Content:-
-Definition
-Types
-Category
-Basic Process for Handling Deviation
-Process how to file deviation
-Requirements for it during filing
Definition: Deviation is a departure from approved procedure or specification.
A deviation is an activity performed differently and/or modified than that
specified in an approved document.
OR
Deviation is an unexpected event
that occurs during the on-going operation / Activity / Documentation / Entries
at any stage of Receipt, Storage and Manufacturing, Analysis and Distribution
of Drug Products / Intermediates / Raw Materials / Packing materials.
Deviations are to be reported as and when they occur and to be investigated for
impact assessment.
There are two types of deviations
1) Planned Deviation
2) Unplanned Deviation.
1.Planned Deviation: Planned deviations, which are described, and
pre-approved deviation from the current operational document/system, covering a
specified period of time or number of batches. Planned deviation shall be
approved before execution
The term “planned deviation” is frequently used to
describe a decision to carry out a process in a different way from which it is
established in a SOP, Method or Manufacturing Batch Record due to an unforeseen
event. Planned deviations need to be fully documented and justified. Usually,
planned deviations associated to onetime events, and change control to
permanent changes.
2.Unplanned Deviation: Unplanned deviations also called as
incident.
Incident can be defined as unplanned
or un-controlled event in the form of non-compliance from the designed systems
or procedures at any stage of manufacturing, packaging, sampling, testing,
holding and storage of drug product due to system failure or equipment
breakdown or manual error.
Incidents are again of two type
1.
Quality Impacting Incident
2.
Quality Non-impacting Incident
1.
Quality
Impacting Incident
Quality impacting incidents are
errors or occurrences during execution of an activity which will affect the
Quality, Purity, and Strength of the drug product.
2.
Quality
Non-impacting Incident
Quality Non-impacting incidents are
errors or occurrences during execution of an activity which may have no impact
on the quality, purity and strength of a drug product
Category of Deviation: Deviations should require a higher
level of analysis and documentation, and are usually covered by a deviation
handling procedure as per SOP made for it. At this point, a decision needs to
be made to categorize the deviation as
Minor, Major or Critical. This decision process should be based as
applicable and as possible on the impact (or hazard) and risk on the process
and product quality by the use of any QRM tool.
-Minor Deviations
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. Possible examples of minor
deviations are given below:
Example of Minor deviation
-Skip of
FEFO principle (first expired-first out) in raw material handling.
-Minor errors in batch records or document that not
affecting the integrity of data.
-Spillage of material during
dispensing.
-Failure to meet environmental
condition during batch processing.
-Balance out
of tolerance used to determine gross weight of raw materials upon reception.
-Pressure
differential out of established limits in class D washing area.
-Inadequately trained personnel to
perform warehouse cleaning activities.
-Major Deviations
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 as such by the appropriate SOP.
Possible examples of major deviations are given below.
Example of Major deviation
- Use of
unapproved reference standard to test an API or drug product.
-
Inadequately trained personnel to perform sterility tests.
- Production
started without line clearance.
-Machine breakdown during processing
-Mix ups of cartons of same product
with different strength.
-Filter
integrity test has been carried out using equipment with no documented installation
qualification completed.
- Gross
misbehavior of staff in a critical aseptic process.
- Pressure
differential out of established limits in aseptic fill areas.
-
Operational parameter out of range for a parameter defined as non-critical.
- Untrained personnel responsible
for segregating the approved and rejected raw-material in the warehouse
Critical Deviations
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 as such by the appropriate SOP.
Possible examples of critical
deviations are given below:
Example of Critical deviation
- Expired or
rejected API component used.
- Mix up of
same product with different strength.
- Forgot to
add any material at respective stage.
- Incomplete
inactivation stage of fermentation.
Notice:
Deviations need to be analyzed based on objective and justified criteria
avoiding the natural bias from different people or groups. Therefore, the
examples of minor, major and critical deviations given above should be
considered as that only, and they could be categorized differently with proper
justification.
Basic Process for Handling Deviation
Initiator shall do the initial assessment and shall take
suitable immediate action according to the nature of deviation and inform to
department head and concern QA person. Initial impact assessment shall be done
by the observing department head / designee and designated person QA.
Recommendation for continuation of process / discontinue the process shall be
given by head of department and Head QA or designee. All deviation and
investigation reports shall be kept in custody of QA and QA shall maintain the Deviation
register. All deviation shall be documented, investigated, tracked and trended.
All deviation shall be reported as when they occur. The person who observes the
deviation shall inform the immediate supervisor or concern department head/designee
and to Quality Assurance. As per the severity of deviation and stage of
process, the process may be stopped for initial assessment. QA
shall issue the “Deviation Control Form “on the request of initiator Concerned
department by
Assigning deviation number. The initiator shall fill the details
like Product Details / Material / Equipment / Document / Other If any/Concerned
person involve during deviation took place and Batch No. / A.R.No. If applicable) in
deviation control form.
1. Planned deviation
Who will raise the deviation?
Concerned department
officer/executive or above can raise the deviation by all details which are
mentioned in deviation form as per SOP of respective industry according to SOP
made and effective by them for every process.
