Pharmaceutical Deviation SOP

(S.O.P)
STANDARD OPERATING PROCEDURE (S.O.P)
‫ﺗﻌـﻠﯾﻣــﺎت‬
SUBJECT : Deviation Reporting
Department : Quality Assurance
Document No. : QQI-216-4/0
Prepared By : Reviewed By : Approved By : Issue Date : / /
QA. Section Head
Dr. Mohamed Wallash
QA. Vice Manager
Dr. Eman Fekry
Management Rep.
Dr. Wael Ebeid
Modification Date: / /
Due Date : / /
Implementation Date: / /
Copy No. :
Date: / / Date: / / Date: / /
1.Purpose( )‫اﻟﻐرض‬ : To provide instructions for the process of reporting, investigating &
handling deviations from defined procedures and processes.
2.Scope :
‫اﻟﺗطﺑﯾق‬ ‫ﻣﺟﺎل‬
2.1 Documents covered under the scope of this standard operating
procedure include the following, but are not limited to:
• Standard Operating Procedures.
• Manufacturing Procedures.
• Packing Procedures.
• Cleaning Procedures.
• Environmental Monitoring.
• Batch analysis (In-Process Control).
• Utility Operations.
• Calibration Procedures.
2.2 Out –Of Specifications (OOS); analytical results & stability results
are not covered by this instruction and are detailed in (QQI-527).
3.Responsibility:
‫اﻟﻣﺳﺋوﻟﯾﺔ‬
3.1 It is the responsibility of each production function/department to
follow the procedure and system by which the root causes of deviation
are identified, investigated and documented.
3.2 It is the responsibility of each production function/department to
undertake and track appropriate and timely corrective and preventative
actions.
3.3 It is the responsibility of Quality Assurance to approve deviation
reports prior to product release decision.
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4. Definition:
‫اﻟﺘﻌﺮﯾﻔﺎت‬ 4.1 Deviation:
Deviation divided into two parts Planned & Unplanned deviation
a) Planned Deviation: Any deviation from documented procedure opted
deliberately for temporary period to manage unavoidable situation without
affecting the quality and safety of drug substances or drug product shall be
termed as planned deviation.
The important thing is to set planned deviations apart from a change within
the framework of Change Control, which involves planned, permanent
changes in existing rules or features. A deviation is no substitute for the
Change Control procedure.
b) Unplanned Deviation: Any deviation occurred in unplanned manner due
to system failure or equipment breakdown or manual error shall be termed
as unplanned deviation.
4.2 Deviations may be categorized according to their severity i.e. impact on
product quality or non-conformance with a GMP standard as follows:
a) Level 3 Deviation:
When the deviation does not affect any quality attribute, a critical process
parameter, or an equipment or instrument critical for process or control, it would
be categorized as Minor, and treated as such by the applicable procedure.
b) Level 2 Deviation:
When the deviation affects a quality attribute, a critical process parameter, an
equipment or instrument critical for process or control, of which the impact to
patients (or personnel/environment) is unlikely, the deviation is categorized as
Major requiring immediate action, investigation, and documented.
c) Level 1 Deviation:
When the deviation affects a quality attribute, a critical process parameter, an
equipment or instrument critical for process or control, of which the impact to
patients (or personnel or environment) is highly probable, including life
threatening situation, the deviation is categorized as Critical requiring immediate
action, investigated, and documented.
Alternatively it may arise as a consequence of numerous repeated L2 deviations.
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4. Definition
(Cont.):
‫اﻟﺘﻌﺮﯾﻔﺎت‬(‫)ﺗﺎﺑﻊ‬
4.3 Immediate & Correction action:
Action to eliminate a detected nonconformity
4.4 Corrective Action:-
A remedial action which can be rapidly effected & whose implementation is
designed to rectify any potential or actual adverse impact to product quality
from the deviation, it is taken to prevent recurrence.
4.5 Preventive Action:-
A remedial action whose implementation should eliminate the possibility of
future recurrence of issue/problems. These may be extensive in nature and
their implementation may not be short term, it is taken to prevent
occurrence.
