Audit Response_Obs_Minor 2A_Safety goggle_2024

(1) Auditing Group (Name): Local Internal Audit Audit Number (as provided by Audit Group): 540769 Observation
Number(s) (which are addressed): 04 (e)
AUDIT OBSERVATION RESPONSE FORM

Part 1
(2) Date Audit 29/11/24 (3) Observation Classification as Assigned by Critical
Report Issued Local Auditing Group (if audit report does not assign a rating, Minor
(issuance date provided in enter rating assigned by Auditing Group; if multiple observations Major
the audit report/cover- responded, enter the highest rating; If a third-party audit report does not Other (must explain)
letter): indicate ratings and Auditing Group has not provided ratings, check the
box next to “Other” and enter “N/A”. If a third-party audit report
indicates a rating other than critical, major, or minor and Auditing Group
has not provided additional instructions, check the box next to “Other”
and explain the rating in the report.):
(4) Description of Observation(s): (Enter observation text or refer to attached audit report)
Observation number: 2(a)
It was observed that no person in E&L laboratory of CRT, was wearing safety goggles, gloves while handling of samples and
working in laboratory. The analyst had prepared labels for standards. However, on all the sample labels, validity was
mentioned as ‘TBD’. Upon discussion with the analyst, it was identified that they don’t use it beyond 24 hours but they
mention TBD as per their internal practice. All sample validity must be labeled as per the respective SOP (BXUA03840). It
was also observed that the study no. was not mentioned from the 2nd page onwards of the study protocol BXU610499.
(5) Check “Yes” if audit report indicates that the observation is a repeat from previous audit and enter the reference
audit information and observation number cited in the audit report.
No
Yes, Reference Audit / Observation:
(6) Does the observation meet the definition of a non-conformance? If yes, enter the Record ID number initiated for
the observation.
No (Proceed to Step 7)
Yes, Reference Record ID #(s): (Skip Steps 7 & 8)
(7) INVESTIGATION / RESULTS

(Describe the tools/methods/thought process used to determine the investigation results, along with rationale for these conclusions)
Screening study of Leachables are usually performed as fit to purpose approach as a method verification. Method
verification is performed to prove method suitability as to screen the Leachables in drug product, by establishing
system suitability & spike sample through class-B study protocol. As solution stability is not established for same,
Solutions were marked as TBD as per SOP BXU572902 Handling of reconstituted solutions.
We acknowledge that Protocol number was missed from Page-2 in BXU610499 Study for Screening of Organic
Leachables in Diazepam Injection USP, 5 mg/mL.
Impact assessment:
Method suitability (on time use method suitability) is established by precision and sensitivity at Target specific
AET/reporting threshold level. These solutions are not evaluated for solution stability due to nature and objective of
method. In case of use beyond 24 hrs due to longer sequences or any other challenges, system suitability solutions
are used till data meets the acceptance criteria. Any degradation of due to aging, will produce a worst case scenario
in terms of sensitivity and precision in System suitability and leachable sample evaluation. Further, appropriate
system suitability including bracketing standard is also being evaluated after samples analysis. There is no impact as
PARENT DOCUMENT(S): GQP-02-01 Page 1 of 4 FORM NO.: GQF-02-01-02
(current rev.) CHANGE NO.: C
BAXTER CONFIDENTIAL – INTERNAL USE ONLY ISSUE DATE: 23-Feb-2022
EFFECTIVE DATE: 25-Mar-2022
(1) Auditing Group (Name): Local Internal Audit Audit Number (as provided by Audit Group): 540769 Observation Number(s) (which are addressed): 04 (e)
all studies are performed with appropriate system suitability.

Missing protocol number (from Page-2) was typo error in header only. There is no impact on study.
(8) Identification of Action(s)

If there are multiple actions, number the actions, responsible people and target completion dates accordingly. If action already complete, enter “Complete” and the date. If
actions are not warranted or applicable, enter “N/A” and give a rationale
N/A, Rationale (if applicable)
Action: Responsible Person(s): Target Completion Date(s):

Corrective Action: Not Applicable Not Applicable
No further Corrective action is required.
Preventive Action:
A safety awareness training will be conducted to
team to carry out any activity with use of proper
PPEs based on types on material to be used in
study
APPROVAL
(Print Name / Sign / Date)
(9) Prepared by: (person who prepared Part1 of observation record)
(10) Observation Owner:
(11) Quality Representative: (If the Observation owner is Quality (Print Name / Sign / Date)
Representative, this rationale can be entered, and approval may be waived.)
(12) Disposition Performed by Lead Auditor
Accept
Reject, Rationale for Rejection:

(13) Lead Auditor:

(14) Auditing Group (Name;same as field 1): Local Internal Audit Audit Number(as provided by Audit Group): 540769 Observation Number(s) (which are
addressed): 04 (e)
AUDIT OBSERVATION RESPONSE FORM

Part 2
ACTION IMPLEMENTATION
(15) Date all actions have been completed:
(16) Objective Evidence of Implementation and Effectiveness:
Attach or reference the supporting documentation:
VERIFICATION
(17) Prepared by:
(18) Observation Owner:
(19) Quality Representative: (If the Observation owner is Quality (Print Name / Sign / Date)
Representative, this rationale can be entered and approval may be waived.)
(20) Disposition

Accept
Reject, Rationale for Rejection:

(21) Audit Group Management / Lead Auditor:


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(1) Auditing Group (Name): Local Internal Audit Audit Number (as provided by Audit Group): 540769 Observation

Number(s) (which are addressed): 04 (e)

AUDIT OBSERVATION RESPONSE FORM

(7) INVESTIGATION / RESULTS

all studies are performed with appropriate system suitability.

(8) Identification of Action(s)

N/A, Rationale (if applicable)

Action: Responsible Person(s): Target Completion Date(s):

(12) Disposition Performed by Lead Auditor

(Print Name / Sign / Date)

PARENT DOCUMENT(S): GQP-02-01 Page 2 of 4 FORM NO.: GQF-02-01-02

AUDIT OBSERVATION RESPONSE FORM

PARENT DOCUMENT(S): GQP-02-01 Page 3 of 4 FORM NO.: GQF-02-01-02

(Print Name / Sign / Date)

PARENT DOCUMENT(S): GQP-02-01 Page 4 of 4 FORM NO.: GQF-02-01-02

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