Stringent global pharmaceutical regulations on quality ensure that all manufacturers and distributors in the pharmaceutical circuit maintain high quality of medicinal products. Every organization has a quality manual of its own that outlines the responsibility of each personnel in upholding quality at each step of the product lifecycle. Such a system not only encourages the importance of quality consciousness but also helps in judicious use of resources and improvisation of techniques that lead to increased production of good quality drug products.
In the pharmaceutical industry, quality control (QC) and quality assurance (QA) are crucial systems implemented through the life cycle of a pharmaceutical product. Many countries have developed their QC and QA systems in accordance to the ICH Q10 guidelines and regional GMP requirements to harmonize the processes involved in developing and manufacturing medicine. Moreover, an efficient pharmaceutical quality system supports public health by allowing global access to safe and effective drugs.1,2
QC involves operations that aid in the production of safe, pure and therapeutically active pharmaceutical products, in line with GMP guidelines.1 As per the USFDA 21 CFR 211, a quality control department is involved in the approval or rejection of any process or procedure that compromises the quality, purity, identity or strength of the final product.3 During USFDA inspection of a facility, the inspector looks at the efficiency of quality control mechanisms at each stage:, i.e., material procurement area, equipment area, production department, laboratories, as well as at the packaging, labeling, and distribution departments.4
Examples of processes that come under the purview of QC are5:
- Testing of materials and end products
- Stability studies of materials and products
- Evaluation of samples that have not met quality standards
- Recording of CAPA
QA is a pharmaceutical quality system that validates and reinforces the quality, safety, and efficacy of the finished product. It also involves the review, approval, maintenance and auditing of all records that are related to the lifecycle of a product.6 A good QA system within the organization not only serves as an effective management tool but also generates confidence about the product quality in the supplier and distributor chain.7 Some functions that are classified as QA systems are5:
- Approval and procurement of raw materials
- Recording of all data per cGMP guidelines
- Equipment handling and calibration
- Fresher, on-the-job, and refresher trainings
- Validation and stability activities
- Proper documentation including recording of complaints
- CAPA measures
- Preparation of quality reports for products and processes
- Mock audits
Quality control versus Quality Assurance5,8
- Although QC and QA are interrelated and focus on quality management, QC focuses on identifying a defect in a product while quality assurance is oriented towards prevention of a defect.
- QC involves correction action while QA is a managerial tool.
- QC makes use of processes that verify the quality while QA necessitates review and approval processes that manage the quality of the final product.
Quality as a Unit
The FDA defines a compliant quality unit to encompass both QC and QA. The pharmaceutical QA document guide by the FDA cites the need for a company to be cGMP compliant while incorporating modern practice into every day pharmaceutical operations and processes.9 Some of the duties listed are:9
- Abidance to all procedures and processes by organization and subcontractors
- Timely inspection, approval, and rejection of all materials and products
- Satisfactory QC completion and maintenance of operations in the manufacturing unit
- Review of documents for unexplained inconsistencies during and after production
- Appointing separate individuals for production and quality functions as much as possible
The pharmaceutical quality system of European Medicines Agency (EMA) comprises of eight quality checks that work together to produce high quality products to meet their customers’ expectations. The strategic eight quality systems are development of SOPs, training, compliance to GMP and GDP, design of a quality risk management system, appointing of qualified personnel, , inspection readiness, and auditing.10
Continual improvement in quality
A successful quality culture lies in the pharmaceutical industry’s ability to continuously learn and implement changes to its quality framework. Any changes made to the quality system should be backed by scientific knowledge, risk assessment, identification and remediation of process weakness along with robust and updated processes to generate products of unparalleled quality.4
Another evolving concept of quality control is total quality management (TQM). TQM is an integrated quality system chain with a multidimensional approach where the focus is on the customer and employee satisfaction. A key element of TQM is continuous improvement to reduce waste and to bring in an integrated working culture to enhance employee engagement at every stage of production.11,12
Pharmaceutical Quality Systems are important tools that allow for consistent delivery of quality pharmaceutical products thereby assuring the public of the safety of a drug. However, it is equally necessary for these quality systems to be involved in continual improvement to address any gaps in pharmaceutical innovation and development.
- Pharmaceutical Quality System, Q10. ICH Harmonised Tripartite Guidelines. June 2008, https://database.ich.org/sites/default/files/Q10_Guideline.pdf
- Levi L, Walker GC, and Pugsley LI. Quality Control of Pharmaceuticals. The Canadian Medical Association Journal. 1964;91(15);781-785.
- 21 Code of Federal Regulations parts 210 and 211. Part 210 – current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general part 211 – current good manufacturing practice for finished pharmaceuticals. Center for Drug Evaluation and Research (CDER). U.S. Food and Drug Administration. http://academy.gmp-compliance.org/guidemgr/files/1-1-1.PDF. Accessed on April 5, 2020
- Friedman R. Pharmaceutical Quality Systems: US Perspective. Pharmaceutical Quality System (ICH Q10) Congres. CDER. U.S. Food and Drug Administration. 2011. https://www.fda.gov/media/82570/download Accessed on April 5, 2020
- Sahoo PK. Quality Assurance and Qualit Control. In Pharmaceutical & Healthcare industries. https://www.assocham.org/upload/event/recent/event_1197/Session_1_QA-and-QC-in-Pharma-Mr-Pradipta-Sahoo-Cipla.pdf Accessed on April 5, 2020
- Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations. Pharmaceutical CGMP Regulations. 2006. https://www.fda.gov/media/71023/download
- World Health Organization. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Volume2, 2nd updated edition. https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualityAssurancePharmVol2.pdf Accessed on April 5, 2020
- Quality Assurance versus Quality Control. https://www.diffen.com/difference/Quality_Assurance_vs_Quality_Control Accessed on April 5, 2020
- Pharmaceutical Quality Assurance: FDA’s Quality Unit Expectations. The FDA group. 2019. https://www.thefdagroup.com/blog/pharmaceutical-quality-assurance-fda-quality-unit-expectations
- Petropoulu A. Quality Assurance / Pharmaceutical Quality Systems in manufacturing medicinal products. European Pharmaceutical Review. 2018. https://www.europeanpharmaceuticalreview.com/article/78981/quality-assurance-quality-systems-making-medicinal-products/ Accessed on April 5, 2020.
- Mazumder B, Bhattacharya S, and Yadav A. Total Quality Management in Pharmaceuticals: A Review. International Journal of PharmTech. 2011;(3)1:365-375