QUALITY PROCESS
Skandanana Pharma - Committed to Reliable Results
The Organization is committed to GxP, reproducible and reliable results.
- The Organization services are prompt and reliable.
- All Organization personnel understood the management system for all operations.
- All personnel shall familiarize themselves with the quality policies and documents and implement the same at all times.
- All the Organization personnel are well trained in validation techniques and as well the quality system procedures.
- The Organization management is committed to comply with the 21 CFR part 11,
- GAMP-5 Categorization, EU Annexure 11 and also to continuously improve the effectiveness of the management system.
- We formed as a professionally managed third party validations and Projects with experience and exposure in complete Computer system and HVAC Projects requirement of pharmaceutical industry, with a services of accurate documentation is at most importance in pharmaceutical industry.
- Supporting and execution of turnkey pharma projects assistance as per Client’s specific.
- Consultancy service for New Testing Lab set-up & approval as per ISO 9001:2015 & ISO/IEC 17025:2017 standards. Consultancy service for New Bioanalytical and Clinical Lab of a BA/BE center set-up & approval as per ISo15189:2012 standards.
- Facility Quality/ Validation, Software Development and Validation, Equipment Validation, Area of Fumigation, Facility Validation, Environmental Chambers, AMC and CAMC Systems shall be taken up through M/s SPCAL LABS PRIVATE LIMITED.
- Visit us : www.spcalibrationlabs.com for more information.