This document outlines procedures for handling deviations from standard operating procedures in a cGMP environment. It defines deviations as planned or unplanned activities that differ from specified procedures. Planned deviations are deliberate temporary changes that don't affect quality, while unplanned deviations result from failures or errors. The procedures describe rules for documenting deviations, evaluating their quality impact, approving corrective actions, and filing reports. Deviations are assigned a control number and approved by quality assurance to ensure proper handling. Repeated deviations must be investigated and corrective actions taken to prevent reoccurrences.

1. cGMP Training Program
Deviation Controlling System
By Deepak Amoli
CERTIFIED TRAINER FROM QUALITY COUNCIL OF INDIA
deepakamoli@gmail.com

2. What is the deviation?
A deviation is an activity performed or occurred
either planned or unplanned in a different or
modified form from specified manner.

3. How many part of deviation?
• Deviation Divided into two parts Planned & Unplanned
deviation :
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.
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. 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)
• Quality control testing
• Utility Operations
• Calibration Procedures
• Analytical Procedures
• Stability Procedures

5. Rules and Regulations
• No process deviation should be permitted under
normal operating conditions however in case the
deviation is unavoidable; the same should be
immediately brought to the notice of QA In-charge.
• No deviation shall be permitted from Pharmacopoeia
and other Regulatory specifications.
• Before initiating the deviation format, an evaluation
shall be done to assess whether the deviation has
any quality impact or quality non-impact

6. Rules and Regulations
• Quality Impact occurs during execution of an activity which
will affect the quality, purity or strength of the drug product.
• Quality Non-impacting occurs during execution of an
activity which will have no impact on the quality, purity or
strength of the drug product
• Only the deviation which is quality non-
impacting in nature can be allowed with corrective actions.
• Planned continuous deviation may be incorporated as
Documentation change through appropriate change control

7. Rules and Regulations
– The initiator shall indicate the deviation and mention the stage of operation
in the deviation report as per format along with the immediate proposed
corrective action in consultation with department head and the deviation
report shall be forwarded to QAD.
– 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.
– QA designated representative shall approve the deviation and assign the
number.
QA designated representative shall forward the report to Head Quality
Assurance for authorization. The Head of Quality Assurance shall review the
report with their own recommendation if required, in the remarks column.
Head QA shall give the final approval for remedial action

8. Rules and Regulations
– In case of deviation related to the products of contract giver, the
deviation shall be immediately brought in to the notice of Qualified
Person of contract giver through e-mail or fax.
– The deviation shall be approved or rejected based on the
recommendation of qualified person of contract giver.
– The report shall then be forwarded to concerned department as
applicable based upon the nature of deviation.
– The department head shall ensure that the authorized remedial
actions are implemented. Quality assurance shall retain the
original for records irrespective of the approved / reject status of
the deviation report, and a photocopy of the same shall be filed
with the subjected batch processing / packing record or analytical
reports.

9. – 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.
– QA designated representative shall maintain summary of
Deviations, Department wise, every year in a logbook.
– Deviation log fill as per format.
– Deviation control numbering system as per SOP.
Rules and Regulations

10. • Originating Department
• When deviation occurs prepare the report
• QA Designated Representative
• Assess type of deviation
• Allot the Deviation Control Number and forward to concerned department head
• Concerned Department Head
• Comments after evaluation / reason for deviation
• Other Department Head
• Other department heads for corrective action to avoid their justification
• Quality Assurance
• Forwarded to Head QA for
• Comments / conclusions
• Quality Assurance
• After approval one copy to deviation log and one copy along with respective report /
record
• End of Deviation Reporting SOP
• Repeat deviations to be investigated
• Yes
• Remedial action to avoid reoccurrences
• Raise change control to make it part of process / procedure if accepted
Procedure/ Function of Deviation Process

11. Practice The Learning
Share the KNOWLEDGE gained with others to
make them aware of cGMP
The more we share, more we learn.
deepakamoli@gmail.com
THANK YOU