QCS-018 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 101

SOP No. QCS-018.00 Effective date: mm/dd/yyyy
Approved by:

LEVEL 3
Page 2 of 4
Attachment No.:
Issued on:
Revision No.:
Initiator name:

A. Preliminary lab investigation checklist (continued) Yes No N/A

• Were positive or negative controls satisfactory? ▭ ▭ ▭

• Equipment sterile ▭ ▭ ▭

• Correct glassware used ▭ ▭ ▭

• Pipettes calibrated ▭ ▭ ▭

• Dilution made correctly ▭ ▭ ▭

• Test tube labeled correctly ▭ ▭ ▭

• Proper storage conditions ▭ ▭ ▭

• Incubation conditions adequate ▭ ▭ ▭

• Sterilization complete ▭ ▭ ▭

• Gowning adequate ▭ ▭ ▭

Other error/s (please specify any other parameter that may contribute to OOS results):

Cause: • Assignable • Nonassignable