WHO GMP vs Indian GMP: A Manufacturer’s Guide to GMP
- Akshay Gautam
- Oct 18
- 13 min read
By harmonizing the gold standard of WHO GMP with India's enhanced Schedule M, the Indian pharmaceutical industry is poised to become a global leader, delivering safe, trusted, and world-class medicines worldwide.
Introduction
Good Manufacturing Practices (GMP) are the foundation of quality in the pharmaceutical industry. They ensure that every medicine is consistently safe, effective, and of high quality. This commitment to excellence protects public health and builds trust in medicines worldwide.
Globally, the World Health Organization (WHO) provides comprehensive GMP guidelines. The most important ones are TRS 986 Annex 2 for general GMP and TRS 1044 Annex 2 for sterile medicines. These guidelines are international benchmarks, especially important for companies that export medicines.
In India, GMP standards are outlined in Schedule M of the Drugs and Cosmetics Rules, 1945. A major update on December 28, 2023, by the Department of Health and Family Welfare, brought Indian GMP standards much closer to the WHO framework. While this update aligns India with global best practices, companies still need to follow specific Indian compliance rules.
For pharmaceutical companies in India or those exporting from India, understanding the differences between WHO GMP and Indian GMP is crucial. It's not just about following the rules; it's essential for competing in the market and being ready for global trade. Walter Healthcare offers expert guidance and solutions to help companies comply with both sets of regulations.
This blog post will simplify these complex rules by looking at their similarities, highlighting key differences, explaining how to put them into practice, and detailing the steps to get certified. Our goal is to provide a practical comparison that helps your pharmaceutical operations achieve and maintain the highest quality standards.
Understanding Good Manufacturing Practices
Good Manufacturing Practice (GMP) is a quality system that guarantees products are consistently manufactured and controlled to established standards. Its purpose is to mitigate risks inherent in pharmaceutical production that cannot be entirely removed through final product testing.
GMP goes beyond final product testing by preventing errors, contamination, and quality failures throughout every stage of production. It applies to:
Strategically sourcing and meticulously handling raw materials
Innovatively designing facilities and state-of-the-art equipment
Empowering personnel through comprehensive training and upholding impeccable hygiene standards
Maintaining meticulous documentation and robust record-keeping
Implementing rigorous process validation and stringent quality control
Ensuring the safest packaging, precise labeling, and efficient distribution
History of GMP
The concept of Good Manufacturing Practice was not developed overnight; rather, it has evolved over decades, with different public health crises, regulatory reforms, and global harmonization efforts and their responses. This is a chronological history of Good Manufacturing Practice (GMP), detailing its evolution through public health crises, regulatory shifts, and international cooperation, all supported by official references.
Roadmap of GMP
This U.S. legislation was the first major step in fighting tainted and misleading food and drugs, beginning formal drug regulation. While it didn't set manufacturing standards, it started a crucial public conversation about controlling what was being consumed.
1930s- Tragedy Drive
1937- The Sulfanilamide Disaster (USA) The tragic deaths of over 100 people, many of them children, due to a sulfanilamide preparation dissolved in diethylene glycol (DEG), marked a critical juncture in global drug safety. This event unequivocally demonstrated that assumptions cannot be relied upon in drug safety and underscored the vital importance of stringent oversight in drug production.
In response, the U.S. enacted the Federal Food, Drug, and Cosmetic Act in 1938. This legislation mandated that drug manufacturers prove the safety of their products before bringing them to market.
1960s- Global Drug Disasters Shape Modern GMP
Initially sold for morning sickness and as a sedative, thalidomide caused a global disaster with over 10,000 babies born with severe birth defects. This tragedy highlighted the need for strict regulatory oversight and rigorous safety standards in the pharmaceutical industry.
1962- Kefauver-Harris Amendments (USA)
In response to the thalidomide tragedy, the U.S. enacted the Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act. These amendments established crucial requirements, including:
Mandatory proof of both safety and efficacy is required before a product can be marketed.
Rigorous regulation of clinical trials.
The groundwork for GMP (Good Manufacturing Practice) requirements in manufacturing.
Late 1960s- The Birth of GMP
The WHO published the first draft of GMP within its Technical Report Series (TRS No. 37), introducing the first draft of Good Manufacturing Practices, a pivotal move towards global drug quality and international harmonization of requirements.
