INTRODUCTION:

Supporting the creation of national greenhouse gas inventories that are easily evaluated for completeness and quality is a key objective of IPCC good practice guidelines. To achieve this, it is best practice to apply quality assurance and quality control (QA/QC) methods when creating national greenhouse gas inventories.¹ The updated 1996 IPCC Guidelines for National Greenhouse Gas Inventories (IPCC Guidelines) are in keeping with the best practices established by this advice.

The feasibility, acceptability, cost-effectiveness, prior experience, and potential for global applicability are all reflected in the QA/QC best practice guidelines presented here. A QA/QC program helps achieve the goals of good practice guidelines, which include enhancing national inventories of emissions estimates' completeness, comparability, transparency, consistency, and confidence. Depending on the results of the QA/QC process, inventory or source category uncertainty estimates may need to be reevaluated. For instance, the uncertainty estimates should be reassessed if it turns out that the data quality is worse than anticipated and that this cannot be fixed within the timeframe of the present inventory. The phrases "quality assurance" and "quality control," which are frequently used, are defined as follows:²

DEFINITION OF QA/QC:

A system of regular technical tasks called quality control (QC) is used to monitor and manage the inventory's quality while it is being created. The purpose of the QC system is to:

(i) Provide routine and consistent checks to ensure data integrity, correctness, and completeness;

(ii) Identify and address errors and omissions;

(iii) Document and archive inventory material and record all QC activities.

QC activities include general methods such as accuracy checks on data acquisition and calculations and the use of approved standardised procedures for emission calculations, measurements, estimating uncertainties, archiving information and reporting. Higher tier QC activities include technical reviews of source categories, activity and emission factor data, and methods.

Quality Assurance (QA) A planned set of review procedures carried out by staff members not directly involved in the inventory compilation/development process is one aspect of quality assurance (QA) operations. After the QC procedures are put into place, a finalized inventory should be reviewed, ideally by impartial third parties. Reviews confirm that the goals for data quality were fulfilled, guarantee that the inventory reflects the most accurate estimates of emissions and sinks given the state of science and data at the time, and bolster the efficacy of the QC program.

PRACTICAL CONSIDERATIONS IN DEVELOPING QA/QC SYSTEMS:

Implementing QA/QC processes calls for time, money, and experience. It is anticipated that decisions will need to be made about the following when creating any QA/QC system: resources allotted to quality control for the compilation procedure and several source categories;

· Time allocated to conduct the checks and reviews of emissions estimates;

· Availability and access to information on activity data and emission factors, including data quality;

· Procedures to ensure confidentiality of inventory and source category information, when required;

· Requirements for archiving information;

· Frequency of QA/QC checks on different parts of the inventory;

· The level of QC appropriate for each source category;

· Whether increased effort on QC will result in improved emissions estimates and reduced uncertainties;

· Whether sufficient expertise is available to conduct the checks and reviews.⁴

ELEMENTS OF A QA/QC SYSTEM:

The following are the main factors to take into account while creating a QA/QC system that will be used to track inventory compilation:

· An inventory agency responsible for coordinating QA/QC activities;

· A QA/QC plan;

· General QC procedures.

· Source category-specific QC procedures.

· QA review procedures;

· Reporting, documentation, and archiving procedures.

INVENTORY AGENCY:

The national inventory's QA/QC operations must be coordinated by the inventory agency. Other agencies or organizations may be assigned duties by the inventory agency to carry out and record these QA/QC procedures. The inventory agency is responsible for making sure that other organizations that prepare the inventory are adhering to the relevant QA/QC protocols.

The inventory agency is also in charge of making sure the QA/QC plan is created and carried out. It is best practice for the inventory agency to assign a QA/QC coordinator, who will be in charge of making sure the program's goals are carried out.

QA/QC PLAN:

It is best practice to create a QA/QC plan since it is a basic component of a QA/QC system. In general, the plan should include the QA/QC tasks that will be carried out and provide a timeline that corresponds to the preparation of the inventory from the beginning to the end of reporting in any given year. An overview of the procedures and a timeline for reviewing each source. Category should be included.

