Shri Balasaheb Mane Shikshan Prasarak Mandal Ambap’s

ASHOKRAO MANE COLLEGE OF PHARMACY, PETH VADGAON

DEPARTMENT OF QUALITY ASSURANCE

TRANSITIONING TO QUALITY SYSTEM

APPROACH & AUDIT CHECKLIST
SUBJECT NAME: AUDIT AND REGULATORY COMPLIANCE

PREPARED BY: RUTURAJ PRASHANT JADHAV

ROLL NO. 05
FIRST YEAR M. PHARM. (SEM-II)
2023-24

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Transitioning to Quality System
Approach
General Outline:
The existing regulatory audit system of USFDA based on 21 CFR 210 and 211.
This code provides the basis for cGMP requirements for the pharmaceutical industry.
2 Approach namely:
1.Process based approach:
-Involves identifying, understanding and managing interrelated processes as system to achieve an
organizational objectives.
Focuses on improving efficiency and effectiveness by optimizing processes rather than merely
inspecting outputs.

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2.Risk based approach:

-Emphasizes that identifying and managing risks to the quality of products or services.
Assessing potential risks over an entire lifecycle of the product and development.
Implementing QRM processes to control, mitigate or eliminate those risks.

Part A: Management Responsibilities:

Provides leadership.
Structure of the organization
Build a quality system to meet the requirements
Establish policies, objectives, goals and plans
Review the system.

Part B: Resources:

General arrangement
Develop personnel
Facilities and equipment
Central outsourced operations.

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Part C: Manufacturing operations:

Design and develop product and processes

Monitor packaging and labelling processes
Examine inputs
Perform and monitor operations
Address non-conformities.

Part D: Evaluation activities:

Analyze data for trends

Conduct internal audits
Risk assessment
Corrective actions
Preventive actions
Promote improvement.

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 Transition Methodology

Thus it provides nine simple steps to make the transition, using the PDCA approach.
Essential to manage the organization’s transitions from the old to the new requirements.

Step 1: Perform the Gap Analysis:

1. Generalized audit question in the gap analysis might help you to highlight new requirements contained in
QMS/6 systems or where they need to be implemented especially when compared with QMS/6 systems.

2. Status of your existing QMS will be known.

3. Allows you to established an accurate budgets, resources, timelines and expectations which are proportional to
the state of your current management when directly compared to the requirements of new standard.

4. Help you to determine the differences or gaps exists between your existing and new management system.

5. Along with the information provided that how the gaps can be fill-up.

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Step 2: Develop the Implementation Plan:

1. Once you have identified the gaps in the management system and have a committed implementation
committee.
2. Its now possible to develop an implementation plan.
3. It focused on result of gap analysis by prioritizing the correction of non-compliance activities.
4. It must be supported by top level management.
5. Implementation planning is about controlling the development process.
6. Organization must take place all the related activities under controlled conditions.
7. Transfer the requirements of existing cGMP guidelines into the new QMS.
8. So a good plan is the key to successful business.
9. While implantation, implementation team must meet the deadlines and take action accordingly.
10. Also they should watch the timelines and milestone while coordinating and implementing of the plan.

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Step 3: Implement Key Requirements:

1. Identify the system that could comprise your whole system, generally two main types like; key processes and
support processes.
2. Key processes are the steps through which you can satisfy the customers need, want and demands.
3. Whereas, support processes are those steps that can provide help or support to key processes to achieve it.
4. Support processes include; Human resources, training and facility maintenance.
5. Upon completion of defined of processes and interfaces, go back to the standard and determine which
processes are responsible for meeting the requirements.
6. while defining your organization think about each processes and departments.
7. The simplest forms are best. Such as by using the clear sticky notes flowcharts and process maps.

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Step 4: Provide Awareness Training:

1. Given to all employees about the new QMS/6 system of the QMS and how it affect their work.
2. Employee should made aware about it’s policies and objectives.
3. After training employee should able to implement ideas and knowledge and can give output accordingly.
4. Employees should know:

I. Types of documented information that applies to their work.

II. Which forms to use? how to complete? And process them?
III. Must know the company’s policies and objectives.
IV. How to report non-conformities and issues for CA.
V. Understand the risk and opportunities that affect their work.

