SOP on Handling of Deviations
- Objective :To describe a procedure for handling of deviations which may occur during the execution of various activities in written procedures in facility.
- Scope:This Standard Operating Procedure shall be applicable to all the departments responsible for carrying activities related to the manufacture of the product, in the formulation plant of (Pharmaceutical Company Name).
- Responsibility
- Personnel of concerned department shall be responsible to notify immediately their respective superiors when any deviation occurs or is noticed.
- Head-Regulatory Affairs or his/her designee shall be responsible for facilitating prior notification or intimation to the regulatory authority, if the deviation has impact on the concerned regulatory submissions.
- Head of the concerned department or his/her designee, and Head-Quality Assurance or his/her designee of respective location shall be responsible for implementation and compliance of this SOP.
- Accountability
4.1 QA Head shall be
accountable for implementation of this SOP.
- Abbreviations and Definitions
BMR:Batch manufacturing
record; a controlled regulated copy, which comprises the recordings against the
manufacture of a batch.
PDR :Planned deviation
report
UDR :Unplanned deviation
report
cGMP:Current good
manufacturing practices
BPR:Batch packing record
ICH:International
conference on harmonization
Written Procedures :Written
procedures are the approved and controlled documents which are followed for the
execution of various activities performed in the organization viz.,Batch
Manufacturing Records detailing manufacturing and packaging procedures,
Standard Operating Procedures (SOPs), Standard Testing Procedures (STPs).
General Test Procedures and various protocols followed for the execution of
validation studies, stability studies, etc.
Deviation : Any non-conformance
/disobeyance in written approved procedures of quality system in the
organization.
Or
We have any written
procedure like standard operating procedure, standard test
procedure, BMR etc. and works against this, then it is called deviation. It
means deviation from any written procedure that we have implemented.
Critical Deviation: The
deviation is likely to or will have a significant impact on critical attributes
of the product.
For example: Manufacturing
instructions are not followed, wrong batch details are printed,
SOPs or methods
of testing not followed during analysis etc.
Major Deviation : The
deviation could or may have a significant impact on critical attributes of the product.
For example: Raw material is
received in a damaged container, manometer readings in the
sampling booth are crossed the action limits etc.
Minor Deviation:The
deviation is unlikely to have a detectable impact on critical attributes of the
product.
For example: Line Clearance is not taken
from QA, physician sample wrongly printed with price, etc.
Critical Attribute :A
critical attribute is one that defines the product and contributes to safety, identity,
purity, strength or quality. Critical attributes are usually
detectable during product testing.
Unplanned Deviation: An accidental
or unanticipated
non-conformance or deviation observed or noticed during or
after the execution of an activity. An unplanned deviation can be
a critical or major or minor in nature.
For example: deviation in
failure of procedure, utility, material, equipment or any system is occurred.
We can consider it as any change from the previous or our written procedure.
Planned Deviation : Any
deliberate or intentional non-conformance or deviation Planned prior to
the execution of an activity, which is to be undertaken following documented,
justifiable and approved rationale. No critical or major deviation, which has potential
to alter the quality of the product, shall be planned.
For example: Calibration or
validation is not carried out as per schedule due to delay for various reasons.
- Procedure
- Deviations may be classified into following two categories:
- Planned Deviation
- Un-planned Deviation
Unplanned & Planned
deviations shall be sub classified on the basis of their impact of product
quality in critical, major or minor.
- Planned Deviation (Planned Deviation Report)
- Any departure from established and approved procedures observed or noticed prior to the execution of an activity, such as SOPs, STPs, processes, systems, standards and protocols, which is done under compulsion or for continuous quality improvement programs will be categorized as planned deviation.
- No critical or major planned deviation shall be allowed, which has potential to alter the quality of the product, only minor deviation shall allow to plan.
- Such a planned deviation shall be taken / implemented only after proper evaluation, risk assessment and pre-approval from Quality Assurance.
- Such planned deviation shall be properly reported, assessed / evaluated for its impact on product quality, process performance or GMPs.
- Any personnel from concerned department shall initiate the “Planned Deviation Format” by detailing the reason for deviation as per Annexure I.
- The department head shall review the proposal of planned deviation, justification given for its potential impact on the product quality and compliance to regulatory requirements for necessity / feasibility of the deviation, by providing supporting data.
- After review by concerned Head of department, the proposal shall be forwarded to Plant Head.
- After review by Plant Head, the proposal shall be forwarded to QA for review and approval.
- QA shall assign a unique number to each planned deviation as follows:
- The numbering system for a planned deviation shall consist of ten (10) alphanumeric characters.
- For example, PDR/16/001 shall be assigned to the first planned deviation of year 2016.
- In the above planned deviation report number, the 1st, 2nd & 3rd characters ‘PDR’ stand for ‘Planned Deviation Report’.