5. Form Used:
‫اﻟﻣﺳﺗﺧدﻣﺔ‬ ‫اﻟﻧﻣﺎذج‬
5.1 Deviation Lifecycle; form No. (IQF-216-002)
5.2 Deviation Report; form No. (IQF-830-101/3) (2 Pages)
5.3 Registration List of Deviations Reports; form No. (QQF - 216 -002)
5.4 Registration List of CAPA; form No. (QQF - 216 -003)
5.5 Deviation Investigation Report; form No. (QQF - 216 -2/3)
5.6 5W2H Method (Appendix I)
5.7 8D Problem solving worksheet (Appendix II)
5.8 Root Cause Analysis Method (Appendix III)
5.9 Fishbone Method (Appendix IV)
6. Procedure:
‫اﻟﺗﻌﻠﯾﻣﺎت‬
6.1 Deviation Reporting:
6.1.1 Time to report a deviation:
Deviations should be recorded and immediately reported to the person in
charge and the quality management department with explicit explanations
and the immediate action(s) within maximum 24 hr.
6.1.2 The deviation report; form No.(IQF-830-101/3 of 2 pages) , contain
three sections, is issued.
6.1.3 Section І:
a) This section to be completed by the initiator.
b) It shall indicate the deviation and mention the stage of operation.
c) What is the problem? This should be a short, simple and concise
definition.
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6. Procedure
(Cont.):
“IF YOU CANNOT SAY IT SIMPLY, YOU DO NOT UNDERSTAND
THE PROBLEM”
d) Determine whether the problem describes a “something changed” or a
“never been there” situation.
6.1.4 Section ІІ:
a) The production area manager suggests the correction action(s) required
to containment the nonconformity.
b) The production area manager initiate and complete the correction
action(s) suggested.
c) The production area manager should provide evidence of action(s)
completed.
d) Then the quality assurance manager should review and evaluate the
initiation and effectiveness of the correction action(s); either approve or
send back for more information.
6.1.5 Section ІІІ:
a) QA designated representative shall evaluate the deviation with respect
to the impact on quality and propose a suitable corrective action based on
the nature of deviation.
b) QA designated representative shall approve the deviation, define the
deviation and its possible classification (Level 1,2,or 3), and allot a
unique deviation control number.
c) The deviation registration number is assigned as follows:
Dev – YY – XX , where:
D-Indicatesthatthereference number pertainstoaDeviation.
YY - Indicates the last two digits of the year in which the deviation is
initiated.
XX -Deviation Number (issued consecutively within year of
occurrence)
For example (Dev – 13 – 35): it is the deviation number 35 in year 2013
d) QA designated representative shall forward the report to Head of
Quality Assurance for authorization.
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6. Procedure
(Cont.):
e) The Head of Quality Assurance shall review the report with their own
recommendation if required.
6.2 Investigation Report:
6.2.1 Deviation timing:
a) In case of L3 deviation: document immediately upon discovery in
batch record and no need for investigation report.
b) In case L2 or L1 deviations: investigation report to be issued within 30
Calendar days (i.e. reporting of investigations and corrective actions.
Some preventative actions may be long term-completion dates and any
subsequent extensions to these, to be agreed by the Head of
Quality Assurance).
c) Intermediate report may be prepared if the investigation cannot be
completed within the time limit.
6.2.2 The production area manager together with QA manager assigns a
team to investigate the problem.
6.2.3 The report should include, but not limited to: (form ……..)
a) What – describe the event/ result/ finding.
b) When – give accurate time when the deviation occurs.
c) How – explain the process/operation involved in the deviation.
d) Where.
e) Who – optional.
f) Investigation details (Rationale /reasoning/experiments/results/ trends).
g) Root cause(s) identified.
h) Quality risk assessment.
i) Identify other batches potentially affected (Justify Selection &
Remember Distributed Lots).
J) Conclusion.
Essentially, the document should contain all the details needed, without
the use of jargon.
