With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Si

chapter 3|12 pages

Organization and Personnel: Subpart B

chapter 4|14 pages

Buildings and Facilities: Subpart C

chapter 5|20 pages

Equipment: Subpart D

chapter 7|32 pages

Production and Process Controls: Subpart F

chapter 8|28 pages

Packaging and Labeling Control: Subpart G

chapter 9|6 pages

Holding and Distribution: Subpart H

chapter 10|20 pages

Laboratory Controls: Subpart I

chapter 11|30 pages

Records and Reports: Subpart J

chapter 13|12 pages

Repacking and Relabeling

chapter 16|12 pages

Contracting and Outsourcing

chapter 17|8 pages

Active Pharmaceutical Ingredients

chapter 18|10 pages

Bulk Pharmaceutical Excipient GMPs

chapter 23|14 pages

Worldwide Good Manufacturing Practices