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Step 5: Begin System Auditing:

1. During the implementation plan you should carry out one or two system audits that covering all the
requirements of QMS.
2. Prepare the narrative for each section of the internal audit report and make copy & paste of the trend tables
and charts.
3. Ensure that audit report is approved and submitted to the top management level for review and action.

Step 6: Review Findings:

1. While reviewing of the audit reports top management must ensure the following points:
2. Corrective Action taken on any adverse event and whether it resolved or not.
3. Made required changes to the QMS and document information.
4. New system is likely to generate numerous CAs.
5. QMS will not be ready for auditing until they are been investigated and completed.

After completion of the internal audit top management should review again for the effectiveness of the system
And provide resources for CAs and improvements.

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Step 7: Implement System Changes:

Implement any changes to the QMS processes that might have arisen from the previous step.
& Once the whole system is implemented, conduct a full system internal audit.
Should look for the improvement.

Step 8: Begin Process Auditing:

1. Once the whole QMS process is completed and everyone is following it.
2. Then you should conduct an audit of each key area.
3. By selecting a key area and identifying the inputs needed by the process and outputs that’re generated by the process.
4. Audit checklist of each area is divided into 2 sections namely;
1st section deals with general questions that supports the functioning of the key area.
2nd section deals with question whose answers will get revealed.

Additionally, you can add another questions that relates how well the area satisfies auditor requirements.
Is the process planned?
How are changes controlled?
Are the CAs being used adequately in this process.

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Step 9: Continual Improvement:

1. QMS requires organization to continually improve the effectiveness of the QMS and it’s processes.
2. Most auditors would expect from you to revise the quality system documentation and processes when QS
matures or when newly implemented.
3. The aim is to increase the needs of satisfying customers by identifying areas that need to be improve.
4. Continuously, improve the degree to which your products and services to meet the customer requirements and
to measure effectiveness of the processes.

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The PDCA cycle is a perfect way of introducing a continual improvement to your organization’s activities.

1. PLAN

1. Establish a timetable for internal audits and management reviews.

2. Establish the objectives and processes necessary to deliver the results in accordance with customer requirements
and organization’s policies.
3. Find out what is going wrong? (customer complaints, internal audit complaints, rework, etc.)
4. And solved this issues by various ideas.

2. DO

Implement changes designed to solve the problems on a small scale first to see the effect.
And ensure whether the changes have worked or not?

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3. CHECK

Monitor and measure product and processes against policies, objectives and requirements and report the results.
Also, check the key activities to ensure that the quality of the output is conforming and not influenced by changes.

4. ACT

Take actions to continually improve the process performance.

Implement changes on a larger scale if it has been succeed on the pilot scale.

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AUDIT CHECKLIST

1. Comprehensive tool used by auditors to ensure compliance with regulatory standards, quality control
measures and best practices.
2. It typically contain sections covering all areas in the pharmaceutical industry such as, facility cleanliness,
equipment maintenance, documentation accuracy, employee training records, adherence to GMPs and storage
and handling of raw materials and finished products and compliance with regulatory requirements such as FDA
requirements.
3. The checklist serve as a guide for auditors to systematically evaluate the various aspects of pharmaceutical
operations and identify areas for improvement or corrective action.
4. It’s essential tool for maintaining the quality safety and regulatory compliance of the product in
pharmaceutical manufacturing process.

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Benefits of Audits

1. Keeps the audit clear.

2. It shows the professionalism of the auditor, by providing evidence of planning.
3. Helps the auditor to maintain audit pace and continuity .
4. To reduce auditors bias.
5. Reduce work-load during auditing.
6. Auditor does not need to think about what to do next? And where?
7. Ensures the compliance of pharmaceutical operations with the regulatory requirements.
8. Identifying and mitigating risks associated with the manufacturing operation.
9. Provide a documented record of audits, facilitating accountability and traceability.
10. Also serve as a reference for future audits.
11. Contribute to continuous improvement.
12. Serve as educational tool for employees. Help them to understand the regulatory requirements that need to be
implement for carrying out the manufacturing operations in the pharmaceutical industry.

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Thank You!!!
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