6.2.4 Investigation & Root cause analysis: may use one of the following
tools according to the deviation criticality (Appendix III)
a) 5W2H method (Appendix I)
b) Ishikawa Charts (Fish Bone) (Appendix IV)
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6. Procedure
(Cont.):
c) Process FMEA
d) Brainstorming
e) Control charts
f) 8D Problem solving methodology (Appendix II)
6.2.5 Data Collection:
a) Interview: Staff, Customers, Suppliers
b) Review: Policies, Procedures, Forms
c) Record Review: (Training, Production, Equipment, Computer, Donor
Chart)
d) Staff may be interviewed individually or as a group to ensure
understanding of the process in question.
6.2.6 Entire investigation report may be made on multiple dates as
completed. Obtain and attach (with pagination) supporting
documentation.
6.2.7 Wherever a deviation could affect multiple batches, e.g. due to
equipment or facility failure or material or process deviation report, a
photocopy of the same shall be filed with the subjected batch processing /
packing record or analytical report.
6.2.8 After completing the investigation, it should be easy to identify the
root cause(s) or the most likely root cause(s) of the deviation and
appropriate corrective & preventive action to potentially prevent
recurrence of similar problem.
6.2.9 All corrective & preventive action should be assigned a target date,
assigned a responsible person & tracked through to closure.
6.210 Every CAPA action item should have：
− What is the specific action?
− Who is responsible for implementation?
− What is the completion time?
− Who will monitor the progress?
− Who will assess the effectiveness?
− Who is to close the action item?
6.2.11 The area responsible manager who concerned with the deviation is
responsible to complete the corrective and preventive actions suggested.
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6. Procedure
(Cont.):
6.2.12 Evaluation of the corrective and preventive action:
a) The evaluation for effectiveness should begin within 60 days &
completed no later than 120 days of the corrective action and preventive
plan implementation date. This ensures that the staff is competent and
familiar with the corrective action submitted.
b) Effectiveness Evaluation Steps:
•Verify that corrective action was properly implemented
•Determine data source for Effectiveness Evaluation
•Determine when to perform Effectiveness Evaluation
•Determine evaluation period
•Consider impact of learning curve
•Determine success criteria
c) In the event of a failed Evaluation:
- Issue a new deviation.
- The Root Cause Analysis will need to be redone.
- Item to consider:
• There may have been multiple root causes that were not initially
discovered.
• There may have been significant contributing factors that were not
discovered.
6.2.13 Operations or Quality Assurance may perform a post corrective
action audit to determine overall effectiveness.
6.2.14 All open deviations are reviewed in meetings and may
continue review until the recommended actions have been completed.
Once completed, the official date of deviation close-out is listed and
is determined once all corrective and preventive actions have been
completed and documented as required. Supporting documentation
may be added as it becomes available (as applicable). QA verifies
completion of Close Out and Follow-up by signing/dating.
6.2.15 Conclusion & Quality decision:
a) Quality assurance has to decide whether the batch can be mobilized or
should it be held pending investigation.
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6. Procedure
(Cont.):
b) No impact of the deviation on the product quality, safety, efficacy- product
can be released.
c) Product is rejected due to major impact of the failure on product quality.
d) Product is recalled.
6.3 Deviation Trending Analysis:
6.3.1 A good deviation system should enable management to identify emerging
trends and any areas of improvement. Therefore, a periodic review and analysis
of the system should be established to identify recurrent deviations and trends.
This formal review should be at least once a year for L1 deviations as a
minimum, and may be performed as part of a total management review or
product review. L2 deviations should also be appropriately reviewed on a
regular frequency.
6.3.2 Trending analyses include, but not limited to：
a) Ratios of different types of deviations, are the trends changing?
b) How about individual departments, are their trends changing?
c) Is the trend of completion times changing?
d) How about the similar/same deviations recurring?
e) What are the root causes – trend changes?
6.4 Product manufactured under license:
Copy of deviation investigation and remedial action taken should be sent to
licensor for products manufactured under license.
6.5 Deviation & CAPA Registration:
Quality Assurance registers all deviations on form No.(QQF-216-002) and
follow up pending corrective and preventive actions on Form No.(QQF- 216-
003) until their completion.
