http://www.japer.in/Issue/Issu%202%20august/32.

pdf Journal of Advanced Pharmacy Education & Research 2: 120-124 (2011) ISSN 2249-3379 120 Pharmaceutical Quality Management System: Current Concept Neetu Dubey1, *, Himanshu Gupta3 , R.K. Sharma2 , Nitin Dubey1 , Nidhi Dubey4 1. IPS Academy, Indore, Madhya Pradesh, India. 2. Prestige Institute of Management, Indore, Madhya Pradesh, India. 3. Pioneer Institute of Management, Indore, Madhya Pradesh, India. 4. School of Pharmacy, Indore, Madhya Pradesh, India. *Corresponding author: nitindubeympharm@yahoo.com ABSTRACT: Pharmaceutical industry is amongst most astringently regulated manufacturing units. Quality management system affects the ultimate quality of the finished product. The article represents and explains the current thinking and harmonized guideline of pharmaceutical regulatory authorities with especial reference to United States food and drug administration. The understanding and implementation of appropriate quality management system model enables a pharmaceutical organization to fulfil its ethical as well as regulatory responsibility of including management of identity, quality, safety,

purity and efficacy of finished medicinal product. It makes good business sense.

Key words: Quality management, Pharmaceutical industry, Pharmaceutical management. INTRODUCTION: The concept of current pharmaceutical quality management system is based on a internationally harmonized guidance ICH Q10 , which is developed by the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and USFDA and in final phases for adoption by the regulatory bodies of the European Union, Japan, and the United States is which describes a model for a pharmaceutical quality system that encourages the use of science- and risk-based approaches and can be implemented throughout the different stages of a product lifecycle. [1-4] It serves as an effective quality management system for the pharmaceutical industry. It integrates the fundamentals of good manufacturing practice (GMP) regulations, International Organization for Standardization (ISO) quality concepts, and complements ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk Management. It is an Journal of Advanced Pharmacy Education & Research 2: 120-124 (2011) ISSN 2249-3379 121 additional guidance as part of technical requirements for registration of pharmaceuticals for human use (ICH) which is not mandatory in nature. It enhances the quality and availability of medicines around the world. It helps to facilitate innovation and continual improvement and strengthen the link between pharmaceutical

development and manufacturing activities. Pharmaceutical quality management system It is applicable to drug products, including biotechnology and biological products, throughout the product lifecycle the systems supporting the development and manufacture of pharmaceutical drug substances. [5] It includes: 1. Pharmaceutical Development A. Manufacturing and development of APIs. B. Manufacture of medical kits and devices for investigation. C. Development of medical delivery systems. D. Pilot plant scale-up activities E. Manufacturing process of formulation F. Development of medical devises for accurate dosing

2. Analytical method development A. During manufacturing process Acquisition and control of materials Provision of facilities, utilities, and equipment Production (including packaging and labeling) Quality control and assurance Release Storage B. During product technology transfer. C. During product discontinuation Retention of sample and related documentation Continued product assessment and reporting Objectives:

Three main objectives are as follows: 1. Achieve Product Realization 2. Effective control over variables 3. Continuous Improvement Journal of Advanced Pharmacy Education & Research 2: 120-124 (2011) ISSN 2249-3379 122 Elements of Pharmaceutical Quality System: Fundamental elements for effective pharmaceutical quality systems are as follows: Managerial review of process performance and product quality Process performance and product quality monitoring system Corrective action and preventive action (CAPA) system Change control management system

The objective is to establish, implement, and maintain a system that allows the delivery of products with the desired quality attributes. Quality risk management also help in developing effective monitoring and control systems for specified process performance that in turn establishes the capability of processes. It is useful for identifying and prioritizing areas for continual improvement in terms of quality attributes, process technology and other technical aspects. These objectives ultimately contribute to the betterment of end product quality and better process understanding [6].The design, organization, and documentation of the pharmaceutical quality system should be appropriate and exhaustive enough in order to facilitate common understanding. The quality manuals should be prepared in line with the quality policy

of the organization.

