M. Pharm . QA [ Semester -II]
Subject : AUDITS AND REGUKLATORY COMPLIANCE
OBJECTIVES AND GOALS OF AUDITING VENDORS AND
PRODUCTION DEPARTMENT
GODALEEYA DEVANG
M.Pharm. QA , Sem –II
Shree S.K. Patel College of Pharmaceutical Education & Research
Ganpat University
CONTENT
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GENERAL INTRODUCTION
INTRODUCTION OF VENDOR AUDIT
GOALS AND OBJECTIVES OF VENDOR AUDIT
VENDOR AUDIT CHECKLIST
INTRODUCTION OF PRODUCTION DEPARTMENT AUDIT
GOALS AND OBJECTIVES OF PRODUCTION DEPARTMENT AUDIT
PRODUCTION DEPARTMENT AUDIT PROCESS
INTRODUCTION:
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Audit is a systematic and independent examination to determine quality activities and
related results comply with the planned arrangements and whether these arrangements
are implemented effectively and are suitable to achieve objectives.
➢ TYPES OF AUDIT:
TYPES OF AUDIT
INTERNAL AUDIT
OR FIRST PARTY
AUDIT
EXTERNAL AUDIT
SUPPLIER
(VENDOR) AUDIT
OR SECOND
PARTY OR CLIENT
AUDIT
THIRD PARTY
AUDIT OR
REGULATORY
BODIES AUDIT
VENDOR AUDIT:
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Vendor audits are vehicles that are usually used by pharmaceuticals and other companies.
They help in inspection, evaluation of the quality of products, documentation, and
practices. The pharmaceutical industry needs a lot of quality.
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For the pharmaceutical companies, it allows them to assess vendors across a fair and level
playing field. As well, they have assurance their products and information are being handled
responsibly and all liability and risk are minimized.
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For a vendor, it allows them to improve efficiencies and their internal processes and
protocols. It also allows them to show other pharmaceutical companies or suppliers they
can with in strict standards and adhere to them.
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In pharmaceutical industry vendor audit is performed for Raw material vendor, Packaging
material vendor, Labelling material, Software and IT material vendor, Contract
manufacture, Contract research organization.
GOALS AND OBJECTIVES OF VENDOR AUDIT:
➢ In order to Reduce cost
➢ To improve the vendor manufacturing process
➢ To gain insight in to supplier processes and Risk reduction or elimination.
➢ It allows for vendors and buyers to quickly establish relationships that will not only increase
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product quality, but reduce duplicated testing efforts, and start a new and constructive
communication between buyer and vendor.
Help management to achieve goals
According to GMP/cGMP it is company sole responsibility to ensure that the supplier’s
manufacturing processes, analytical tests and examinations are carried reliably by the
supplier and are in compliance with applicable standards and regulations.
It will provide your company a means to verify that vendors meet the applicable FDA laws
and regulations, while reducing liability and effort on your part.
The goal of any vendor audit is to assess quality management of entire organization,
through its procedure and processes.
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The main areas that need to be appraised in a vendor audit are vendor viability,
management responsibility, system accuracy, and data integrity.
A Vendor audit is very crucial in CMO and CROs.
Vendor Audit in Pharmaceutical
➢ ISO CERTIFICATION 9001
➢ USFDA 21 CFR PART 820
➢ DOCUMENTED QUALITY POLICY
➢ PACKAGING AND LABELLING STANDARDS
According to (Title 21 CFR 312.52) , CROs should expect sponsors’ oversight and should be
prepared to perform vendor oversight for responsibilities the CRO contracts to others.
The frequency of audit depends on how important is that vendor and his products for
company's business. Based on that, one can decide on the kind and times an audit should
be done.
Generally Vendor evaluation should be done once in a year.
➢ In Vendor audit, the vendor's location, the products and his manufacturing unit should be
audited and checked well.
➢ Most audits are conducted on-site by a team each member has a specific expertise. An
audit is performed by a representative of Purchase department and QA department. On site
activities are scheduled so the appropriate vendor resources are on site to ensure overall
process is expeditious and follows all protocols.
