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2. Good manufacturing, laboratory, clinical, distribution and pharmacy practices


2.1. Full projecting and consulting in the scope of establishment, implementation, training and development of the GMP standards.


2.2. Assessment of the actual state of the whole company, different organizational parts or products including preparation and issuing of the executive assessment report.


2.3. On request of the company, conduct of external GMP audits, as the part of preparation for the official GMP inspection, or for the company management targets and needs (independent, objective assessment of inner resources and actual state).


 

2.4. Preparation of the projects of the general strategy for the implementation and development of GMP standards for the whole company, single organizational parts or products (assumed that point 2.2. is available or contracted beforehand).


2.5. Preparation of plans for implementation and development of GMP standards for different elements of GMP and realization of such plans using own resources or by engagement and subcontracting of specialized foreign companies or experts according to requirements and needs of the sponsor company.


2.6. Planning, restructuring or projecting of organization schemes of the whole company or its separate parts, according to GMP standards.


2.7. Planning and conducting of initial GMP training of staff on all levels of an company. Development of strategy and plans for the continual on-job GMP training of employees and realization of such training plans.


2.8. Preparation and realization of commercial GMP courses and seminars presenting general principles of GMP to wide interest target groups, with or without engagement of foreign experts.


2.9. Projecting, planning and consulting activities for companies in realization of implementation and development of QA (or TQM) systems in compliance to GMP standards. Qualification, re-qualification or upgrade of present (implemented) ISO 9000 systems to GMP systems.


2.10. Development of validation master plans and validation protocols and supervision to realization of validation processes. Verification of conducted validation activities and consulting services in connection to re-validation and requalification activities. Specialized experience in the scope of validation of analytical equipment and methods, as well as in the scope of validation of pharmaceutical processes. For the purpose of validation of manufacturing equipment and/or special manufacturing conditions we could recommend contracting of specialized companies under our supervision.


2.11. Organization, consulting and monitoring/supervision and auditing of pre-clinical and clinical studies, as well as pharmacokinetic and bioavailability studies for sponsor companies conducting contract studies in other institutions/laboratories.


2.12. Consulting services in the scope of GLP, GCP, GDP and GPP standards, development and implementation.


 

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