GMP (Good Manufacturing Practice): Definition, Requirements, and Compliance

GMP (Good Manufacturing Practice) is a regulatory framework that establishes minimum standards to ensure manufacturing processes consistently produce safe, effective, and high-quality products.

GMP covers all aspects of production, including raw material handling, personnel training, facility hygiene, process validation, quality control, documentation, and distribution.

The purpose of GMP is to safeguard public health by minimizing risks such as contamination, mix-ups, and errors, ensuring that each product batch meets pre-defined quality and safety criteria.

The 5 P’s of GMP refer to the foundational components – people, products, processes, procedures, and premises. Together, the 5 P’s ensure consistent product quality and GMP compliance in manufacturing.

The most common GMP requirements include U.S. Food and Drug Administration (FDA) regulations such as 21 CFR Part 210 and 211 for drug products and Part 820 for medical devices. EudraLex Volume 4 outlines GMP standards for human and veterinary medicinal products in the European market. WHO GMP guidelines form the basis for many national regulatory systems and are recognized by regulatory authorities globally.

Core components of GMP include validated processes, qualified personnel, suitable and clean facilities, calibrated equipment, quality control testing, controlled documentation, and standardized procedures for handling complaints and recalls.

An electronic Quality Management System (eQMS) software enables companies to digitize GMP-critical activities such as training, document control, calibration management, deviation handling, supplier qualification, and audit management. An eQMS enhances traceability, ensures version control, and facilitates inspection readiness.

SimplerQMS offers a life science eQMS that supports compliance with major GMP requirements such as FDA 21 CFR Parts 210/211, 820, and EudraLex Volume 4. SimplerQMS complies with GMP requirements for computerized systems (FDA 21 CFR Part 11 and EU Annex 11).

What Is GMP?

GMP stands for Good Manufacturing Practice. GMP is a regulatory framework that defines minimum quality standards to ensure that manufacturing processes consistently produce products that are safe, effective, and meet defined specifications. Good manufacturing practice principles include but are not limited to, validated manufacturing and analytical processes, calibrated equipment, hygienic facilities, trained personnel, and complete, traceable documentation.

GMP mandates that procedures like personnel hygiene, equipment cleaning, raw material handling, and in-process controls must be strictly defined and continuously monitored by the company. Production environments must be purposefully designed to prevent contamination.

GMP originated as a response to public health tragedies. In 1937, the sulfanilamide disaster in the United States led to over 100 deaths due to a toxic drug formulation, prompting stronger regulation under the FDA. Later, in the 1960s, the thalidomide crisis in Europe, where a medication caused severe birth defects, highlighted the need for proof of efficacy and safety in pharmaceutical manufacturing. These incidents laid the groundwork for GMP frameworks, first in the US and later adopted or adapted by other national authorities.

The objectives of GMP are to safeguard product quality and safety, ensure efficacy, and prevent contamination or errors during manufacturing. GMP remains central in protecting public health, underpinning confidence in pharmaceutical, medical device, food, and cosmetic products. GMP ensures that every batch of product released meets specifications through a documented, reproducible, and controlled manufacturing process.

Pharmaceuticals and medical devices follow the most rigorous GMP requirements because failures in these sectors pose direct risks to patient safety. Legally binding frameworks such as FDA 21 CFR Parts 210 and 211 for pharmaceuticals, and Part 820 for medical devices, are enforced in the US. The EU GMP guidelines are legally required for medicinal products marketed in Europe. In contrast, WHO’s GMP standards serve as non-binding guidance, especially valuable in regions with weak regulatory oversight. Cosmetics and food manufacturing sectors also apply GMP principles, although often under broader hygiene and safety rules rather than strictly medicinal GMP frameworks.

International GMP frameworks vary but share core principles. US FDA guidelines emphasize continuous improvement and integration of new technologies under “current” GMP (cGMP). While the EU does not use the term “current” GMP, they expect GMP systems to evolve and continuously improve to align with updated requirements in EU GMP Annexes. EU GMP includes a modular structure composed of multiple annexes that provide expectations for specific topics or product types, while FDA GMP regulations are consolidated into unified parts. EU GMP imposes the additional role of the Qualified Person (QP), in Annex 16, who certifies product batches for release—a requirement not present in the US system.

