Who should follow training programs?
All the staff of the company must be trained according to the task each individual performs. Moreover, staff whose activities can have an effect on the final quality of the product must be properly trained in those relevant GxP aspects applicable to each job position. Therefore, staff who perform activities related with manufacturing, quality control, logistics, maintenance, cleaning, IT and others must be considered. Training recently hired or external staff requires special concern, who will need to be acquainted and trainend in GxP concepts before starting to work within the company.
What criteria must be considered when planning a training program?
Training should be performed periodically according to a well stablished training program, which must be carried out according to training needs detected by the heads of each department and section and by Quality Assurance unit. Therefore, in addition to specific aspects concerning each business area, a training program must be designed in order to strenghten GxP´s concepts. The content of the training courses and sessions will be schemed in such a way that main GxP concepts are reviewed and, specifically, other lacking concepts regarding other activities such as audits, guides review and other monitoring activities realized by the company.
How can TDV help us to achieve our training needs?
TDV offers highly qualified services designed to cover succesfully your training needs. Therefore, we offer courses concerning basic GxP reviews and specialized sessions in which specific areas and new trends are considered so that magement staff, heads of departments and other staff who is already familiar with GxP can deepen. Anyway, we consider your particular needs bearing in mind the specific processes carried out in your company.
I must transfer the manufaturing process of a product to a new plant. What steps should I follow to tranfer the process correctly?
The main activities to consider are the transfer of analytical methods used to analyze the final product and process controls, the validation of the manufacturing process in order to demonstrate that the manufacturing process to transfer is equivalent to the current one and the inclusion of the manufactured lots in an stability program.
Is it necessary to validate a manufacturing process of an oral form that we have been manufacturing for many years and merchandasing to european countries around?
The validation of the manufacturing process is a GMP requirement included in Annex 15 of European GMP. In this case, it is correct to carry out a retrospective validation if the manufacturing process has not been modified by changes that can have a direct effect on the quality of the product.
How must we apply the new Q9 guide “Quality Risk Management” to a new process equipment qualification?
The application of the new policy regarding Risk Management from the begining of the project, that is, from the definition of user requirements, will allow you to identify the functions and critical process parameters and to define the control mechanisms that the equipment will need to incorporate in order to minimize those detected risks. Besides, qualification activities will be focused on verifying that the established control mechanisms function properly as expected.
Why do we have to audit suppliers of produts that are involved in our manufacturing process?
Audits are just another activity to carry out during the homologation/validation process of your suppliers. According to 2004/27/EC and 2004/28/EC directives, the holder of the manufacturing license is responsible for assuring that Active Products are manufactured in accordance with directives described in good manufacturing practices for raw materials (that is, according to applicable GMP´s).
Do we have to audit all raw materials manufacturers that are involved in the manufacturing process of our drug?
As established in 2004/27/EC and 2004/28/EC directives, it is only obligatory to assure that Active Products have been manufactured in accordance with good manufacturing practices. In spite of this current requirement, excipients will need to be considered as well, as described in a new directive that is being developed.
What´s the purpose of the training courses that TDV provides?
Training should be oriented to clear and defined goals and should not become a routine or oridinay activity in which standard contents and no goals are present. Training must be focused on each company, considering its business needs and assuring always the quality of the final product and traceability of operations carried out. To reach these goals, a training plan must be defined according to each operative or responsibility levels, and whose contents must be reviewd periodically.
We need support in the registering process and merchandasing of a new drug. How can TDV help us?
TDV has been enroled in Regulatory affairs projects, offering its experience and technical knowledge during the whole process from design to merchandasing of a new drug. We are able to lead our customers, helping them to make DMF´s, Supplier audits, CTD, etc.