BRANCH&YEAR OFFERED: B. PHARM IV & D. PHARM II

GDP is the fundamental component of a pharmaceutical organization's GMP requirements. Appropriate documentation shows an accurate representation of all previous and ongoing manufacturing operations, and so serves as a foundation for planning what has to be done in the future. A company's quality assurance system supervises the documentation of all procedures. It is used as a foundation tool to audit a company's production and testing activities. Regulatory inspectors conduct inspections of a business's manufacturing plants using company documentation and records.

Therefore, an effective documentation system reflects the competency of the quality assurance system of a company.

COURSE OBJECTIVE & OUTCOME:

1. To provide the training required to assist students in understanding Good Documentation Practices in light of data integrity requirements.

2. To learn to Write Effective Standard Operating Procedures (SOPs),

3. To know how and when to apply GDP

4. To get Knowledge about the various types of documents

COURSE DURATION: 35hrs