Quality Risk Management: Putting GMP Controls First

No-Touch Transfer (NTT) of pre-sterilised ready-to-use (RTU) containers is an alternative methodology that follows Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) principles. NTT de-bagging ejects contents from secondary bag packaging without direct contact with contents or exposure to an environment that is a lower grade than the zone being entered. The pre-sterilised containers and sterile barriers offer assured sterility at manufacture and are qualified to remain sterile through the supply chain and the stepwise NTT de-bagging process. This eliminates the requirement for in-process material disinfection steps for transfer into Grade A environments. The present article focuses on design qualification of pre-sterilised RTU container packaging, including definition of sterile barriers together with bioburden study data through the supply chain and simulated NTT. It completes a series of EJPPS articles to support peer-reviewed references on NTT. Together, these articles can be defined as end-to-end qualification of the NTT process, demonstrating a high level of assurance that sterility is maintained from manufacture to point of use. Key Words: Aseptic processing, Design qualification, Good Manufacturing Practice (GMP), Life cycle, No-Touch Transfer (NTT), Pharmaceutical packaging, Pre-sterilised containers, Qualification, Quality by Design (QbD), Quality Risk Management (QRM), Ready-to-use (RTU), Supply chain

The revised Schedule M under India’s Drugs and Cosmetics Rules, 1945 has emerged as one of the most significant regulatory reforms in the pharmaceutical manufacturing landscape in recent years. It upgrades the framework for good manufacturing practices (GMP) by emphasizing pharmaceutical quality systems, quality risk management, product quality review, validation, computerized record control, and enhanced accountability in premises, plant, and equipment. This review examines the scenario of Indian pharmaceutical micro, small, and medium enterprises (MSMEs) in the context of the revised Schedule M, with a focus on the regulatory shift, compliance burden, preparedness, and policy implications. Using publicly reported secondary data, the paper performs descriptive statistical analysis, proportion testing, confidence interval estimation, and state-level comparison to quantify the readiness gap. The results indicate that 1,700 of 6,500 non-GMP MSME drug manufacturers had submitted upgrade plans, equivalent to 26.15% preparedness, while 73.85% remained outside the reported transition pipeline. The 95% confidence interval for readiness is 25.08%–27.23%, indicating a stable but low compliance rate. Gujarat’s reported gap-analysis submission rate of 98.77% stands far above the national MSME average, underscoring sharp interstate variation. The review concludes that while revised Schedule M can strengthen product quality, export readiness, and patient safety, its success among MSMEs depends on phased implementation, technical handholding, affordable financing, and cluster-based infrastructure support.

The suitability of good manufacturing practice (GMP) for the quality assurance of the preparation in hospital pharmacies is investigated. It is expected that the recent expansion of GMP with quality...

The European Qualified Person (QP) holds unique legal responsibility for certifying batch release, ensuring patient safety, and maintaining regulatory compliance. Modern pharmaceutical manufacturing-especially in biologics, advanced therapy medicinal products (ATMPs), and personalized medicines-generates complex, multi-site, data-rich environments that challenge traditional oversight. Artificial Intelligence (AI) offers predictive analytics, anomaly detection, and trend recognition to support decision-making but cannot currently replace the QP's scientific judgment or legal accountability. The forthcoming Annex 22 introduces Human-in-the-Loop (HITL) frameworks that embed human oversight within AI-supported processes, aligning technological advancement with regulatory control. This review explores evolving QP responsibilities, core and emerging competencies, AI integration within Quality Risk Management (QRM) and Good Manufacturing Practice (GMP) frameworks, and ethical considerations, illustrated with practical case studies. By developing AI literacy and applying HITL oversight, QPs can more effectively translate technological potential into transparent, science-based, and patient-centered batch-release decisions.

