QCS-018 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 100

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

18.8 attachment forms

abc Pharmaceutical comPany

LEVEL 3

Page 1 of 4

Attachment No.:

Issued on:

Revision No.:

Initiator name:

OUT-OF-SPECIFICATION RESULTS
FORM 01

Originator: Title: Date:

INVESTIGATION AND DISPOSITION FORM

Product: Code: Batch No.:

Material: Code: Lot No.:

Test: Method No.: Acceptance Criteria:

Problem: (Results not meeting defined acceptance criteria) OOS description:

Actual Results:

A. Preliminary lab investigation checklist Yes No N/A

• Analyst trained in the procedure? ▭ ▭ ▭

• Instrument failure (correct equipment or

instrument used) ▭ ▭ ▭

• Reagent problem (reagent/standard/media expired) ▭ ▭ ▭

• Nonrobust method (method validation) ▭ ▭ ▭

• Was the correct method used? ▭ ▭ ▭

• Were there any deviations from the method? ▭ ▭ ▭

• Were there any arithmetical errors in calculations? ▭ ▭ ▭

(calculation data correct)
• Was the equipment functioning correctly?

▭ ▭ ▭

• Was the equipment calibrated? ▭ ▭ ▭

• Were reagents, prepared samples, and standards

correctly prepared? ▭ ▭ ▭

• Were system suitability requirements deined in the

method met? ▭ ▭ ▭

• Were acceptance criteria deined in the method for

precision of replication met? ▭ ▭ ▭

• Were there any obvious physical problems with the

laboratory sample? ▭ ▭ ▭