Pharmaceutical Quality Management System (QMS)

A Quality Management System (QMS) is a structured framework of processes, responsibilities, and resources designed to ensure customer and regulatory compliance, as well as consistent quality and services across various industries.

A pharmaceutical QMS is a structured set of documented processes, responsibilities, and resources that ensure the consistent production and control of pharmaceutical products. Pharmaceutical QMS is governed by requirements such as ISO 9001, FDA 21 CFR Parts 210 and 211, ICH Q10, EU GMP, and PIC/S GMP.

A pharmaceutical QMS operates through a tiered documentation structure comprising a quality manual, quality policy, SOPs, work instructions, and records. Core QMS elements include document control, change management, training management, deviation management, and CAPA management. Other core elements are complaint management, audit management, supplier management, equipment management, product lifecycle management, and management review.

Compliance with pharmaceutical QMS requires lifecycle-based implementation, adherence to cGMP, defined critical quality attributes (CQA), application risk assessment tools, and good documentation practices (GDocP). Furthermore, compliance is ensured through the use of validated equipment and processes, internal audits, tracking of deviations, CAPA implementation, supplier control, personnel qualification, and regular management reviews.

Pharmaceutical companies can utilize an electronic Quality Management System (eQMS), which streamlines QMS processes, enhances traceability, and helps ensure compliance with applicable requirements.

SimplerQMS is a validated, cloud-based eQMS for the pharmaceutical industry that streamlines compliance with ISO 9001, FDA 21 CFR Parts 210 and 211, ICH Q10, EU GMP, and PIC/S GMP by centralizing document control, and streamlining CAPA, training, audit management, and other key processes.

Looking to improve pharmaceutical QMS in your company? Book a demo to see how SimplerQMS can optimize pharmaceutical quality management processes and help ensure compliance.

What Is a Pharmaceutical Quality Management System (QMS)?

A Pharmaceutical Quality Management System (QMS) is a structured set of documented processes, responsibilities, and resources that ensure the consistent production and control of pharmaceutical products.

Pharmaceutical QMS aims to help ensure that pharmaceutical products meet quality standards related to safety, efficacy, and compliance with applicable customer and regulatory requirements.  A pharmaceutical QMS maintains robust processes, standardized procedures, and continuous quality monitoring to fulfill customer and regulatory requirements consistently.

The pharmaceutical QMS covers the entire product lifecycle of pharmaceutical products. A pharmaceutical QMS covers every product lifecycle stage, from research and development to clinical trials through manufacturing, packaging, and distribution.

The pharmaceutical QMS helps ensure proper documentation, risk management, deviation control, and change management at each product lifecycle stage. Additionally, it includes corrective and preventive actions (CAPA), supplier oversight, equipment calibration, audit management, and management review of product and process performance​.

Implementing a quality management system helps mitigate risks, improve operational control, and facilitate compliance with customer and regulatory requirements. Several applicable requirements include FDA 21 CFR Parts 210 and 211, EU GMP (EudraLex Volume 4), ISO 9001, and more.

Pharmaceutical QMS can be tailored based on a company’s size, complexity, and regulatory obligations.

Some pharmaceutical companies use paper-based systems, while others adopt electronic quality management systems (eQMS). Quality management software for the pharmaceutical industry, such as SimplerQMS, offers a validated, cloud-based QMS platform.

What Is Quality in the Pharmaceutical Industry?

Quality in the pharmaceutical industry means that a pharmaceutical product consistently meets its intended use by ensuring quality dimensions such as identity, safety, efficacy, consistency, stability, and compliance.

Pharmaceutical quality refers to a product’s ability to deliver therapeutic benefits without causing harm under all conditions of use.

The pharmaceutical dimensions of quality are listed and explained below.

• Identity and Purity: Ensures the correct active pharmaceutical ingredient (API) is present and impurities remain within acceptable limits, confirming both identity and purity.
• Potency and Efficacy: Verifies API strength, applies in-process controls, and confirms assay’s accuracy, ensuring each dose delivers the intended therapeutic effect.
• Safety and Tolerability: Combines risk assessments, deviation management, CAPA, cleaning validation, and personnel training to prevent contamination and adverse effects.
• Consistency and Uniformity: Ensures the drug maintains uniform composition and performance across all batches.
• Stability and Shelf Life: Confirms the pharmaceutical product retains its quality and efficacy throughout its defined shelf life.
• Regulatory Compliance and Traceability: Ensures that every step is fully documented, from raw material intake to product distribution, and meets specific requirements, including FDA 21 CFR 210/211 and others.

Quality is measured through specifications, validated test methods, and process controls, forming the foundation for consistent performance across the pharmaceutical product’s life cycle.

What Are the Quality Standards, Guidelines, and Regulations in the Pharmaceutical Industry?

Several quality standards, regulations, and guidelines in the pharmaceutical industry are listed below.