7. Change
History:
‫اﻟوﺛﯾﻘﺔ‬ ‫ﺗﻐﯾﯾرات‬
Previous Issue: 3rd
Issue on date 21/04/2011
4Th
Issue: Upgrading the procedure.
8. References:
‫اﻟﻤﺮاﺟﻊ‬ Not Applicable.
9. Copy Owners:
‫اﻟﻧﺳﺧﺔ‬ ‫ﺣﺎﺋزى‬
As in the attached distribution list.
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Distribution List
Copy
No.
Copy Owner Dist.
Copy
No.
Copy Owner Dist
Copy
No.
Copy Owner Dist.
1 Management rep. 16 Liquid & semi solid dept 31 Electrical maintenance dept
2 Manufacture G.M. 17 Penicillin area dept 32 Workshops & utilities dept
3 Financial sector 18 Powder & instant dept 33 Auditing g. management
4 Production g. mange. 19 Packaging area dept 34 Accounting & budgeting g. manage.
5 Quality g. mange. 20 Sterile area dept 35 Expenses Auditing dept
6 Commercial sector 21 Programs. & prod. planning dept 36 Revenue Auditing dept
7 Engineering g. mange. 22 Soft gelatin capsule dept. 37 Costing dept.
8 Quality assurance dept 23 EHS dept 38 Public relation dept
9 Quality control dept 24 Exportation dept 39 Secretary g. management
10 TRA g. mange. 25 HR Sector 40 Information technology g. manages.
11 Planning dept. 26 Org. & HR Development dept 41 Business Development dept
12 Stores dept 27 Pay roll dept 42 Sterile penicillin factory
13 Purchasing dept 28 Vehicles dept 43 Logistics g. management
14 Research dept 29 Tenders dept
15 Solid dosage forms dept 30 Mechanical maintenance dept
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DEVIATION LIFECYCLE
IQF-216-002
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EVENT OBSERVED
IMMEDIATE ACTION TAKEN
(TO PREVENT DETERIORATION)
DEFINE & DOCUMENT
DEVIATION (LEVEL 1- LEVEL 3)
NO FURTHER ACTION ID CORRECTIVE ACTIONS ID CORRECTIVE ACTIONS
CAPTURE
COMMENT IN DOC'N
(eg. BX SHEET)
INTIATE AND
COMPLETE CORRECTIVE
ACTIONS
INTIATE/ COMPLETE
CORRECTIVE ACTIONS &
SCOPE INVESTIGATION
BATCH HOLD?
APPROVE AND
CLOSE OUT
FULLY INVESTIGATE
(PREVENTATIVE ACTIONS
ASSESSMENT AS
PART OF DISPOSITION
AGREE & ISSUE INVESTIGATION
REPORT (INC PREVENTATIVE
ACTIONS)
ASSESSMENT & EVALUATION
INTIATE & COMPLETE
PREVENTATIVE ACTION
FOLLOW UP
PREVENTATIVE ACTIONS
NB: Release could occur at
any time dependents upon
corrective actions completion
L1L2
L3
N Y
Maximum
24 hrs.
30
Calendar
days
CARRY INVESTIGATION TO ID
THE ROOT CAUSE
Begin within
60 days &
completed no
later than 120
days

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Section І
(To be completed by the initiator)
Product/ Material / Code: Batch No / Direction & Size: Quantity affected (if applicable):
The deviation was/is:
Unplanned (Already occurred) Planned (Required prior to CCR)
Deviation was discovered by: [ Name:………………………………. Position:……………………………….]
Investigator Monitor Customer complaint Out of specification Audit finding
Trend analysis Material inspection Other:…………………………………….
Date of deviation(occurrence):……/……/……… Date of report(discovery):………/………/………
Date site become aware of deviation: ……/……/……… Location / Area:……………………………………..
Production line:…………………………………….. Machine name:………………………………………
Machine operator:………………………………….…………………………………………………………………..
Deviation :
Initiator:-
Name: Department: Sign:
Section ІІ
Immediate & correction action taken:
Suggested by:
Production Area Manager
……………………………………………
Date: / /
Approved by:
Quality Assurance Manager
……………………………………………..