- The 4th character “/” is a forward slash.
- The 5th & 6th characters ‘16’ represent the last two digits of the year 2016.
- The 7th character “/” is again a forward slash.
- The 8th, 9th & 10th characters ‘001’ represent sequential number.
- Head QA shall review the planned deviation with respect to impact on product quality, necessity / feasibility of the deviation proposed, rationale / justification & compliance to cGMP / regulatory requirements, along with the adequacy of the supporting data attached.
- Head QA shall assess the requirement for any additional testing or checks for quality monitoring of the Planned Deviation and documents for the same.
- QA shall consult Regulatory Affairs, where applicable, for any planned deviation before providing approval. The RA may provide inputs as necessary based on GMP and regulatory requirements.
- Head QA shall approve / reject the Planned Deviation with appropriate recommendations.
- If approved, the deviation shall be applicable for a defined number of batch (es) or defined number of days as mentioned in the Planned Deviation Report.
- After QA approval, the concerned department shall implement the planned deviation and the observations and data generated shall be documented.
- QA shall review the implementation and documented data obtained from respective departments to ensure that the recommendations are complying with quality profile of the batch (es) impacted by the deviation. This data shall support with the “Planned Deviation Report”.
- The closure of planned deviation shall be the responsibility of the Department Head and Head-QA.
- If the deviation is related to the batch which is for sale, then the batch shall be released only after QA approval and closure of deviation.
- Recommendations may be conferred during the review.
- If the planned deviation in the process / procedures leads to improvement in the product quality / process / assurance / GMP, then the deviation / change can be made permanent by following the change control procedure (SOP on change control procedure).
- In conclusion, Head of concerned department and Head QA shall close out the deviation.
- QA shall maintain a logbook for the approved planned deviations as per Annexure III.
- Unplanned Deviation (Unplanned Deviation Report)
- While carrying out day-to-day activities, there is a probability of unplanned deviations (unforeseen deviations) occurring. Such unexpected events may be related to any procedures, processes, systems, equipment and utilities. These deviations may occur for many reasons, such as following (not all inclusive):
- Equipment failure / Breakdown / Malfunctioning.
- Power supply failure / interruption.
- Accident in the plant.
- Breakdown in support services / utilities.
- Documentation Errors
- Laboratory failure / Error.
- An unplanned deviation report (UDR) shall be initiated as a part of the approved system for handling of deviations, in order to provide a mechanism for ensuring the recording of the deviation and assess the impact on product quality. If required, corrective and preventive action shall be performed to ensure product quality.
- User department shall make request for issuance of unplanned deviation Format to Quality Assurance department through Issuance from.
- Any individual on the job shall inform concerned department supervisor regarding the occurrence of deviation and details of initial observations.
- The concerned department personnel shall fill the details of the unplanned deviation along with cause and investigation details as per Annexure II and forward the same to department head for review, assessment and comments.
- While review, concerned head of the department shall incorporate corrective and preventive action based on assessment. Then the ‘Unplanned Deviation Report’ shall be forwarded to Plant Head for review.
- Then ‘Unplanned Deviation Report’shall be submitted to the QA for review and approval.
- QA shall assign a unique number to each unplanned deviation report as follows;
- The reference number for an unplanned deviation report shall consist of ten (10) alphanumeric characters.
- For example, UDR/16/001 shall be assigned to the first unplanned deviation of year 2016.
- In the above unplanned deviation report number, the 1st, 2nd & 3rd characters ‘UDR’ stands for ‘Unplanned Deviation Report’.
- The 4th character “/” is a forward slash.
- The 5th & 6th characters ‘16’ represent the last two digits of the year 2016.
- The 7th character “/” is again a forward slash.
- The 8th, 9th & 10th characters ‘001’ are a sequential number.
- QA shall maintain a logbook for the unplanned deviations as per Annexure III.
- The filled form shall be forwarded to QA head after review by QA.
- Head – QA & Head – concerned department shall assess unplanned deviation for its impact on product quality. Details shall be documented as per Annexure II.
- Head QA may recommend for performing any additional studies, if required.
- If the deviation does not affect product quality, Head – QA shall allow further processing of the batch in question.
- If there is probability of product quality getting affected, Head – QA shall assess the impact on product quality before allowing further processing of the batch.
- Product may be “Quarantined” in sealed containers, if required. Containers shall be labeled, indicating product name, Batch No., Manufacturing Date, Expiry Date & Batch size. The labeled containers shall be kept in secured quarantine area.
- Head – QA along with the Head of concerned department shall investigate & find out the root cause of the problem that resulted in the deviation as per SOP on CAPA.
- Based on the investigation, the proposed corrective and preventive action shall be taken to avoid any such reoccurrence and the same shall be implemented.