• ISO 9001:2015: ISO 9001:2015 is an international standard for quality management systems emphasizing consistent product quality, customer satisfaction, and continual improvement.
• FDA 21 CFR Part 210: 21 CFR Part 210 is a US regulation that defines minimum Current Good Manufacturing Practice (cGMP) requirements on the manufacturing, processing, and packing of drugs.
• FDA 21 CFR Part 211: 21 CFR Part 211 is a US regulation for finished pharmaceuticals covering components, equipment, records, packaging, labeling, storage, and distribution.
• ICH Q7A (Good Manufacturing Practice for Active Pharmaceutical Ingredients): ICH Q7A sets GMP guidelines for API manufacturing, ensuring quality and purity prior to formulation into drug products.
• ICH Q8(R2) (Pharmaceutical Development): ICH Q8(R2) outlines principles of Quality by Design (QbD), emphasizing formulation and process understanding to maintain consistent product quality.
• ICH Q9 (Quality Risk Management): ICH Q9 presents a systematic, science-based method for identifying, controlling, and communicating risks throughout the pharmaceutical product lifecycle.
• ICH Q10 (Pharmaceutical Quality System): ICH Q10 is an international guideline for pharmaceutical quality systems. ICH Q10 describes a model for a lifecycle-based Pharmaceutical Quality System that integrates GMP.
• ICH Q11 (Development and Manufacture of Drug Substances): ICH Q11 provides guidance on drug substance development and manufacture, focusing on process design, control strategy, and critical quality attributes.
• EU GMP (EudraLex Volume 4): EU GMP is an EU guideline for GMP for Medicinal Products for Human and Veterinary Use to ensure products meet quality requirements.
• Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP PE 009-14: PIC/S GMP PE 009 provides a GMP framework for safe, effective, and consistently high-quality pharmaceutical products.

ISO 9001:2015

ISO 9001:2015 is an international standard that defines the criteria for a QMS, applicable across all industries, including the pharmaceutical industry. ISO, the International Organization for Standardization, publishes and maintains ISO 9001:2015. ISO 9001:2015 replaced ISO 9001:2008 version.

In the pharmaceutical industry, ISO 9001:2015 promotes quality through standardized procedures, risk-based thinking, continuous improvement, and data-driven decision-making.

ISO 9001:2015 aligns with pharmaceutical regulatory frameworks, such as cGMP and ICH guidelines, through its emphasis on documented processes, quality objectives, and proactive risk management.

By promoting standardization, accountability, and continuous improvement, ISO 9001:2015 enhances regulatory readiness. Additionally, ISO 9001:2015 reduces the risk of quality failures, leading to improved product quality and safety.

ISO 9001:2015 outlines key QMS components, including the list below.

• Context of the Organization: Understand the internal and external factors that affect objectives.
• Leadership: Define clear roles and responsibilities and ensure top management commitment.
• Planning: Identify risks, and opportunities, and set quality objectives.
• Support: Secure resources, competence, and control over documentation.
• Operation: Execute and manage processes to meet quality standards and requirements.
• Performance Evaluation: Monitor, measure, and audit system performance.
• Improvement: Use performance data to drive continual improvement.

Some pharmaceutical companies adopt ISO 9001:2015 to enhance operational performance and ensure their QMS aligns with quality requirements.

FDA 21 CFR Part 210

FDA 21 CFR Part 210 defines the cGMP requirements necessary for establishing a QMS in pharmaceutical manufacturing. 21 CFR Part 210 sets foundational requirements to ensure that all drug products maintain their identity, strength, quality, and purity throughout the production lifecycle. 21 CFR Part 210 mandates that manufacturers implement robust cGMP systems to consistently produce compliant pharmaceutical products.

The FDA, under the U.S. Department of Health and Human Services, enforces this requirement through routine site inspections, document audits, and product sampling. Non-compliance may result in warnings, recalls, import alerts, or legal actions.

Key elements of 21 CFR Part 210 include the listed below.

• 210.1 Status of current good manufacturing practice regulations: Details the scope and status of cGMP and define the minimum good manufacturing practices for drugs.
• 210.2 Applicability of current good manufacturing practice regulations: Explains which entities and products are subject to cGMP requirements, including manufacturers, processors, packers, or holders of drug products.
• 210.3 Definitions: Provides essential definitions and ensures consistency in interpreting terms like “batch,” “drug product,” “active ingredient”, “manufacturing,” “processing,” and “holding”.

Compliance with 21 CFR Part 210 not only enhances regulatory readiness but also reduces risks of contamination, mislabeling, and product defects, ultimately protecting patient safety and product quality throughout the pharmaceutical supply chain.

21 CFR Part 210 aligns with FDA 21 CFR Part 211, ICH Q10, and PIC/S GMP guidelines, collectively supporting an integrated QMS that emphasizes control over facilities, equipment, personnel, and processes.

FDA 21 CFR Part 211

FDA 21 CFR Part 211 defines the cGMP requirements for finished pharmaceuticals. 21 CFR Part 211 ensures that finished drugs are consistently produced and controlled to meet quality requirements, reducing risks such as contamination, mix-ups, and deviations that could compromise public health.

As the practical extension of FDA 21 CFR Part 210, 21 CFR Part 211 integrates with global QMS frameworks such as ICH Q10, PIC/S GMP, and ISO-based systems. 21 CFR Part 211, which focuses on documentation, traceability, risk mitigation, and continuous improvement, reinforces QMS integrity across the pharmaceutical lifecycle.

Key subparts A to K within 21 CFR Part 211 govern areas such as personnel training, facility sanitation, equipment calibration, component control, process validation, labeling accuracy, laboratory testing, recordkeeping, and the handling of returned or salvaged products.

The FDA, under the U.S. Department of Health and Human Services, enforces this requirement. The FDA enforces compliance through inspections and regulatory audits under the Federal Food, Drug, and Cosmetic Act. Noncompliance may trigger corrective actions, recalls, import bans, or legal enforcement.

Adherence to 21 CFR Part 211 requirements not only demonstrates robust QMS implementation but helps enhance product safety, and quality, and secures US market access.

