection

5. A. PLANNING Inspector Objective Type Timing Depth
The first step is to define the objective of the inspection that is to be carried out. Why is the inspection being performed? What is the purpose of the inspection? Is it a first visit to a new company or a continuation of an established inspection programme?
Which type of inspection will be performed? Will it be a routine inspection and review of all aspects of GMP, or a concise inspection of selected aspects of GMP? Can you still remember the other types of inspections and when these are performed? (Follow-up inspections to monitor corrective actions, special inspections to carry out spot checks and quality systems review).
You also need to decide whether the inspection will cover the entire factory or just part of it. You have to determine what the scope and depth of the inspection will be to enable you to prepare properly for the inspection. You may want to spend time in just one area rather than trying to cover all manufacturing sections or departments in the same inspection.
Once the purpose of the inspection has been determined, and the depth, you can then decide on the amount of time that will be required to carry it out.
You can also plan the date when the inspection will take place. Whether this is done in conjunction with the company in question will depend on the objective of the inspection and the accepted practice within your inspectorate.
Some inspections are carried out by individuals while others involve teams of inspectors. In some cases, it may be better to have a team performing the inspection. In such cases, it allows the workload to be split, and the involvement of people with different specializations. It also provides a “sounding board” for developing the conclusions of the inspection.
If the team approach is used, a chief or lead inspector must be appointed to co-ordinate and lead the inspection. The lead inspector is usually the main spokesperson during the closing or exit meeting at the end of an inspection, and has the overall responsibility for the inspection report.
Timing
Depth 5

6. B. INSPECTION TEAM
Generally, one GMP Inspector will be involved per inspection. If required, a team consist of 2 inspector may be established.

7. C. DOCUMENTATION REVIEW
Company file
Site Master File
Manufacturing license
In preparing for the inspection, it is advised that you review some documentation relating to the manufacturer to be inspected.
Most regulatory authorities have a company file in which general correspondence and previous inspection reports are filed. Review the information on file as there may be aspects that you would like to investigate when performing the inspection.
Some regulatory authorities require manufacturers to submit a site master file (SMF) to the DRA. By studying the SMF, you will have a better understanding of the layout and design of the manufacturing facility, and some of the systems the manufacturer has in place to ensure quality in manufacture of products. You can make notes in your aide memoire when reviewing the SMF and verify some aspects stated in the SMF during your inspection, e.g. equipment, procedures and personnel aspects.
Another source of useful information, is the manufacturing licence and registration dossiers. You can use these documents to make notes for verifying compliance with licence conditions, and data verification.
Reports on previous inspections and ADRs may also assist you in guiding you to do some investigations to verify corrective action taken by the manufacturer.
For special inspection, you will have to review records of the company in relation to complaints and recalls, and regulatory test results (surveillance).
The trainer can also make reference to the format of a Site Master File as recommended by the WHO (See WHO GMP Text) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). 7

8. C. DOCUMENTATION REVIEW (cont.)
Reports
Previous inspections
Records
Complaints and recalls
Reports on previous inspections and ADRs may also assist you in guiding you to do some investigations to verify corrective action taken by the manufacturer.
For special inspection, you will have to review records of the company in relation to complaints and recalls, and regulatory test results (surveillance). 8

9. C. DOCUMENTATION REVIEW (cont.)
Checklist and/or
Aide-memoire inspection
When reviewing all this documentation, draw up a checklist or aide memoire of points you would like to verify during your inspection. 9

10. D. INSPECTION PLAN Develop inspection plan.
Inspection plan need to be flexible so as to accommodate any changes required
Having done this, develop the programme for the inspection. From this the inspection team needs to produce an outline of what will be covered each day. It is probably not worth going into too much detail at this point, since all inspections have unforeseen events and plans have to be revised as you go along. However, it is important to know what each member of the team will be doing every day or half-day of the visit. Indicate in your programme which sections or departments will be inspected, and when.
Once it is prepared, the programme will need to be distributed. If it is an announced inspection, you could inform the company of the proposed inspection programme. The managers will find it very useful to see the programme in advance as this will help them in their preparation for the inspection. They can make sure that the appropriate people are available at the right times, rather than keeping everyone on stand-by for the whole time.
The team members should also be given copies of the final version of the programme.
*Audit Plan Image 10

11. D. INSPECTION PLAN (cont.)
Key elements may include :
The type, scope, objective of the inspection
Information from previous GMP inspection
The time, date and place for the opening meeting
The expected time and duration for each major inspection activity

12. D. INSPECTION PLAN (cont.)
Key elements may include :
Names of the inspection team members and their respective roles
The organizational units to be inspected, taking into consideration if the company has multiple sites
A tentative time, date and place for theexit meeting

13. D. INSPECTION PLAN (cont.)

14. D. INSPECTION PLAN (cont.)
Day / Time
Inspectors
Inspector A
Inspector B
Inspector C
hrs
Opening Meeting
hrs
Site Tour
hrs
Break
Area / scope of inspections
Document Records Review
hrs
Inspections
hrs
hrs
Continue Inspections
End of Day 1 Inspection
1600 hrs
Inspectors Meeting
1630hrs
Exit Meeting
End of Inspection

15. E. PRE-INSPECTION MEETING
Prior to conducting the inspection
Attended by all the inspectors.
Issues to discuss;
The objectives & scopes;
The inspection plan;
Chapters/areas covers by each inspector;
Arrival time, transport, lodging, etc

16. INSPECTION TOOLS Inspection tools…
The ASEAN Guideline on GMP for TM/HS
Last audit report
Inspection agenda
Note books
Check list/aide-memoire
Camera/recorder etc.

17. F. INSPECTION ANNOUNCEMENT
The company being inspected
When you have decided when the inspection is due to be performed, it would be proper to notify certain people of the proposed inspection.
If your policy is to announce the inspections in advance to the manufacturers, you would have to contact the manufacturer and inform the company of the proposed inspection.
If the inspection will be performed by a team of inspectors, you would obviously have to inform the other members of the team. Remember to inform the other inspectors who will be part of the team as well as any specialists of the finalized date for the inspection.
There may also be other interested parties that you could inform of the proposed or planned inspection. This could include evaluators of the registration dossiers (as they may request you to investigate any aspect of the dossier or submitted data during your inspection. This will depend on the structure and policy f your regulatory authority. 17

18. REFERENCES
NPRA PROCEDURE FOR CONDUCTING OF AN INSPECTION : PKP/200/308