WHO GMP acts more as a reference guideline. Harmonization efforts through the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the International Council for Harmonization (ICH), and Mutual Recognition Agreements (MRAs) aim to align these standards globally to reduce duplication in inspections and accelerate cross-border regulatory approvals.

What Is the Importance of GMP?

The importance of GMP lies in its role in ensuring that products are consistently manufactured to meet quality, safety, and efficacy criteria. GMP enforces strict controls across production environments to prevent errors, contamination, and variability. In life sciences, where patient health is at stake, GMP compliance ensures that every product batch adheres to predefined and approved specifications.

GMP is critical in manufacturing because it prevents mix-ups, and cross-contamination, and addresses risks that can compromise product quality and safety. GMP safeguards product quality and safety by requiring defined workflows, validated processes, controlled environments, and trained personnel.

Every step—from raw material handling to final product release—must be documented and traceable.

Standard operating procedures (SOPs), change control systems, and deviation management prevent unapproved changes and help maintain consistency. GMP ensures that end users receive products that perform as intended, with minimal risk.

Failure to follow GMP may expose manufacturers to serious consequences. Non-compliance can result in regulatory actions such as warning letters, fines, revocation of manufacturing licenses, product recalls, and market access restrictions. More critically, GMP violations can lead to patient harm.

GMP supports regulatory trust and consumer confidence by demonstrating that the manufacturer operates within strict, transparent processes and quality controls. Adhering to GMP is essential for accessing international markets. Many regulatory authorities such as the FDA, EMA, and PMDA require GMP compliance as a condition for legal market access in their territories.

GMP helps companies to reduce errors and waste by enforcing discipline. Discipline is enforced through standardized procedures, qualified personnel, and documented records that minimize manual mistakes. Quality management systems, enforced by GMP, track and resolve deviations and implement Corrective Actions and Preventive Actions (CAPAs), addressing process inefficiencies and supporting continuous improvement.

What Is the Difference Between GMP and cGMP?

The main difference between GMP and cGMP is in the level of rigor and modernization enforced in manufacturing practices. GMP refers to a general framework for ensuring product quality and safety. cGMP stands for current Good Manufacturing Practice, where the “c” emphasizes using the most up-to-date systems, technologies, and methods.

cGMP requires manufacturers to adapt to evolving standards, using the best available practices to ensure consistent product quality and safety. Current Good Manufacturing Practice ensures that production processes do not rely on outdated technologies or quality controls, even if those meet older GMP standards. cGMP implementation may involve higher costs due to the need for advanced equipment, frequent training, and continued process validation. However, these investments reduce quality risks and support regulatory approval.

cGMP compliance is enforced by the FDA, which uses cGMP as a term under 21 CFR Parts 210 and 211. European authorities interpret the “current” aspect in EU GMP annexes, outlining the most up-to-date requirements for specific product types, like sterile products, as well as for processes such as parametric release. European authorities additionally emphasize continuous improvement through the adoption of the ICH Q10 guideline.

What Are the 5 P’s of GMP?

The 5 P’s of GMP refer to the foundational components (People, Product, Processes, Procedures, and Premises) that ensure consistent product quality and GMP compliance in manufacturing.

The 5 P’s of GMP are explained below.

• People: GMP requires that all personnel involved in the product lifecycle be appropriately trained, qualified, and competent to perform their duties. Training management ensures that individuals are up to date with current procedures and legislative requirements, and their competencies are documented before performing tasks.
• Product: Each product must meet clearly defined and approved specifications. Quality Control verifies that raw materials, intermediates, and finished products conform to specifications through sampling, testing, and release.
• Processes: All processes must be clearly defined, validated, and controlled. The company shall have work instructions for manufacturing and quality control based on process validation and analytical method validation to guarantee consistency and reproducibility. The cleaning processes shall also be clearly described in work instructions, upon their successful validation.
• Procedures: Standard Operating Procedures (SOPs) describe every critical task to ensure consistent execution. Procedures must be written, approved, followed, and periodically reviewed to maintain control over operations.
• Premises: Facilities and equipment must be designed, maintained, and cleaned to prevent contamination. Calibration schedules, routine maintenance, and environmental controls ensure that premises remain suitable for purpose and compliant with GMP expectations.

What Are the GMP Requirements?