ICH Q7A

ICH Q7A defines internationally harmonized GMP requirements for the production of Active Pharmaceutical Ingredients (APIs) used in human medicines. ICH Q7A serves as a critical bridge between upstream API manufacturing and downstream finished drug product quality systems. It is established by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

ICH Q7A helps ensure that APIs are consistently manufactured and controlled according to quality requirements aligned with their intended use. ICH Q7A further helps enhance global pharmaceutical integrity by establishing a framework that governs production practices, quality assurance, documentation, and supply chain.

ICH Q7A requires a documented QMS that includes independent quality units, procedures for handling deviations, internal audits, and regular product quality reviews. ICH Q7A scope encompasses critical QMS dimensions such as personnel qualifications, facility design, and sanitation. Document control, raw material traceability, validated production processes, laboratory requirements, change management, and systems for complaints and recalls are also included.

ICH Q7A supports broader QMS frameworks including ICH Q10, FDA 21 CFR Parts 210/211, and EU GMP. Regulatory bodies such as the FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and Health Canada recognize and enforce ICH Q7A through GMP inspections and audits.

ICH Q8(R2)

ICH Q8(R2) is a harmonized guideline on pharmaceutical development issued by the ICH. ICH Q8(R2) is used to establish a scientific and systematic foundation for integrating product design and process development within the QMS.

ICH Q8(R2) aims to ensure that processes consistently deliver the desired product performance. ICH Q8(R2) introduces Quality by Design (QbD) principles and risk management tools to embed quality into pharmaceutical products through a deep understanding of formulation and manufacturing processes.

Key requirements of ICH Q8(R2) are listed below.

• Quality Target Product Profile (QTPP): Defines the desired product characteristics such as route of administration, dosage form, strength, and stability.
• Critical Quality Attributes (CQAs): Identifies measurable properties that must be controlled to ensure safety and efficacy.
• Risk Assessment: Links material attributes and process parameters to CQAs to check possible risks.
• Design Space: Describes the multidimensional combination of input variables and process parameters proven to ensure quality.
• Control Strategy: Establishes a plan for monitoring and controlling parameters to maintain consistent product quality.
• Lifecycle Management: Encourages continuous improvement using data gathered throughout the product’s commercial life.

ICH Q8(R2) aligns closely with ICH Q9 and ICH Q10, reinforcing the integration of risk-based thinking and scientific control into the QMS framework. It complies with GMP expectations and regulatory requirements set by the FDA, EMA, PMDA, and other ICH member agencies.

Globally adopted, ICH Q8(R2) standardizes the expectations for the Pharmaceutical Development section of Common Technical Document (CTD) submissions. ICH Q8(R2) enhances product quality and transparency and strengthens product quality and safety.

ICH Q9

ICH Q9 is the internationally harmonized guideline for Quality Risk Management (QRM) in the pharmaceuticals industry, developed by the ICH.

ICH Q9 aims to provide a structured methodology to assess, control, communicate, and review risks affecting product quality throughout the lifecycle and integrate it into QMS.

By embedding risk-based thinking into QMS frameworks, the core process of ICH Q9 includes risk assessment, risk control, risk communication, and risk review. ICH Q9 promotes the use of formal tools such as Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and statistical models for evaluations. It reinforces key QMS functions, including change control, deviation management, validation, and regulatory readiness.

ICH Q9 aligns closely with ICH Q10 and complements ICH Q8, enabling QMS integration with requirements such as GMP, ISO, and FDA compliance practices.

ICH Q9 enhances risk visibility and traceability across development, manufacturing, testing, and distribution, reducing variability, optimizing resource allocation, and boosting market trust. Its systematic hazard control helps ensure consistent product quality and safety across the pharmaceutical lifecycle.

ICH Q10

ICH Q10 is the internationally harmonized guideline titled “Pharmaceutical Quality System,” developed by the ICH. ICH Q10 is adopted by major ICH regulatory bodies including the FDA (USA), EMA (EU), PMDA (Japan), Health Canada, and Swissmedic (Switzerland).

ICH Q10 aims to provide a comprehensive model for QMS in the pharmaceutical industry. ICH Q10 spans the entire product lifecycle, from development and technology transfer to commercial manufacturing and product discontinuation.

The three principles – product realization, state of control, and continual improvement are the ICH Q10 structure that is built. These principles are operationalized through core QMS system elements, including process and product monitoring, CAPA systems, change management, and management review.

ICH Q10 incorporates enablers like knowledge management and ICH Q9 to drive informed, proactive quality assurance within the QMS. ICH Q10 aligns with GMP regulations such as FDA 21 CFR Parts 210/211, EU GMP, ICH Q7, and ISO 9001, while uniquely integrating ICH Q8 and Q9 into a lifecycle-wide QMS. Moreover, ICH Q10 explicitly includes pharmaceutical development and post-market phases.

By standardizing global quality practices, ICH Q10 reduces process variability, enhances product quality and safety, facilitates efficient change management, and helps ensure responses to issues.

ICH Q11

ICH Q11 provides harmonized guidance for drug substance development and manufacturing established by the ICH. ICH Q11 aligns process development, control, and lifecycle management with QMS principles.

ICH Q11 aims to ensure consistent drug substance quality by supporting robust manufacturing processes based on scientific knowledge and risk assessment.

The ICH Q11 guideline defines critical quality attributes, selects and justifies starting materials, and develops control strategies using process parameters, material specifications, and in-process testing. ICH Q11 includes a reproducibility-based approach and an enhanced strategy using design space principles. The control strategy links material and process parameters to CQAs using risk assessment and experimentation. Validation or continuous process verification are also key requirements.

