On Nov 17, 2008, the Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled "Process Validation: General Principles and Practices." With this FDA is revising its guidance for industry entitled "Guideline on General Principles of Process Validation," which was issued in May 1987 (the 1987 guidance). The revised draft guidance promotes a "lifecycle" approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. When finalized, this draft guidance will replace the 1987 guidance. The draft guidance can be downloaded from the FDA website.

FDA Presentations on New Approaches and Expectations for Process Validation

Several FDA officials gave presentations on process validation. For example, FDA's McNally gave a presentation on the lifecycle approach for process validation. The slides illustrate the process and give details of all four lifecycle steps: Chris Joneckis, PhD, CBER, gave a presentation on "Regulatory Expectations for Process Validation". Starting from the 1987 Guide Dr. Joneckis explains the evaluation of process validation that ends with the lifecycle approach as recommended in the 2008 draft guide. Barry Cherney, Ph.D. Deputy Director at CDER gave "A Product Reviewer's Perspective" with comments on 483's and recommendations such as: Process validation is an activity that should continue throughout the entire life cycle of the product. The slides can be downloaded from the Labcompliance Usersclub. Scroll down to G-245,247 and G-248. For preview and ordering, click here.

FDA Warning Letter for Inadequate Process Validation

FDA and other regulatory agencies expect processes used in API and drug manufacturing to be validated. This became obvious in a recent warning letter that included several deviations related to process control and validation. For example "process validation studies have not been conducted for any of the human drug products manufactured by your firm.". Obviously the company had a validation plans and templates, but a plan is not enough. The letter stated: "The response does not provide a timeline, plan, or estimated completion date for the process validation studies." In addition, the company failed to adequately clean, maintain, and sanitize equipment and utensils at appropriate intervals, and to have laboratory records that include complete data derived from all tests necessary to assure compliance with established specifications. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 214).

Labcompliance Releases new Network Qualification Package

Labcompliance has developed a new release of it's popular Network Qualification Package. It includes eight more SOPs, an updated primer, a new network qualification project plan, a risk management master plan and several new validation examples. Several new documents address internet and intranet compliance. The package is an ideal training tool to get a good understanding, it has 30+ tools for easy implementation and is ideally suited to prepare your infrastructure and networked systems for FDA and other inspections. For more information and ordering click here.

FDA Publishes Article on Product Recalls

Once an product is in widespread use, unforeseen problems can sometimes lead to a recall. A recall is most effective means for protecting the public. In a recent article the FDA describes the process for product recall, which FDA regulated products are subject to product recall and how the products are classified in different categories according to the level of hazard involved. In addition the article describes how the FDA should be informed if a problem is found by the manufacturer, how FDA alerts the public and checks the effectiveness of the recall, The article is available for on-line reading and as PDF file for download.

Integrity and Security of Electronic Records Issues Again in a Warning Letter

While the FDA is still working on the next Part 11 regulation inspectors focus on electronic records. The main issue is security and integrity of computerized data and they find lots of problems with unauthorized access to systems and data, with deleting and changing data without audit trail and insufficient documentation. An example is a recent warning letter with citations such as "No password control for analysts and supervisors", "Data stored on the computer can be deleted, removed, transferred, renamed or altered", and "There were no written protocols to assign levels of responsibilities for the system". The letter also gave recommendations such as: "There should be a record of any data change made, the previous entry, who made the change, and when the change was made". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 209). To learn everything about FDA compliant electronic records, click here

Seven New SOPs from Labcompliance

FDA and ISO 17025 require various routine activities to follow written procedures. Healthcare professionals typically use Standard Operating Procedures (SOPs) to address this. Labcompliance has been offering examples SOPs that help user firms to get started or to confirm their SOPs with external resources. Now we have added 7 more SOPs. Examples are "Retrospective Validation of Computerized Systems", "Bioanalytical Method Validation", "Validation of Stability Indicating Methods", "Handling (Certified) Reference Material", "Out-of-Specification Data Trending", and "Auditing Suppliers" In the meantime over 113 example SOPs are available from Labcompliance to develop and maintain your own SOPs. They help you to comply with FDA and equivalent international regulations: GLP, GCP, GMP, Part11, PIC/S and with ISO 17025. For a complete list and ordering, click here.

FDA Does not Require three Validation Batches for API and Drug Release

The FDA has updated its Questions&Answers website related to product and process controls of finished drugs and APIs. Q&As deal with equipment status identification as part of batch records, multiple media fill failures, acceptance of ISO 14644-1 and ISO 14644-2 for facility qualification and about implementing the FDA PAT guidance. An interesting question is whether CGMPs do require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution FDA's answer is no. Neither the CGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process. As part of the answer the the FDA gives also recommendations for successful validation of manufacturing processes. The Q&As can be downloaded from the FDA website.

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP: Configuration Management and Version Control of Software. To download your free copy, go to the CSV Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on Dec1). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

2 Day Interactive Workshop by Dr. Ludwig Huber

ECHO Consulting Group
Computer System Validation and Part 11 Compliance for (Bio)Pharmaceutical and Device Industry
Jan. 20/21, 2009 San Juan, PR, USA
Learning through examples: 50% of the time will be dedicated to case studies

New Audio Seminars - Updated Schedule

Effective Gap Analysis for ISO 17025
With Practical Tools for Easy Implementation
December 4, 2008
Auditing Computer Systems for FDA and EU Compliance
For Validation and Part 11 Compliance in Pharmaceutical and Device Industries
Dec 11, 2008

Conferences

Conference Calendar Echo Consulting

Labcompliance News, November 2008

FDA Publishes New Guidance on Process Validation