1970s- 2000s- Global Expansion of GMP
1970s- Adoption by National Authorities
The U.S. FDA adopted GMP regulations (later called cGMP -current GMP).
The European Economic Community (EEC) issued directives requiring pharmaceutical manufacturers in Europe to follow GMP.
WHO began assisting member states in adopting GMP into their national laws.
WHO published “Good Manufacturing Practices for Pharmaceutical Products: Main Principles” in TRS 908, Annex 4, which became a global reference point for national regulators.
2009- Strengthening the WHO GMP
WHO TRS 986 (2009), Annex 2. This unified document set the standard for international GMP, highlighting:
Quality management systems
Documentation control
Process validation
Risk-based approaches
2017- Sterile Products Guidance
WHO TRS 1044 (2017), Annex 2: Given the intricate nature of sterile manufacturing (think injections and ophthalmic products), the WHO has revised its GMP guidance for sterile pharmaceuticals, bringing it into close alignment with the EU GMP Annex 1.
GMP in India- Evolution of Schedule M
India’s regulatory framework was established under the Drugs and Cosmetics Act 1940 and Rules, 1945, with the minimal initial manufacturing standards.
1988- Schedule M GMP Introduction
Mandating the basic requirements in terms of premises, equipment, and documentation for the very first time, India introduced GMP under Schedule M.
A significant amendment, notified on December 11, 2001, updated Schedule M to better align with WHO Good Manufacturing Practices (GMP), thereby making GMP a mandatory requirement for all pharmaceutical manufacturing facilities in India.
India made a monumental move on December 28th, 2023, with the G.S.R. 912(E) notification. This landmark update introduces a revamped Schedule M, ushering in:
Pharmaceutical Quality System (PQS), perfectly aligned with ICH Q10 standards.
Risk Management Principles, mirroring the robust guidelines of ICH Q9.
Present condition
GMP is a global standard, adopted by over 100 countries, either directly via WHO guidelines or indirectly by aligning with regulations from the U.S. FDA, EMA, or PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme). It forms the essential basis for regulatory compliance in the pharmaceutical industry, ensuring that patients consistently receive medicines that are safe, effective, and of high quality.
What is WHO GMP
WHO GMPs are global standards for pharmaceutical quality, safety, and consistency. It's a system focused on preventing risks during production, rather than solely relying on end-product testing, to ensure products are consistently produced and controlled according to quality standards.
Why WHO GMP required
The World Health Organization (WHO) introduced Good Manufacturing Practices (GMP) in 1968 through its Technical Report Series (TRS No. 37). The need arose from:
Public Health Tragedies
Tragedies like the 1937 Sulfanilamide disaster in the USA and the 1961 Thalidomide disaster in Europe demonstrated that unsafe medications can lead to widespread deaths and lasting health problems.
These events underscored that ensuring quality requires preventing errors, contamination, and unsafe practices during manufacturing, rather than relying solely on testing finished products.
Lack of Global Harmonization
Previously, each country, if it had any regulations, adhered to different standards. Developing nations often lack manufacturing regulations, posing risks to patients and hindering international trade.
The WHO established GMP to set a global standard for medicine quality, particularly for member states without well-developed regulatory systems.
Global Public Health Needs
WHO GMP was created to guarantee that safe, effective, and high-quality medicines are available globally, especially in low- and middle-income nations.
It serves as the foundation for national GMP regulations, such as India's Schedule M, EU GMP, and PIC/S standards.
Principle of WHO GMP
WHO GMP emphasizes quality assurance and risk prevention by ensuring that:
Products are consistently manufactured to predefined specifications.
Cross-contamination, mix-ups, and adulteration risks are minimized.
Documentation, traceability, and accountability are maintained.
Personnel, premises, equipment, and processes adhere to stringent quality standards.
Certification WHO for GMP
WHO GMP certification is not directly issued by WHO; rather, it is a vital endorsement issued by a country’s National Regulatory Authority (NRA), like in India, it is done by CDSCO. It's proof that a manufacturer adheres to the rigorous quality standards set by WHO Good Manufacturing Practices.