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VENDOR AUDIT PROCESS:
❑ Initiation
❑ Pre audit and audit planning
❑ Preparation of audit
❑ Audit Execution
❑ Generation of Audit report and CAPA Plan
❑ Audit Response
❑ Audit Closing
❑ Metrics and Tracking
VENDOR AUDIT CHECKLIST:
➢ 1.0 General Observation
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1.1
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• 1.5
• 1.6
➢ 2.
• 2.1
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• 2.3
• 2.4
Building maintenance
Reception
Administrative Block/Office
Utility block
Maintenance facility
Surroundings
Personnel:
Organizational structure
Qualification and experience of technical staff
Provision for pre-employment
Periodical medial check-up
-For staff:
-For operators:
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2.5 Factory cloths
-For staff:
-For operators:
2.6 Personnel Hygiene
- Shower / Wash Basins
- Toilet
- Lockers
- Canteen
3.0 Plant & Building
3.1 Well equipped and sufficient area for stores :
-Raw material -Packaging material -Intermediate -Finished goods -Cleaning / Schedule
-Cleaning of used equipment and accessories
3.2 Equipment
➢ 3.4 Measuring and indicating devices
-Well Maintained
-Condition
-Identification
-Calibration procedure
-Cleaning requirement
➢ 3.5 Special procedure / precaution
3.3 Housekeeping & sanitation
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4.0
4.1
4.2
4.3
4.4
4.5
4.6
5.0
5.1
5.2
5.3
5.4
5.5
6.0
6.1
6.2
6.3
Manufacturing Control
Identification level for material under processing
Written manufacturing procedure
Deviation control procedure
Mean of communication
Status label for rejected released material
Used container control
Record Keeping
Material issue control
Equipment log
Process record
Accountability
In-process results
Raw-material Control
Raw material receipt control
Approved material segregation
Rejected material control
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7.0
7.1
7.2
7.3
7.4
Quality Control
Raw material specification / test procedure and its control
Calibration record
Finished product analysis and release control.
Testing facilities
➢ 8.0 Information Related to other Product Manufactured
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8.1
• 8.2
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➢ 9.0
• 9.1
List of product manufactured (attach sheet)
Product change over control
Control over equipment in common use
Others
Filing system
PRODUCTION DEPARTMENT AUDIT:
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Production process is defined as a process of making and fabricating by converting the raw
material (input) to finished good (output). The Production Department audit can be defined
as an activity to evaluate the process of making and fabricating for its effectiveness and
efficiency. It also includes an assessment of a product being produced.
It includes Process and Product Audit.
An audit is performed by necessary expertise to identify problems and determine
corrective actions needed. Head of QA Department, Head of Production department. It can
be Internal or Third party audit.
Product audits examine the services and products that a company offers to ensure they’re
compliant with performance standards as well as customer, government, and company
quality standards.
Process audits ensure that all company processes are performing efficiently within their
established limits. This type of audit will check operation time and responsiveness as well as
the effectiveness of each procedure and process specifications.
1st Party
Audit
3rd
Party
Audit
Production
2nd
Party
Audits
Audit
GOALS AND OBJECTIVES OF PRODUCTION DEPARTMENT AUDIT:
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To Ensure that procedures are running according to expectations and practices.
It will allow to implement corrective action should there be any issue found.
To uncover how consistent process is and what can be done to improve workflows.
To assure consistency, effectiveness and efficiency of the process.
To ensure quality of product.
To Determine necessary countermeasures for preventing recurrence.
To ensure a complete inspection of final product before delivery to a customers.
To ensure that Finished product Tests are carried out or not and Test Results are
under acceptance criteria or not.
To check the reasons behind OOS and OOT.
AUDIT PROCESS:
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• Audit Planning & Preparation
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• Audit Execution
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• Audit Reporting
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• Audit Follow Up Action & Closure
REFERENCES:
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AUDIT AND REGULATORY BCOMPLIANCE By Dr . Prem Goel, Pg No: 3.1 to 3.33
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https://www.pharmaguideline.com/2017/02/vendor-audits-checklistpharmaceuticals.html?m=1
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https://www.gmpsop.com