STANDARD OPERATING Document # Revision No.
Effective Date Next Review On
00
PROCEDURE 01-02-2023 01-02-2025
Copy #
PROCEDURE FOR INTERNAL AUDIT 01
PURPOSE:
The purpose of this procedure is to verify that company’s QMS, GMP, and other regulatory requirements are
compiled and that these are effective.
To evaluate whether a company’s operation remains compliant with GMP
Assist in ensuring quality improvement.
The program should be designed to detect shortcomings in the implementations of QMS, and GMP. Recommend
corrective actions and set a timetable for corrective actions to be completed.
Identify non-conformances.
Ensure documented compliance.
SCOPE:
This procedure applies to all sites related to production, Quality Control and Storage, as well as systems, processes,
and procedures of the company related to production, Quality Control, Quality Assurance and other allied
areas departments and activities.
RESPONSIBILITIES:
CHIEF EXECUTIVE OFFICER:
Chief Executive Officer of the company will approve and monitor the procedure compliance.
GENERAL MANAGER:
General Manager is responsible to review this procedure.
REVISION FREQUENCY:
This procedure will be revised and issued, when there is a new guideline from CEO, or Regulatory requirement or
change in specification.
ABBREVIATIONS:
SOP Standard Operating procedure
FDA The Food and drugs administration
QCM Quality Control Manager
QA Quality Assurance
PL Policy
QF Quality format
IDC In charge document control
DEFINITIONS
Audit:
The audit is a systematic assessment of systems, processes, procedures, facilities, products, studies, reports, records,
and is data for compliances with policies, standard procedures, guidelines, regulations and regulatory requirements.
Audit may access both in house and external activities that may be planned or undertaken for a cause basis.
Critical Observations (Major Non-conforming reports (NCR) :
Deficiencies with company standards, and or current regulatory expectations that provide an immediate and
significant risk to product quality, patient safety or data integrity, or a combination/repetition of major deficiencies
that indicate a critical failure of the system.
Immediate corrective action and reporting to management is required.
Minor NCR:
Written by Reviewed by Approved by
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STANDARD OPERATING Document # Revision No. Effective Date Next Review On
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PROCEDURE FOR INTERNAL AUDIT 01
Deficiencies with company standards, and or current regulatory expectations that provide a potentially significant
risk to product quality, patient safety or data integrity, or could potentially result in significant observations from a
regulatory agency or a combination/repetition of other deficiencies that indicate a failure of the system.
Observations:
Observations are of a less serious or isolated nature that is not deemed critical or major, but requires correction, or
suggestions given on how to improve the system or procedures that may be complied with standard, but would
benefit from improvement.
Communication skills of auditors
Tactful
Ability to listen
Reword questions when needed
Use local terminology
Objective
Flexible
Persistent
Curious
Techniques of auditors
The auditee may be stressed
Smile
Relax
Point out good things that you see
Summarize with “Everything looks good here” when you can,
As the auditor, you are creating the audit culture for your organization
Use open ended questions, they provide more information.
Ask
a. What
b. Where
c. Why
d. Who
e. When
Ask for clarification or more information if you do not understand.
Keep people informed of what you are finding.
Point out non-conformances as you go.
Make sure the auditee understands what you see as the nonconformance.
There should not be surprises at the closing meeting when you present your findings.
As an auditor you will:
f. Check documents and records.
g. Ask questions.
h. Observe processes and compare them with documented procedures and work instructions.
i. Investigate any differences.
j. Follow audit trails, be curious.
k. Throughout the audit, take detailed notes on what you find.
Be specific on what is reviewed and what is found.
The information you write down will be used to identify non-conformances and to assist the department in finding
and understanding what you observed.
PROCEDURE:
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STANDARD OPERATING Document # Revision No. Effective Date Next Review On
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PROCEDURE 01-02-2023 01-02-2025
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PROCEDURE FOR INTERNAL AUDIT 01
Audits are planned and scheduled by Lead auditor in consultation with the concerned section/departmental heads,
auditors and general manager, ensuring that all departments are audited after every six months. Additional audits are
scheduled as and when required.