Journey of Certification
Apply to the NRA: The manufacturer initiates the process by applying to their country's regulatory body.
Dossier Deep Dive: The NRA meticulously reviews crucial documents – think quality manuals, standard operating procedures (SOPs), and detailed facility information.
On-Site Verification: Inspectors pay a visit to the manufacturing facility, ensuring everything aligns perfectly with WHO GMP standards.
The Green Light: If all checks out, the authority proudly issues the WHO GMP Certificate.
Time Duration
Typically valid for 2-3 years, subject to renewal and further inspections to maintain those high standards.
It can be tailored either for a specific product or the entire manufacturing site.
Why is it a Game-Changer?
Export Powerhouse: This certification is your passport to exporting medicines to a multitude of countries and agencies that demand WHO GMP compliance.
United Nations Approval: It's a non-negotiable requirement for supplying life-saving medicines to UN procurement agencies like WHO, UNICEF, and UNFPA.
Global Credibility: More than just a certificate, it provides international recognition, significantly boosting your credibility and opening doors to new markets worldwide.
What is Indian GMP
Good Manufacturing Practice (Indian GMP) sets quality standards for pharmaceutical manufacturing under Schedule M of the Drugs and Cosmetics Rules, 1945. This ensures safe, effective, and consistent quality products, produced under controlled conditions to prevent issues and comply with regulatory requirements for both domestic and export markets.
Requirement for Indian GMP
Patient Safety: Guarantees safe and effective medicines.
Regulatory Compliance: Mandated by Indian law; ensures license validity.
Global Competitiveness: Enables export to regulated markets via WHO GMP.
Drug Quality: Reduces counterfeit and substandard medicines.
Quality by Design: Integrates quality into all production phases.
Principles of Indian GMP
The revised Schedule M (2023) outlines detailed GMP principles for Indian manufacturers, including:
Pharmaceutical Quality System (PQS): Based on ICH Q10, ensuring quality throughout the product lifecycle.
Quality Risk Management: In line with ICH Q9, assessing, controlling, and reviewing risks to product quality.
Good Documentation Practices (GDP): Clear, accurate, and traceable documentation of all manufacturing activities.
Premises & Equipment: Design and maintenance to minimize contamination and mix-ups.
Personnel & Training: Qualified, trained staff following strict hygiene protocols.
Validation & Qualification: Validating manufacturing processes, equipment, and cleaning for reproducibility.
Data Integrity: Accurate, complete, and tamper-proof records (ALCOA+ principles).
Self-Inspection & Audits: Regular internal audits for GMP compliance.
Control of Materials: Ensuring raw materials, intermediates, and packaging meet quality requirements.
Sterile Manufacturing Requirements: Strict controls for aseptic processing and sterile facilities.
Certification of Indian GMP
The Central Drug Standard Control Organization (CDSCO) or the State Licensing Authority (SLA) holds the key to what you are manufacturing.
The Certification Journey:
Apply: Send your application to the SLA/CDSCO, including all your facility and product details.
Review: The authorities will carefully check your documents against Schedule M requirements.
Inspect: Get ready for an on-site visit, as they'll thoroughly examine your premises, equipment, staff, and records.
Report: If you meet all GMP standards, you'll receive a compliance report.
Certify: Finally, you'll get your highly sought-after GMP compliance certificate, directly linked to your manufacturing license.
Time Duration
Typically, certification is valid for 3 years, but remember, renewals and re-inspections keep you on your toes.
Why is it a game-changer
The 2023 Schedule M revision transforms Indian GMP into a globally aligned, risk-based quality framework by:
Implementing Risk-Based Quality Systems: Aligns with ICH Q9 & Q10.
Integrating Data Integrity (ALCOA+): Ensures accurate, traceable data.
Including SMEs: Provides phased deadlines for small and medium manufacturers.
Enhancing Global Market Access: Foundation for WHO GMP certification.
Strengthening Global Reputation: Elevates India as a trusted medicine hub.
Difference Between WHO GMP And Indian GMP
Pharmaceutical Quality System (PQS)
What it is: The PQS is a framework of processes, procedures, and responsibilities, ensuring high quality of pharmaceutical products throughout their lifecycle.
WHO GMP: Emphasizes a risk-based quality system from product design to distribution, aligning with ICH Q10 guidelines.
