QAS-031 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 510

ANNEXURE E

QUALITY AGREEMENT

This quality agreement is by and between M/S <manufacturer name> with office at
___________________ hereafter referred to as supplier and M/S ABC Pharmaceutical Company
with office at <address of the company> hereafter referred to as ABC Pharmaceutical Company,
whereas manufacturer supplies APIs/excipients suitable for pharmaceutical use for ABC
Pharmaceutical Company.
This agreement pertains to the following primary APIs/excipients:

1. The manufacturer shall manufacture, test, and release the APIs/excipients in accordance
with and will comply to

a. WHO GMP guidelines and/or guidelines applicable to the countries in which the APIs/

excipients is being registered, (e.g. FDA, EU, etc).

b. Guidelines applicable to the country of origin and other regional certifications (if

applicable).

c. ISO-9001:2000, current version (optional).

d. ISO-14001:2004, current version (optional).

2. This quality agreement will outline the responsibilities of the supplier and ABC
Pharmaceutical Company with regard to the quality activities discussed in the quality cri-
teria listed above.

3. The manufacturer/supplier shall not allow a third party to manufacture, package, label, or
release the APIs/excipients unless agreed upon in writing with ABC Pharmaceutical
Company .

4. M/S <Manufacturer> will be responsible to ensure that the specifications for APIs/excipi-
ents are in compliance with those sent by ABC Pharmaceutical Company.

5. Upon request by ABC Pharmaceutical Company, M/S <Manufacturer> shall disclose to
ABC Pharmaceutical Company recent regulatory agency inspections and findings pertain-
ing to the APIs/excipients.

6. <Manufacturer> shall notify promptly if in the course of a regulatory inspection, negative
findings are made related to the quality of material supplied.

7. <Manufacturer> shall provide certificate of analysis with each lot of the corresponding
APIs/excipients supplied.

8. <Manufacturer> shall communicate the recommended storage and transportation condi-
tions of the APIs/excipients.

9. <Manufacturer> shall ensure that APIs/excipients are stored and supplied in accordance
with recommended storage conditions.

10. <Manufacturer> have a written procedure to investigate and document quality-related
complaints. A root cause analysis, action taken for correction of the problem, and the for-
mal conclusion will be provided to the ABC Pharmaceutical Company within a reasonable
time after receipt of the complaint related to APIs/excipients.

11. The parties shall cooperate in the exchange of information required to effectively conduct
an investigation.

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