Pharmaceutical Lesson 2.

5: QRS: Self-Inspection
Manufacturing Dr.Kim Alexandra Pedrosa
AY 2023-2024 08/24/2203
1st Semester

o the need to review previous reports classification of

OUTLINE NonConformities (NCs) with corresponding desired
1. Principle timeframe to close out the NCs
 Self-Inspection program / plan may cover:
2. Importance and Benefits of Self-Inspection
o all areas/chapters in one single self-inspection
3. What is needed (annually) or
4. Scope o have several self-inspections within a year (i.e. split
5. How can self-inspection be conducted the areas/chapters and perform self-inspections on
6. Inspection Techniques several occasions)
7. Example of Self-Inspection Plan o Provide report for each self-inspection.
8. Who should be involved
9. Self-inspection report Inspection Techniques
10. Points to consider when performing self-
inspection
11. Stages of Self-Inspection
12. Example of Self-Inspection Checklist
13. Advantages & Disadvantages of Checklist

Principle

Self-inspections shall be conducted to monitor the

implementation and compliance with Good Manufacturing Practice
(GMP) principles and to propose necessary corrective measures.

Importance and Benefits

 To monitor and identify the shortcomings in implementation Example of Self-Inspection Plan

and evaluate compliance with the Good Manufacturing
Practice principles and quality management system
 Company is able to address any issues internally and sooner
therefore avoid potentially bigger problems

What is Needed
 A pre-arranged programmed at regular interval is needed to
examine the compliance with the Quality Assurance and shall
cover:
o Personnel matters
o premises, equipment
o documentation, production
o quality control
o distribution of the products
o arrangements for dealing with complaints and product
recalls
o self-inspection

Scope
 All chapters/requirements in the GMP Guide [including
Appendix 2 (Verification)] and;
 All aspects that might influence the quality of products shall
be included in the scope of the self-inspections
 Self-inspections shall assess and look at adequacy and
compliance of systems, processes, premises and equipment,
documents, etc.
 Areas for improvements could also be recommended.
 SOP needs to be established as per clause 5.43.10 which
states the following:
o frequency (and possible need to establish an audit
plan)
o the scope and standard to be used
o how to record/report the self-inspection carried out
o training and experience for personnel involved in self-
inspection,
PH MANUF TRANSCRIBED BY: MARK HAROLD C. GONZALES 1 of 3
 Pharmaceutical Lesson 2.5: QRS: Self-Inspection
Manufacturing Dr.Kim Alexandra Pedrosa
AY 2023-2024 08/24/2203
1st Semester
Who should be Involved?  Good and legible notes are essential to good inspection as
you will never remember everything without notes
 Should consider having a self-inspection team with multiple  Use “trace-back” method • Include positive observations
representatives from different areas of work/responsibility.  Keep the report simple and clear
 Self-inspection should be conducted in an independent
manner:
o no conflict of interest Stages of Self-Inspection
o one shall not inspect his/her own work or area of
work
 Should conduct thorough inspection that is objective and
evidence-based.
 Can consider using the approach used by regulatory
inspectors.
 Qualification of self-inspection team:
o Trained
o Competent
o Independent
 With the training and knowledge, self-inspection team
members can then explore matters with the view to improve
the system or address any gaps.
 Independent audits by external experts who have more
experience in inspecting more companies can help to identify
blind spots and suggest good practices for further
improvement of the system.
PLANNING
Self-Inspection Report  Risk based Inspection Programme
 Management appoint self-inspection team
 Clause 10.3 - All self-inspections shall be recorded. Reports
 initiate self-inspection:
shall contain all the observations made during the inspections
o prepare inspection schedule
and, where applicable, proposals for corrective actions and
o Notify / brief self-inspection team and auditee of
preventive actions, and corresponding time frames.
Statements on the actions subsequently taken shall also be the inspection plan
recorded. o Allocate documents to team members for
 Provide Evidence review and creation of checklists
o Liaise with Management on inspection timing
 Can be various formats depending on the company’s
preference (including changes to timing
 Allows traceability to all the follow-up actions to be taken o Study documents and develop checklists
 If company decided to use a checklist, must make sure that (where applicable)
the checklist is appropriately designed and in a way to allow
the recording of any Non Conformance (NCs) PERFORMING
 Root cause identified for each Non Conformance (NCs) and  Conduct Opening Meeting
there should be corresponding Corrective / Preventive Actions  Conduct on-site self-inspection and record findings
(CAPAs) following suitable audit techniques
 NCs that have higher impact to quality of product shall be  Document Review
addressed sooner  Conduct Closing Meeting
 Should be followed through and closed-out within reasonable
timeframe REPORTING
 Record all objective evidence and what has been observed  Prepare self-inspection report and classify the NCs by
the team
Points to consider when performing self-inspection  Draft of report reviewed by auditee
 Send inspection report to auditee • Request corrective
and preventive actions (CAPA) to address the NCs
 Shall ask appropriate and right questions during self-
inspections and shall focus on identifying flaws/gaps of  Assigned personnel to identify the root cause to establish
processes and systems rather than finding faults on an appropriate CAPA
individual or nitpicking.  Set time frame
 Use “who”, “what”, “where”, “when”, “why” and “how” rather
than “closed questions” which will end up getting a “Yes” or FOLLOW-UP
“No” as an answer.  Verification of CAPA, especially for critical and major NC
 Superficial questions often produce superficial findings.  Present findings at Management Review meeting
 Shall create win-win situation with the view to help  Ensure follow-up on NCs until they are satisfactorily
company/organization to improve the processes and systems close-out by Lead Inspector.
 Don’t just focus on hardware and documents, should also
interview different personnel to verify effectiveness of Example of an Self-Inspection Checklist
established systems or processes

PH MANUF TRANSCRIBED BY: MARK HAROLD C. GONZALES 2 of 3

 Pharmaceutical Lesson 2.5: QRS: Self-Inspection
Manufacturing Dr.Kim Alexandra Pedrosa
AY 2023-2024 08/24/2203
1st Semester

Advantage and Disadvantage of Checklist

Advantages of a Checklist
1. Serve as a good inspection planning tool
2. Help to focus on the essential parameters
3. Serve as aids to memory
4. Provide a useful means for quick recording of findings
5. Help to maintain inspection direction

Disadvantage of Checklist
1. Inhibit flexibility
2. Become a Questionnaire
3. Encourage copy-cats inspection
4. May discourage probing and investigation

 The quality of an inspection depends to a great extent of the

quality of the checklist.
 There is a need to incorporate “impromptu questions in
response to auditee’s responses. This requires much skill and
experience.

REFERENCES
 ASEAN Guidelines on Good Manufacturing Practices
for Traditional Medicines.
 ASEAN Guidelines on Good Manufacturing Practices for
Health Supplements.

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