Pharmaceutical

Quality management system Preparation and Training

• ISO 9001:2008 Quality management systems
• IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
• OHSAS 18001:2007 International Occupational Health and Safety Management Standard.
• ISO 14001:2004  Environmental Management Systems
• ISO 27001:2005 Information Security Management Systems (ISMS).
• BS 25999-2 2007 Business Continuity Management (BCM)
• ISO 50001:2011 Energy Management

international regulations Preparation and training

• ICH requirements
• EMEA requirements
• 21CFR210/211 USA pharmaceutical requirements
• registration of products worldwide

Good Practices Preparation and training

• GMP Good Manufacturing practice
• GLP Good Laboratory Practice
• GHP Good Hygiene Practice
• GDP Good Distribution Practice
• GSP Good Storage Practice
• GCP Good clinical Practice

Validation and testing

• Microbiology testing
• Moist heat validation including microbiology testing
• Clean room validation including microbiology testing
• packaging validation
• accelerated stability study
• environmental monitoring testing
• warehouse thermal mapping
• layout creation of new factory