Phase III:
Upgrading the select Mini Development Centres (Lab Scale & Non–GMP) in Pharma colleges spread across the state of Andhra Pradesh to proper Lab scale Development centres with the required Equipments, Instruments and Qualified Personnel in order to comply for the requirements in getting a Test Licence for at least a few products in the selected Dosage Form

In this Phase, the emphasis will be more on - Updating Theoretical inputs on the procedures, practices & documentation that are being followed in an approved Development centre and Providing Real time Practical exposure in Formulations Development and Scale up.

DOCUMENTATION, DOCUMENT CONTROL (QA), GOOD DOCUMENTATION PRACTICE:

• Developmental Quality Assurance
• In-process Quality Assurance
• Quality Assurance related to Manufacturing & Testing
• Batch Processing & Packaging Records
• Raw Material & Packaging Material Records
• Product in-process Finished Goods Specifications & Records
• Qualification/Validation Protocols
• Calibration Procedures & Records, Lab Books, Log Books etc

FACILITY, INSTRUMENTS, EQUIPMENTS & UTILITIES QUALIFICATIONS:

• Design Qualification
• Installation Qualification
• Operational Qualification
• Performance Qualification

VALIDATIONS:

• Validation Master Plan
• Process Validation
• Analytical Method Validation
• Cleaning Procedure Validation
• Computer Validation

PRECLINICAL, CLINICAL, BA/BE STUDIES, PHARMACO VIGILANCE:

• Introduction to Preclinical study including Animal study
• Brief on Phase-I, Phase-II, Phase-III and Phase-IV Studies
• Basic Understanding on BA/BE Studies
• Cleaning
• Activities related to Pharmacovigilance, Pharmacogenomics & Drug Safety Studies. Adverse Drug Reactions, Adverse Event Reporting (Good Clinical Practices) Applicable guidelines in India and Abroad