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Labcompliance News, February 2003

Feb 21, 2003

FDA Published a New Part 11 Draft Guidance

On Feb 20 the FDA released a new part guidance on "Scope and Application". Simultaneously all other part 11 guidance documents including the compliance policy guide from May 1999 have been withdrawn. It is intended to describe the Food and Drug Administration's (FDA’s) current thinking regarding the scope and application of Part 11. The guide narrows the scope of part 11 and the content is significantly different from previous FDA guidances and much more industry friendly. The guidance states the FDA may revise provisions of Part 11 as a result of its current good manufacturing practice (CGMP) initiative and that the FDA will not normally take regulatory action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of Part 11 as explained in this guidance. However, records must still be maintained or submitted in accordance with the underlying predicate rules.

Feb 10, 2003

 Version 2 of the Labcompliance Network Quality Package Released

On February 10, 2003, version 2 of the popular network quality package has been released for shipment. The package includes training material, reference material and tools like SOPs, checklists and templates that help to qualify network infrastructure and validation of networked systems. Version 2 now also includes three standard operating procedures for change control and training, a gap analysis with a section on configuration management, more warning letters related to networks, a project schedule template and a template for identification of network hardware and software and an article on the qualification of (multiple) PC clients. It also includes five information rich guidance documents from NIST, such as on security, risk assessment and contingency planning for IT. For more information and for ordering, click here.

Feb. 10, 2003

EU Annex 11 and 27 page APV Interpretation available as PDF Files

Annex 11 of the EU GMP directive specifies requirements for computers used in GMP regulated environments. It includes 19 paragraphs with requirements for personnel, validation during development and use, audit trail, built-in checks for correct entry of data, authorized and limited access to the system, verification of manual data entry, automated identification and recording of operators, procedures for change control, back-up and protection of data, contingency planning, disaster recovery, automated detection of errors, qualification of 3rd party service provider and release of batches by a 'Qualified Person'. To some extent the Annex has similar requirements as FDA's 21 CFR Part 11. To download the file click here For easier implementation APV has developed a 27 page interpretation Guide. This guide can be downloaded from the Labcompliance UsersClub, section C-030. For preview and ordering the Usersclub, click here

Feb 10, 2003

Computerized Systems and Part 11 Compliance for Bioresearch Monitoring

FDA's has published through the Office of Regulatory Affairs the Bioresearch Monitoring (BIMO) Compliance Program 7348.808. Attachment A focuses on Computerized Systems
The intent of this attachment is to collect, in one place, recommendations on how to inspect computer systems as part of the program. The document makes references to part 11: If a firm is keeping electronic records or using electronic signatures, determine if they are in compliance with 21 CFR Part 11. Determine the depth of part 11 coverage on a case by case basis, in light of initial findings and program resources. At a minimum ensure that: (1) the firm has prepared a corrective action plan for achieving full compliance with part 11 requirements, and is making progress toward completing that plan in a timely manner; (2) accurate and complete electronic and human readable copies of electronic records, suitable for review, are made available; and (3) employees are held accountable and responsible for actions taken under their electronic signatures.

Feb 4, 2003

FDA Withdraws Part11 E-copies Guidance

The Food and Drug Administration (FDA) announced the withdrawal of the draft guidance entitled ‘‘Guidance for Industry, 21 CFR Part11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records.’’ The guidance has been released as draft in November 2002 for public comments. The FDA announced that the guidance may no longer represent FDA’s approach under the CGMP initiative. The agency may decide to reissue the draft guidance once it has reviewed it under the CGMP initiative. Under the new initiative, primary responsibility for implementing part 11has shifted to the Center for Drug Evaluation and Research, with continued involvement from other Centers and the Office of Regulatory Affairs.

Feb 3, 2003

ISPE Submits White Paper to FDA: Risk-Based Approach to 21 CFR Part 11

The US FDA recently announced a significant new initiative to enhance the regulation of pharmaceutical manufacturing and product quality, by applying a risk-based and science-based approach to current Good Manufacturing Practice (cGMP). See Labcompliance News from January 2003. The FDA also plans to apply some of the concepts to 21 CFR Part 11. The FDA plans to work together with the industry to develop guidelines on interpretation and enforcement of the initiative and has asked the ISPE for inputs. A team of technical experts has prepared a white paper outlining their view of risk based implementation of part 11.


Feb 3, 2003

FDA Starts New Initiative to Speed up New Drug Approval

The initiatives will be implemented through pre-market review programs in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Center for Veterinary Medicine (CVM).
Three key areas have been identified for increased effort:
Examining root causes of multi-cycle reviews, to identify and address avoidable delays and multiple cycles in review of new products,
Instituting a continuous improvement/quality systems approach throughout pre-market review and
Expanding collaborative clinical and pre-clinical guidance development, to reduce uncertainty and increase efficiency for innovator product development.

The FDA describes the initiatives in the agency's new report:
Improving Innovation in Medical Technology: Beyond 2002


Feb 3, 2003

FDA Adds Electronic Copies Guidance to the Investigations Operations Manual

The Investigations Operations Manual (IOM) is the primary source of guidance regarding FDA policy and procedures for field investigators and inspectors. The section on records instructs field investigators on how to obtain electronic records. Recommendations are in line with 21 CFR Part 11: "The methods used must maintain the integrity of the electronic data and prevent unauthorized changes.". Investigators are also advised: "Request for electronic information should be in a format compatible with software applications knowledgeable to you and available from the Agency." Investigators are not advised to take application software away from the company! Companies can refer to this guidance in planning their approach to respond to FDA inspector requests for electronic copies and diskettes and should expect inspectors to follow these guidelines.