Labcompliance News, May 2008

Cost Reductions for Computer System Validation through GAMP® 5

The new release of GAMP®5 helps to improve compliance and quality, efficiency, and also helps to reduce costs for computer system validation. Risk based approaches for overall cost savings and better use of resources are in line with initiatives of the FDA and with the new Annex 11 to the European GMPs. Cost savings also come from leveraging the supplier's validation activities, scalable lifecycle phases and more efficient validation of Excel® type spreadsheet applications. The new document can be ordered from the ISPE website. Labcompliance will conduct an audio seminar for better understanding and implementation of cost savings from various initiatives promoted by the FDA, in Annex 11 and GAMP®5.

"The Software Controlling Processes not Validated" Draws FDA Warning

FDA's renewed focus on automated systems and software became very clear during an inspection of a diagnostics device manufacturer. For example, the letter stated: "The filling, capping, packaging, and sealing processes, which utilize semi-automated and automated equipment, are not validated. In addition, the software applications controlling these processes are not validated for their intended uses. Furthermore the company failed to investigate and to document root cause of failures. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 200).

Case-Study: Stability Indicating Methods

The case study with the title "A stability-indicating HPLC procedure for determination of diltiazem hydrochloride in extemporaneously compounded oral liquids." has been authored by Galina Hollowa, Heather Rowe-Joyce and Samir Wahab. This article describes the development and validation of a stability-indicating HPLC procedure for the determination of diltiazem HCl in diltiazem HCl oral suspension and diltiazem HCl oral suspension, sugar free. The development of a stability-indicating HPLC procedure for the determination of diltiazem HCl in extemporaneously compounded oral liquids was based on the United States Pharmacopeia–National Formulary (USP–NF) monographs. The article is complementary to the Labcompliance audio seminar related to the same topic on "Development and Validation of Stability Indicating Methods" that gives the regulatory background, and recommendations for generating study samples, for systematic development and optimization and for the validation of the stability indicating methods. Validation and related to the same topic. As of May 2008 the article is available on the PTE website. Copyright rests with the publisher. For other articles from PharmTech Europe, click here.

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

FDA's regulation for GLPs is easy to find documented in a single regulation 21 CFR Part 58. Drug cGMPs are documented in two regulations 21 CFR Parts 211 and 212. The situation is not so clear for so called Good Clinical Practices (GCP). They are spread out over more than 10 individual regulations. The FDA seemed to understand the difficulty and has set up website with links to all FDA regulations related to Good Clinical Practices and Clinical Trials. The site has also a link to preambles to GCP regulations with valuable information about the development of final rules for Good Clinical Practices and clinical trials.

"No Procedures for Software Design Validation" Cited in FDA Warning Letter

The FDA expects companies developing software to establish and maintain adequate procedures that ensure design validation for software. This became clear during an inspection of a medical device manufacturer. For example, the company failed "to establish and maintain adequate procedures that ensure design validation to include software validation and risk analysis": The firm also "failed to document structural (white box) testing of xxx software, including independent code reviews". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 199).

New Article: Electronic Records&Signatures - Legal Requirements and Technology

The biggest advantages of electronic records and signatures are access to documents, information sharing, digital archiving, speed, and the efficiency available to people entering into transactions either internally or externally Despite of all these advantages most of signatures on documents are executed by handwriting, even though they are generated electronically. Reasons are legal and technical concerns. This article authored by Markus Roemer and Peter Beach explains legal details and gives recommendation for implementation. The article has been published by Pharmaceutical Formulation & Quality and as of May 2008 is available on the publishers website. Copyright rests with the publisher. For more articles from the publisher, click here

Labcompliance Conducting the 100th Audio Seminar

Labcompliance audio seminars enjoy always increasing popularity. Thousands of professionals from over 100 companies have attended the seminars since the first launch in December 2002. During the seminars companies and attendees get fast and up-to-date information on new regulations and other hot topics from the convenience of their own seminar rooms or desks. Most popular are 10+ Best Practice documents that can be downloaded from dedicated seminar websites: SOPs, forms, master plans and checklists help attendees to quickly implement what they have learned in the one hour presentation. On July 2, 2008, we celebrate our 100th seminar. The topic will be on GMP Compliance for Laboratories. As a "Thank You" for their on-going support all registered attendees can choose at no additional charge one of the five video seminars that have been introduced by Labcompliance (Value $399). All 100 audio seminars have been recorded and are available with all reference material.

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 Part 11 Master Plan. To download your free copy, go to the Part 11 Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on June 10, 2008). Labcompliance offers more than 100 SOPs. For tiles and ordering, click here.

New Audio Seminars - Updated Schedule

Contingency and Disaster Recovery Planning for Computer Systems (197)
To Ensure Business Continuity and Compliance
June 12, 2008
Writing Effective SOPs For Regulatory Compliance
Content, format, approval, training and distribution.
Thursday, June 26, 2008
FDA/EU cGMP Compliance for Laboratories
Requirements and Tools for Implementation
Wednesday, July 2, 2008
Out-of-Specification Data Trending
GMP requirements and tools for implementation
July 3, 2008
Cost Effective Software and Computer System Validation
Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
July 24, 2008