Quality assurance (QA): Introduction, Need, Objectives, Principle, Essential Tools, Quality control, Difference with QC, Relationship of QM, QA, and QC

Quality assurance

(for pharmaceutical products)

Introduction:

• Quality assurance (QA) is a set of activities for ensuring quality in the processes by which products are developed.
• It’s a proactive process and aims to prevent defects by concentrating on the process used to make the product.
• The goal of QA is to improve development and test processes so that defects don’t arise when the product’s being developed.
• QA can be achieved by establishing a good quality management system and assessing its adequacy.
• Everyone on the team involved in developing a product is responsible for quality assurance.
• Quality assurance is a wide concept that covers all aspects that collectively or individually impact the quality of the product.
• The sum of organized arrangements that are made with the aim of ensuring pharmaceutical products are of the required quality as per the intended use.
• Quality assurance is a good practice in the manufacture of pharmaceutical products, as it is the process of vouching for integrity of products to meet the standard for the proposed use.
• It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability.
• Quality is a benchmark of perfection for the end-user.
• In developing products and services, quality assurance is any systematic process of checking to see whether a product or service being developed is meeting specified requirements.
• Many companies have a separate department devoted to quality assurance.
• A quality assurance system is said to increase customer confidence and a company’s credibility, to improve work processes and efficiency, and to enable a company to better compete with others.
• Quality assurance was initially introduced in World War II.
• Today’s quality assurance systems emphasize catching defects before they get into the final product.

Need of QA

• The surge of substandard, fake and adulterated medicine is global threat.
• The pharmaceutical industry saw an increase in regulation after the 1957 thalidomide disaster.

Note: The thalidomide disaster is one of the darkest episodes in pharmaceutical research history. The drug was marketed as a mild sleeping pill safe even for pregnant women. However, it caused thousands of babies worldwide to be born with malformed limbs. The damage was revealed in 1962.

• The stringent, scientific, systematic and sustainable approach to commercial drug production ensures protection of public health.
• The system of specifications as well as practice control measures in the industry, which is also referred to as standard operating procedures (SOPs) that are designed by regulatory authorities and scientific community to ensure good manufacturing practice.

Objectives of Quality Assurance

• Quality assurance exists to serve a number of objectives that include the following:
• To offer a guarantee that the person who is administering medicine is confident that every unit will achieve the desired effect.
• To protect users for products from possible accidental defect in the manufacture, design, storage as well as usage instructions.
• To ensure the law is complied with to the latter.
• To offer protection of the manufacturing organization.

Quality assurance Principle:

• “Quality assurance” is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product.
• It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
• Quality assurance therefore incorporates GMP and other factors, including those outside the scope of this guide such as product design and development.

Fig: Inter-relationship between quality assurance, good manufacturing practice, quality control and in-process control

Essential Tools for QA

• The system of quality assurance appropriate to the manufacture of pharmaceutical products should ensure that:
• pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP);
• production and control operations are clearly specified in a written form and GMP requirements are adopted;
• managerial responsibilities are clearly specified in job descriptions;
• arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
•  all necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out;
•  the finished product is correctly processed and checked, according to the defined procedures;
•  pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products;
• satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical
• products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life;
• there is a procedure for self-inspection and/or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system;
•  deviations are reported, investigated and recorded;
•  there is a system for approving changes that may have an impact on product quality;
• regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.
• The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy.
• The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment of staff in many different departments and at all levels within the company, the company’s suppliers, and the distributors.
• To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control.
• It should be fully documented and its effectiveness monitored.
• All parts of the quality assurance system should be adequately staffed with competent personnel, and should have suitable and sufficient premises, equipment, and facilities

Quality Control: (Defect Identification)

• Quality control (QC) is a set of activities for ensuring quality in products by identifying defects in the actual products produced.
• It’s a reactive process and aims to identify (and correct) defects in finished products.
• QC can be achieved by identifying and eliminating sources of quality problems to ensure customer’s requirements are continually met.
• It involves the inspection aspect of quality management and is typically the responsibility of a specific team tasked with testing products for defects.

Difference between Quality assurance and Quality Control

Relationship between the Quality Management, Quality Assurance, and Quality Control

Fig: Relationship between the Quality Management, QualityAssurance and quality Control

Quality management works on the organizational level to implement an overall quality policy. A quality system refers to the organizational resources, processes, and procedures to implement quality management, which is broader than both quality assurance (QA) and quality control (QC). However, a QA program is the backbone of the quality system. QA provides a management tool within the organization. In contractual settings, QA provides confidence to the customer. QC is a process within the QA program. The process is to collect evidence that the desired level of quality is achieved, and the process itself has no impact on product quality.

References:

• https://en.wikipedia.org/wiki/Quality_assurance
• https://www.guru99.com/all-about-quality-assurance.html
• https://www.diffen.com/difference/Quality_Assurance_vs_Quality_Control