D.C. Mun. Regs. tit. 22, r. 22-B10712

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10712 - PROCESS VALIDATION

10712.1

Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.

10712.2

Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

10712.3

Each manufacturer shall ensure that validated processes are performed by qualified individual(s).

10712.4

For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.

10712.5

When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.

D.C. Mun. Regs. tit. 22, r. 22-B10712

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.