Date: / /
IQF-830-101/3
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Registeration No.:
Dev - ............. - ............
Deviation Report
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Section ІІІ
Deviation Classification Levels According to SOP QQI-216-4/0
L3: The deviation closed after immediate action taken
L2 or L1: Carry out further investigation L3 L2 L1
QA designated representative
………………………………
Date: / /
Recommendation:
………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………
Quality Assurance Manager
………………………………
Date: / /
Original: In B.P.R.
Copy to: - Quality Assurance
- Quality control
- Concerned Departmment.
IQF-830-101/3
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Registeration No.:
Dev - ............. - ............
Deviation Report
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Investigation Team
Team Member Department Postion Signature
QQF - 216 -2/3
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Deviation regestiration No. : (Dev - ............. - ............) Manufacturing Area:
Investigation start date: ..…/…../…….
Product Name: ……………………………. B.No’s: ………………………………..
Deviation Investigation Report
Investigation Details: (Attach extra pages, if needed)
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
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Product Name: B.No’s:
Investigation Details: (Attach extra pages, if needed)
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
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……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
Reported By:……………………..
Date:……/……/…….
Attachments □ Yes □ No (# of pages)…...
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The root cause(s) or the most likely root cause(s):
QA sign
Investigation end date: / /
Corrective & Preventive action taken :::
Action
Responsible
person
Target date Completion date
QQF - 216 -2/3
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QQF - 216 -2/3
Evaluation the effectiveness of CAPA: (should begin within 60 days & completed no later than 120 days of the corrective action
and preventive plan implementation date)
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
……………………………………………………………………………………………………………
…………………………………………………………………………………………………………..
QA sign:
Date / /
CAPA Closed Date: ……./……./………
Comment
Concerned Dep. Manager : Q.A. sign.
Date / / Date / /
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Appendix I
5W2H Method
5W and 2H Response
5 W What is the problem? Describe
it in a single sentence, so that
others will be able to
understand what you mean.
The problem is…
Why is it a problem? What is
the pain?
This is a problem because…
Where do we encounter the
problem?
We encounter the problem at (Location) (Time)
when (Specific circumstance)…
Who is impacted? This impacts: (Staff) by…, (Patients) by…, (Other
providers) by … (others) by…
When did we first encounter
the problem?
We first encountered this problem…
2H How did we know there was a
problem?
The symptoms of this problem are…
How often do we encounter
this problem?
We encounter this problem (x) times and each
encounter is (this big). The problem is getting
(better/worse).
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Appendix II
8D Problem Solving Worksheet
Step 0 1 2 3 4 5 6 7 8
Action Prepare Team Describe Contain Diagnose Solve Validate Prevent Recognizing Team
Efforts
0
Prepare for Problem Solving - Does
the problem warrant/require an 8D? If so
comment why and proceed.
Is an Emergency Response Action Needed?
(If needed document actions in Action Item Table)
1
Assemble Team - Establish a small
group of people (from 2 to 8) with the
process/product knowledge, allocated
time, authority and skill in the required
technical disciplines to solve the problem
and implement corrective actions.
Team Goals:
Team Objectives:
Name (Team Leader First)
2A
Describe Problem - Provide the starting
point for solving the problem or
nonconformance issue.
Need to have “correct” problem
description to identify causes. Need to use
terms that are understood by all.
Sketch of Problem
B.No / Process:
Area / Machine / Line:
List all of the data and documents that might help
you to define the problem more exactly?
Is there an action plan to collect additional
information?
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Appendix II (Cont.)
2B IS IS NOT (but could be)
Who
Who is affected by the problem?
Who first observed the problem? (internal/external)
To whom was the problem reported?
Who is not affected by the problem?
Who did not find the problem?
What
What type of problem is it?
What has the problem?
What is happening?
Do we have physical evidence of the problem in
our possession?
What does not have the problem?
What could be happening but is not?
What could be the problem but is not?
Why
Why is this a problem?
Is the process where the problem occurred
stable?