Internal audit steps:
a. Create audit schedule/Plan
b. Hold opening meeting
c. Conduct audit
d. Document Findings
e. Prepare audit report
f. Hold closing meeting
g. Prepare audit file
h. Follow up
Preparing for the Audit:
Check the audit schedule thoroughly.
Gather information about the section/department to be audited.
Prepare checklist, discuss with LA if required.
Make sure you have copies of audit report, nonconformity reports and QM if required.
Conducting the Audit:
Contact the auditee a couple of days before the audit and remind him /her about audit date.
Telephone the auditee before arrival.
Auditor shall conducts a short opening meeting, introduce yourself and describe his job including scope of the
Audit and terms used.
There will be a preliminary tour of the audited area to get a general orientation (to check the flow of material, flow
of staff, to check personnel hygiene, working pattern etc.)
The Auditor shall state which documents he needs to study once he has completed his preliminary tour of the Site.
Items to be checked for audit & self-inspection:
Results of previous audit and any corrective steps taken,
Documentation (Procedures, work instruction and record etc.)
Sanitation & personal hygiene,
Safety of human, machines, material and environment,
Calibration of instruments or measurements systems,
Implementation of critical control points.
Covering all aspects of GMP including:
Personnel
Premises including personnel facilities
Maintenance of buildings and equipment
Storage of starting materials, intermediates and finished products
Equipment
Production and in-process controls
Quality control
Auditor shall also interact with staff that actually carries out the work, to check their training and working
knowledge.
Take notes on the check list.
Obtain confirmation (by Signature) of non-conformities from the auditee’s representative.
Make sure of 100% coverage of check list.
Thanks, the respondents for co-operation and detailed information provided.
Written by Reviewed by Approved by
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STANDARD OPERATING Document # Revision No. Effective Date Next Review On
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PROCEDURE FOR INTERNAL AUDIT 01
Closing the Audit:
Discuss the findings with the auditee including improvement points in the closing meeting.
Confirm corrective actions and implementation dates with the auditee.
Thank the auditee for support and understanding.
Re-confirm audit scope, explain terms used and end with a disclaimer.
D-Reporting the Audit:
Once you complete your audit, you will prepare an audit report and document any non-conformances.
The report will also include:
A. General information
B. Documents reviewed
C. Persons interviewed
D. General summary and assessment of how the system is performing
Prepare audit report, non-conformity reports if any and attach check list.
Get signature on the audit report, report the findings to LA.
Complete entries of non-conformities in the non-conformity report register.
Sign and confirm implementation of corrective action to complete the non-conformity report register.
Get a photocopy of complete set of documents for the auditee and retain original.
In case of no NC’s insert the original in the master file.
Hand over the original copy to LA on the implementation of corrective actions and positive re-audit results.
Monthly Surprise Audit:
Monthly Surprise audits are conducted On the Order of management.
Corrective actions and non-conformities are checked and verified in next audit.
Note: Officers may be inducted as “Observer” in internal audit for training purpose.
CRITICAL
Complaints related to defective / dangerous / potentially life- threatening Pharmaceutical Products that
predictably or probably could result in serious health risk / adverse events or even death (but not limited to) such
as:
i. Wrong product (label and contents are different)
ii. Correct product but wrong strength, with serious medical consequences
iii. Wrong ingredient in a multi-component product
iv. Mix-ups of some products
MAJOR
Complaints that could cause illness or mistreatment, but are not critical, (not limited to) such as:
i. Mislabelling (wrong or missing text or figures)
ii. Missing or incorrect information (leaflets or inserts)
iii. Chemical /physical contamination
iv. Non-compliance with specification
MINOR
Complaint which may not pose a significant hazard to health,
Complaints due to secondary packing materials,
Shortage complaints,
Damage of containers
PROCEDURE:
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STANDARD OPERATING Document # Revision No. Effective Date Next Review On
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PROCEDURE 01-02-2023 01-02-2025
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PROCEDURE FOR INTERNAL AUDIT 01
Product complaint received, serves as an indicator of product quality and potential source of danger or concern
following distribution for sale, therefore, each complaint or inquiry, either oral or written, is to be evaluated as
per this SOP.