By integrating ICH Q8 for development, ICH Q9 for risk management, and ICH Q10 for quality systems, ICH Q11 enables ongoing control and improvement within drug substance development and manufacturing.

ICH Q11 supports GMP compliance by using documented processes to demonstrate compliance with key processes within drug substance development and manufacturing.

EU GMP

EU GMP defines the legally binding pharmaceutical manufacturing quality standard in the European Union. EU GMP is published in EudraLex Volume 4 by the European Commission.

EU GMP’s purpose is to ensure consistent production and control of medicinal products. EU GMP establishes a comprehensive Pharmaceutical Quality System aligned with ICH Q10 and incorporates principles from ICH Q8, Q9, Q11, and ISO 9001.

The regulation safeguards public health by requiring controlled manufacturing, testing, packaging, and storage of pharmaceutical products. EU GMP minimizes contamination, cross-contamination, and potency inconsistency, supporting the production of safe, effective, and high-quality medicines.

EU GMP governs QMS elements through structured chapters in Part I. Examples include Chapter 2, which addresses personnel qualifications, Chapter 3, which defines facility and equipment design, and Chapter 4, which covers documentation and data integrity.

Chapter 5 governs production controls. Chapter 6 establishes quality control. Chapter 7 regulates oversight of outsourced activities. Chapter 8 manages complaints and product recalls. Chapter 9 focuses on internal audits. Part II defines GMP for active substances. Part III provides expanded guidance and harmonization with global requirements.

EU GMP compliance is enforced by the European Commission and inspections are managed through the EudraGMDP database.

The main importance of compliance with EU GMP is that it is required for EU-based manufacturers and non-EU exporters to the EU. Compliance ensures that products meet marketing authorization specifications and supports regulatory approval.

PIC/S GMP (PE 009-14)

PIC/S GMP (PE 009-14) guideline is a foundational framework for QMS and manufacturing controls. PIC/S GMP aims to ensure the production of safe, effective, and consistently high-quality pharmaceutical products.

The guideline is developed by PIC/S which harmonizes GMP guidelines and inspection procedures across over 50 regulatory authorities. The 50 participating authorities include the FDA (USA), EMA and EU national agencies, PMDA (Japan), Swissmedic (Switzerland), Therapeutic Goods Administration (TGA) in Australia, Health Canada, and others.

PIC/S GMP guidelines (PE 009-14) outline the operational structure of QMS in pharmaceutical environments, including responsibilities, personnel qualifications, and premises requirements. Documentation, process controls, quality testing, outsourcing oversight, and complaint handling are also key elements of PIC/S GMP guidelines (PE 009-14). Furthermore, the guidelines mandate CAPA implementation, internal audits, and continuous improvement.

ICH Q7-Q11, FDA and EU GMP regulations, and ISO 9001 principles align with PIC/S GMP (PE 009-14) guidelines.

The importance of PIC/S GMP (PE 009-14) guidelines is that it strengthens regulatory convergence and supply chain reliability by aligning national and international quality systems. PIC/S GMP (PE 009-14) harmonizes pharmaceutical quality systems to ensure quality and safety, reduce regulatory fragmentation, and foster global market access.

What Is the Documentation Structure of a Pharmaceutical QMS?

A pharmaceutical QMS usually follows a tiered quality documentation structure consisting of a quality manual, policies and objectives, SOPs, work instructions, and records.

The typical structure of QMS documentation is described below.

• Quality Manual: The quality manual defines the structure, scope, and core processes of the QMS. While not explicitly mentioned by requirements such as 21 CFR 210/211 and ISO 9001, mention of a Quality Manual or equivalent document for outlining the QMS structure and responsibilities are in ICH Q10, PIC/S GMP, and EU GMP.
• Policies: The QMS policies, such as quality policies, company policies, and objectives, reflect the organization’s commitment to quality, risk management, and regulatory compliance. A policy statement aligning with global requirements such as 21 CFR 210/211 and EU GMP.
• Procedures or Standard Operating Procedures (SOPs): SOPs ensure consistent execution of quality processes within the QMS. In the pharmaceutical industry, common SOPs include document control, batch control, risk management, CAPA, and supplier management.
• Work Instructions (WIs): WIs provide task-specific, step-by-step guidance derived from SOPs to ensure the accurate and consistent execution of processes.
• Records: Records such as batch records, cleaning logs, deviation reports, and laboratory reports provide documented evidence of compliance, traceability, and quality assurance within the QMS. These are essential for demonstrating GMP adherence and supporting regulatory inspections.

The standard structure of documentation in a pharmaceutical QMS is shown in the image below.

What Are the Core Processes and Elements of a Pharmaceutical QMS?

The several core processes and elements of a pharmaceutical QMS are listed below.

