GMP TMHS INSPECTION REPORT

[draft]
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Report Reference Number : [Internal Numberring System]

Inspected site(s) : [Name and full address of the Inspected site]

Activities carried out by company Manufacture of Active Ingredient

Manufacture of Finished Product
Manufacture of Intermediate or bulk
Packaging
Laboratory Testing
Other : ____________

Inspection date(s): [Date(s), month, year]

Inspector(s): [Name of the inspector(s)]

[Name of expert / assessor (if applicable)]

[Name of the Competent Authority(ies)]

References: ASEAN GUIDELINE ON GMP FOR TM & HS

List of Number of Marketing and / or
Manufacturing Authorisations
Inspection reference number(s). If applicable [i.e. Letter of Assignment, previous
inspection report]
Introduction:
[Short description of the company and the activities of the company]

[Date of previous inspection]

[Names of Inspectors involved in previous inspection]

[Major changes since the previous inspections]

Brief report of the inspection activities undertaken:
Scope / type of Inspection: [Short description of the inspection (General
GMP inspection). The reason / type for the
inspection should be specified (e.g. new
manufacturing facility / GMP recertification,
routine, investigation of product defect)]
Inspected area(s): [Each inspected area should be specified]

Personnel met during the inspection: [The names and titles of key personnel met,
should be specified]
 GMP TMHS INSPECTION REPORT
[draft]
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NRA

NO DEFICIENCIES CATEGORY*

1 QUALITY MANAGEMENT

1.1

1.2

1.3

2 PERSONNEL

2.1

2.2

2.3

3 PREMISES AND EQUIPMENT

3.1

3.2

3.3

4 SANITATION AND HYGIENE

4.1

4.2

4.3

5 DOCUMENTATION

5.1

5.2

5.3

6 PRODUCTION

6.1

6.2
 GMP TMHS INSPECTION REPORT
[draft]
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NO DEFICIENCIES CATEGORY*

6.3

7 QUALITY CONTROL

7.1

7.2

7.3

8 CONTRACT MANUFACTURE AND ANALYSIS

8.1

8.2

8.3

9 COMPLAINTS AND PRODUCT RECALLS

9.1

9.2

9.3

10 SELF INSPECTION

10.1

10.2

10.3

11 VERIFICATION

11.1

11.2

11.3

*Category : Risk Classification of GMP Non-Conformance: C (critical), M (major), m (minor)

Other specific issues identified [e.g. Relevant future changes announced by

 GMP TMHS INSPECTION REPORT
[draft]
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company]
Site Master File (SMF) [Assessment of SMF if any; date of SMF]
Distribution of Report 1.
2.
Summary and conclusions:
[The Inspection Team should state if the Company operates in accordance with the ASEAN
GUIDELINE ON GMP FOR TM / HS and mention any other item to alert requesting authority.]
Inspector(s)
Name(s) Signature and date