Document No.

QA-SOP-41
Revision No “1”
UDL Pharmaceuticals Issue Date: 01.12.2016
Revision Date: 01.12.2018
(A Division of First UDL Modaraba)
Standard Operating Procedures Quality Assurance Department
Subject / Title
PAGE 01 of 02
INTERNAL AUDIT AND MANAGEMENT REVIEW
Prepared By: Reviewed By: Approved By:

Q. A. MANAGER Q.C. MANAGER G.M. PLANT

1. PURPOSE

1.1. This procedure defines the process and methods for conducting internal quality
management system (QMS) audits.
1.2. This procedure defines the process and methods for conducting both formal and informal
management reviews of the quality management system.
2. SCOPE

2.1. This procedure applies to all activities at UDL Pharmaceuticals. It responds to and
complies with the UDL Quality Manual.

3. TERMS AND DEFINITIONS

 Audit – systematic and formal comparison of documentation and practice against

requirements, performed for the purpose of finding areas of nonconformity or
opportunities for improvement.
 Evidence – data or examples which can be proven true and verified for the purposes
of proving an audit finding.
 Finding – any summary of audit evidence; findings may be positive (reports of
compliance) or negative (reports of nonconformity)
 Nonconformity / noncompliance – any instance where practice or evidence does not
comply with requirements.

4. RESPONSIBILITIES

4.1. The GM Plant is responsible for implementation and management of this procedure.
4.2. Top management is responsible for attending formal management review meetings.

5. PROCEDURE: CONDUCTING INTERNAL QMS AUDITS

5.1. Internal quality audits are conducted to ensure ongoing compliance with requirements of
the QMS standards, company’s policies and procedures. This is accomplished by auditing
against all important processes and areas, and by applying all applicable sections of the
standard. Audit requirements include those of ISO 9001, the company’s quality system
documentation, as well as requirements of customers or regulatory authorities, as
applicable.
 Document No. QA-SOP-41
Revision No “1”
UDL Pharmaceuticals Issue Date: 01.12.2016
Revision Date: 01.12.2018
(A Division of First UDL Modaraba)
Standard Operating Procedures Quality Assurance Department
Subject / Title
PAGE 01 of 02
INTERNAL AUDIT AND MANAGEMENT REVIEW
Prepared By: Reviewed By: Approved By:

Q. A. MANAGER Q.C. MANAGER G.M. PLANT

5.2. Audits are conducted by process, and each process must be audited at least once
annually. MR adjusts the frequency of audits based on the status and importance of an
activity, as well as the results of previous audits
5.3. An auditor may audit any clause of the applicable standard, and writing findings against
them, depending on how the audit unfolds.
5.4. Additional processes of other activities or facilities, outside of the process model, may
also be scheduled. For example, this may include safety audits, configuration
management audits, etc. In such cases, unique audit forms may be developed for such
non-process related audits.
5.5. The GM Plant or MR plans audits according to need, management decision, or customer
requirements, and assigns a Lead Auditor for each, as well as any supporting auditor
team members. Scheduling is recorded in the Internal Audit Schedule portion of the
Internal Audit Log.
5.6. Auditors are independent of the area being audited; UDL Pharma may therefore use
approved third-party contract auditors for its internal audit program; the requirements for
third party auditors are defined in the Quality System Manual. Employees selected as
internal auditors will have attended at a minimum a 4 hour internal auditor training
program or at least 8 hours of shadow auditing with a previously qualified internal auditor,
or third party auditor.
5.7. Auditor will use Audit Report for the relevant clause / element that are applicable in the
relevant activities or departments.
5.8. While conducting an Audit, the Auditors seek objective evidence, demonstrating whether
the audited activities comply with the requirements of the documented QMS Procedures
and ISO 9001 requirements. When non-compliance is noted it is brought to the attention
of concerned Auditee / Department head through CAR form. Before the end of an Audit,
each non-compliance noted during the audit is documented on the corrective action
request (CAR). Efforts should be made by the auditors to combine related CAR’s
wherever possible so number of CAR’s raised during an audit can be minimized. Auditors
fill out the top part of CAR describing the noted non-compliance, and hand over the form
to the concerned Department Representative for acknowledgment, who identifies the
proposed corrective action, root cause and action taken to prevent recurrence then
agrees to a time schedule with the auditor to undertake this action. At the end of the audit,
the auditor presents the non-conformities and observations made during the audit.
5.9. The Auditor prepares and sends the Audit Report to M.R. for review.
5.10. Auditing shall be performed by obtaining objective evidence to support each requirement,
or indicate where nonconformances are found. All findings are recorded on the Internal
 Document No. QA-SOP-41
Revision No “1”
UDL Pharmaceuticals Issue Date: 01.12.2016
Revision Date: 01.12.2018
(A Division of First UDL Modaraba)
Standard Operating Procedures Quality Assurance Department
Subject / Title
PAGE 01 of 02
INTERNAL AUDIT AND MANAGEMENT REVIEW
Prepared By: Reviewed By: Approved By:

