Qualification and Validation are integral steps in building quality into any facility. Spectrum with an experience for over a decade and a half provides an efficient and effective documentation system that meets the requirements of International Regulatory authorities.

Validation Protocol Preparation & Execution:

• Validation Master Plan
• IQ protocols for all types of Equipment
• OQ Protocols
• PQ protocols
• Conducting Process Validation at your site
• Purified Water Validation Protocol & Validation

In addition, Spectrum can also prepare the following documents and conduct training programs as detailed further.

Documentation as per ICH / Orange guide:

• Quality Assurance Procedures
• Quality Control Procedures
• Raw Material Specifications
• Finished Product specifications
• Packaging Material specifications
• Equipment Cleaning Procedures
• Manufacturing batch records
• In process Test specifications
• Stability Protocols

Regulatory:

• Drugs Master File in CTD format
• Site Master file as per PIC/s & Local FDA requirement.
• Liaison with FDA for drug License
• Schedule ‘M’ Requirements & documentation for compliance to Indian FDA’s norms

Training Programs on:

• Standard Operating Procedures –QA/QC/Manufacturing /Maintenance
• On the job Training for QA/QC/Shop floor employees
• Process Validation
• Installation Qualification
• Operational Qualification Method Validation
• Facility Qualification
• Purified Water validation
• current Good Manufacturing Practices
• Good laboratory Practices
• How to prepare & FACE  Regulatory audits
• WHO guideline
• COST Improvement Projects
• Technology Transfer
• Statistical Process Control