Indian GMP: The 2023 update to Schedule M mandates a Pharmaceutical Quality System (PQS), including documentation, validation, change control, and self-inspections. This translates the WHO GMP principles into a legally enforceable framework in India, making quality management a mandatory and structured process.
Quality Risk Management (QRM)
What it is: Pharmaceutical Quality Risk Management (QRM) proactively identifies, assesses, and controls risks to product quality, ensuring patient safety and efficacy by minimizing defects.
WHO GMP: The World Health Organization's GMP guidelines champion risk assessment as a vital tool to combat contamination and mix-ups. They offer a flexible framework, letting manufacturers tailor their approach.
Indian GMP: Mandates the ICH Q9 risk-based approach. This isn't just a suggestion; it's a legal obligation for every pharmaceutical manufacturer in India. We're talking meticulously documented, regularly reviewed risk assessments to ensure top-notch product quality. This isn't just about compliance; it's India's unwavering commitment to aligning with the absolute best in global pharmaceutical quality and safety.
Validation and Qualification
What it is: Guaranteeing consistent, top-quality products involves meticulously designed processes for equipment, manufacturing, cleaning, and analytical methods. Ever wondered about the difference between WHO GMP and Indian GMP? While WHO GMP offers a flexible, risk-based approach to validation, adapting to product types, Indian GMP takes a more prescriptive stance. It mandates detailed IQ/OQ/PQ, cleaning validation, and process validation, all meticulously documented as per Schedule M.
Furthermore, while WHO GMP requires DQ, IQ, OQ, and PQ/PV for facilities, equipment, and processes, Indian GMP expands this to include rigorous validations for cleaning, analytical methods, and computerized systems, with strict inspection enforcement.
Documentation and Records
What it is: Documentation and records are vital for GMP adherence, demonstrating consistent product quality and control. They ensure traceability, accountability, and integrity throughout manufacturing, from raw materials to finished goods, proving products meet established quality standards.
WHO GMP focuses on the ALCOA principles: Attributable (who acted), Legible (information is readable), Contemporaneous (recorded at the time of the action), Original (the first or primary recording), and Accurate (free from errors).
Indian GMP expands upon these principles with ALCOA+, which adds Complete (all necessary information is present), Consistent (data is uniform and coherent), Enduring (records are durable and retrievable over time), and Available (records are accessible when needed). Additionally, Indian GMP specifically mandates the implementation of Standard Operating Procedures (SOPs), detailed batch records, robust deviation management systems, and regular self-inspections to ensure compliance and quality assurance.
Infrastructure Requirements
What it is: The infrastructure of a pharmaceutical manufacturing facility is the foundation of GMP compliance. It ensures that products are manufactured in an environment that maintains quality, safety, and efficacy from start to finish.
WHO GMP: Offers a more flexible approach, providing recommendations for facility design that prioritize preventing contamination and mix-ups without prescribing rigid specifications. This allows for adaptation to various manufacturing contexts and evolving technologies.
Indian GMP: Takes a more detailed and prescriptive approach. It sets specific standards for the layout of facilities, the types and installation of utilities, and the equipment used. It also mandates segregation for sterile and non-sterile processes to prevent cross-contamination and outlines comprehensive monitoring requirements for environmental parameters and equipment performance.
API Manufacturing and Movement
What it is: These standards specifically address the production, sourcing, and internal handling of Active Pharmaceutical Ingredients (APIs). APIs are the biologically active components of a drug product that produce the desired therapeutic effect. Adherence to these standards ensures the quality, safety, and efficacy of these crucial ingredients.
WHO GMP: WHO GMP encourages robust quality management for APIs, with direct implementation varying by local authorities. Adherence ensures product quality and traceability throughout the supply chain. These guidelines are crucial for maintaining high standards, but their application depends on each country's regulatory framework, leading to some regional differences in enforcement.
Indian GMP (Indian Good Manufacturing Practices): In India, compliance with GMP is mandatory for all API manufacturers. This includes a stringent requirement for comprehensive documentation at every stage of the API lifecycle, from the initial sourcing of raw materials to the various testing procedures and the movement of the API within and between facilities. This mandatory compliance and detailed documentation are designed to ensure full accountability and traceability, contributing to the overall quality and safety of medicines produced in India.