Why is it not a problem?
Where
Where was the problem observed?
Where does the problem occur?
Where could the problem be located but is not?
Where else could the problem be located but is not?
When
When the problem was first noticed?
When has it been noticed since?
When the problem could have been noticed but was
not?
How
Much/
Many
Quantity of problem?
How Much is the problem causing in dollars,
people, & Time?
How many could have the problem but don’t?
How big could the problem be but is not?
How
Often
What is the trend (continuous, random, cyclical)?
Has the problem occurred previously?
What could the trend be but is not?
2C
Problem Description - Combine the relevant information, this will be your Problem
Description
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Appendix II (Cont.)
3
Interim Containment Actions - Temporary actions to contain the problem and “fix” until
permanent correction is in place. (Note: Validate that the action taken works).
Document Actions in the Action Item Table
4A
Diagnose Root Cause – Analyze for “Root Cause” of the problem. Identify and verify the
Escape Point.
Brainstorm the possible causes of the problem (attach)
4A Cause and Effect Diagram (Attach copy of complete diagram(s) as appropriate)
How made/operated? Why did it get out/ fail?
People Materials/Info Machine Problem (effect) People Materials/Info Machine
Method Environment Measurement Method Environment Measurement
Note on Diagram(s) circle the most likely contributors (3 max) from each side.
4B 5 – Why Analysis
Ask – Why did this happen?
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Appendix II (Cont.)
5 Identify Solutions – Solutions that address and correct the root cause. Solutions determined to
be the best of all the alternatives. Document and verify the Permanent Corrective Action (PCA) in
the Action Item Table.
6
Validation - Implement and validate to ensure that corrective action does “what it is supposed to
do.” Detect any undesirable side effects. Document this on the Action Item Table. Return to root
cause analysis, if necessary.
7
Prevention (Design / Information Systems Review) - Determine what improvements in systems
and processes would prevent problem from recurring. Ensure that corrective action remains in place
and successful.
7A Address Similar Systems - List similar systems. Assign Action Item and Individual to Follow Up to correct
products/ machine with the potential for the same defect.
Product/ Machine / Process / Action Assignee
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Appendix II (Cont.)
7B Review the following documents / systems.
Check if
Applicable
Document Assignee
Completion Date
Planned Actual
Master Batch Production Record
Engineering Master Specifications
In Process Form
PM Procedure(s)
Job Descriptions(s)
8
Congratulate Your Team! - Use all forms of employee recognition and document as necessary. Celebrate
successful conclusion of the problem solving effort. Formally disengage the team and return to normal duties.
Was the Problem Solving Worksheet Effective?
Yes/No Signature/Title Date
The 8D approach is used to solve critical, major, chronic and recurring problems. The 8D use is typical when:
- The problem complexity exceeds the ability of one person (an expert) to resolve the problem.
- Communication of the problem resolution (during & after) must go across company levels, other departments
and/or to customers.
- The customer or management requests 8-D
However, the 8D is not effective for:
- Non-recurring problems or problems which can be solved quickly by individual effort.
- Problems with known root causes.
- Making a decision between different alternatives.
- Problems where the simplest and most obvious solution is likely to be the best or adequate solution.
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QQF-216-002
QQF-216-003
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Event
Date
Deviation #
Assigned
Assigned
By/Date:
Level of
deviation
Product
name
Deviation
description
Final
Impact
Close out
Date/By
Follow Up
Required
Follow-Up
complete
Date/By
1 □ No
□ Yes
□ N/A
Completion
date:
2
3
Deviation # Assigned Suggested CAPA ( By / Date ): Close out ( Date / By ): Follow Up
Required
Follow-Up complete
( Date / By ):
1 □ No
□ Yes
□ N/A
Completion date:
2
3
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Appendix III
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Appendix IV
Fishbone Method
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Root cause
Milieu (Mother Nature /
environment)
Factor X Factor X
Method
Factor X Factor X
Material
Factor X
Machine
Factor X Factor X Factor X
Man
Factor X
Measurement
Factor X
Factor X

Pharmaceutical Deviation SOP

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