Good manufacturing practice requirements establish the baseline conditions for producing safe, consistent, and high-quality products across regulated industries. GMP compliance is mandated by regulatory authorities for market access and public health protection.

The main GMP requirements are listed below.

• FDA (U.S.) Regulations: In the United States, GMP requirements are enforced under Title 21 of the Code of Federal Regulations (21 CFR). Drug manufacturers must comply with 21 CFR Parts 210 and 211, medical devices with Part 820, biological products with Parts 600–680, and positron emission tomography (PET) drugs with Part 212. FDA regulations are legally binding, and required to manufacture and distribute products within the U.S. market.
• EU Requirements: In the European Union, GMP compliance is a legal prerequisite for supplying medicinal products. The EU-GMP guidelines, enforced through the EudraLex Volume 4, are based on regulation No. 1252/2014 for active substances for human use, directive 2001/83/EC and directive (EU) 2017/1572 for medicines for human use, directive 91/412/EEC and regulation (EU) 2019/6 for veterinary medicines, directive 2001/20/EC and regulation (EU) 536/2014 for investigational medicinal products. EU- GMP consists of a main body and annexes that serve as specialized supplements.
• International Guidelines: Globally, GMP principles are outlined in non-binding guidelines such as the WHO GMP guidelines, ICH Q7 for active pharmaceutical ingredients, and the PIC/S GMP Guide. While not enforceable by law, these frameworks are widely adopted by national authorities and support global regulatory alignment, helping manufacturers meet quality and safety expectations in multiple jurisdictions.

FDA (U.S.) Regulations

FDA regulations for GMP, codified in Title 21 of the Code of Federal Regulations (CFR), are listed below.

• FDA 21 CFR Part 210: Establishes the general GMP definitions and requirements applicable to the manufacturing, processing, packing, or holding of drug products.
• FDA 21 CFR Part 211: Sets forth detailed GMP regulations for finished pharmaceuticals, including requirements for personnel, facilities, equipment, production, packaging, labeling, and laboratory controls.
• FDA 21 CFR Part 820: Defines the Quality System Regulation for medical devices, requiring procedures and documentation to ensure devices meet design, production, and performance specifications.
• FDA 21 CFR Part 212: Applies GMP standards specifically to the manufacturing of positron emission tomography (PET) drugs, with emphasis on component control, production, and quality assurance.
• FDA 21 CFR Part 600-680: Covers biological products and specifies requirements for licensing, labeling, reporting, and manufacturing to ensure consistency and product safety.

FDA 21 CFR Part 210

FDA 21 CFR Part 210 defines the status, scope, and applicability of current good manufacturing practice regulations for drug manufacturing in the United States.

FDA 21 CFR Part 210 applies to all pharmaceutical manufacturers operating within or supplying to the U.S. market, regardless of their geographic location. The U.S. FDA enforces Part 210 as the primary regulatory authority for drug quality assurance.

The key objective of Part 210 is to establish the foundational framework that mandates compliance with GMP principles. Primary requirements of Part 210 include definitions and general provisions that clarify the applicability of GMP rules and direct manufacturers to the detailed operational requirements found in Part 211.

FDA 21 CFR Part 211

FDA 21 CFR Part 211 outlines the cGMP requirements for finished pharmaceutical products intended for human use. FDA 21 CFR Part 211 regulates production, quality control, packaging, labeling, storage, and distribution to ensure drug products consistently meet quality standards.

FDA 21 CFR Part 211 applies to pharmaceutical manufacturers supplying the U.S. market, regardless of location. The U.S. FDA enforces Part 211 under its statutory authority to ensure public health protection.

The key objective of Part 211 is to ensure that finished drug products are safe, effective, and manufactured under controlled and documented conditions. Part 211 primary requirements include written procedures, documented batch records, validated processes, trained personnel, environmental controls, equipment calibration, sanitation, quality control units, and procedures for handling complaints and recalls.

FDA 21 CFR Part 820

FDA 21 CFR Part 820 establishes the quality system regulation for medical devices intended for human use. FDA 21 CFR Part 820 regulates design, manufacturing, packaging, labeling, storage, installation, and servicing processes to ensure medical devices are safe and effective.

FDA 21 CFR Part 820 applies to all medical device manufacturers supplying the U.S. market, including domestic and foreign firms. The U.S. FDA is responsible for enforcing Part 820 under the Federal Food, Drug, and Cosmetic Act.

