Title 21

PART 111 SUBPART I

Subpart I - Production and Process Control System: Requirements for the Batch Production Record

• 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.
• 72 FR 34942, June 25, 2007, unless otherwise noted.

21:2.0.1.1.11.9.1.1	SECTION 111.255	111.255 What is the requirement to establish a batch production record
21:2.0.1.1.11.9.1.2	SECTION 111.260	111.260 What must the batch record include

---