Good Manufacturing Practices (GMP) play a critical part in ensuring the quality, safety, and efficacity of nutraceutical products during their manufacturing process. This abstract provides an overview of the significance of GMP in enhancing conditions for nutraceutical products. It highlights crucial rudiments of GMP, including installation design and conservation, labor force training and qualifications, raw material sourcing, and control, manufacturing processes and controls, packaging and labeling, and quality control and testing procedures. The epitome also discusses the challenges and considerations in enforcing GMP in nutraceutical manufacturing, along with strategies for successful perpetration and compliance. Also, it explores advances in GMP, similar to emerging technologies and inventions, and the integration of quality operating systems and robotization for better effectiveness and safety. Likewise, this emphasizes the significance of routine GMP checkups and examinations to ensure compliance and provides best practices for preparing and navigating examinations. Incipiently, it presents unborn perspectives and recommendations for further enhancing product safety and consumer health through ongoing advancements in nutraceutical GMP. Overall, this underscores the pivotal part of GMP in elevating the norms and conditions for nutraceutical products, eventually contributing to the production of high-quality and safe nutraceutical products.

In the healthcare industry, maintaining high-quality standards is crucial to ensure the safety and efficacy of medical products. Good Manufacturing Practices (GMP) provide a set of guidelines and regulations that help ensure the consistent production, control, and quality assurance of pharmaceuticals, medical devices, and other healthcare products. This paper explores the significance of GMP in the healthcare industry, highlighting its background, objectives, role in safeguarding patient health and maintaining public trust. It examines the key principles of GMP, its regulatory framework, and its impact on various aspects of the healthcare sector, including drug manufacturing, quality control, product safety, and regulatory compliance. Furthermore, the paper discusses the challenges and future perspectives of GMP implementation, emphasizing the need for ongoing advancements to meet the evolving demands of the industry. To summarize, adherence to GMP standards is crucial for the healthcare industry to produce high-quality, safe, and effective healthcare products. GMP compliance promotes patient safety, regulatory compliance, and innovation in the pharmaceutical industry.

PICS : un système de coopération en matière d’inspection des produits pharmaceutiques

This paper covers key quality assurance/quality control issues from a Canadian perspective. Canadian Good Manufacturing Practices (GMP) regulations and guidelines, present and future, are discussed. The Canadian situation with respect to GMPs for active pharmaceutical ingredients (APIs) is explained. GMPs, with a focus on APIs, are discussed. A future direction for GMPs for APIs is offered. Key Canadian GMP regulation and guideline issues in development are reviewed. Concerns for APIs manufactured without GMP compliance are expressed, suggestions for API GMP requirements are offered, guiding principles for GMP regulations are suggested, a need for uniform quality standards is stated, and quality standard compliance advice for drug exporters to Canada is offered. ISO 9000 as not being a substitute for GMP compliance is also mentioned.

Emphasizes issues faced by analytical chemists working in the pharmaceutical industry subject to federal regulations, such as the FDA's Good Manufacturing Practice (GMP) rules.

In order to assure the quality of medicines and to encourage the implementation of the international system for the certification of the quality of pharmaceuticals, it was deemed necessary to specify the conditions under which pharmaceutical establishments should operate to provide full assurance that their products are safe for public health.The French Government Order of 1. October. 1985 therefore provides for the establishement of new recommendations on good pharmaceutical manufacturing practices: “Bonnes Pratiques de Fabrication et de Production Pharmaceutiques: BPF 1985”.Within the system of quality assurance, good pharmaceutical manufacturing practices represent that part which is concerned with manufacture.Their implementation requires that the specification of the raw materials and packaging materials, the manufacturing and packaging processes and the control methods be defined and written beforehand, that the premises and equipment be adapted to the intended uses and that the staff have received appropriate training.Good pharmaceutical manufacturing practices directly concern production departments and packing area, control laboratories, storage areas, purchasing departments, departments receiving raw materials and dispatching finished products. They also concern departments issuing instructions and written or computerised documents intended for the departments previously mentioned.Although the collection of recommendations thus published constitutes a detailed document, the possibility of there being different methods for attaining the same objective is recognised.