The primary objective of FDA 21 CFR Part 820 is to ensure devices consistently meet quality requirements and perform as intended throughout their lifecycle. Part 820 key requirements include design controls, production and process controls, corrective and preventive actions, complaint handling, device master and history records, internal quality audits, employee training, equipment calibration, and document control.

FDA 21 CFR Part 212

FDA 21 CFR Part 212 sets forth the cGMP requirements specifically for the production of positron emission tomography (PET) drugs for human use. FDA 21 CFR Part 212 regulates all aspects of PET drug preparation, including components, production, quality assurance, holding, and distribution, to ensure product safety and efficacy.

FDA 21 CFR Part 212 applies to PET drug manufacturers supplying the U.S. healthcare and pharmaceutical sectors. The U.S. FDA enforces Part 212 as the competent authority overseeing PET drug manufacturing compliance.

The primary objective of Part 212 is to ensure that PET drugs are safe, properly identified, and meet the required strength, quality, and purity standards. Part 212’s main requirements include appropriate documentation and quality assurance, process verification, competent personnel, adequate facilities and equipment, and established product specifications.

FDA 21 CFR Part 600-680

FDA 21 CFR Parts 600–680 establishes regulatory requirements for the manufacture, licensing, labeling, testing, and post-market surveillance of biological products for human use. FDA 21 CFR Parts 600–680 regulate biologics such as vaccines, blood products, allergenic products, and cell or gene therapy products to ensure their safety, purity, and potency.

FDA 21 CFR Parts 600–680 applies to any company involved in the production, testing, or distribution of biological products for the U.S. market. These requirements are enforced by the U.S. FDA, primarily through its Center for Biologics Evaluation and Research (CBER), with the Centre for Drug Evaluation and Research (CDER) overseeing certain biologics like monoclonal antibodies and therapeutic proteins.

The main objective of Parts 600-680 is to protect public health by ensuring biologics are consistently manufactured in compliance with cGMP and meet their licensed specifications for safety, purity, and potency. Core requirements include personnel training, suitable work areas and equipment, and robust recordkeeping, including records of sterilization, where applicable. Post-marketing safety reporting requirements include adverse event reporting, 15-day alert reports, and periodic safety update reports.

EU Requirements

EU Requirements that define the legal framework for manufacturing and distributing medicinal products in the European Union are presented below.

• EudraLex Volume 4: The EU Good Manufacturing Practice guidelines (EudraLex Volume 4) apply to human and veterinary medicinal products.
• Regulation (EU) 2017/745 (MDR): Although not a GMP regulation, the Medical Device Regulation includes GMP-related principles such as quality management system requirements for medical device manufacturers.
• Regulation (EU) 2017/746 (IVDR): The In Vitro Diagnostic Regulation, while not under GMP, mandates a quality management system, which is aligned with GMP principles.

EU-GMP does not apply to medical devices, which are instead governed by MDR and IVDR that embed selected GMP concepts.

EudraLex Volume 4

EudraLex Volume 4 is the set of European Union guidelines that interpret the principles of good manufacturing practice for medicinal products for human and veterinary use. EU-GMP regulates the manufacturing, quality control, and distribution of pharmaceuticals to ensure they meet required safety, quality, and efficacy standards.

EU-GMP guidelines apply across all EU member states and cover manufacturers of human and veterinary medicines, including importers. The EMA and national competent authorities in EU member states enforce EudraLex Volume 4 through inspections and authorization processes for manufacturing and marketing medicinal products.

EudraLex Volume 4’s main objective is to ensure that medicinal products are consistently produced, controlled, and distributed according to quality standards to safeguard patient safety. Key GMP requirements include documented procedures, validated manufacturing and analytical processes, trained personnel, quality control testing, appropriate premises and equipment, and document control to ensure traceability of GMP-related actions.

Regulation (EU) 2017/745 (MDR)

Regulation (EU) 2017/745 (MDR) is the European Union regulation governing medical devices, and although it is not a GMP regulation, it embeds several GMP principles such as QMS requirements, manufacturing controls, traceability requirements, and quality assurance. EU MDR regulates the medical device industry to ensure medical devices are safe and perform as intended.