An internal document used to plan, organize, and carry out QA/QC operations is the QA/QC plan. Once created, it can be referred to and utilized in later inventory preparation or adjusted as necessary (for example, in response to process modifications or independent reviewers' recommendations). This proposal ought to be open to outside evaluation. The International Organization for Standardization (ISO) has developed standards and recommendations, such as the ISO 9000 series, that may be helpful in creating and carrying out the QA/QC strategy. Despite not being created especially for emissions inventories, several nations have used ISO 9000 standards to assist in planning QA/QC operations.⁵

ISO AS A DATA QUALITY MANAGEMENT SYSTEM:

As a component of a quality management system, the International Organization for Standardization (ISO) series program offers standards for data documentation and audits.⁶ Many of the concepts in the ISO series can be used to guarantee the creation of a high-quality inventory, even though they are not specifically intended for the collection of emissions data. These materials could be a helpful resource for inventory agencies creating QA/QC plans for greenhouse gas inventories. Certain nations, like the Netherlands and the United Kingdom, have already included some IS standards into their data management and inventory development procedures.⁷

The following standards and guidelines published under the ISO series may supplement source.⁸

ISO 9004-1: General quality guidelines to implement a quality system.

ISO 9004-4: Guidelines for implementing continuous quality improvement within the organisation, using tools and techniques based on data collection and analysis.⁹

ISO 10005: Guidance on how to prepare quality plans for the control of specific project

ISO 10011-1: Guidelines for auditing a quality system.

ISO 10011-2: Guidance on the qualification criteria for quality systems auditors.

ISO 10011-3: Guidelines for managing quality system audit programmes.

ISO 10012: Guidelines on calibration systems and statistical controls to ensure Measurements are made with the intended accuracy.

ISO 10013: Guidelines for developing quality manuals to meet specific needs¹⁰.

QA PROCEDURES:

An objective evaluation is necessary as part of good practice for QA procedures in order to evaluate the inventory's quality and pinpoint areas that could use improvement. It is possible to review the inventory in its entirety or in sections. In addition to Tier 1 and Tier 2 QC, QA methods are used. Involving reviewers who can do an objective assessment of the inventory is the goal of QA implementation. Using QA reviewers who were not involved in creating the inventory is best practice.

These reviewers should ideally be impartial specialists from other organizations or a national or international expert or group that is not directly involved with the production of national inventories. Staff members from another division of the inventory agency that is not involved in the area of the inventory under review can also perform QA duties in the event that third-party reviewers from outside the inventory agency are unavailable. Before submitting an inventory, inventory agencies should perform a basic expert peer review (Tier 1 QA) to find any potential issues and, if feasible, make the necessary modifications. Applying this review to every source category in the inventory is also a smart idea. However, due to time and resource restrictions, this will not always be feasible.

Priority should be given to key source categories and source categories that have undergone substantial data or method modifications. Additionally, inventory authorities may decide to carry out more thorough audits, peer reviews, or both as extra (Tier 2) QA processes using the resources at hand.¹¹

QUALITY ASSURANCE REVIEW PROCESS:

A thorough evaluation conducted in compliance with international standards is guaranteed by the QAR procedure. The four typical phases—planning, carrying out, reporting, and follow-up are typically involved.¹²

1) Planning Phase.

Planning

· Understand the OAGN or Audit environment

· Define QAR ○ objective & scope

· Identify key areas for QAR

· Select appropriate audits for QAR Decide

· methodology

· Define roles and responsibilities

· Estimate resources including time

· Prepare QAR plan

2) Conducting Phase:

The QAR plan is used by the review team to direct the evidence collection throughout the second part of the review.

Conducting of QAR

· Conduct entry meeting

· Gather information

· Record and analyse information

· Discuss QAR findings with audit team

3) Reporting Phase:

In the third phase, the review team creates a draft QAR report using the results (preliminary findings and suggestions) from the conducting phase.

Reporting of QAR

· Prepare draft QAR Report

· Conduct exit meeting with

· Finalise QAR Report

4) Follow-up:

In the last stage, the review team evaluates the degree of execution of the QAR recommendations and, if any, the reasons for non-implementation using the action plan created by the audit line functions as inputs.

Follow up QAR

· Management

· implements action Assess

· implementation of action plan

· Prepare follow-up QAR Report¹³

METHODOLOGIES AND TECHNIQUES FOR CONDUCTING QA REPORT:

Techniques and Methodologies for Performing QA Reviews The methods and strategies listed below can be applied to quality assurance.

