D.C. Mun. Regs. tit. 22, r. 22-B10713

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

Rule 22-B10713 - RECEIVING, IN-PROCESS, AND FINISHED DEVICE ACCEPTANCE

10713.1

Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.

10713.2

Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

10713.3

Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.

10713.4

Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:

(a) The activities required in the device master record (DMR) are completed;

(b) The associated data and documentation is reviewed;

(c) The release is authorized by the signature of a designated individual(s); and

(d) The authorization is dated.

10713.5

Each manufacturer shall document acceptance activities required by this chapter. These records shall include:

(a) The acceptance activities performed;

(b) The dates on which acceptance activities are performed;

(c) The results;

(d) The signature of the individual(s) conducting the acceptance activities; and

(e) Where appropriate, the equipment used. These records shall be part of the DHR.

D.C. Mun. Regs. tit. 22, r. 22-B10713

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.