EU MDR applies across all EU countries and covers manufacturers, importers, and distributors of medical devices. EU MDR is enforced by national competent authorities, through notified bodies, and supervised at the EU level by the European Commission and the Medical Device Coordination Group (MDCG).

The primary objective of MDR is to ensure a high level of safety for patients. MDR’s main requirements include maintaining a quality management system, technical documentation, post-market surveillance, personnel qualification, vigilance reporting, and conformity assessments by notified bodies.

Regulation (EU) 2017/746 (IVDR)

Regulation (EU) 2017/746 (IVDR) is the European Union regulation for in vitro diagnostic medical devices. EU IVDR, while it is not a GMP regulation, incorporates several GMP-related principles such as QMS requirements, manufacturing controls, performance evaluation, quality assurance, and document control.

EU IVDR regulates in vitro diagnostic devices to ensure they are safe, effective, and reliable for diagnostic purposes. EU IVDR applies across all EU member states and governs manufacturers, importers, and distributors of IVDs. The regulation is enforced by national competent authorities and relies on designated notified bodies for conformity assessments, particularly for higher-risk devices. EU IVDR is supervised by the European Commission and the MDCG, similar to EU MDR.

The objective of EU IVDR is to strengthen patient safety and improve diagnostic accuracy. EU IVDR’s core requirements include maintaining a quality management system, technical documentation, and post-market surveillance.

International Guidelines

International Guidelines that provide globally recognized frameworks that support GMP implementation are listed below.

• ICH Q7: ICH Q7 provides GMP guidance for the manufacture of active pharmaceutical ingredients (APIs) and outlines requirements for quality management, personnel, documentation, and change control in API production.
• WHO GMP: The World Health Organization (WHO) GMP guidelines serve as a non-binding global standard, helping countries—especially those with developing regulatory systems—establish and improve pharmaceutical quality assurance practices.
• PIC/S GMP Guide: The Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide harmonizes GMP standards among participating countries and supports mutual recognition of inspections through aligned regulatory expectations.

GMP guidelines are complemented by ICH Q8 for Pharmaceutical Development, Q9 for Quality Risk Management, and Q10 for Pharmaceutical Quality Systems. These ICH guidelines introduce quality-by-design, risk assessment, and lifecycle-based system management.

ICH Q7

ICH Q7 is a guideline that outlines good manufacturing practices for the production, quality control, and distribution of active pharmaceutical ingredients (APIs). ICH Q7 defines the framework needed to ensure the quality and purity of APIs used in drug products.

ICH Q7 applies internationally across the pharmaceutical industry and is relevant for API manufacturers supplying regulated markets. Although ICH Q7 is not legally binding, regulatory authorities worldwide—including the FDA, EMA, and others—commonly use it as a framework during inspections of API facilities.

The main objective of ICH Q7 is to ensure that APIs are consistently produced with suitable quality and full traceability through effective control measures. ICH Q7 key requirements include document control, validated manufacturing and analytical processes, personnel training, suitable facilities and equipment, change control, and deviation management.

WHO GMP

WHO GMP refers to the good manufacturing practice guidelines published by the World Health Organization to ensure the consistent production of pharmaceutical products with assured quality and safety. WHO GMP provides a framework for manufacturing practices, quality control, hygiene, and documentation for medicines, vaccines, and other medicinal products.

WHO GMP applies globally and supports pharmaceutical manufacturers, regulators, and procurement agencies. Although not legally binding, WHO GMP serves as a foundation for national regulations in many countries and is adopted by regulatory bodies worldwide.

WHO GMP’s primary objective is to promote public health by ensuring the availability of safe, effective, and quality-assured medical products. Key requirements of WHO GMP include written procedures, trained personnel, clean and maintained premises, validated processes, and quality control.

PIC/S GMP Guide

The PIC/S GMP guide is a harmonized set of good manufacturing practice standards developed by the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international partnership of regulatory authorities aiming to enhance cooperation and inspection uniformity. PIC/S GMP guide sets expectations for the manufacture and quality control of medicinal products for human and veterinary use.

PIC/S GMP guide applies across member countries, which include regulatory authorities from Europe, the United States, South America, Asia, and other regions, covering pharmaceutical and biopharmaceutical industries. PIC/S GMP guide is not legally binding but serves as the inspection standard for member authorities and supports mutual recognition agreements to reduce regulatory duplication.