- If required Formulation Research & Development (FR&D) shall be consulted by QA to review impact on product quality and decide upon the future course of action(s).
- Closure of Deviation
- In conclusion, Head – QA shall close the deviation by reviewing and assessing the impact of deviation on the quality of the product.
- Any supporting data and comments required to close the deviation (e.g.stability data) shall be recorded or attached to the deviation report.
- The time line for closure of deviation (planned or un-planned) shall be not more than 30 working days. If required, extension should be taken.
- Both planned and unplanned approved deviations shall be controlled by QA and the same shall be documented in the respective BMR also.
(Note:
The planned deviation shall be implemented after
the approval of QA).
- Forms and Records (Annexures)
- Planned Deviation Report – Annexure-I
- Unplanned Deviation Report – Annexure-II
- Logbook for Planned/Unplanned Deviation Reports – Annexure-III
- Distribution
- Master Copy- Quality Assurance
- Controlled Copies -Engineering, Human Resource, Production, Quality Assurance, Quality Control, Regulatory Affairs, Warehouse
- History
Date
|
Revision Number
|
Reason for Revision |
–
|
00
|
New SOP |
Annexure – I
Planned Deviation
Report
1.0
Review by Department Head
(Comments):
|
|||
Reviewed
by
|
Name
|
Signature
|
Date
|
2.0
Review by Plant Head(Comments):
|
|||
Reviewed
by
|
Name
|
Signature
|
Date
|
- QA Review / Approval
- Comments received from QP attached: Yes /No / NA
- Any additional studies required: Yes / No
- Stability Studies, Additional Quality Testing,Others
___________________________________________________________________________
- QA Comments:
___________________________________________________________________________
- Deviation: Approved Rejected
- The Planned Deviation is limited to time / No. of Batches: _________________
Review
by Head – QA
|
Name
|
Signature
|
Date
|
- Implementation of Deviation
- Deviation implemented by (department) :_______________________________
- Observations (If any):______________________________________________
- Data Generated (If any): _________________________________________________
- Quality Profile of batches affected (If applicable): _____________________________
Implemented By
Department Head
|
Name
|
Signature
|
Date
|
- QA Review of Implementation & Closure
- QA comments: ____________________________________________________
All recommendations
fulfilled: Yes /No
- If No, Justification: ______________________________________________________
- Data generation completed: Yes / No
- If No, Justification: ______________________________________________________
- Can the Deviation/Change be made permanent through change control? Yes/ No
- Remarks (If any): _______________________________________________________
- Affected batch can be released? Yes/No
Closure
Approved By Department Head / Nominee
|
Name
|
Signature
|
Date
|
Closure
Approved By Head-QA/ Nominee
|
Annexure – II
Unplanned Deviation
Report
Date _______
- Deviation Initiation
1.1
|
Unplanned
Deviation Report No.:
|
________________
(to be assigned by QA)
|
||||||
1.2
|
Deviation
Reported By
(Department):
|
|||||||
1.3
|
Product
Name: ___________
|
Batch No.:
_________
|
Market:
___________
|
|||||
1.4
|
Batch
Size: ______________
|
Mfg. Date:
_________
|
Expiry
Date: _______
|
|||||
1.5
|
Deviation
related to:
|
Procedure
Process
Equipment
Standard Batch Size
Others(
If any) specify:
|
||||||
1.6
|
Potential
Impact On
|
Quality
Yield GMPs
Manufacturing Process Others ( If any)
specify :
|
||||||
1.7
|
Deviation
Details:
|
|
||||||
1.8
|
Cause for
Déviation
|
|
||||||
1.9
|
Investigation
Details:
|
|
||||||
1.10
|
Proposed
Corrective Action
|
|
||||||
1.11
|
Proposed
Preventive
Action
|
|
||||||
Initiated
By
|
Name
|
Signature
|
Date
|
|||||
2.0
|
Review
by Department Head (Comments):
|
||
Reviewed
by
|
Name
|
Signature
|
Date
|
3.0
|
Review
by Plant Head(Comments):
|
||
Reviewed
by Plant Head
|
Name
|
Signature
|
Date
|
4.0
|
QA
Review for implementation of CAPA (Comments):_____________
|
||
Details
of any additional studies Required / Performed:
|
|||
Reviewed
by QA
|
Name
|
Signature
|
Date
|
5.0
|
Review
& Deviation Closure by Head – QA (Comments):
|
||
Reviewed
by
Head-QA
|
Name
|
Signature
|
Date
|
Annexure -III
Log Book for Planned/Unplanned Deviation Reports
Sr.
No.
|
Date
|
PDR/UDR
No.
|
Deviation
Related to
|
Initiated
By
& Deptt.
|
Expected
date for Implementation
|
Approved
/ Rejected
|
Closed
out on
(sign/date)
|
Remarks
|
No comments:
Post a Comment