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Sop Oos

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94 views4 pages

Sop Oos

sop

Uploaded by

neilok
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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SOP-ORI-035.01.

Standard Operating Procedure (SOP)


For
Out-of-Specification (OOS) Results Investigation
SOP-ORI-035.01.1

YIXING JIANGSHIAN BIO-TECH CO. LTD.


Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email: sales@jsbio-tech.com
SOP-ORI-035.01.1

1. Purpose

To establish a standardized procedure for the investigation of Out-of-Specification (OOS)


results obtained during the manufacturing and quality control testing of Ascorbic Acid,
ensuring timely and accurate resolution and preventing recurrence.

2. Scope

This SOP applies to all OOS results obtained during the manufacturing and quality control
testing of Ascorbic Acid, including raw materials, in-process materials, finished products,
and stability samples.

3. Definitions

 OOS Result: Any analytical result that falls outside the established specifications.
 Specification: A predetermined limit or range of values for a particular quality
attribute.
 Deviation: Any unplanned or unexpected event that differs from an established
procedure, specification, or standard.

4. Responsibilities

 Analyst:
o Identify and report OOS results immediately to the supervisor.
o Document all observations and data.
 Supervisor:
o Review the OOS result and initiate the investigation.
o Guide the investigation process.
 Quality Control Manager:
o Oversee the OOS investigation.
o Approve the investigation report and disposition of the affected material.
 Quality Assurance Department:
o Monitor the OOS investigation process.
o Ensure the implementation of corrective and preventive actions (CAPAs).

5. Procedures

5.1 OOS Result Identification and Reporting

 The analyst performing the test shall immediately notify the supervisor of any OOS
result.
 The analyst shall document the OOS result in the laboratory notebook, including:
o Date and time of analysis
o Test method used
o Observed result
o Specifications
o Analyst's initials
 The analyst shall retain all original data and samples until the investigation is
complete.
YIXING JIANGSHIAN BIO-TECH CO. LTD.
Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email: sales@jsbio-tech.com
SOP-ORI-035.01.1

5.2 OOS Investigation

 Phase 1: Initial Investigation


o Review all relevant documentation, including:
 Batch records
 Analytical records
 Standard Operating Procedures (SOPs)
 Equipment maintenance records
 Environmental monitoring data
o Check for any obvious errors, such as calculation errors, transcription errors,
or instrument malfunctions.
o If an assignable cause is identified and resolved, retest the sample. If the retest
result is within specification, the original OOS result may be considered
invalid.
 Phase 2: In-depth Investigation
o If the initial investigation does not identify an assignable cause, conduct a
more in-depth investigation, which may include:
 Re-analysis of the sample by a different analyst or using a different
analytical method.
 Review of historical data for similar trends.
 Investigation of potential root causes, such as:
 Raw material issues
 Equipment malfunctions
 Process deviations
 Environmental factors
 Analyst errors
 Documentation:
o Document all investigation steps, findings, and conclusions in an OOS
Investigation Report.
o The report should include:
 Date and time of the OOS result
 Description of the OOS result
 Investigation steps undertaken
 Root cause analysis
 Corrective and Preventive Actions (CAPAs)
 Conclusions and recommendations
 Signatures and dates of all personnel involved in the investigation

5.3 Disposition of Affected Material

 Based on the investigation findings, determine the disposition of the affected material:
o Re-analysis: If an assignable cause is identified and resolved, the material
may be re-analyzed.
o Re-work: The material may be re-worked if feasible and safe.
o Rejection: The material may be rejected and disposed of according to
established procedures.
o Quarantine: The material may be quarantined until the investigation is
completed and a disposition decision is made.

YIXING JIANGSHIAN BIO-TECH CO. LTD.


Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email: sales@jsbio-tech.com
SOP-ORI-035.01.1

5.4 Corrective and Preventive Actions (CAPAs)

 Implement appropriate CAPAs to prevent the recurrence of the OOS result.


 CAPAs may include:
o Modification of SOPs
o Equipment maintenance or repair
o Personnel training
o Process improvements
 Verify the effectiveness of implemented CAPAs.

6. Record Keeping

 Maintain accurate and complete records of all OOS investigations, including:


o OOS Investigation Reports
o CAPA plans and implementation records
o All supporting documentation

7. Review

 Review this SOP periodically to ensure its continued effectiveness and compliance
with regulatory requirements.

8. Training

 Provide training to all personnel involved in the manufacturing and quality control
processes on this SOP and their responsibilities related to OOS investigations.

YIXING JIANGSHIAN BIO-TECH CO. LTD.


Address: Xudu Village, Zhoutie Town, Yixing City, Jiangsu Province
Tel: +86-510-87571899; +86-510-87579012
Email: sales@jsbio-tech.com

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