• Document Control: Manages the creation, approval, distribution, revision, and retirement of QMS documents, ensuring version control and proper archiving.
• Change Management: Governs the process of evaluating modifications before implementation to processes, systems, facilities, equipment, and documentation.
• Training Management: Identifies training needs, delivers programs, and evaluates effectiveness to ensure personnel are competent for their roles.
• Deviation Management: Oversees the documentation, resolution, trending, and review of unplanned or undesirable events.
• Complaint Management: Captures, logs, and investigates customer complaints.
• CAPA Management: Identifies root causes of recorded issues (e.g., deviation, nonconformance, complaint, audit finding) and implements CAPA to resolve and avoid future issue occurrences.
• Audit Management: Schedules, conducts, and records audits (internal, external, supplier), tracking findings and ensuring timely closure of audit findings.
• Supplier Management: Qualifies suppliers, monitors performance, conducts risk assessments, and enforces quality agreements to ensure materials and services meet requirements.
• Equipment Management: Includes calibration, preventive maintenance, qualification (IQ/OQ/PQ), and validation to avert equipment-related deviations and ensure compliant production.
• Product Management: Oversees product flow from concept to distribution through batch review, QC testing, labeling, storage, final release, and documentation (e.g., CoA).
• Management Review: Conducts scheduled, structured evaluations of QMS metrics (quality KPIs, audits, deviations, CAPAs, risks) at the executive level to drive continual improvement.

Document Control

Document control manages documents, including creation, review, approval, distribution, revision, retirement, and archiving of retired documents.

Document control ensures the use of current, approved SOPs, protocols, policies, and specifications. Compliant documents and records through pharmaceutical document management support audits, training, inspections, investigations, change control, and other QMS processes.

A typical document control workflow begins with the creation or update of a document. Authorized personnel review and approve the document, which is assigned a unique identifier, and then release and make it accessible to relevant personnel. Users follow the issued procedures, and training is provided if changes are significant. Documents are reviewed periodically to confirm relevance, while outdated versions are either revised or archived.

Document control is required under several requirements. For example, ISO 9001:2015Clause 7.5, “Documented Information,” emphasizes the creation and maintenance of clear, organized documentation to ensure that processes are performed consistently and correctly. EU GMP has a dedicated chapter – Chapter 4: Documentation. Chapter 4 requires a clear and organized hierarchy of documents (e.g., SOPs, batch records), strict version control with proper review and approval, timely and accurate data recording, and secure accessibility for authorized personnel.

Change Management

Change management controls the evaluation, approval, implementation, and documentation of any change to products, critical processes, or changes within the organization.

Change management helps ensure product quality, safety, and compliance by preventing unauthorized changes and mitigating risks through structured assessments.

In a change management procedure, each change request typically includes a proposal, justification, and a list of affected systems or documents, which are assessed by cross-functional teams for impacts such as on quality, validation, regulatory filings, and the supply chain. QA and relevant departments review the risk assessments to approve or reject changes. Approved changes follow predefined actions and timelines. Afterward, QA verifies the implementation, updates the documents, confirms that training has been conducted, and formally closes the change.

ISO 9001:2015 requires organizations to plan and control changes to processes, products, or services under Clauses 6.3 (Planning of Changes) and 8.5.6 (Control of Changes). ICH Q10 Section 3.2.3  Change Management System integrates change management across the product lifecycle. Section 3.2.3 requires an assessment of the change’s impact on product quality and safety, followed by CAPA or other actions to maintain compliance.

Training Management

Training management plans, executes, tracks, evaluates, and documents training to ensure personnel are qualified to perform assigned tasks.

Training management helps ensure that only qualified personnel perform GMP-related tasks, enforces SOP compliance, maintains audit readiness, meets regulatory expectations, and reduces operational errors.

Training needs arise from job roles, SOPs, regulatory requirements, and system changes, and are addressed through training plans or training matrices that define content, delivery methods, frequency, and responsibilities. Personnel receive training and undergo competency assessments through tests, observation, or hands-on evaluations, with all records linked to their individual records. Retraining is conducted following audits, poor performance, or updates to processes.

ISO 9001:2015 clauses 7.2 (Competence) and 7.3 (Awareness) require organizations to define personnel competence, provide necessary training, and maintain qualification records. EU GMP Chapter 2 Personnel mandates a training program to ensure employees understand GMP principles and their responsibilities, with records available for inspection.

Deviation Management

Deviation management controls the identification, documentation, investigation, and resolution of events that fail to follow approved procedures, specifications, or expectations.

Common workflows include issue detection, such as deviations, nonconformities, complaints, or audit findings. Deviations are investigated and documented with the time, location, personnel involved, and incident details. Secondly, deviation impact is typically classified as minor, major, or critical and evaluated for risk to product quality, safety, and compliance. Investigations employ structured methods, such as the 5 Whys or Ishikawa, and CAPAs are implemented to address both the root cause and the specific incident. Typically, the quality unit reviews all data, verifies the resolution, and formally closes the deviation. Lastly, data is analyzed to detect recurring or systemic issues.

Deviation management ensures the early detection of quality issues, prevents the release of unverified products, supports process improvement, ensures audit readiness, and documents compliance decisions. Deviation management integrates with CAPA for remedial actions, change management for process updates, training management for error-related retraining, document control for procedural revisions and records, and audit management for effectiveness checks.

Deviation management is required under several requirements. ISO 9001 Clause 10.2, Nonconformity and Corrective Action, mandates that organizations identify the root causes of nonconformities, implement corrective actions, and prevent recurrence. EU GMP Chapter 1 requires all deviations to be recorded, evaluated, and investigated through a formal system to ensure GMP compliance.

Additionally, ICH Q10 Section 3.2.2 Corrective Action and Preventive Action (CAPA) System establishes a structured CAPA process to manage deviations.

Complaint Management

Complaint management structures the entry, investigation, evaluation, and resolution of complaints related to product quality or service.

