Best Practices, Regulations, Guidelines
Organizations
Production and Validation
100

GMP

What is good manufacturing practices?

100

FDA

What is the Food and Drug Administration?

100

PPE

What is personal protective equipment?

200
GDocP (or GDP)

What are good documentation practices?

200

ICH

What is International Conference on Harmonizing?

200

SOP

What is standard operating procedure?

300

SISPQ

What is safety, identity, strength, purity, quality?

300

OSHA

What is Occupational Safety and Health Administration?

300

URS

What is user requirement specifications?

400

ALCOA+

What is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available?

400

ISPE

What is International Society for Pharmaceutical Engineering?

400

OQ

What is operational qualification?