The APIC audit program was launched on December 19, 2002. Dr. L. Hartmann of F Hoffmann-La Roche, Vice President of APIC, and O. Schmidt, Managing Director of CONCEPT HEIDELBERG, signed a cooperation agreement. “The quality management system should also include a procedure to ensure that any supplier of API, packaging equipment or service is able to consistently meet the pre-agreed requirements,” said APIC. The responsibilities of independent quality units within this system should also be tendered in the form of a contract or agreement. The API Compliance Institute was established on December 19, 2002. The activities of the API Compliance Institute are based on a contractual agreement between APIC, CEFIC Group, and CONCEPT HEIDELBERG. It is the responsibility of the API Compliance Institute to standardize GMP audits of API manufacturers and minimize the costs of compliance audits. “The material must be stored in such a way as to have sufficient space for cleaning and inspection,” warns APIC. The following directive can be ordered by the address in the “Source/Publisher” category.
In cases where you can order on the Internet, we have set up a hyperlink. Copyright – Unless otherwise stated, all content on this website is © 2020 – William Reed Business Media Ltd – All rights reserved – Full details of the use of materials on this site are available in the Terms and Conditions Participation in the “APIC Audit Program” is optional and not limited to APIC members. Frequently asked questions and answers about the third-party audit program, click here. For longer-term storage, APIC recommends setting alert limits for temperature and humidity limits and procedures for dealing with these situations. In the case of temperature excursions during storage, companies can use stability studies, cycling studies and other risk assessments to measure the effects on the IPY. 04-Jun-2014 – Updated on 05-Jun-2014 at 08:21 GMT Based on WHO policy good Trade and Distribution Practice for Starting Pharmaceutical Materials (GTDP), APIC cites “the only GDP directive for APIs” calls on APIC manufacturers and instruction distributors to implement a quality management system that sets out specific procedures and principles for interaction with suppliers.