Management responsibility: Leadership is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Management has the responsibility to achieve quality related goals as per the quality policy. There must be a clear understanding and unambiguous set of authority and responsibility at all levels including individual and collective role. Strict commitment toward the quality objectives should be demonstrated. Management should participate in the design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system. Quality audits should be performed periodically for appropriate improvement in process performance. Training needs of staff should be effectively identified and follow up system should be established to ensure proper training. Adequate resource management, effective communication between all levels of management and periodical review of the quality system helps to achieve desired pharmaceutical quality system governance. Continuous improvement in process performance and product quality: Product quality depends on appropriate design of quality attributes during product development phase. Technical knowledge or specification, control strategy and validation approaches should be effectively transferred within or between manufacturing sites for commercial Journal of Advanced Pharmacy Education & Research manufacturing. Product discontinuation aspects include retention of relevant documents, samples and review of product assessment, complaint handling and

stability related problems as per regulatory provisions. [1] Objectives of quality management system may be achieved by following means: A. Knowledge Management B. Quality Risk Management The technical aspects of the process, peculiarity of the product design and problems during product life cycles helps to create a knowledge database and should be systematically documented. ICH Q9 provides principles and examples of tools for quality risk management and approach to identifying, scientifically evaluating and controlling potential risks to quality. Innovation, continual improvement the outputs of process performance and product quality monitoring and CAPA drive changes. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. Developing a new pharmaceutical quality system or modifying an existing one requires careful assessment of size and complexities of the companys activity; Identification of management responsibilities; systems, responsibility and specifications for contract manufacturing activities; Change control measures; identification and establishment of performance indicators. Quality risk management strategy should identify attributes for measurement and analysis of state of control with various approaches including statistical indicators. [4] Appropriate analytical tools should be available to verify the process performance and product quality. External or internal audits should evaluate problems indicators such as complaints, failures of batches, deviations, FDA warnings or recalls. REFERENCE: 1. Q10 Pharmaceutical Quality System , U.S. Department of Health and Human

Services Food and Drug Administration Centre for Drug Evaluation and Research (CDER) Centre for Biologics Evaluation and Research (CBER) , 2009; 2-19. 2. Lachman L, Hanna SA, Lin K. Quality control and assurance. The Theory and Practice of Industrial 804-855,1976. 3. Lakhal,L., Pasin,F., and Liman, M. Quality management practices and their impact on performance. Int J Qua. Rel. Mgmt. 2006; 23(6): 625-646. Journal of Advanced Pharmacy Education & Research 2: 120-124 (2011) ISSN 2249-3379 124 4. Moy A. EMEA and FDA approaches on the ICH Q10 on pharmaceutical quality system. Pharma Times. 2009; 41 (8): 15-18. 5. Mohanty, R.P. and Lakhe, R.R. Understanding TQM, Production planning and control.1994; 5(5):426-441. 6. Kakkar S. and Narang A.S. Recommending a TQM model for Indian Organizations. The TQM Magazine. 2007; 19(4): 328-353. Pharmacy. 2nd Ed., Varghese Publishing House, Bombay.

FUNCTIONS
1. To establish the quality system a. Establish the quality management system to describe how the firm follows CGMPs and operates to maintain a state of control b. Keep the quality management system current with good industry practices 2. To audit compliance to the quality system a. Audit for compliance to policies and procedures: on paper vs. practice. b. Report quality system performance metrics, including trends, that help decisionmaking and taking proactive targeted actions 3. To establish procedures and specifications a. Ensure that procedures and specifications are appropriate and followed b. Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for thirdparty services providers (contract manufacturers, contract laboratories, etc.) 4. To establish manufacturing controls a. Ensure that appropriate manufacturing in-process controls are implemented b. Ensure in-process controls are performed during manufacturing operations and results are satisfactory 5. To perform laboratory tests or examinations a. Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications

b. Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor. c. Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions 6. To review and approve or reject all things CGMP a. Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications including changes to these documents b. Review and approve/reject reprocessing and rework procedures c. Review and approve/reject production batch records and make the final decision to release a product lot into commerce. 7. To ensure investigation of nonconformance a. Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes b. Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected 8. To keep management informed a. Report on product, process and system risksand keep management informed b. Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closureand keep management informed. c. Keep management informedget it? 9. To describe responsibilities in writing a. Have a complete and compliant procedure that describes responsibilities b. Follow the procedure 10. To remain independent a. Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities b. Be independent reviewer and approver with respect to manufacturing and process/ product development units c. Dont drink the Kool-Aid