Complaints are received from customers, such as healthcare providers or distributors, and are logged into a tracking system. Each complaint is classified by urgency and assessed for its validity. Investigations are carried out and CAPAs are implemented. Reportable complaints are submitted to regulatory authorities and the complainant is updated on the status of the complaint. Complaints are formally closed, and if applicable, notify the complainant. Complaint data is analyzed to identify recurring issues, supporting continuous improvement.

Complaint management links to CAPA and deviation management, change management for procedural updates, training management for performance gaps, audit management for review, and product management for product recall when required.

ISO 9001:2015 clause 8.2.1 (Customer Communication) requires organizations to implement processes for receiving and managing customer feedback. ISO 9001:2015 Clause 10.2 (Nonconformity and Corrective Action) mandates the investigation and resolution of nonconformities identified through complaints.

EU GMP Chapter 8 (Complaints and Product Recall) requires a formal system to record, investigate, and manage complaints, determine root causes, and apply corrective actions to protect patient safety. Moreover, ICH Q10 Section 3.2.2 (CAPA System) integrates complaint handling into the CAPA process.

CAPA Management

CAPA management is the identification, investigation, and resolution of issues affecting product quality, compliance, or operations. Corrective actions remove the cause of the issue, while preventive actions are designed to avoid future issue occurrences. Triggers for CAPA include deviations, complaints, nonconformities (which can result from audit findings), or trends.

CAPA aims to eliminate root causes and prevent issue recurrence, ensuring continuous improvement, compliance, and consistent product quality.

The high-level process of pharmaceutical CAPA management involves conducting root cause analysis using methods such as 5 Whys and Fishbone diagrams. CAPA planning and CAPA execution follow. Actions are executed, tracked, and verified for effectiveness. CAPA is documented with supporting records and closed following the impact review.

CAPA integrates with deviation management, complaint management, audit management, and other QMS processes where issues have been identified.

CAPA management is required under several requirements, including ISO 9001:2015, ICH 10, and EU GMP.

ISO 9001 clause 10.2 (Nonconformity and Corrective Action) requires organizations to identify nonconformities, analyze root causes, implement corrective actions, and verify effectiveness to prevent recurrence.

ICH Q10 Section 3.2.2 requires a formal CAPA process within the pharmaceutical quality system.

EU GMP Chapter 1 Pharmaceutical Quality System mandates an integrated CAPA system to manage deviations, complaints, and audit findings, ensuring effective corrective measures and the prevention of further issues.

Audit Management

Audit management structures the planning, execution, documentation, and follow-up of internal and external audits. Audit management identifies compliance gaps, evaluates QMS effectiveness, drives system improvement, ensures inspection readiness, and supports supplier oversight. Audits are essential as they assess compliance with SOPs, GMP, and regulatory requirements.

Typically, pharmaceutical audit management begins with audit planning, which defines the scope, frequency, roles, and responsibilities. Audits are scheduled and notified and are conducted using checklists, interviews, and observations, with findings recorded and classified. Audit results are reported to stakeholders and assigned to CAPA, if applicable. CAPAs are tracked and re-audited as needed. Audit trends are monitored to identify recurring issues and support improvement.

Audit management is often integrated with CAPA, deviation, document control, supplier management, and other related quality elements.

Clause 9.2 Internal Audit of ISO 9001:2015 requires organizations to plan and conduct internal audits at regular intervals to confirm effective implementation and maintenance of ISO 9001 and internal QMS requirements.

Another example, EU GMP Chapter 9 (Self Inspection) mandates a self-inspection program to assess GMP compliance, identify opportunities for improvement, and ensure timely implementation of corrective actions.

Supplier Management

Supplier management controls the selection, qualification, auditing, monitoring, and deactivation of suppliers of materials, components, or services that impact product quality, safety, or customer and regulatory compliance.

Vendor management ensures suppliers meet GMP and contractual requirements, with selection based on quality requirements, regulatory history, capabilities, and risk.

The common workflow is to start with the supplier qualification. Qualification includes audits, documentation reviews, and the establishment of quality agreements. Supplier performance is monitored through KPIs such as out-of-stock (OOS) rates, delivery timelines, deviation trends, and periodic reviews to reassess risk and compliance status. Suppliers are required to notify the company of any changes to materials, processes, or sites, and underperforming suppliers are deactivated in accordance with company procedures.

Supplier management integrates with audit management for compliance checks, change management for updates, document control for agreement handling, and CAPA for issue resolution.

Supplier management is required under several requirements. ISO 9001:2015 Clause 8.4 (Control of Externally Provided Processes, Products, and Services) requires organizations to evaluate and select suppliers based on defined criteria, monitor their performance, and ensure externally provided goods and services meet specified requirements.

EU GMP Chapter 7 (Outsourced activities) mandates written agreements and quality oversight for outsourced activities, including supplier qualification and continuous monitoring to ensure GMP compliance.

Moreover, ICH Q10 Section 2.7 (Management of Outsourced Activities and Purchased Materials) requires a systematic approach to selecting, monitoring, and auditing suppliers and service providers.

Equipment Management

Equipment management encompasses the installation, qualification, calibration, maintenance, cleaning, use, monitoring, and decommissioning of manufacturing and laboratory equipment.

Equipment is selected based on intended use and qualified through installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). IQ confirms that the equipment installation meets the design specifications and requirements. OQ confirms that installed equipment operates consistently within defined parameters under controlled conditions. PQ demonstrates that the equipment performs reliably under routine production conditions and consistently delivers the intended results.

Calibration verifies accuracy using traceable standards and should be performed at an established frequency. Scheduled maintenance, on the other hand, prevents failures. Cleaning is performed according to validated procedures to prevent contamination. Equipment performance is continuously monitored, and decommissioning is conducted in accordance with internal procedures.

