2.1 Has the company a sufficient number of qualified employees for these operations?
2.2 Have all (including administrative) personnel, involved in handling and distributing Food, Cosmetic or/and Pharma grade products been made aware of the risks for human health?
2.3 Have all (including administrative) personnel, involved in handling and distributing Food, Cosmetic or/and Pharma grade products been formally qualified according to written criteria?
2.4 Is there a person with the specific responsibility and the appropriate authority to deal with excipient related quality issues within the company?
2.5 Are employees qualified according to GDP principles?
2.6 Is there a specific qualification required for employees responsible for key activities in Health, Safety, Environment (HSE) and Quality?
2.7 Are the HSE responsible persons providing regular training to employees dealing with hazardous materials?
2.8 Have job descriptions been made and regularly updated?
2.9 Has an evaluation been made of all activities to identify training needs?
2.10 Are personnel qualified for GTDP relevant operations with specific (technical) background/education?
2.8 Compliance with the requirements of re-processing or recycling of tails？
2.9 Whether the audit requirements of the batch record？
2.10 Whether complete verification program to verify the records and reports？
2.11 Is initial and ongoing training provided?
2.12 Are GTDP principles part of regular training?
2.13 Are employee training and qualification records maintained?
2.14 Are internal and external training courses documented?
2.15 Are contracted service providers included in the training program?
2.16 Are contractors provided with information relevant to the job to be done?
2.17 Are contractors provided with appropriate training if necessary?
2.18 Are contractors provided with appropriate personal protective equipment?
2.19 Are there procedures in place ensuring good hygiene of the personnel where exposure to material in open containers may occur (e.g. monitoring of health conditions, wearing of protective clothes, respecting food/drink policy, etc.)?