Q. A. MANAGER Q.C. MANAGER G.M. PLANT

Audit Report. The internal auditor submits CARs as necessary to address the
nonconformances recorded on the report.
5.11. Once CARs are filed, the responsible managers or parties shall ensure timely corrective
action is taken to remedy any nonconformances found. During the CARs effectiveness
review, the results of actions taken to address audit findings are evaluated.
5.12. Prior the due date for implementation of the corrective action, auditor in consultation with
M.R must determine if the corrective action has been implemented and it is effective.
When there is objective evidence that the corrective action is effective, the CAR is closed
out. If more work is needed to fully implement the action, a new follow up date is agreed
on the CAR form.
5.13. The M.R Supervisor shall update the audit schedule within the Internal Audit Log to reflect
to closure of the audit, and enter a summary of audit findings. Based on the results of the
audits, and previous audits, the M.R will then schedule the next audit of the particular
process. Processes for which internal audits discover a high number of findings, or critical
findings of any number, should be audited more frequently until the process is proven
effective again.
5.14. The completed Internal Audit Report is then sent to the appropriate managers of the
areas audited, in order to report the findings and results. In this way, and in conjunction
with the submission of CARs, all necessary managers are notified of the audit results and
may make informed decisions for their departments based on those results.
5.15. The results of internal audits are also gathered and summarized on the Audit Trend
Analysis, generated by the Internal Audit Log, for review by top management during
management review.
5.16. In all cases, auditees are expected to cooperate fully with the audit team.

6. PROCEDURE: CONDUCTING MANAGEMENT REVIEWS

6.1. Top Management reviews the suitability, adequacy and effectiveness of the Quality
Management System through two primary methods: a formal “Management Review
Meeting” held periodically, and ongoing management activities conducted throughout the
rest of the year.
6.2. The formal “Management Review Meeting” is held at a minimum of once per year.
6.3. The attendance for Management Review Meeting shall be the recorded in the meeting
minutes, employees shall attend as needed to meet the requirements of the agenda
indicated below.
 Document No. QA-SOP-41
Revision No “1”
UDL Pharmaceuticals Issue Date: 01.12.2016
Revision Date: 01.12.2018
(A Division of First UDL Modaraba)
Standard Operating Procedures Quality Assurance Department
Subject / Title
PAGE 01 of 02
INTERNAL AUDIT AND MANAGEMENT REVIEW
Prepared By: Reviewed By: Approved By:

Q. A. MANAGER Q.C. MANAGER G.M. PLANT

6.4. If any attendee is absent, draft minutes will be sent to him, for review and so that the
person may amend the minutes with any additional data, notes, opinions or opportunities
for improvement they may wish to add.
6.5. This review shall include assessing opportunities for improvement and the need for
changes to the quality management system, including the quality policy and quality
objectives.
6.6. Minutes of the meetings are taken and maintained. The form Management Review
Meeting Minutes may be used as a template for the records, or may be completed and
filed as the finished record.
6.7. The Management Review Meeting shall include analysis of the following inputs:

 review and updating of the COTO Log, including Issues, Risks and Opportunities
 review and updating of the Strategic Plan
 review and updating of process objectives, metrics and KPIs
 review of customer feedback
 review of the CAR system and related trends
 review of internal and external audit results
 review of the performance of external providers;
 review of the adequacy of resources;
 review of the effectiveness of actions taken to address risks and opportunities;
 review of opportunities for improvement.
 review of the Quality Policy for adequacy and to ensure it remains consistent with
the needs of customers and the industry;
 recommendations for improvement of the quality management system
 follow-up activities from previous Management Reviews
6.8. The Management Review Meeting shall generate Corrective and/or Preventive Action
Requests, or take other recorded action, as a result of review topics in an effort to
improve the management system, products, processes and services, and to address
resource needs.
6.9. This includes any decisions and actions related to the improvement of the effectiveness
of the quality management system and its processes, improvement of product related to
customer requirements, and resource needs.
 Document No. QA-SOP-41
Revision No “1”
UDL Pharmaceuticals Issue Date: 01.12.2016
Revision Date: 01.12.2018
(A Division of First UDL Modaraba)
Standard Operating Procedures Quality Assurance Department
Subject / Title
PAGE 01 of 02
INTERNAL AUDIT AND MANAGEMENT REVIEW
Prepared By: Reviewed By: Approved By:

Q. A. MANAGER Q.C. MANAGER G.M. PLANT

6.10. Additional informal management review activities may also be conducted, and include:
6.10.1. Updating of some objectives data and trending in real time, and making such data
available on the company server for constant review. This includes product
nonconformity data, CAR data, internal audit data, and customer complaints.
6.10.2. Quarterly meetings are held to discuss issues and problems encountered, and to
ensure ongoing compliance with established quality objectives.
6.10.3. Monthly informal meetings between the management team to ensure ongoing
compliance with established quality objectives, as well as to manage daily
processing of orders and manufacturing efficiency.

5 DOCUMENTS & RECORD

Internal Audit Schedule
Internal Audit Report
Corrective Action Request
Internal Audit Log
CAR Log
Management Review Meeting Minutes