PIC/S GMP Guide’s core objective is to facilitate global alignment in GMP enforcement, ensure consistent product quality, and promote trust among participating regulators. The guide requires qualified personnel, validated processes, suitable and maintained equipment and premises, effective complaint handling, and traceable records and documentation throughout the manufacturing lifecycle.

What Are the Core Components of GMP?

Core components of GMP are the foundational elements required to ensure consistent product quality, safety, and regulatory compliance along the product lifecycle.

The core components of GMP are presented below.

• Quality Management System: A documented quality management system must be in place defining responsibilities, procedures, and resources required for quality management. A GMP QMS ensures compliance and continuous improvement.
• Personnel and Training: Personnel must receive role-specific training that ensures an understanding of job tasks and GMP requirements. All personnel training activities must be documented.
• Premises and Equipment: Facilities and equipment must be designed, maintained, and cleaned to prevent contamination or mix-ups and ensure controlled manufacturing environments. Equipment calibration logs and preventive maintenance records must be maintained to ensure ongoing process control.
• Production and Process Controls: Critical manufacturing processes must be validated and defined with sufficient detail to ensure reproducibility and product quality. In-process controls, batch record reviews, and deviation handling must be part of routine operations.
• Quality Control and Testing: Materials and finished products must meet established specifications. Testing must be performed with validated methods. Raw material and finished products shall not be released without successful testing results.
• Documentation and Recordkeeping: Every GMP activity must be supported by documented procedures and captured in real-time using ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) and ALCOA+ (Complete, Consistent, Enduring, Available) principles. All actions must be documented and traceable, ensuring data integrity and inspection readiness.
• Validation and Qualification: Critical processes, equipment, methods, and systems must be validated and qualified to demonstrate suitability for their intended use. Periodic re-evaluation of processes and systems shall be performed to ensure consistent and compliant performance.
• Sanitation and Hygiene: Comprehensive cleaning procedures, environmental monitoring, proper gowning, and personnel hygiene programs must be implemented. Materials handling procedures must include segregation and contamination prevention controls.
• Complaints and Recalls: Quality procedures must be in place for managing complaints, conducting root cause analysis, and executing product recalls. These quality procedures ensure risk mitigation and compliance with regulatory authorities’ expectations.

How to Ensure GMP Compliance?

To ensure GMP compliance, organizations must implement standardized procedures that align with regulatory expectations and foster a culture of quality and accountability.

The steps to achieve GMP compliance are listed below.

1. Establish a Quality Management System (QMS): Implement a QMS that aligns with GMP principles, including procedures such as deviation management, change control, batch release, and documentation handling. The QMS must support risk-based thinking, facilitate Good Documentation Practices, and maintain continuous GMP audit readiness.
2. Train Personnel: Develop a formal GMP training program. All employees must undergo initial and ongoing training to ensure they are competent and qualified for their roles. Training should cover SOPs, hygiene practices, and GMP principles.
3. Control Documentation and Records: Implement strict control over documents and records using ALCOA+ principles to ensure data integrity and traceability. All documents must be version-controlled, and approved and must be properly retained for predefined retention periods.
4. Validate Processes and Systems: Perform validation of all critical manufacturing, cleaning, and analytical processes. Confirm that all systems (including computerized systems) perform as intended.
5. Qualify Facilities and Equipment: Qualify, maintain, and clean facilities and equipment properly to ensure controlled manufacturing environments free from cross-contamination. Monitor and control environmental conditions in manufacturing rooms to prevent contamination and ensure consistent product quality.
6. Qualify Suppliers: Develop a supplier qualification procedure that includes supplier audits, quality agreements, and performance tracking.
7. Implement CAPA Procedures: Establish Corrective and Preventive Action procedures to systematically address root causes of deviations, complaints, or audit findings and prevent recurrence.
8. Conduct Self-Inspections: Regularly inspect operations for GMP compliance. During self-inspections identify any deviations from written procedures and areas for improvement, supporting proactive compliance and readiness.
9. Promote Continuous Improvement: Foster a culture of ongoing enhancement through methods like Kaizen, integrating audit findings, CAPA, and employee feedback to refine quality systems.
10. Prepare for Regulatory Inspections: Ensure inspection readiness by maintaining compliant systems, complete and accessible records, and well-trained personnel capable of demonstrating compliance with GMP requirements at any time.

