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Appendix1-QAS15-625_01092015

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11 views5 pages

Appendix1-QAS15-625_01092015

Infoemative

Uploaded by

sodeeke2
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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1 APPENDIX 1 TO WHO WORKING DOCUMENT QAS/15.

625:
2 MODEL INSPECTION REPORT
3

PART 1 GENERAL INFORMATION


Manufacturer
details
Company Name of manufacturer
information Corporate address of manufacturer (including telephone, fax, email and 24-hour telephone numbers).
Contact person, telephone number and email address.
Inspected site Address of inspected manufacturing site if different from that given above (including GPS coordinates in WGS 84: latitude
and Longitude expressed in decimal degrees, taken at the main entrance of the site; D-U-N-S number: NNNNNNNNN if
available) and specific production blocks/workshops inspected if the whole site was not inspected.
Site number (e.g. unit number, site master file number or number allocated by the responsible authority).
Manufacturing licence number (if applicable)
Key personnel
Summary of For example, manufacture of active pharmaceutical ingredient(s) (APIs), manufacture of finished pharmaceutical products (FPPs),
activities intermediates or bulk packaging, laboratory testing, batch release, distribution and importer activities, etc.
performed at the
site
Inspection details
Date(s) of …
inspection(s)
Type of inspection For example, initial, routine, follow-up, special, etc.
Inspector(s) Name(s) and agency affiliations of lead inspector, inspector(s), accompanying experts and observers
2

Competent For foreign inspections, state whether the national regulatory authority (NRA) of the country where the inspection took place
regulatory was informed and whether it took part in the inspection.
authority
GMP guidelines List the relevant guidelines stating the title of the guideline, the title of the publication and web address where the guideline
used for assessing can be accessed, for example:
compliance 1. WHO good manufacturing practices for pharmaceutical products: main principles. WHO Expert Committee on
Specifications for Pharmaceutical Preparations. Forty-eighth report. Geneva, World Health Organization, 2014
(WHO Technical Report Series, No. 986), Annex 2
http://www.who.int/entity/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf?ua=1
Introduction
Brief summary of Description of main activities (including, e.g. FPP(s) or API(s) manufactured and their reference/registration/APIMF/DMF/
the manufacturing CEP numbers, as appropriate); other manufacturing activities carried out on the site (e.g. manufacture of cosmetics, research
activities and development); use of outside scientific, analytical or other technical assistance in manufacture and quality control
Brief description of the quality management system of the firm responsible for manufacture. Reference can be made to a site
master file if one is available.
History Previous inspection date and history of regulatory agency inspections
Summary of past inspections; observations on CAPA from previous inspection
Major change from previous inspection and planned future changes
GMP-related recalls from the market of any product in the last two years
4
3

Brief report of
inspection
activities
undertaken
Scope and limitations
For example, blocks inspected, areas of interest, focus of inspection
Out-of-scope: areas, activities or product lines not inspected
Restrictions: constraints experienced in inspecting specific areas

Areas inspected For example, dosage form(s) included in the inspection


Key persons met Names and job titles

PART 2 BRIEF SUMMARY OF THE FINDINGS AND RECOMMENDATIONS (WHERE APPLICABLE)


1. Pharmaceutical The observations made during the inspection that are considered to be noncompliant with GMP should be listed. Where
quality system positive observations are included in the report, clear distinction should be made between positive and non-compliant.
2. Production Noncompliant observations can be classified, e.g. as critical, major and minor if the Member State concerned has defined
system these terms. The date by which corrective action and completion are requested in accordance with the policy of the NRA
3. Facilities and should be given.
equipment system
4. Laboratory
control system
5. Materials
system
6. Packaging and
labelling system
Samples taken (if applicable)
4

Assessment of the site


(if master
applicable)
file
Annexes attached …
5

List of deficiencies Deficiencies should be listed by category with reference to the relevant section(s) of GMP guidelines. This may be presented
in a tabular format, giving references to the relevant GMP requirement:

Deficiencies References
1. Critical 1.1 …. …
1.2 … …
2. Major 2.1 …. …
3. Other 3.1 … …

PART 3 OUTCOME
Initial conclusion Statement regarding the GMP status, including information on any restrictions in scope:
. • other deficiencies only: operating at an acceptable level of compliance with GMP guidelines; OR
• other and a few major deficiencies (e.g. <6): decision on level of compliance to be made after receipt and evaluation of
CAPAs; OR
• critical or several major deficiencies (e.g. ≥6): operating at an unacceptable level of compliance with GMP guidelines.
References List of GMP guidelines referenced in the inspection
Brief narrative on …
the adequacy of the
company’s response to issues
to be addressed
5

Final conclusion Final statement of GMP compliance

Risk rating For example, Low (L), Medium (M), High (H), Critical (C)
following the
inspection
Next inspection due The inspectorate may decide to include this information for internal use only.
date (for planning
purposes)
Name (lead
inspector)
Signature (lead
inspector)
Date
6
7 ***
8

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