Drug categories
What it is: This section precisely defines and delineates the specific categories of pharmaceutical products and related substances that fall under the mandatory purview of Good Manufacturing Practices (GMP) regulations. Understanding these categories is crucial for manufacturers, regulatory bodies, and consumers alike, as it dictates the application of rigorous quality and safety standards throughout the entire manufacturing process.
WHO GMP: The WHO GMP guidelines are crucial for global pharmaceutical quality, covering all types of drugs. They ensure the safety and efficacy of sterile products, complex biologics, generic drugs, active pharmaceutical ingredients (APIs), and finished pharmaceutical products (FPPs), promoting consistent high standards across the industry.
Indian GMP: Indian GMP is mandatory for all drugs manufactured and distributed in India, encompassing a wide range of products, including Allopathic, Ayurvedic, Siddha, Unani, Homeopathic, and Herbal products, as well as manufacturers of all sizes. This broad scope ensures consistent quality and safety for all products consumed, protecting public health.
Similarities in WHO GMP and Indian GMP
Objective and Authority
Ever wondered about the quality? WHO GMP provides global guidance, like a trusted compass for safety. Indian GMP, however, is the mandatory law for manufacturers here, enforced by CDSCO. While both champion patient safety, one offers advice, the other demands legal adherence.
Principles of GMP
While both WHO and Indian GMP share the same core quality philosophy of contamination control, consistent manufacturing, risk management, and documentation, Indian GMP translates these universal principles into specific, mandatory, and auditable requirements for enforcement within India.
Quality System (PQS and QRM)
Comparative Insight: WHO defines “what should be done”, Indian GMP enforces “how it must be executed”. While WHO GMP encourages Pharmaceutical Quality Systems (PQS) and Quality Risk Management (QRM), Indian GMP mandates their implementation, including detailed processes like deviation handling, CAPA, and change control, effectively defining the practical execution of these quality principles.
Validation and Documentation
While WHO GMP recommends validation and ALCOA principles as a concept, Indian GMP mandates the execution with strict documentation through validation protocols (IQ, OQ, PQ) and expands to ALCOA+, making data integrity legally binding and comprehensively enforced.
Global vs Domestic Scope
WHO GMP safeguards global pharmaceutical quality and trade. Indian GMP, while regulating the domestic market, acts as a stepping stone for international certification. This reflects India's commitment to national standards with an eye towards global recognition and ensuring the quality and safety of medicines worldwide.
Walter Healthcare's Role in GMP Compliance
Good Manufacturing Practices (GMP) are vital in the pharmaceutical industry for quality, safety, and reputation. While the WHO GMP provides global benchmarks and the Indian GMP (Revised Schedule M, 2023) ensures national adherence, implementing these complex regulations daily poses a challenge for manufacturers. Walter Healthcare addresses this by acting as a strategic enabler, helping pharmaceutical companies navigate GMP intricacies. We offer comprehensive compliance strategies, practical implementation support, and certification guidance. From securing Indian GMP certification to aligning with WHO GMP for international recognition, Walter Healthcare helps manufacturers build sustainable, inspection-ready quality systems, ensuring both regulatory excellence and global competitiveness.
Conclusion
Good Manufacturing Practices (GMP) are fundamental to ensuring the quality, safety, and global trustworthiness of pharmaceutical products. While the WHO GMP establishes international guidelines, the Indian GMP (Schedule M, 2023) translates these principles into legally binding domestic standards. A thorough understanding of their similarities, differences, and practical application is crucial for manufacturers aiming for compliance, global competitiveness, and market credibility. Navigating these intricate regulations demands expertise in quality systems, risk management, validation, documentation, and infrastructure. Walter Healthcare steps in as a vital partner, bridging the gap between regulatory frameworks and operational execution. By providing compliance strategies, hands-on implementation support, and guidance for certification, Walter empowers pharmaceutical companies to build sustainable, inspection-ready quality systems. Ultimately, adhering to both WHO and Indian GMP standards not only fulfills regulatory requirements but also fosters a reputation for excellence, safety, and reliability in both domestic and international markets, ensuring a future where patient trust and product integrity go hand-in-hand.
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