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Change Control – Continuous Quality Improvement in FDA and ISO Environments

Change Control – Continuous Quality Improvement in FDA and ISO Environments

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Published by mastercontroldotcom
Globalization of the marketplace has greatly intensified competition. It has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.
Globalization of the marketplace has greatly intensified competition. It has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.

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Published by: mastercontroldotcom on Jan 06, 2011
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05/12/2014

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 White Paper 
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FDA & ISO Change Control
Introduction
Globalization of the marketplace has greatly intensied competition. It has increased the pressure on manufacturers todevelop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick tomeet customer demands and even quicker in adapting to changing market conditions.The situation could not be more acute than in the FDA and ISO environments, where manufacturers must contend notonly with cutthroat competition and a dynamic market, but also stringent regulatory requirements. Consider the ercelycompetitive pharmaceutical industry. Only one of every 10,000 potential medicines investigated by American research- based pharmaceutical companies makes it through the rigorous FDA approval process, according to the PharmaceuticalResearch and Manufacturers of America. It takes about 15 years at a cost of more than $800 million before a newmedicine is approved.The road toward product development — and FDA approval or ISO certication — is clearly long, arduous, and costly.After a product is launched in the market, the manufacturer must continue to comply with regulatory requirements to stayin business. Regulations exist to ensure the safety and reliability of products. In this context, any change that affects the“purity” and effectiveness of the approved product is critical.
Denition of Change
In the manufacturing environment, change refers to any modication in equipment, manufacturing materials, facilities,utilities, design, formulations, processes, packaging/labeling, computer systems, and all associated documentation (SOPs,quality manual, etc.).A change may be a simple adjustment brought on by a new customer specication, or an updated document, or a partreplacement, or other production needs. It may be caused by a deviation from an approved regulatory ling or written procedures. A change may be temporary or permanent, routine or emergency, innocuous or serious enough to shut down production.The fact that change is inevitable makes control a critical factor, especially in FDA and ISO-environments, whereinappropriate or “uncontrolled” changes could affect the safety and reliability of products and directly impact publichealth and safety.Here’s an example. On Oct. 24, 2005, the FDA announced a voluntary recall of certain models of Omron instantthermometers because the thermometer tips could potentially overheat and pose risk to young children using the device.The FDA noted that the overheating was a result of a change in the manufacturing process. The agency’s press release was brief and did not describe the circumstances of the change that caused the quality problem, but it illustrates the criticalimplications of change in the manufacture of medical devices in this case, or any other product for that matter. Whether it’s a car or a computer or a pacemaker, the goal of regulatory bodies is to protect public safety by ensuring the highestquality standards. For this reason, the concept of change control is closely interweaved with FDA and ISO compliance.
Regulatory Requirements
Change control requirements for medical device companies are outlined in FDA’s 21 CFR Part 820.30 (design changes),820.40 (document changes), and 820.70 (production and process changes). 21 CFR Part 820 requires that manufacturersestablish written change control procedures, which describe company-approved procedures.For pharmaceutical companies, written procedures are considered part of Current Good Manufacturing Practice (CGMP)outlined in 21 CFR Part 210-211. Any changes in production and processes must be controlled — meaning recorded,reviewed, and approved by the quality control unit. CGMP requirements are meant to prevent harm by building qualityinto the development and production of medicines.
 
 White Paper 
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FDA & ISO Change Control
Manufacturers certied to ISO 9000:2000 and ISO 13485 standards are required to ensure that any changes affecting thequality management system (including product requirements, design, and development changes) should be controlled.The underlying message in these regulations is that all changes should be made according to approved (approval impliessuccessful testing or thorough review/investigation) written company policies and procedures. Change control procedureshave to be written as a way of standardizing instructions. Written procedures are also more reliable compared with passingon information verbally. “Uncontrolled” change in this context refers to modications made without review and approvalof the quality control unit and other departments affected by the change.In the FDA and ISO environments, strict adherence to approved policies and procedures is key in keeping manufacturingoperations in a state of control and it is what makes change control crucial.
Elements of Change Control
Change is typically introduced by an initiator or originator. Depending on the company and industry, the initiator mayor may not be the person who will carry the change through implementation. Initiating a change usually involves llingin a change request form, which then moves through a process or system of review and approval. Most organizationshave a change control committee or board, which may be a single entity for an entire company, or there may be onefor a company’s every manufacturing site. The committee usually includes representatives from different departmentsinvolved in production, such as quality, manufacturing, regulatory affairs, and engineering. Depending on the change, thecommittee may also involve legal, sales, or marketing departments.For pharmaceutical companies, the CGMP requires that all changes should be reviewed and approved by the qualitycontrol unit. In these companies, there may be a “change administrator,” a role usually assumed by the quality unit.Change control records usually cover: identication of the item/entity being changed, a description of the change,identication of the affected documents, signatures of the approvers, approval date, and effective date.In the medical device industry, each modied device, accessory, labeling, packaging, and process must be thoroughlyveried and or/validated by the appropriate department. The change control committee then reviews the test results andother pertinent information.
Challenges
A change control system is necessary to prevent inappropriate modications. While this sounds simple, implementationcan be complex and an inadequate system can cause internal confusion, noncompliance, or worse, a product recall or a product liability lawsuit.What makes change control so challenging? There are many factors, but the following are the most common issues:
Poor Communication
– Lack of communication between departments, failure to follow up or escalate changerequests, and delayed or inappropriate notication of changes made by suppliers are some of the communication-related issues that impact the change control process. Companies using a paper-based change control systemare likely to rely on face-to-face exchanges, such as change control board meetings, to discuss changes. Theeffectiveness of these meetings depends on their frequency and the availability of members to meet as emergencychanges arise.
Poor Turnaround
– Timeliness can make or break a product’s chances of succeeding in the market. Companiesthat rely on a manual system to generate data and to route and track submissions and change orders are likely tohave poor turnaround for change implementation because the system requires more time and effort. The problem becomes worse when there is an unexpected change — a deviation — and supporting data is not generated in a

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