What is the difference between Quality Control (QC) and Quality Assurance (QA)?

Quality control vs quality assurance

 

Quality Control

A technique or collection of procedures known as quality control (QC) is designed to make sure that a service or product is made in accordance with a specified set of quality criteria or that it satisfies the needs of the client or customer.

Importance of quality control

  • The pharmaceutical industry’s quality control department performs crucial duties. To guarantee the consistency, safety, efficacy, and predictability of their final products, drug manufacturers must rigorously test their materials, processes, equipment, procedures, environments, and employees.
  • The primary goal of quality control in the pharmaceutical industry is to test the medications at different stages of production to ensure that they can move on to the next stage and are produced in line with the rules and standards necessary for human use.
  • Testing units to see if they meet the requirements for the finished product is known as quality control. The testing’s goal is to identify any areas in which the production process needs correction. Companies can better satisfy consumer requests for better products with effective quality control.

The type of product or industry heavily influences the quality control practices utilized in a corporation. For instance, quality control in the production of food and drugs entails making sure the product won’t make a customer sick, therefore the business tests samples from the production line for chemicals and microorganisms.

Quality Assurance

When we talk about quality assurance, we mean all the tasks and duties necessary to guarantee that the treatment or drug is both effective and safe for the patient. To determine whether the medication satisfies quality criteria. It is also a technique to stop mistakes and flaws in manufacturing goods.
The pharmaceutical product’s quality is determined by performing or evaluating quality control laboratory tests and observing product performance.

  • Although quality assurance and pharmaceutical quality control have different purposes in the manufacturing and distribution of medicines, both are essential.

The following presumptions apply when using the pharmaceutical product to treat patients:

  • It has been established that active pharmaceutical ingredients (API) are both safe and efficient for this treatment.
    -Prescriber has correctly determined that the patient needs the treatment.
  • Product is of high enough caliber to produce positive results.
  • Patient successfully follows the recommended treatment plan. Patient is aware of how to utilize the product.

Processes for pharmaceutical assurance include:

  • Product Registration
  • Manufacturing, import, and distribution regulations:
  • Good manufacturing practices
  • Assuring qualifications of suppliers
  • Quality of drugs in the distribution system.
  • Regulation of pharmaceutical promotion and information, including post-marketing pharmacovigilance and consumer education.

Why is quality assurance important?

  • Planning and management of product quality compliance as per quality assurance requirements.
  • Conduct a quality control review of the standards and practices for quality assurance.
  • Perform technical modifications to make sure the requirements are met.
  • coordinating with the manufacturing division to make sure that QA is carried out at all times, including during testing, auditing, and reporting.
  • To increase client satisfaction

What do we focus on while doing Quality Assurance?

  • if it is helpful
  • the knowledge about the product
  • the knowledge about the customer(you need to know what the customer wants)
  • productivity

The difference between Quality Control and Quality Assurance

Although the phrases quality control and quality assurance are frequently used similarly, they have distinct meanings. In order to ensure that a part complies with specifications, quality control focuses on quality requirements. Quality assurance is the conclusion of all procedures and actions required to prove that the standards are met.

For quality experts, this difference means that as you advance in your career in quality control, you might switch from quality control to quality assurance. Quality assurance programs and departments ensure that products fulfill all quality criteria and safety standards for higher management, customers, and government inspectors. Quality control is a component of quality assurance.

  • Quality assurance(QA) in pharmaceutical industry is used for ensure that product or service will satisfy requirement for “Quality” and covers all matters related to factors influencing quality of a product.
  • Quality control(QC) is concerned with sampling, specifications, testings, organization, documentation and release procedures which ensures that necessary and relevant tests are actually carried out and that materials are not released for sale, supply until their quality has been judged to be satisfactory.

In simplistic form QC is a part of QA. QC checks if product fulfill its requirement or not and approves it. QA ensures all QC activity are going well by inspection and by checking document. There is a linear relation as:

  • Quality Management(QM) -> Quality Assurance(QA)[Quality risk management(QRM) and Product Quality Review(PQR)] -> Good manufacturing practices(GMP) -> Production and Quality control(QC)

Why is Senieer the best choice?

Senieer offers ONE STOP SOLUTION and is a leading supplier and manufacturer of pharmaceutical equipment globally. Senieer is the ideal international partner for businesses in the pharmaceutical, food, chemical, and cosmetics industries. Senieer has spent over 34 years in China, mostly focusing on solid dosage forms. Integral and reliable process solutions. In accordance with international standards like GMP, cGMP, and US FDA, we manufacture equipment.

Members of the Senieer technical team enhance the one-stop solution services for comprehensive projects, from consulting to design. In order to fix all of your issues, we strictly follow your strategy and requirements.

Please visit our website at www.senieer.com for further details.

 

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