Regulation 21 CFR Part

Transcription

1 Regulation 21 CFR Part

2 Regulation 21 CFR Part The demand for healthcare products is ever increasing as the landscape of modern society evolves. These trends are reshaping the Pharmaceutical and Biologics industries. With the demand for products, comes the concern among pharmabio manufacturers for regulatory scrutiny. Noncompliance is fiscally damaging and potentially life-threatening, both to a manufacturer and its customers. Warnings, fines and recalls ultimately will impact a company s bottom line, but the real risk is the potential for human harm. Taking a proactive approach in addressing the risk of non-compliance is leading today s drug manufacturers to implement a vigorous, enterprise-wide compliance management solution that can be leveraged to enhance business processes. Organizations are seeking strategies for minimizing their exposure to risk while staying ahead of the competition in delivering safe and compliant products to the marketplace. 21 CFR Part , or Current Good Manufacturing Practices (CGMP) in Manufacturing, Processing, Packing or Holding of Drugs (210); CGMP for Finished Pharmaceuticals (211), require that all drugs are compliant with the latest GMPs. The regulations ensure that drug products meet regulatory requirements as to safety, strength, quality and purity. Pilgrim Software 21 CFR Part Reference Chart Subpart Section (s) B Document Management Training Management Training Management F Supplier Quality Management Document Management J SmartSolve CAPA Management Complaints Management 2

3 (Subpart B Section c, d)* The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of drug product. The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed (Subpart B Section a)* Each person engaged in the manufacture, processing, packing or holding of a drug product shall have education, training, and experience or any combination thereof to enable that person to perform assigned functions. Training shall be in the particular operations that the employee performs and in CGMP as they relate to the employee s functions. Training in CGMP shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. (Subpart B Section c)* There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product. (Subpart B Section )* Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide. Pilgrim s electronic Document Management system manages all document and procedure approvals. Approval decisions, notes and comments are maintained for each build of each document revision. Electronic notifications and escalations ensure that the document approval process is completed in a timely manner. Pilgrim s Training Management documents employee skills and employee training to ensure that employees are adequately trained to perform their assigned job functions. Training Management tracks any type of training, including CGMP training and operational / job related training. Training Management provides reports and notifications to keep managers informed of employee skills and employee training needs. Managers can utilize these reports to ensure an adequate number of qualified personnel for each task. Training Management maintains a history of consultant education, training, experience, qualifications, contact information, etc. All training tracking features and reports that are available for internal training records are also available for consultant training records. B

4 (Subpart B Section b)* Representative samples of each shipment of each lot shall be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, shall be based upon appropriate criteria such as statistical criteria for component variability, confidence levels, and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve where required by (Subpart F Section a, b)* There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. (Subpart J Section c)* All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph. Pilgrim s Supplier Quality Management maintains supplier quality history as well as supplier sampling and inspection criteria. Supplier Quality Management provides inspection records to document supplier inspections and tests. Pilgrim s Document Management manages any type of procedure created within an organization, including procedures for production and process control. This includes the approval, release, training, distribution and obsolescence of the procedure. Document Management s document policies and templates assure that the appropriate organizational units participate in the draft, review and approval of each type of document. Pilgrim s overall SmartSolve platform maintains a centralized, 21 CFR Part 11 compliant database of all quality records including audit records, documents and document records, training history, CAPA workflows and history, equipment records and supplier history. Records are immediately retrievable through user friendly searches and reports to be viewed in electronic format. They may also be printed as paper copies. 4

5 (Subpart J Section e)* Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations SmartSolve records are maintained for easily retrieval as described in Section c. Either Pilgrim s Document Management or Audit Management may be used to manage procedure evaluations for batches, complaints and other processes. (Subpart J Section f)* Procedures shall be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under , , or of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration. (Subpart J Section )* Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed...a written record of the investigation shall be made and shall include the conclusions and follow-up. Pilgrim s CAPA Management investigations provide for notification to responsible personnel and officials if they are not personally involved in an investigation. This notification is pre-definable to ensure consistent notifications and CAPA processes. CAPA Management also provides the flexibility to add notifications pertinent to a specific CAPA record. CAPA Management manages the tracking of any product discrepancies as well as their associated investigations. CAPA Management is a closedloop CAPA management system that allows users in any department to initiate a corrective and preventive action process to address and resolve an issue. By facilitating an effective CAPA process, CAPA Management helps to resolve issues quickly and prevent recurrence - ensuring compliance with industry and regulatory requirements 5

6 (Subpart J Section a)* Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit. Pilgrim s Complaints Management manages complaint procedures and workflows. This includes provisions for review by the quality control unit as well as a determination of the need for an investigation. Review workflows and personnel notification may be pre-defined to ensure that the appropriate personnel are notified of the complaint and are involved in the appropriate review and follow-up. (Subpart J Section b)* A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. Written records involving a drug product shall be maintained.. Items 1, 2 and 3 describe information to be maintained within each complaint record. The ability to pre-define personnel and workflows drives consistency in the complaint workflow and ensures that complaints are investigated in an accurate and timely manner. Complaints Management maintains complaint records for as long a timeframe as needed to meet the requirements in this section. Each complaint record is accessible using Complaints Management user-friendly searches and reporting features. Since Complaints Management is a web based application, records are accessible from any organizational unit or location. Complaints Management s records document all of the information described in this requirement, including the name and strength of the drug product, lot number, name of complainant, nature of complaint, reply to complainant and investigation / non-investigation information. The daily challenges that pharma-bio companies face are countless. A growing elderly population, consolidation of the healthcare markets, increased R&D spending, and expanding product pipelines require that these manufacturers continue to stringently adhere to regulatory requirements to remain competitive. When not met, the consequences can be financially devastating. Therefore, every process and every practice must rely on procedures that can be controlled with logical solutions and well-informed management. The world s leading enterprise compliance and quality management companies, like Pilgrim Software, are lowering those risks and strengthening the profitability of organizations, through enterprisewide automated solutions. Drug manufacturers then are able to dedicate their resources to developing quality products that will directly benefit their bottom line. 6

7 ABOUT PILGRIM SOFTWARE Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management (ECQM) solutions for highly regulated industries. Pilgrim has pioneered effective, integrated software solutions for the Life Science and FDAregulated industries, as well as manufacturers in the automotive, aerospace and defense, and other regulated manufacturing industries. Pilgrim s reputation for excellence in innovation has attracted an impressive portfolio of global customers. More than a half-million end-users employ Pilgrim products every day to meet the diverse challenges of the world s highly competitive marketplace. Pilgrim s fully Web-based, integrated solutions help businesses centrally manage domestic and international operations to ensure product safety and compliance, reduce manufacturing costs and improve customer satisfaction. United States Headquarters 2807 W. Busch Blvd. Tampa, FL Tel. (813) Fax (813) sales@pilgrimsoftware.com European Headquarters Hilversum The Netherlands Tel. +31 (0) Fax +31 (0) emea@pilgrimsoftware.com 2010 Pilgrim Software, Inc. All Rights Reserved.