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Labcompliance News, July 2006

July 1, 2006

US FDA Intends to Join PIC/S

The United States Food and Drug Administration (FDA) has officially applied for a membership of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and is waiting for evaluation through the organization. This is part of FDA's 21st Century Drug cGMP initiative with global harmonization as being one of the key objectives. PIC/S is a cooperative arrangement between regulatory authorities. It's' mission is to lead the international development, implementation and maintenance of harmonized Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products. With currently 29 national agencies as official members and many others having observer status and attending the trainings, PIC/S is one of the most important organizations for the pharmaceutical industry. To prepare your laboratory for PIC/S inspections you can register for the Labcompliance Audio Seminar: Inspection of Pharmaceutical Quality Control Laboratories: Understanding the New PIC/S Inspection Guide.

July 1, 2006

FDA Publishes ICH Q9 Risk Management Document as Industry Guidance

The purpose of the guidance is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. These aspects include development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products). The guidance does not bind FDA or the public. Industry can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

July 1, 2006

Joint US FDA/ISPE Industry cGMP Training at the Peking University

The US Food and Drug Administration (FDA) in in collaboration with the Peking University and the International Society for Pharmaceutical Engineering (ISPE) did conduct a three day training session in Beijing, China. The intent was to educate participants from China and other Asian countries on current methods for compliance with good manufacturing practices (cGMP). Number of attendees was limited to 200. They came from pharmaceutical industry, consulting companies and from regulatory agencies in China. The training consisted of plenary lectures and interactive workshops. Sessions have been presented by a total of 11 cGMP experts including four speakers from the US FDA. For example, Joseph Famulare, FDA's Acting Director of the Office of Compliance, gave a presentation on "FDA'S current perspective on CGMP compliance" and Paul D'Eramo, Executive Director, Quality and Compliance Worldwide, J&J, gave the Industry's perspective.

July 1, 2006

FDA Continues Inspections for Part 11 Compliance

An inspection of a pharmaceutical manufacturer revealed serious regulatory problems with electronic records. The FDA found that computer data including analyses results could be changed after they have been approved by the supervisor. This was documented in the FDA establishment report and cited as an observation in an 483 form inspectional observation: "The computerized system is not secure in that it is possible for data entered to be changed. This was observed following a request during inspection for a challenge to be performed during which it was determined that previously recorded input including sample gross and net weights and the final result could be changed". Obviously the computer system did not have the functionality as required for Part11 compliance, e.g., electronic audit trail. The company responded with a 3-step corrective action plan: "The computerized system will be upgraded to appropriately address the concerns raised. The system will be totally renovated so that it will be appropriately comply with the requirements of 21 CFR Part 11. The date and time of operator entries and actions that create, modify and delete electronic records will be independently recorded as computer generated audit trail." The 483, the full inspection report (EIR), the company's correction plan and FDA's answer to the corrective action plan can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.. To learn everything on how to successfully pass FDA inspections of electronic record systems, attend the Labcompliance Audio seminar.