1.1 Is there a quality management system implemented (Covered by an ISO 9001:2000 certification)?
1.2 Are the GTDP*/HACCP** principles part of the quality system?
1.3 Is there a file defined the responsibilities of the various departments and the responsible person
1.4 Is there a third party certification of the quality system (Covered by ISO 9001:2000 certification or third party HACCP verification)?
1.5 Is there a library of relevant regulations on excipients for pharmaceuticals?
1.6 Is a person designated or a source defined to keep the company informed about legislative developments in the area of starting materials for pharmaceuticals?
1.7 Are responsibilities for assessing the impact of such legislative developments and for proposing actions to comply with these clearly defined?
1.8 Is a regular review made of the system for compliance with legal requirements?
1.9 Does the company have a written policy including management's active commitment to Quality?
1.10 Is the policy signed by top management?
1.11 Does the company operate a documented system for quarantining suspect product?
1.13 Do those carrying out auditing have training in auditing and evaluation techniques?
1.14 Is a formal management review of the Quality Management System held at least once a year?
1.15 findings of internal audits, recommendations made and corrective actions taken?
1.16 - the overall effectiveness of the system in achieving quality objectives?
1.17 - opportunities for updating and/or improving the system?
1.18 Do management reviews consider trends in customer complaints?
1.19 Do management reviews consider trends in supplier related non-conformance claims?
1.20 Does the distributor demonstrate his responsibilities to assure compliance with Product Stewardship principles along the entire supply chain?
1.21 Is there an adequate number personnel available either in-house or contracted out to carry out all the operations in compliance with the IPEC GDP Guide?
1.22 Are there authorized release procedures in place?
1.23 Is there a copy of the manufacturers’ documents (such as COA or COC) supplied with each delivery?