The purpose of the study is to substantiate the scientific implementation of a safety management system based on HACCP principles in the production of juice. Research Methods: Integral Risk Analysis, Decision Tree to Identify Critical Control Points. On the basis of theoretical data and research of the production process, an analysis of hazardous factors affecting the safety of the finished product is made. Based on the requirements of good hygiene and manufacturing practices (GMP and GHP), 13 prerequisite programs have been developed for the enterprise. The prerequisite programs specify which operational records should be maintained by the enterprise. According to the normative documents, which establish requirements for the HACCP system at the Ukrainian enterprises. Obligations in Ukraine are regulated by the provisions of the Code for the Association of Ukraine with the European Union and that it is consolidated on the basis of legislation and regulatory acts. The HACCP group at the enterprise, juice description, identification of specific consumer groups, development and validation of the block diagram, analysis of dangerous factors, establishment of critical control points, establishment of critical limits, monitoring systems, corrective actions, validation and verification procedures, and document management. The description of the juice includes the composition; structure and physicochemical characteristics; microbiological and chemical criteria; type of processing, method of consumer and transport packaging; type of marking; storage and transportation conditions; expiration date; method of consumption, marketing method; information about the intended consumer consumption (use). The production flowchart is based on the technological instructions of the enterprise and tested. Hazardous factors analysis includes biological, chemical and physical factors. On the basis of the analysis of the uncertainties, a critical production control point was established. The critical control point is determined at the stage of heat treatment of the product. Critical limits and monitoring system identified - critical points should be checked daily. Also, monitoring records of critical control points should be maintained on a daily basis. Keywords: safety management system, good manufacturing practices, prerequisite programs, hazard analysis, critical control points (ССР). REFERENCES 1. Uhoda pro asotsiatsiyu, March 21, 2014. – Avialable at: https://zakon3. rada.gov.ua/laws/show/984_011. 2. Pro osnovni pryntsypy ta vymohy do bezpechnosti ta yakosti kharchovykh produktiv Law of Ukraine of December 23, 1997 No. 771 – Avialable at: https://zakon.rada.gov.ua/laws/show/771/97-%D0%B2%D1%80. 3. Plakhotin, V. Ya. Problems of development and implementation of the HACCP system and ways of solving, (2009). – Vol. 36 (2). – Avialable at: http://nbuv.gov.ua/ UJRN/Np_2009_36%282%29__59. 4. HACCP & HARPC: What is the difference between the HACCP and HARPC (2019). – Avialable at: https://safefoodalliance.com/haccp/what-is-the-difference-between-thehaccp-and-harpc/. 5. HACCP, VACCP, TACCP and HARPC – Food Safety Plans Explained, (2019). – Avialable at: https://www.foodsafety.com.au/blog/haccpvaccp-taccp-and-harpc-food-safety- plansexplained. 6. Kafetzopoulos, P. Measuring the effectiveness of the HACCP Food Safety Management System (2013). Food Control, Volume 33, Issue 2, October 2013, P. 505–513. – Avialable at: https://www.sciencedirect.com/science/article/ abs/pii/S0956713513001667. 7. Goodrich, Schneider R. M. The Juice HACCP Program: An Overview / R. M. Goodrich Schneider, K. R. Schneider // IFAS Extension University of Florida. – Avialable at: https://edis.ifas.ufl.edu/pdffiles/fs/fs12400.pdf. 8. Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs. – Avialable at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R2073. 9. Khellier, M. Eksport zamorozhenykh dribnykh fruktiv do YES: Praktychnyy posibnyk dlya ukrayinsʹkoho ahrobiznesu (2017). – Avialable at: http://www.krcci.pl.ua/uploads/files/FrozenBerries_2017.pdf. 10. Schmidt, R. H. A Model HACCP Plan for Small-Scale, Fresh-Squeezed (Not Pasteurized) Citrus Juice Operations 1 (2007). – Avialable at: https://www.researchgate.net/publication/260401936_A_Model_HACCP_ Plan_for_Small-Scale_Fresh-Squeezed_Not_Pasteurized_Citrus_Juice_Operations_1. 11. Pyvovarov, YE. P. Systema upravlyannya yakistyu ta bezpechnistyu kapsulʹovanykh napivfabrykativ z probiotychnymy mikroorhanizmamay (2016). – Avialable at: http://repository.kpi.kharkov.ua/bitstream/KhPI-Press/21871/1/vestnik_KhPI_2016_12_Pyvovarov_Systema_upravlinnia.pdf. 12. Pro zatverdzhennya Vymoh shchodo rozrobky, vprovadzhennya ta zastosuvannya postiyno diyuchykh protsedur, zasnovanykh na pryntsypakh Systemy upravlinnya bezpechnistyu kharchovykh produktiv (НАССР) : Nakaz Ministerstva ahrarnoyi polityky ta prodovolʹstva Ukrayiny from October 01, 2012, № 590 – Avialable at: https://zakon.rada.gov.ua/laws/main/z1704-12. Published : 2020-05-12

