• Industry Regulations (ISO,FSMA,HACCP,CFR)

     

    Regulation/
    Standard
     

    Description 

    21 CFR Part 4 FDA published 21 CFR Part 4 “Current Good Manufacturing Practices for Combination Products” (Docket No. FDA-2009-N-0435) which will become effective July 22, 2013. This rule was determined after receiving many questions and comments based on a Guidance Document regarding combination products that was released in 2004. This cGMP rule does not create any new cGMP requirements, but rather, it clarifies which cGMP rules are needed to be enforced when producing a combination product as in the following:
    • If the constituent parts of a pharmaceutical or biotechnology product are manufactured and marked separately and also cross labeled, they remain separate for the purpose of applying cGMP regulations and need to be manufactured under the separate drug device or biologic cGMP’s 
    • Companies have two options for single entity and co-packaged combination products
      • Demonstrate compliance with the specifics of all cCGMP regulations applicable to each of the constituent parts included in the combination product 
      • Demonstrate compliance with the specifics of either the drug cGMP’s or the device quality system regulation, rather than both, when the combination contains both a drug and device under certain conditions. These conditions include demonstrating compliance with specified FDA provisions from the other of these two sets of CGMP requirements. 
       
     

    21 CFR Part 11

    The FDA regulation that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.  TrackWise supports this life science industry regulation by ensuring the software is compliant using secure, automated processes including CAPA, complaint management and risk management.

    21 CFR Part 58

    Good laboratory practice for non-clincal laboratory studies. Sparta Systems has software processes available to help pharmaceutical companies electronically manage CAPA, audits, complaints, change control and risk management.

    21 CFR Part 110

    Current good manufacturing practice in manufacturing, packing, or holding human food.  Sparta Systems software solution, TrackWise, ensures compliance, improves quality, and reduces costs by centralizing and integrating quality processes, including management and reporting of deviations, complaint handling, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, and others.

    21 CFR Part 111

    Companies that manufacture, package, label, or hold a dietary supplement, including a dietary supplement manufactured but is packaged or labeled by another person; and a dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.  This does not pertain to retail establishments holding dietary supplements for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.  Sparta Systems’ Trackwise allows companies to automate vital quality processes that enable conformance to legal regulations including CAPA, auditing and supplier quality management.

    21 CFR Part 210

    Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs.  Sparta Systems software solution, TrackWise, ensures compliance, improves quality, and reduces costs by centralizing and integrating quality processes, including management and reporting of deviations, complaint handling, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, and others.

    21 CFR Part 211

    This ruling requires the manager of any regulatory controlled manufacturing company to manufacture all medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety, quality or efficacy.   TrackWise automated quality management software provides automated processes that achieve the highest level of safety and efficiency required by law to meet this FDA standard.

    21 CFR Part 1271

    Companies are required to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P's) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P's.  This requires companies to register and list HCT/P's with the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research, whether or not the HCT/P enters into interstate commerce. Sparta Systems’ Trackwise solutions address the government requirements through automated processed including product registration tracking.

    FDASIA (Food and Drug Safety and Innovation Act), Title VII – Drug Supply Chain 

    In effect as of July 9, 2012, this regulation addresses some of the supplier management challenges, creates new systems and makes other changes to ensure the safety of drugs through domestic and foreign establishment of registrations, inspections and new penalties. TrackWise allows companies to automate vital quality processes that enable conformance to this new legal regulation including CAPA, auditing and supplier quality management.

    European Union’s Falsified Medicines Directive 

    In effect as of July 1, 2012, this directive is designed to address counterfeiting in Europe, whereby pharmaceutical manufacturers must audit their suppliers and distributors, who are required to follow good manufacturing practices and good distribution practices. The TrackWise audit management solution ensures compliance to this directive and improves quality and reduces costs by centralizing and integrating audit processes.

    ISO 9001

    The most commonly used international standard that provides a framework for a quality management system. ISO 9000 is a name given to a family of standards developed to provide a framework around which a quality management system can effectively be based. A quality management system is a common sense and well documented system that ensures consistency and improvement of working practices. This includes the products and services produced. It is based on standards, which specify a procedure for achieving effective quality management. The ISO 9000 family comprises a number of different standards (ISO 9000, ISO 9001 and ISO 9004). Each covers a different facet of the whole.

    ISO/IEC 17025

    General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. It applies directly to those organizations that produce testing and calibration results. The contents of ISO/IEC 17025 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory.  Technical requirements include factors which determine the correctness and reliability of the tests and calibrations performed in laboratory.

    OHSAS 18001

    The OHSAS specification gives requirements for an occupational health and safety management system, to enable an organization to control its OH&S risks and improve its performance. It was developed to be compatible with both the ISO9001 and ISO14001 management systems standards. This includes employee and workplace safety, events, observations, etc.

    Good Manufacturing Practice (GMP)

    GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors.

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