Some points covered here which are
commonly added during planned deviation
1) Document/Material/Product
description
2) Item code /Document No./ A.R No./
Batch No.
3) Current procedure
4) Proposed Deviation
5) Reason for Deviation and
Justification for deviation
6) Initiator by/prepared by/
Approved by
Who will review and authorize the deviation?
Concerned department head shall
review deviation.
In case of any additional information
required on the deviation, department head send back the form to the initiator.
If the deviation is found
acceptable, Department Head shall make the comments on the deviation and send
to QA for further evaluation.
Who will approve the deviation?
QA Manager is responsible for
approve or reject it. On receipt of the deviation, QA Manager shall allocate a
number to the deviation report. QA Manager shall evaluate the deviation and
send the deviation format to other departments (QC/Engineering /SCM/RA), if
require for their opinion. Respective Department Heads shall write their
comments on the deviation report by evaluating the impact of deviation. QA
manager shall evaluate the deviation report along with the opinion of the other
Department Heads for the impact of deviation
On complete evaluation of the
content of the deviation, QA Manager shall either approve or reject with
comments.
On receipt of the deviation, shall
allocate a number to the deviation report.
While indicating the corrective and
preventive actions it shall be ensured that the actions committed are with
timelines.
On confirmation of the corrective
action as mentioned in the deviation report by QA Executive, QA Manager shall
close the deviation and the same shall be recorded in the Deviation Log.
2. Unplanned
deviation/Incident Report
Whenever
any incident occurs, the identifier together with the department head shall
evaluate the impact of the incident on the Quality, Purity and Strength of the
Product.
Based
on the evaluation, the incident shall be classified as Quality impacting or
Quality non-impacting.
For the Quality
impacting Incident,
For
the Quality impacting Incident, the identifier shall immediately notify the QA,
and shall raise the incident report by filling the relevant information in the
incident format.
QA
officer/ Executive shall register the incident in the Incident Log.
Concerned
Department Head shall carry out detailed investigation immediately after the
occurrence of the incident.
All
documents or operations which give an information about the cause of the
incident shall be investigated.
To identify the root cause five
generic causes shall be considered and investigated according to that
a) Material
b) Method
c) Personal
d) Equipment
e) Environment
Identify the probable causes, which may
be the reason of incident. Evaluate the probable causes and summarize to
conclude and identify the root cause.
Details of investigation, conclusion
shall be recorded by concerned department head
Based on the investigation,
evaluation and conclusion, concerned department head shall take the immediate
actions.
CAPA shall be mention to avoid the
recurrence of the incident.
Concerned department head shall
submit the incident report to QA Manager for evaluation and disposal.
QA manager or designee shall monitor
the CAPA and on ensuring the compliance, incident shall be disposed.
Once the planned CAPA have been
executed, QA officer/Executive shall close the Incident report.
If preventive action is planned in
phased manner, the incident report shall remain open till the preventive
action(s) is completed.
For Quality Non impacting incident,
For Quality Non impacting incident,
the identifier shall register the incident by filling the relevant information
in format.
The identifier and the concerned
department head shall carry out the detailed investigation
All operations /analysis/ documents
which give an information about the cause of the incident shall be
investigated.
The details of investigation,
conclusion shall be recorded by initiator/concerned head.
Based on the investigation,
concerned HOD shall mention the CAPA to avoid the recurrence of the incident
and the same shall be recorded
After taking corrective and
Preventive actions, the Incident Report shall be disposed by concerned
department head.
What are the contents in Deviation format?
Deviation
no
Department
Document
/Material /Equipment/ Product
Document
No. / AR No. / Item Code No. /Equipment No./ Batch No
Current
Procedures & Proposed procedures
Reasons
& Justifications
Corrective
and Preventive Action
Initiator
Name, signature and date
Comments
with Signature and Date of initiator department head, RA head and other
department head (if applicable)
QA
Manager opinion : Approve/Reject
Verification
of CAPA by QA team
Incident
no
Department
Date
of Occurrence & date of report
Document
/Material /Equipment/ Product
Document
No. / AR No. / Item Code No. /Equipment No./ Batch No.
Brief
description of incident -description and Observer and QA officer sign and date
Investigation
& Conclusion.-description and concerned officer and concern department head
sign and date
Immediate
correction done & CAPA. –description and concern department head sign and
date
Evaluation
and Disposition by QA Manager
More details will be added shortly
on Current note of Pharmaceutical deviation.
Kindly Feedback on this notes so we
can cover more on this and other topics.
Your Response makes us to do more
work for you.
Comment your response…..
HOPE :- Hub Of Pharmaceutical Employment
4 comments:
Awesome, briefly describe the contents.
Thanks for feedback
I always like to read amazingly useful and quality content. Thank you for sharing this article.
BASF India Limited
Basant Agro Tech (India) Limited
Bartronics India Limited
Baroda Extrusion Limit
I have just started learning Value investing... Really its a great information. Thanks for sharing.
Berger Paints India Limited
Benares Hotels Limited
Bengal & Assam Company Limited
Bengal Tea & Fabrics Limited
Post a Comment