Share Price of  API Manufacturer drop 13 % after FDA inspection with 483 form Observations

It is well known that FDA inspections with enforcement actions such as Warning Letters, shipment stop, import alert or consent decree can have a high impact on a company's share price. It is quite unusual that a 483 form inspectional observation can have similar consequences. However, exactly this happened with an Indian API manufacturer. As a result of the 483 the company made an announcement to voluntarily stop API shipments from the inspected  plant. Next day the company's share was down 13 %. For more information click here.

 FDA publishes Strategic Priorities 2014-2018 for Public Comment

This 40-page draft document provides an overarching Agency-level view of how FDA is addressing the public health challenges. The paper lists four major goals with detailed  3 or 4 objectives for each of them. The goals are 1)Enhance Oversight of FDA-Regulated Products, 2)Improve and Safeguard Access to FDA-Regulated Products to Benefit Health, 3)Promote Better Informed Decisions About the use of FDA-Regulated Products, 4)Strengthen Organizational Excellence and Accountability.  Objectives are in line with ongoing initiatives such as addressing the impact of globalization through collaboration with regulatory counterparts to leverage resources and avoid duplication of inspections as well as build a model for mutual reliance by sharing inspection reports. As another example the FDA is encouraging submission of new drug applications using Quality by Design (QbD) elements – a risk-based approach to pharmaceutical development and manufacturing to help ensure product quality. Furthermore FDA plans to Improve risk-based approaches to conducting inspections that maximize public health benefit by ensuring high rates of compliance. The document also includes a current high-level FDA org chart. The paper is available on the FDA website for download.

EU GMPs require Procedures for handling OOS and OOT Results

The European Commission published a new revision of the EU GMP Chapter 6 - Quality control. The final version of the revised Chapter 6 was published in late March 2014 and becomes effective Oct 1, 2014. One change in the update is related to handling out-of-specification situations. The new GMP not only requires a procedure for investigation of OOS results but also significant atypical Out-of-Trend results. So far the US FDA industry guidance for handling OOS results was used in preparation EMA inspections, it seems this is not enough any more. Manufacturers of drugs and drug substances are advised to study the new regulation and to prepare SOPs accordingly. Attend the new audio seminar on "Handling Out-of-Specification Tests Results" and receive example SOPs for managing OOS and OOT results.

Two Identical Audio Seminar Sessions targeted for different Time Zones

Future Labcompliance audio seminars will be presented twice for different time zones. This will allow all attendees to participate during normal working hours.
Timing will be

• Session 1 for: Eastern and Central Europe, Middle East, Asia, Australia
  India: 12.30 p.m. Singapore SGT: 3 p.m,, Japan and South Korea 4 p.m.
  Eastern/Central Europe: 9 a.m. CET (Berlin)

• Session 2 for  America, Western Europe
  North America: EDT 11 a.m.  CDT 10 a.m. PDT 8 a.m.,
  Western Europe: UK, Ireland 4 p.m. BST (London)

The first two seminars delivered for two time zones have been:  Handling Out-of-Specification Tests Results and Failure Investigations and Learning from recent Warning Letters related to Part 11 and Computer Validation

FDA extending Part 11 Inspections to outside Asia and finds many Violations

Based on bad experiences with data integrity and system security issues the FDA extended Part 11 inspections from India and China to other parts of the words. And they are found signification deviations during an inspection of an API manufacturer. For example, the firm did not retain complete raw data from testing performed to ensure the quality of  APIs. Specifically, the firm deleted all electronic raw data supporting  high performance liquid chromatography (HPLC) testing of all API products released to the U.S. market. Furthermore the firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. In addition the API manufacturer failed to prevent unauthorized access or changes to data and to ensure that employees receive appropriate and documented training on the particular operations that the employee performs. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-291. Non members can preview excerpts. Attend the new Labcompliance audio seminar "Learning from Recent Warning Letters Related to Computer Validation and Part 11" to learn all about recent Part 11 related findings and get clear recommendations for corrective and preventive actions

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 "Multinational GMP Inspections: Preparation, Conduct, Follow-up". To download your free copy, go to the FDA Inspection Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August 15 , 2014). Labcompliance offers more than 150 SOPs and examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering of the examples click here