50 New Documents in the Labcompliance Usersclub

We have added 50 new documents to the Labcompliance Usersclub. They include 18 new SOPs, 12 examples for practical validation and compliance including checklists . 5 forms/templates, 1 primer, 1 Part 11 implementation plan, 3 important FDA presentations and 10 recent FDA warning letters/483's related to GMP/GLP or GCP. To see the new titles, click here.. User club members can instantly download the new additions. To see the complete list and ordering the users club, click here, and scroll down to 'new additions'. With these additions, the Usersclub has more than 500 documents ready for download.

FDA's Focus on Computer Validation Ongoing

While FDA was quiet about software and computer system validation between 2002 and 2006 this has changed significantly since 2006. Software and computer system validation has become an inspection focus for pharmaceutical, API and device industry. Deviations have been cited related to all steps of computer validation from writing specification and risk assessment to IQ/OQ/PQ, revalidation, reporting and change control. To see examples, click here.  To prepare your organization for FDA inspections, and to avoid FDA warning letters related to computer validation, attend the upcoming Audio seminar: Computer System Validation: Step-by-Step, with Case Studies and IQ, OQ, PQ protocols for easy implementation

FDA Answers Questions related to ICH Q8/Q9/Q10 Implementation

The Questions and Answers have been published as an FDA Industry Guidance. The document is intended to clarify key issues that came up after the Q8, Q9, and Q10 guidances were made final and experiences implementing the guidances regions have given rise to requests for clarification. Questions are related to quality by design, pharmaceutical quality system, real-time release testing versus end-product testing, impact of new ICH quality guidance on GMP inspection practices, knowledge management and software solutions. The guidance is available on the FDA website.

"Corrective Action for inadequate Method Validation too late", FDA Warning Letter says

In case of severe violations of GMP regulations the FDA expects a detailed response with timely corrective actions. Fixing a method validation within 14 months is not timely and resulted in an FDA warning Letter. The letter from May 2011 reads: "Your firm has failed to establish and document the accuracy,  sensitivity, specificity, and reproducibility of test methods. In your response, your firm states that the expected completion date for the validation of all analytical methods is June 2012. Your response, however, is not adequate since you have not provided interim actions to ensure the reliability of data until the analytical methods are validated", Other deviations included: Inadequate laboratory testing, inadequate suitability testing, failure investigations insufficient  or too late, ,OOS results not reported to clients, SOPs not followed, response for corrective actions not detailed, missing signatures or initials of analyst and reviewer on test reports. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-258. Non members can preview excerptsTo learn everything about FDA's expectation for validation of analytical methods, attend the Labcompliance audio seminar and receive 10+ best practice guide for easy implementation.

PIC/S Reaches Membership Milestone: 40 Members

The Slovenian Agency For Medicinal Products And Medical Devices (JAZMP) will join the Pharmaceutical Inspection Co-operation/Scheme in January 2012 as member #40. The was reported in a PIC/S press release. Another important News was that authorities of Japan had confirmed their intention to apply for PIC/S membership in the 2012. Also South Korea underlined the strong commitment expressed at all levels by the Korean Food and Drug Administration (KFDA) in acceding to PIC/S.

Missing Robustness Testing for Analytical Methods cited in FDA Warning Letter

FDA expects robustness testing to be included in validation studies. For example, the impact of chromatographic column batch-to-batch variability on peak resolution  should be studied. "For example, your firm failed to validate the xxx compound to quantify Peak A for potency and robustness. Your firm has been unable to determine why the chromatographic columns of the same make and model had variability and could not provide adequate separation", Other deviations included: Responsibility of Quality Control Unit not established and inadequate response to failure investigations. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-259. Non members can preview excerptsTo learn everything about FDA's expectation for validation of analytical methods, attend the Labcompliance audio seminar and receive 10+ best practice guide for easy implementation.

Russia to follow India and China as Pharma Drug and API Manufacturer

Russia has the potential to follow India and China as a major manufacturer of drugs and APIs. This was the conclusion of Pharmtech.report from Nov 2.. Bio/pharmaceutical companies, including many of the leading global players in patented and generic drugs, are starting to invest heavily in Russia under the expectation that the country will remain one of the world's fastest growing drug-manufacturing markets. Bio/pharmaceutical sales are increasing at around three times faster than the country's GDP. By 2016, total revenue in the Russian bio/pharmaceutical market is forecast to reach more than $37 billion, that's 2.4 times higher than 2009 levels and equivalent to an annual growth rate of 13.5%. One of the major  barriers of the Russian pharma/API industry is the low level of GMP compliant manufacturing and quality control,. Currently only 10% of the country's 400 bio/pharmaceutical plants comply with GMP standards. As of October 2011 the article is available on the PharmTech website. .Copyright rests with the publisher. For other articles from PharmTech, click here.

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 "Subcontracting of Testing and Calibration". To download your free copy, go to the ISO 17025 Accreditation Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 10 , 2011). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.