Review:

1. The purpose of the interview is to get pertinent information from the audit team. In this situation, the quality assurance team might request information from the audit team, listen to and evaluate their answers, follow up with inquiries, and, if necessary, confirm the information. Information from the audited entity can also be obtained through the interview technique.

2. Observation is watching someone else carry out a process or activity. It offers proof for that moment in time and by them, which is insufficient to make inferences about events that have transpired over time.

3. Reading records or documents, whether electronically or visually, is known as documentation review. Correspondences, memoranda, minutes, reports, and so on are examples of records or documentation.

4. Walking through or repeating operational steps is known as re-performance. For instance, the auditor may duplicate efficiency measurement methods in order to verify the precision of efficiency metrics. The auditor can use replication to verify that the system or a portion of it functions as stated.

5. A confirmation is an answer to an inquiry, usually in writing, that serves to validate facts. It can be applied to confirm that a task was completed in the field.

6. Analysis, whether done electronically or visually, shows the similarities and differences between two or more papers, physical objects, or data. Experts or individuals with understanding of the topics under analysis who can draw logical conclusions and value judgments from the facts gathered should provide analytical evidence. Data or information can be analyzed using a variety of statistical procedures.

7. Focus groups are gatherings of a chosen group of people to talk on particular audit-related issues. Their main purpose is to gather qualitative information and statistics. Information about the execution and effects of government initiatives is gathered through focus group procedures, which are based on the perspectives of stakeholders and recipients.

8. It is possible to arrange seminars and hearings to learn more about specialized fields, talk about issues and observations, and discover potential solutions. Seminar attendees may include specialists, stakeholders, and interested parties.¹⁴

QUALITY ASSURANCE IN REGULATORY AFFAIRS OF PHARMACEUTICAL INDUSTRY:

As the headline states, "a regulatory affair," the first thing that comes to mind when we hear the word "regulatory" is "regulation and laws." This section will address the relationship between quality assurance and the regulatory affairs division and how they collaborate to improve the specific pharmaceutical sector and increase corporate profits. The regulatory side of the pharmaceutical and drug industries is specifically handled by regulatory affairs; therefore, QA documentation is also included in the regulatory aspect to secure approval on any associated regulatory difficulties.

Working closely with the authorities to guarantee that the product is registered in accordance with the regulation guidelines is the overview of the regulatory affairs job scope. An essential component of a regulatory affairs department are dossiers, which are typically used to register manufactured goods abroad. This dossier should include information on all facets of the medications; the Certificate of Analysis (COA) and quality assurance information are the two main components of a drug dossier. For the drug to be registered in that nation, the prepared dossier is forwarded to the relevant authorities. A drug's registration on an export basis in another country will take over two years.

Before the drug dossier is forwarded for registration, a report detailing every aspect of the analysis and assay completed in the QA department is provided.¹⁵

Two Types of Dossiers:

· Common Technical Dossier (CTD)

· Asean Common Technical Dossier (ACTD)

Drugs in nations outside of Asean are registered using the CTD, which is the standard format. Since every authority is more concerned with the quality of the medicine, QA documentation is crucial in CTD. When the drug is of excellent quality, there is a greater possibility that it will be registered in the specific nation.¹⁶ These directly contribute significantly to the industry's revenue. The ACTD is a standard format for drug dossiers that are used to register drugs in Asean countries. Based on this format, QA documentation is a crucial component that is needed; if the drug is of very high quality, it has a high chance of being registered in Asean countries. Furthermore, the corporation benefits and makes a substantial profit from having medications registered in multiple nations. This demonstrates unequivocally how quality assurance affects medications that are set to be registered in different nations and how it affects the specific pharmaceutical industry's earnings. If a medication is registered in a certain nation and changes need to be made to it, the national authorities should be notified and we must get their approval. This has provided a clear explanation of how regulatory affairs and quality assurance are related.¹⁷

CONCLUSION:

