Quality Assurance (QA) is a framework that ensures product and service quality through a systematic approach. Pharmaceutical QA is the systematic approach that ensures quality throughout the entire lifecycle of the pharmaceutical product, including development, manufacturing, and post-market.
QA encompasses processes and procedures for maintaining consistent quality across all product or service lifecycles.
Different approaches to QA can be utilized simultaneously to ensure quality. These approaches include product development QA, manufacturing QA, supplier QA, and distribution QA.
To systematically conduct QA activities, pharmaceutical companies implement what is commonly known as a quality assurance system. A pharmaceutical QA system is a system to help ensure that a product or service consistently meets internal quality specifications and customer and regulatory requirements.
Pharmaceutical QA is an integral part of the Quality Management System (QMS), with its processes aligning directly with those of the QMS. The main processes of a pharmaceutical QA system include document control and records management, change control, training management, audit management, and others.
Knowing the difference between QA and Quality Control (QC) is important, as they represent different aspects of ensuring and maintaining product or service quality. The primary difference between QA and QC in the pharmaceutical industry lies in their focus. QA ensures quality, while QC controls and tests the quality of the product or service.
Quality management software streamlines and automates the processes of a pharmaceutical QA system.
SimplerQMS provides QMS software solutions tailored to life science companies, including those in the pharmaceutical industry. Book a personalized demo to see for yourself how SimplerQMS can streamline your QA system processes.
What Is Quality Assurance (QA) in the Pharmaceutical Industry?
Quality Assurance (QA) in the pharmaceutical industry is a framework supported by systematic approaches designed to ensure pharmaceutical products and services quality. QA encompasses a range of activities and processes to ensure that the final products are of uniform and high quality, safe, and effective.
The primary goal of quality assurance is to ensure quality. Pharmaceutical QA helps ensure products and services consistently comply with quality specifications and relevant requirements. Pharmaceutical QA also helps prevent issues in the product or service lifecycle and ensures that each product batch meets predetermined specifications and requirements.
An important part of pharmaceutical QA is the quality assurance plan. The quality assurance plan outlines the specific procedures, applicable requirements, and personnel required to achieve quality objectives. The QA plan ensures that all QA activities are systematically implemented and that any deviation is promptly addressed. With a well-defined QA plan, pharmaceutical companies ensure consistent quality across all lifecycle stages.
Some pharmaceutical QA systems implement Good Manufacturing Practices (GMP) to control processes, such as development, manufacturing, testing, and more.
Why Is Pharmaceutical Quality Assurance Important?
Pharmaceutical quality assurance is essential as it ensures the quality, safety, effectiveness, and compliance with internal, customer, and regulatory requirements of products and services.
QA in the pharmaceutical industry ensures that each product batch complies with quality specifications and relevant requirements. Pharmaceutical QA helps identify and manage risks across the product lifecycle, minimizing issues and increasing product quality.
Pharmaceutical QA fosters a culture of continuous improvement, encouraging ongoing improvement of processes, procedures, products, and services. These improvements are essential for complying with regulatory requirements, which are requisites for gaining and maintaining access to global markets.
The primary purpose of QA in the pharmaceutical industry is to ensure the production of high-quality, safe, and effective pharmaceutical products and services for patients. Pharmaceutical QA accomplishes its purpose by defining quality standards, implementing procedures, and monitoring relevant Key Performance Indicators (KPIs).
What Are the Approaches to Quality Assurance in the Pharmaceutical Industry?
There are four main approaches to quality assurance in the pharmaceutical industry, as described in more detail below.
- Product Development Quality Assurance: Ensures that pharmaceutical products are developed in compliance with relevant requirements and quality specifications.
- Manufacturing Quality Assurance: Focuses on consistently producing pharmaceutical products that meet predefined quality specifications and requirements.
- Supplier Quality Assurance: Concerns the qualification and control of suppliers to ensure the quality of all materials and services provided by a supplier.
- Distribution Quality Assurance: Ensures that pharmaceutical products are stored, handled, and transported under suitable conditions to maintain their quality and integrity until they reach the consumer.
Product Development Quality Assurance
Product development quality assurance involves ensuring that new pharmaceutical products are developed in compliance with quality specifications and customer and regulatory requirements.
The product development QA helps minimize risks associated with product development, ensuring that new pharmaceutical products and services are safe, effective, and meet the intended therapeutic use.
Some pharmaceutical product development QA activities include the following:
- Developing procedures for product development.
- Reviewing and approving specifications for raw materials and components.
- Conducting internal audits of Research and Development (R&D) activities.