What Is the GMP Certification Process?

The steps of the GMP certification process are presented below.

1. Regulatory Understanding and Preparation: Manufacturers must understand applicable GMP regulations for their product category and market, such as EU-GMP or FDA cGMP.
2. Gap Analysis and Compliance Planning: An assessment is conducted to identify compliance gaps, followed by a structured plan to resolve deficiencies.
3. Development of Quality Management System (QMS): A GMP-compliant QMS is established, covering documentation, roles and responsibilities, change control, risk management, deviation handling, and quality metrics, among others. Consider using a recognized standard such as ISO 13485 as a framework.
4. Assurance of GMP Compliance: The facilities and equipment must be qualified to meet cleanliness and operational requirements. Critical processes must be validated. Personnel must be trained for their duties. Document control must be implemented. GMP compliance must be verified through self-inspections.
5. Regulatory Authority Inspection: Competent authorities inspect the site to verify GMP compliance, reviewing processes, records, facilities, and systems.
6. Closure of Inspection Findings: Any deficiencies are addressed through a documented Corrective and Preventive Action process to close findings effectively.
7. Compliance Status Determination: Regulatory authorities determine the compliance status of the facility based on inspection outcomes. In the EU, competent authorities issue a GMP certificate or a non-compliance statement following inspection, which is available in the EudraGMDP database. In contrast, the FDA does not issue GMP certificates; instead, the FDA provides CGMP compliance letters to foreign regulators upon request.

How Does GMP Relate to Other GxP Guidelines?

GMP is one of the GxP components, specifically focused on ensuring the quality, safety, and consistency of manufactured products. GxP is a collective term for regulations and quality guidelines that govern Good x Practices in life sciences, where “x” represents a specific area such as Manufacturing, Laboratory, or Clinical.

GxP requirements complement each other by governing different stages of the product lifecycle to uphold quality and patient safety across the life sciences sector.

The major GxP guidelines are listed below.

• GLP (Good Laboratory Practice): Governs non-clinical laboratory studies to ensure data reliability and integrity of studies.
• GCP (Good Clinical Practice): Applies to clinical trials involving human subjects, ensuring that studies are ethically conducted, scientifically sound, and that participant rights and safety are protected.
• GDP (Good Distribution Practice): Controls the storage, transport, and distribution of medicinal products to maintain product integrity and prevent contamination or falsification.
• GVP (Good Pharmacovigilance Practice): Regulates post-market monitoring of drug safety by requiring the collection, evaluation, and reporting of adverse effects and safety signals.
• GAMP (Good Automated Manufacturing Practice): Provides guidance for validation and use of automated systems in regulated environments, ensuring computerized systems are reliable and compliant.
• GRP (Good Regulatory Practice): Refers to a set of practices that promote consistent, transparent, and evidence-based regulatory decision-making processes. FDA has developed Good Review Practices (GRPs) within the Center for Drug Evaluation and Research that guide the review process of new drug products.

How Does QMS Software Support GMP Compliance?

A QMS software supports GMP compliance by digitizing the processes required to meet regulatory expectations for product quality, safety, and traceability. QMS software enables companies to maintain controlled documentation, manage equipment calibration and maintenance, monitor changes, qualify suppliers, and more. Electronic QMS reduces human error and improves data integrity, through automated workflows and access restrictions. An eQMS provides a real-time overview of the open tasks, promoting timely completion.

SimplerQMS offers QMS software for life sciences, designed specifically to help pharmaceutical, biotech, and medical device companies comply with stringent requirements, including GMP. SimplerQMS supports quality processes, including document control, change control, CAPA, training management, supplier management, audit management, and equipment management among others.

SimplerQMS supports compliance with major GMP regulations and guidelines such as FDA 21 CFR Part 210/211, Part 820, and EU-GMP. SimplerQMS helps life science companies to ensure that their documents are version-controlled, equipment is calibrated on schedule, change requests are tracked through review and approval workflows, and supplier documentation is complete and up to date, among others. SimplerQMS complies with FDA 21 CFR Part 11 and EU Annex 11, fulfilling the GMP requirements for computerized systems, and is fully validated according to ISPE GAMP 5.