As a summary of the entire conversation, it is evident that quality assurance is connected to every department in the pharmaceutical sector in some way and is crucial to improving the operations of each department. As the title states, quality assurance is essential and is regarded as the foundation of the pharmaceutical sector. Quality Assurance places a strong emphasis on client happiness and follows the rules established by the government. The thalidomide episode, which occurred a long time ago, demonstrates a glaring breakdown in quality control at the clinical trial stage that resulted in such a major catastrophe that induced teratogenicity (Phocomelia). The medication was initially created to treat pregnant women's morning sickness. A negative past has resulted from improper analysis and quality control, which amply demonstrates the critical function that quality assurance plays in the manufacturing of pharmaceuticals. Quality assurance is applied or prioritized in all production industries that are connected to all senses, not just the pharmaceutical sector. Since customers are the primary source of profit and revenue for every sector, it was stated that QA operates on their satisfaction. In the event that the product lacks attributes, the industry will suffer greatly.¹⁸ Every aspect of an industry that is interconnected has a function for quality assurance (QA), which can create numerous departments "under their umbrella" to raise the standard of quality and its efficacy using all means necessary.

REFERENCES:

1. Intergovernmental Panel on Climate Change (IPCC) (1997). Revised 1996 IPCC Guidelines for National Greenhouse Gas Inventories: Volumes 1, 2 and 3. J.T. Houghton et al., IPCC/OECD/IEA, Paris, France.

2. Handbook of International Auditing, Assurance, and Ethics Pronouncements, International Federation of Accountants, March 2008

3. Rodionova, O. Y., Sokovikov, Y. V., Pomerantsev, A. L. Quality control of packed raw materials in pharmaceutical industry. analytica chimica acta, 2009; 642(1): 222-227.

4. Quality Assurance in Financial Auditing, A Handbook, IDI-ASOSAI, 2009

5. Handbook on Quality Assurance in Performance Auditing, IDI-ASOSAI, 2011

6. International Organization for Standardization (ISO) (1994). Air Quality, Determination of Performance Characteristics of Measurement Methods. ISO 9196:1994. ISO, Geneva, Switzerland

7. Quality Assurance Handbook, IDI-AFROSAI-E, 2007

8. Feigenbaum, Armand V (1956). "Total Quality Control"; Harvard Business Review. 34(6):93–101.

9. https://www.firsttimequality.com/Blog/bid/235096-Essential-Elements-of-a-Construction-Quality-QA-QC-Plan-Framework#:text=An%20executive%20overview%20G%20your%20QA%20company%20does%20to%20manage%20quality&text=The%20HOW%20details%20should%20be%20included%20in%20your%20policies%20and%20procedures%20document

10. EN ISO 9001: 2000 “Quality Management Systems – Requirements”, published December 2000

11. Ezzelle, J., Rodriguez-Chavez, I. R., Darden, J. M., Stirewalt, M., Kunwar, N., Hitchcock, R., D'souza M. P. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. Journal of pharmaceutical and biomedical analysis, 2008; 46(1): 18-29.

12. Bakshi, M., Singh, S. Development of validated stability-indicating assay methods critical review. Journal of pharmaceutical and biomedical analysis, 2002; 28(6): 1011- 1040

13. https://www.browserstack.com/guide/setup-qa-process.

14. Cockburn, I. M. The changing structure of the pharmaceutical industry. Health Affairs, 2004; 23(1): 10-22

15. Carpenter, D. P. The political economy of FDA drug review: processing, politics, and lessons for policy. Health Affairs, 2004; 23(1): 52-63

16. Kayser, O., Warzecha, H. Pharmaceutical biotechnology: drug discovery and clinical applications. John Wiley & Sons 2012.

17. Lund, W. The pharmaceutical codex: principles and practice of pharmaceutics (No. Ed. 12). Royal Pharmaceutical Society of Great Britain 1994.

18. Henderson, R., Orsenigo, L., Pisano, G. P. The pharmaceutical industry and the revolution in molecular biology: interactions among scientific, institutional, and organizational change. Sources of Industrial Leadership: Studies of Seven Industries, 1999; 267-311

Received on 27.06.2025 Revised on 02.08.2025

Accepted on 01.09.2025 Published on 15.10.2025

Available online from October 30, 2025

Research J. Science and Tech. 2025; 17(4):319-324.

DOI: 10.52711/2349-2988.2025.00044

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