Manufacturing Quality Assurance
Manufacturing quality assurance focuses on maintaining consistent product quality during the manufacturing process.
Manufacturing QA helps ensure that pharmaceutical products are manufactured under controlled conditions that comply with relevant requirements. Manufacturing QA aims to produce safe, effective, and high-quality batches.
Manufacturing QA includes activities such as:
- Performing in-process checks.
- Validation of equipment and processes.
- Conducting regular audits of manufacturing facilities to ensure compliance with GMP.
- Performing design review and design qualification to verify the design of the facilities, equipment, or systems is suitable for the intended purpose.
Supplier Quality Assurance
Supplier quality assurance involves evaluating and ensuring the quality of raw materials, components, and services provided by suppliers to pharmaceutical manufacturers.
Supplier QA ensures that materials and services sourced from suppliers comply with required regulations, standards, guidelines, and specifications.
Some activities of supplier QA encompass:
- Conducting supplier audits.
- Establishing contracts with suppliers.
- Performing incoming inspections and testing of raw materials before use in production.
Distribution Quality Assurance
Distribution quality assurance focuses on maintaining the quality and integrity of pharmaceutical products during storage, transportation, and distribution.
Distribution QA prevents product degradation, contamination, or mishandling during distribution.
Distribution QA activities can include:
- Implementing temperature-controlled storage and transportation.
- Monitoring environmental conditions.
- Conducting regular inspections of distribution suppliers.
- Ensuring compliance with Good Distribution Practices (GDP).
- Ensuring compliance with packaging requirements.
What Are the Processes of a Pharmaceutical Quality Assurance System?
A pharmaceutical quality assurance system can encompass, among others, twelve primary processes, as described below.
Pharmaceutical QA processes are part of the pharmaceutical quality management system. The pharmaceutical QMS is a set of processes that ensures consistent production and control of pharmaceutical products in compliance with customer and regulatory requirements.
- Document and Records Management: Control and management of documents to ensure accuracy and compliance with requirements.
- Change Control: Control and management of changes to prevent adverse effects on product quality.
- Training Management: Creating, planning, assigning, and tracking training activities for personnel.
- Out of Specification (OOS) Management: Identification, investigation, and correction of results outside established specifications.
- Equipment Management: Control and maintenance of manufacturing and testing equipment.
- Audit Management: Planning, conducting, and reporting on internal, supplier, customer, and regulatory compliance audits.
- Supplier Management: Evaluation, monitoring, and maintenance of supplier relationships.
- Deviation Management: Documentation, investigation, and resolution of procedure deviations.
- CAPA Management: Identification of issues and implementation of corrective and preventive actions (CAPA).
- Complaint Management: Handling and resolution of complaints regarding product quality.
- Risk Management: Identification, assessment, and mitigation of risks throughout the product lifecycle.
- Batch Records Management: Control and maintenance of batch documentation from manufacturing processes for accuracy and traceability.
Below, we offer detailed explanations of the QA system processes and provide examples presenting how SimplerQMS streamlines each process.
Document Management
Document management involves controlling the creation, review, approval, distribution, and retirement of documents. Document management ensures the documentation accuracy, accessibility, and compliance with relevant requirements.
Document management is essential for maintaining consistent documentation, helping ensure compliance, and providing accurate data throughout the product lifecycle to support quality and safety.
SimplerQMS provides robust document management capabilities that streamline control and records management processes. The eQMS provides pre-defined workflows to guide users through document review and approval tasks. The software offers electronic signatures, time-stamped audit trails, and controlled printing capabilities, ensuring document traceability and accessibility.
Change Control
Change control is the process of managing proposed changes to documents, products, processes, procedures, work instructions, or equipment in a controlled manner. Change control helps prevent unplanned consequences and maintains product quality and safety.
Change control involves evaluating proposed changes, documenting justifications, obtaining approvals, implementing changes, and assessing outcomes.
Change control ensures that modifications are made in a systematic way that minimizes risks to product quality and compliance.
SimplerQMS offers predefined workflows for initiating, reviewing, and approving changes. The QMS change management module creates time-stamped audit trails of changes and notifies relevant employees through notifications and reminders. SimplerQMS simplifies monitoring of change status, updating documentation, and fostering department collaboration.
Training Management
Training management refers to the systematic planning, tracking, and documentation of training activities to ensure personnel are competent in their roles and responsibilities. Training management includes training needs assessment, development of training programs, scheduling of training sessions, evaluation of training effectiveness, and maintenance of training records.