Equipment management ensures reliable operation, product quality, data integrity, GMP compliance, and audit readiness. Equipment management is integrated with document control for procedural control, training for operator qualification, deviation and CAPA for issue handling, change control for equipment updates, and audit management for compliance verification.

ISO 9001:2015 Clauses 7.1.3 (Infrastructure) and 7.1.5 (Monitoring and Measuring Resources) require organizations to provide suitable infrastructure and ensure all monitoring and measuring devices are calibrated and maintained to remain fit for purpose.

EU GMP Chapter 3 (Premise and Equipment) mandates that equipment be properly designed, located, maintained, and cleaned in line with GMP to avoid any negative impact on product quality.

ICH Q10 under Section 3.2.1 (Process Performance and Product Quality Monitoring System) includes equipment management as a core element of the pharmaceutical quality system.

Product Management

Product management controls the lifecycle of a drug product from development to discontinuation and helps ensure the product meets defined quality, safety, and customer and regulatory requirements. In other cases, product management is not part of the QMS core processes and is handled by the product management life cycle.

Product development defines the quality target product profile (QTPP) and critical quality attributes (CQAs), and process design establishes validated manufacturing steps. Manufacturing adheres to GMP-compliant procedures, with QC personnel conducting in-process and final testing. QA then reviews batch records and authorizes the product release. Distribution is executed under controlled conditions depending on the product. In the event of discontinuation, it follows company internal procedures, and record retention of product information is required.

Product management ensures consistent product quality, regulatory compliance, safe distribution, and lifecycle efficiency. Product Management integrates with document control, change management, CAPA, deviation, supplier management, audit, complaint, training, and equipment management.

Product management is required under several requirements. ISO 9001:2015 clauses 8.3  (Design and Development) and 8.5 (Production and Service Provision) require organizations to manage product design, control production processes, and ensure that final products meet specified regulatory and customer requirements.

EU GMP Chapter 5 (Production) mandates strict manufacturing controls, in-process checks, and comprehensive documentation to ensure GMP compliance.

Sections 2.1 (Pharmaceutical Quality System) and 3.2 (Pharmaceutical Quality System Elements) of ICH Q10 emphasize lifecycle-based product management.

Management Review

Management review evaluates performance, compliance, and effectiveness with senior leadership at defined intervals or risk-driven scope. Management review ensures top-level accountability, aligns quality goals with business needs, identifies compliance risks early, supports system improvement, and maintains audit readiness.

The management review process begins with the preparation of key inputs, including quality metrics, audit results, CAPAs, customer complaints, training records, supplier performance data, and relevant customer or regulatory updates. During the management review, senior management evaluates these inputs to identify areas for improvement, make strategic decisions, and determine necessary actions and resource allocations. The management review outputs include documented action items, assigned responsibilities, and timelines for completion, all of which must be tracked to ensure follow-through and effectiveness.

Management review integrates with processes such as CAPA and deviation systems for trend analysis, audit management for issue tracking, training for capability review, and change management for decision-making.

Management review is required under several requirements. For example, ISO 9001:2015 Clause 9.3 (Management Review) requires top management to regularly assess QMS performance by reviewing audit results, customer feedback, and opportunities for improvement.

EU GMP Chapter 1 (Pharmaceutical Quality System) mandates periodic reviews of the QMS to confirm its suitability, adequacy, and effectiveness, and to support continual improvement.

ICH Q10 Section 2.1 (Management Commitment) emphasizes that senior management must evaluate QMS and product performance at defined intervals to drive ongoing enhancement of the quality system.

How to Ensure Quality Management Compliance in the Pharmaceutical Industry?

To ensure compliance with quality management in the pharmaceutical industry, consider the steps outlined below.

1. Implement a Pharmaceutical Quality System (PQS): Establish a lifecycle-based QMS aligned with relevant requirements to manage products and processes from development to discontinuation.
2. Follow GMP Regulations or Relevant Requirements: Adopt and implement cGMP guidelines, such as EU GMP, FDA 21 CFR Parts 210/211, and PIC/S. These ensure standardized pharmaceutical production, facility hygiene, personnel qualification, and consistent batch quality.
3. Define and Control Critical Quality Attributes (CQAs): Identify CQAs that impact product efficacy, safety, and purity. Ensure control through validated manufacturing processes, in-process checks, and quality control testing aligned with relevant guidelines such as ICH Q8.
4. Perform Risk-Based Quality Management: Use principles such as ICH Q9 to proactively assess, control, and mitigate quality risks. Use Quality Risk Management (QRM) tools to guide decisions in manufacturing, analytical testing, supply chain, and equipment qualification.
5. Ensure Proper Documentation: Maintain compliant records using Good Documentation Practices (GDP). Ensure traceability, controlled versions, and secure archival of SOPs, batch records, audit trails, and validation protocols.
6. Validate Equipment, Processes, and Methods: Conduct comprehensive validation activities including IQ/OQ/PQ for equipment, process validation, method validation, cleaning validation, and computerized system validation per requirements such as GAMP 5 and FDA Part 11.
7. Monitor Quality Through Internal Audits: Schedule and execute internal audits and self-inspections to evaluate QMS performance. Identify nonconformities, document findings, assign CAPAs, and track closure to improve compliance readiness and QMS maturity.
8. Manage Deviations and Implement CAPA: Capture deviations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA). Utilize deviation logs, investigation reports, and CAPA plans to address quality failures and prevent the recurrence of issues.
9. Ensure Supplier and Outsourcing Controls: Qualify suppliers and contract manufacturing organizations (CMOs) through technical quality agreements, risk-based audits, and ongoing performance monitoring to maintain control over outsourced GMP activities.
10. Train and Qualify Personnel: Provide role-specific training based on a training matrix. Ensure all staff understand their responsibilities in maintaining the state of operational readiness.
11. Conduct Regular Management Reviews: Engage senior leadership in periodic reviews of QMS performance, audit outcomes, CAPA trends, and risk indicators. Compliance status, and identifying opportunities for improvement. Use review outcomes to make strategic decisions and demonstrate top management’s commitment to compliance.
12. Leverage eQMS: Use validated eQMS tools, such as SimplerQMS, to automate and centralize document control, CAPA, audits, training, and change control processes. eQMS such as SimplerQMS have KPI tracking and real-time visibility into QMS metrics.

