Maas & Peither GMP Supplier Assessment Question-

Pharma GmbH naire for Active Pharmaceutical In-

gredients (API) and Excipients page 5 of 24

2.2 Quality Requirements

Does the company have a Quality Management System? yes

no

Are sub-suppliers included in the Quality Management System? yes

no

Do you produce complying with special regulations

(e.g. EU-GMP-Guide Part II, IPEC)?

Are you complying with the EU-GMP standard? yes

no

Do you have a currently valid GMP certificate? yes

If yes, please attach a copy no
n.a.

Is there any supervisory authority? yes

no
n.a.

Is there any local supervisory authority?

<Name of the authority>

Date of the latest inspection:

Do you have a written confirmation for yes

the product in question? no
n.a., GMP-standards are comparable
according to listing of third countries
(see O.J. of the EU) or production within
EU or EEA

Is a certificate according EN/ISO 9001 available for the manufacturing yes

site? no
If yes, please attach a copy. n.a.

Have you been inspected by other local and foreign authorities in the yes
last five years? no
If yes, please specify which authorities.

If yes, please attach a copy of the latest GMP certificate thereof.

2013 Maas & Peither AG GMP Publishing

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Maas & Peither GMP Supplier Assessment Question-
Pharma GmbH naire for Active Pharmaceutical In-
gredients (API) and Excipients page 6 of 24

2.3 Release and Rejection

Are there written procedures for release and rejection for

Raw materials
yes
no

Intermediates
yes
no

Finished products
yes
no

2.4 Risk Management and PQR

Is risk management implemented in your system? yes

no

Is there a written procedure for risk management? yes

no
SOP-No.

Is a product quality review (PQR) implemented? yes

no

2.5 Change Management

Do you routinely inform the customer about changes of the production yes
process? no

Do you routinely inform the customer about changes of the production yes
site or rebuilding? no

Do you routinely inform the customer about changes of the product yes
specification? no

Which person in your company is responsible for communicating change infor-

mation?

2013 Maas & Peither AG GMP Publishing

6