Effective training management ensures that personnel are adequately trained to perform tasks according to established procedures. Training management helps promote consistency, compliance, and continuous improvement in pharmaceutical operations.
The SimplerQMS training management module streamlines the creation, management, and tracking of training plans, competency assessments, and laboratory personnel records. The eQMS monitors training completion statuses, assigns employees to appropriate training groups based on job roles or departments, and provides reminders for upcoming assignments.
Out of Specification (OOS) Management
Out-of-specification (OOS) management involves procedures to investigate and address test results that fall outside established specifications. OOS management includes investigation protocols, root cause analysis, corrective actions, and documentation.
The OOS management goal is to promptly identify and resolve departures from specifications to prevent product quality issues and help ensure compliance.
The SimplerQMS out-of-specification management capabilities facilitate the capture, investigation, and resolution of OOS results. SimplerQMS allows for the direct escalation of OOS results into the CAPA process, reducing human error and ensuring complete data.
Equipment Management
Equipment management is the systematic process that encompasses the purchasing, maintenance, utilization, and disposal of equipment. Equipment management encompasses equipment qualification, maintenance schedules, calibration protocols, and equipment status and performance documentation.
Proper equipment management ensures equipment reliability, accuracy, and consistency in manufacturing processes, contributing to product quality.
SimplerQMS equipment management capabilities streamline calibration and maintenance processes through tools for scheduling, tracking, and documenting activities. The QMS software facilitates identifying quality-critical equipment, setting calibration schedules, and providing notifications for upcoming tasks to prevent oversights. Centralizing equipment records in SimplerQMS simplifies access to historical data, maintenance logs, and compliance documents, ensuring efficient retrieval and review.
Audit Management
Audit management involves planning, conducting, and documenting audits to evaluate compliance with internal, customer, and regulatory requirements. Audit management includes audit planning, audit scheduling, and documenting audit findings.
The purpose of audit management is to verify adherence to procedures, identify areas for improvement, and ensure ongoing compliance with relevant requirements.
The SimplerQMS audit management module streamlines the entire audit process, from planning, scheduling, and execution to documenting and tracking audit findings and actions. SimplerQMS supports all types of audits, such as internal, customer, supplier, and external audits by notified bodies. SimplerQMS provides features for assigning tasks, escalating audit findings to the CAPA process, and securely storing audit records with time-stamped audit trails.
Supplier Management
Supplier management encompasses the evaluation, selection, and monitoring of suppliers to ensure the quality and reliability of raw materials and services. Supplier management involves supplier qualification, performance monitoring, quality agreements, supplier audits, and managing supplier relationships.
Effective supplier management ensures that suppliers consistently provide products and services that comply with specifications and relevant requirements. Supplier management helps minimize supply chain risks and ensure timely and reliable access to materials, supporting overall manufacturing operations and compliance.
The SimplerQMS supplier management module helps pharmaceutical companies centralize supplier data, maintain an approved suppliers list (ASL), identify quality-critical suppliers, and streamline evaluations and audits. The eQMS also automates notifications and reminders for re-evaluations, Â supplier-related assignments, and other activities.
Deviation Management
Deviation management is the process of identifying, documenting, investigating, and resolving deviations from established procedures, specifications, or applicable requirements. Deviation management supports companies in addressing deviations such as OOS results, adverse events, and product recalls, among others. Deviation management includes deviation reporting, root cause analysis, impact assessment, corrective and preventive actions, effectiveness checks, and record keeping.
The goal of deviation management is to identify the causes of deviations, implement corrective actions, and prevent the recurrence of similar issues. Deviation management helps maintain product quality and process integrity, contributing to continuous improvement in pharmaceutical manufacturing.
SimplerQMS provides a deviation management module with predefined workflows for documenting, reviewing, investigating, and closing issues efficiently throughout their lifecycle. The eQMS integrates quality processes, such as CAPA management, ensuring comprehensive issue resolution.
CAPA Management
Corrective and Preventive Action (CAPA) management involves identifying, investigating, and addressing issues to prevent the recurrence of deviations or nonconformances. CAPA management includes CAPA planning, root cause analysis, action implementation, effectiveness assessment, and documentation.
CAPA management aims to continuously improve processes, prevent quality issues, and improve compliance with relevant requirements, ensuring sustained product quality and safety.
SimplerQMS CAPA management module streamlines the entire CAPA process, providing tools to initiate CAPA directly from any recorded issue, such as deviations, complaints, or audit findings. The QMS software enables the creation and implementation of corrective and preventive actions, tracks CAPA progress, and allows the creation of CAPA effectiveness checks.