All the product complaints are to be promptly forwarded to QA department.
The originator shall provide full details of complaint in prescribed format and send to production department
along with preferably complaint sample.
All complains if received by telephone or verbally must be written with details information including but not
limited to:
i. Name
ii. Address
iii. Date and Time
iv. Sample name, how received, and who prescribed
v. Nature of the issue
vi. Is sample under question deliverable to?
Complaints received from regulatory authorities are to be attended and evaluated as per the directives received
from them. The production department must inform the management within 24 hours.
Upon receipt of complaint at production department, the production manager shall enter the details of
complaint
Complaint No. format should be like: C-YY-SSS
i. C stands for Complaint
ii. YY stands for Year
iii. SSS stands for serial number
Production department shall formalize and investigate any verbal complaint from drug authority / regulatory
authority /actual user.
After logging of complaint, production department shall start the investigation of complaint, check the nature
of the complaint, verify the complaint sample if available or control sample and on the basis of initial
investigation categorize the complaints into ‘Critical’ / ‘Major’ / ‘Minor’.
In case of critical complaints, intimate the distribution department for the stoppage of further sale and
distribution within 24 hours from the receipt of communication.
Communicate to regulatory affairs and client/ customer regarding market complaint based on nature of market
complaint (if required).
Record the observations (i.e. critical/major/minor) in the record for market complaint and start the complete
investigation.
In case of quality related complaint, send the complaint sample, if available, (or sample from control sample)
to state laboratories for analysis. Depending on the nature of complaint the control sample and complaint
sample (if any) is to be analysed for the relevant test parameters. Carry out the analysis of the sample as per
specification by which the product was initially released.
After completion of analysis, state laboratory sends the report of analysis to facility for further investigation.
Production department consults (as per requirement) with research distribution/ production for necessary
investigation at the end and an appropriate action is chosen from the following, depending on the nature of the
complaint:
i. Observation and analysis of complaint sample and packing slip (if any)
ii. Observation and analysis of retained sample of the same batch or other batches of same product
iii. Comparison of results of above
iv. Review of product specification, batch manufacturing record, batch analytical records
v. Facility or equipment problem
vi. Training records of concerned operators’ staff and identify the training needs if any
vii. Trend analysis, stability data, process validation report, product development report; based on the
observations, identify the root cause of the incidence
Review of control sample of ± three batch Nos. from market complaint batch
Take medical opinion (if any) from medical experts with concern Human (if any) as part of investigation.
Prepare an investigation report.
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STANDARD OPERATING Document # Revision No. Effective Date Next Review On
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PROCEDURE FOR INTERNAL AUDIT 01
Mention all the corrective and preventive actions in detail & target date for the completion of the corrective
action in the investigation report. Forward it to the General Manager for approval.
Prepare a reply, based on the complete investigation.
Forward the duly filled complete investigation details to distribution department along with the reply letter
mentioning the corrective and preventive actions taken to avoid future recurrence of the incidence ( In case of
domestic complaint ).
In case of product recall, recall the product as per SOP
Initial response shall be sent to distribution department within 7 days for domestic complaints and 10 days in
case of export complaints.
Distribution department shall forward the reply to the customer with a copy of same to production department.
Feedback from the customer/complainant on the reply is to be taken. Feedbacks (if any) received from the
customers/complainant are to be forwarded to production department for records.
The complaint shall be treated as “Closed” after receiving feedback from the customer.
The time period for receiving feedback from the customer is: Customer feedback from domestic market within
3 weeks
Customer feedback from international market within 4 weeks
If feedback is not received within the stipulated time, the complaint shall be treated as closed.
Review the customer complaint status and customer complaints every quarter to evaluate specific or recurring
problems which require further attention.
Maintain all the records involving market complaints handling till one year after the date of expiry of the
product or one year after the date of complaint received whichever is longer.
AMENDMENT HISTORY
Rev.# Date Nature of Amendment
00 01-02-2023 NEW SOP
DISTRIBUTION LIST:
1. Chief Executive Officer
2. General Manager
3. Production manager
4. For Audit
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