Quality Risk Management (QRM) is a systematic process for identifying, evaluating, and controlling risks to product quality and patient safety in compliance with regulatory standards such as ICH Q9. In the pharmaceutical industry, QRM is essential for decision-making, process optimization, and maintaining regulatory compliance. However, its practical implementation faces several challenges, including inadequate training, inconsistent application across departments, insufficient and unreliable data, subjective risk scoring, and limited integration with Quality Management Systems (QMS). Organizational resistance, resource constraints, and varying expectations of global regulatory agencies further complicate the process. These issues can result in incomplete risk assessments, delayed mitigation measures, and reduced overall effectiveness of QRM frameworks. Addressing these challenges requires strong management commitment, harmonized procedures, regular training, and effective integration of QRM with QMS elements such as CAPA, deviation management, and change control. A proactive, data-driven, and continuously reviewed QRM system can transform risk management from a regulatory obligation into a strategic tool for quality improvement, efficiency, and patient safety. This review highlights key barriers in QRM and emphasizes the importance of targeted strategies to enhance its effectiveness and long-term sustainability in pharmaceutical quality assurance

The translation of experimental cell-based therapies to volume produced commercially successful clinical products that satisfy the regulator requires the development of automated manufacturing processes to achieve capable and scaleable processes that are both economic and able to meet the unpredictable demands of the market place. The Healthcare Engineering group at Loughborough has conducted novel demonstrators of the transfer of manual human cell culture processes to the CompacT SelecT (The Automation Partnership) automated cell culture platform, including an osteoblast cell line, embryonic carcinoma cell line, primary bone marrow-derived mesenchymal stem cells, primary umbilical cord-derived progenitor cells, and human embryonic stem cells. The work aims to develop and optimize automated cell culture processes for manufacturing cell-based therapies in a quality system and current good manufacturing practice (cGMP) compliant manner and is underpinned by the application of a six-sigma inspired quality engineering approach. In this technical brief, we outline the need for automated cell culture systems and automated process engineering for the manufacture of cell populations for therapeutic applications. We review the transfer of a manual cell culture process to an automated process and the subsequent methodology for process improvement using examples from our laboratory of the application of these principles to an important regenerative medicine cell type, the human mesenchymal stem cell. We believe that systematic process improvement methodologies combined with the process stability provided by automation are essential to engineer optimized cGMP compliant manufacturing processes that will be required to realize the promise of cell-based therapies.

BackgroundPharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations.MethodThe cost benefit of improving the quality of Chi Pharmaceuticals Limited’s facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR).ResultCost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0–5.5).ConclusionInvestment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

Implementation of good manufacturing practice (GMP) is an intelligent investment in building the good quality generics. It is the matter of fact that key GMP requirements for both generics and innovator drugs almost covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to personnel. This work helps in bringing the awareness about the key GMP requirements for manufacturing of generics in Brazil and Russia—the two pharma emerging BRICS nation which in turn reduces the trade barrier for international commerce. It demonstrates industry support and regulatory authority’s commitment for an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Keywords : BRICS, good manufacturing practice (GMP), generics manufacture, emerging market, Roszdranvadzor Cite this Article Kumar J, Jain A, Venkatesh MP. An Overview of GMP Requirements for Generics in Brazil and Russia. Research & Reviews: A Journal of Drug Formulation, Development and Production . 2016; 3(2): 7–14p.