What Is the Role of Quality Control and Quality Assurance in a Pharmaceutical QMS?

Quality Assurance (QA) and Quality Control (QC) are essential components of a pharmaceutical QMS that help ensure pharmaceutical products meet the requirements and specifications for identity, safety, efficacy, and quality.

QA is proactive and system-focused, ensuring compliance across all stages of development, manufacturing, and distribution. QC is reactive and product-focused, identifying and correcting quality issues through testing and inspection.

QA and QC support pharmaceutical quality by maintaining distinct but complementary roles. QA prevents defects through system oversight, SOP development, internal audits, CAPA, GMP compliance, and regulatory readiness. QC detects defects through analytical testing of raw materials, intermediates, and finished products, equipment calibration, and specification-based product release.

How Does a Pharmaceutical QMS Differ From a Biotechnology QMS?

The primary distinction between a pharmaceutical QMS and a biotechnology QMS lies in the nature of the products they manage. A pharmaceutical QMS oversees quality systems for chemically synthesized drugs and finished dosage forms, whereas a biotechnology QMS focuses on biologics derived from living organisms, such as recombinant proteins or cell-based therapies.

Pharmaceutical QMS is guided by requirements like FDA 21 CFR Parts 210/211, ICH Q10, and EU GMP, emphasizing chemical stability, precise dosing, and consistent batch production. Pharmaceutical QMS supports processes related to drug manufacturing and distribution, with strict environmental controls and analytical testing to ensure purity and product quality.

In contrast, a biotechnology QMS governs complex biological processes such as recombinant DNA techniques, cell cultures, and fermentation. In addition to adhering to requirements such as 21 CFR Parts 210/211, it often includes additional layers of requirements, such as 21 CFR Part 600 for biologics, or 21 CFR Part 820, the EU MDR, and the EU IVDR, for products that function as medical devices. Biotechnology QMS processes can involve bioreactors and specialized assays, such as bioassays and immunological testing, to manage variability and ensure product consistency.

An organization that handles both pharmaceutical and biotechnology sectors may implement a single integrated QMS, provided it effectively addresses each industry’s unique regulatory frameworks and operational requirements. An integrated QMS approach streamlines compliance, reduces duplication, and promotes consistency. This is effective when the system is structured to address sector-specific requirements such as GMP for pharmaceuticals, GCP or GLP for biotechnology, and standards like ISO 9001 or ISO 13485.

How Does a Pharmaceutical QMS Differ From a Medical Device QMS?

A pharmaceutical QMS governs the manufacturing and quality of pharmaceutical products while a medical device QMS helps manage medical device instruments, implants, or software used for diagnosis and treatment.

Pharmaceutical QMS follows requirements such as ICH Q10, FDA 21 CFR Parts 210/211, and EU GMP. In contrast, medical device QMS aligns with requirements such as FDA 21 CFR Part 820, EU MDR, EU IVDR, and ISO 13485, emphasizing design controls, design history files, technical files, and usability testing which are not central to pharmaceutical QMS.

In post-market surveillance, medical device QMS includes terms such as vigilance reporting and clinical follow-up, whereas pharmaceutical QMS uses the term pharmacovigilance.

What Is the Role of QMS Software for the Pharmaceutical Industry?

The role of pharmaceutical QMS software is to help manage processes, ensure regulatory compliance, and operational control of pharmaceutical products. The pharmaceutical eQMS streamlines quality management processes and helps ensure compliance with ISO 9001, FDA 21 CFR Parts 210/211, ICH Q10, EU GMP, or other GxP-related requirements.

Key capabilities of pharmaceutical eQMS include document control, CAPA management, audit management, change control, training management, risk management, equipment qualification, and batch traceability. Pharmaceutical eQMS is capable of automating and standardizing quality operations, thereby enabling continuous compliance with applicable requirements.

SimplerQMS offers a fully validated pharmaceutical QMS software, compliant with ISPE GAMP5. SimplerQMS complies with FDA 21 CFR Part 11 and EU Annex 11 requirements for the use of electronic records, electronic signatures, and computerized systems in regulated environments.

SimplerQMS helps pharmaceutical companies ensure compliance with applicable QMS requirements, including ISO 9001, FDA 21 CFR Parts 210/211, ICH Q10, and EU GMP. The software offers comprehensive QMS process support, including document control, change control, design control, training management, CAPA, audits, supplier management, pharmacovigilance reporting, and more.

Book a demo today to find out how SimplerQMS can streamline compliance, improve efficiency, and support your pharmaceutical QMS processes.