Complaint Management
Complaint management refers to the systematic handling, investigation, and resolution of complaints and feedback related to product quality, safety, or efficacy. Complaint management involves complaint and feedback recording, evaluation, investigation, resolution, and communication with customers, employees, and stakeholders.
The purpose of complaint management is to address product or service users’ concerns promptly. Complaint management helps identify potential issues, implement corrective actions, and improve customer satisfaction while ensuring compliance with relevant requirements.
The SimplerQMS complaint management module streamlines the logging, tracking, and resolution of complaints while enabling seamless communication across departments. SimplerQMS maintains a centralized repository for all complaints, facilitating easier access and analysis, and ensures timely responses through automated alerts and reminders.
Risk Management
Risk management involves the systematic identification, assessment, mitigation, and monitoring of risks throughout the product or service lifecycle. Risk management encompasses risk identification, risk assessment, risk mitigation strategies, and ongoing risk monitoring.
The goal of risk management is to proactively manage risks to product quality, safety, and efficacy. Effective risk management helps ensure continuous improvement and compliance and minimizes potential harm to end-users and business operations.
The risk management module in SimplerQMS provides pre-defined workflows for handling risk-related tasks, with notifications and reminders keeping employees informed about their actions. SimplerQMS integrates risk-related records with processes, documents, deviations, nonconformances, and CAPAs, providing a comprehensive overview of risk management activities.
Batch Records Management
Batch records management involves documenting all manufacturing processes and activities for each batch of pharmaceutical products. Batch records management includes documentation, storage, and review of batch-related data, ensuring accuracy, completeness, and compliance with relevant requirements.
The purpose of batch records management is to streamline the management of batch records by improving data integrity, traceability, and access.
The electronic batch records management capabilities in SimplerQMS simplify batch record processes by linking batch packing records (BPR) and batch master records (BMR) to related documents, product release notes, laboratory control reports, equipment, products, audits, and inspection reports, among others.
What Is the Difference Between Pharmaceutical Quality Assurance and Quality Control?
The main difference between Quality Assurance and Quality Control in the pharmaceutical industry lies in their focus and scope.
Pharmaceutical QA is a framework supported by systematic approaches to ensuring that products and services meet quality specifications and relevant requirements. QA helps ensure that pharmaceutical products are consistently safe, effective, and of high quality.
QC in the pharmaceutical industry involves controlling and testing the products to ensure uniform and high quality. QC acts as the detection mechanism that operates throughout the product lifecycle to ensure the final product’s quality and safety.
Quality assurance and quality control are integral components of the overall quality management system, as shown in the illustration below.
What Is a Pharmaceutical Quality Control (QC) System?
A pharmaceutical quality control system is a set of processes, procedures, work instructions, and activities for controlling and testing the quality of a product or service. Pharmaceutical companies implement QC systems to help ensure that products and services meet quality specifications and relevant requirements.
The pharmaceutical QC system involves the testing and inspection of individual batches of products, conducting incoming inspections from suppliers, and performing outgoing inspections before shipment to customers. Pharmaceutical QC helps ensure product batches meet established specifications for quality, safety, identity, purity, and strength.
The purpose of the pharmaceutical QC system is to control and test the quality of the manufactured products throughout their lifecycle. QC helps to prevent the distribution of poor-quality or unsafe pharmaceutical products by identifying issues in product quality.
What Is the Role of QMS Software in Supporting Pharmaceutical QA System Processes?
QMS software, also known as eQMS, supports QA system processes in the pharmaceutical industry by streamlining and automating various QA activities. The eQMS helps ensure compliance and improve operational efficiency.
SimplerQMS offers an effective eQMS solution designed specifically for life science, including the pharmaceutical industry. Our pharmaceutical QMS software improves efficiency, transparency, and traceability across all quality-related activities, supporting pharmaceutical companies in maintaining product quality, safety, and compliance throughout their operations.
SimplerQMS supports all quality processes, such as document management, change control, training management, CAPA management, audit management, supplier management, and others.
With comprehensive process support, SimplerQMS assists companies in complying with the various requirements of the life science industry, such as 21 CFR Part 210, 211, and 212, ISO 9001:2015, EU Volume 4 GMP Part I, ICH Q7, ICH Q10, and more.
SimplerQMS software is a fully validated solution according to ISPE GAMP5. SimplerQMS manages all software validation processes, relieving customers from the need to allocate extra resources, time, or expenses for validation.
Learn more about how the SimplerQMS solution can streamline quality assurance processes. Book a Demo and talk with our Quality Solution Consultants experts to better understand how SimplerQMS can support your company.
