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Six Steps to Successful FDA GMP Inspections
With Tool Kits for Preparation, Conduct and Follow-up
Recorded, available with all reference material at any time

 

Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
Recorded, available with all reference material at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments
With FDA's
Dennis Cantellops

Recorded, available with all reference material at any time

 

Labcompliance News, July 2009

New FDA Guidance on Physical-Chemical Anti-Counterfeit Identifiers

Pharmaceutical manufacturers aiming to thwart drug product counterfeiting have been investigating technologies that may make drug products more difficult to duplicate. One approach that pharmaceutical manufacturers appear to be considering involves adding a trace amount of an inactive ingredient(s) to an existing section3 of the dosage form. A unique physical-chemical characteristic of that ingredient makes it possible to detect and authenticate legitimate dosage forms and identify counterfeits.  Examples of substances that may be incorporated into solid oral dosage forms (SODFs) as physical-chemical identifiers (PCIDs) include inks, pigments, flavors, and molecular taggants. The new FDA draft guidance prrovides recommendations design considerations for incorporating PCIDS into SODFs, supporting documentation to be submitted in NDAs and ANDAs to address the proposed incorporation of PCIDs in SODFs, supporting documentation to be submitted in postapproval submissions to report or request approval to incorporate PCIDs into SODFs, and procedures for reporting or requesting approval to incorporate PCIDs into SODFs as a postapproval change. The guiadnce can be downloaded from the FDA website.

U.S. Marshals Seize Drug Products to Prevent Repeated Drug Quality Problems

On June 25, 2009, U.S. Marshals, at the request of the Food and Drug Administration, seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the CDER, FDA. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

South East Asia Moving to Harmonized GMP Inspections

On April 10, 2009, all 10 member countries of the Association of Southeast Asian Nations (ASEAN) have signed a Mutual Recognition Agreement (MRA) to harmonize GMP inspections. Member states are obliged to establish inspection services for conducting GMP audits and issuing Reports/Certificates. Also, each member state is obliged to accept and recognize GMP certificates/Reports issued by listed inspection services of another member state. GMP certificates are issued in accordance to the PIC/S GMP Inspection Framework. This also means, drug companies marketing products in all ASEAN member countries should implement PIC/S GMP guidelines. While Singapore and Malaysia are already PIC/S members, PIC/S GMP compliance is not easy for some countries For example, it is estimated that currently only 5% of the drug industry in the Philippines complies with international GMP regulations. To learn more about the history, status, process and steps for implementation of the MRA and to download a presentation given by Sia Chong Hock, chairman of the ASEAN MRA taskforce, click here.

FDA Requests Meeting with Senior Management to Discuss Inspection Outcome

After an inspection of a manufacturer of biological vaccine products, bulk drug substances, and drug components the FDA requested a follow-up meeting with senior management The letter states: "To facilitate your remediation efforts we request a meeting with you and other senior management to further discuss the issues cited in this letter and your proposed responses to address them". Cited deviations included: Computer output not checked for accuracy, failure investigations not extended to other batches, expiration date of reference material extended without supporting data, procedures to prevent facility contamination incomplete, written procedures for equipment maintenance not followed. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 217).  To prepare your organization for FDA inspections, and to avoid FDA warning letters, attend the upcoming Audio seminar: Successful FDA Inspections - preparation, conduct, follow-up.

FDA Requests Certification by an Outside Consultant

During an inspection of a device manufacturer FDA inspectors found several GMP deviations. Examples included: "No or inadequate procedures for design control, no procedures to ensure quality of purchased products and services, no procedures for document control". The letter stated towards the end; "We are requesting you submit to this office, on the schedule below, certification by an outside expert consultant to state he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device Quality System regulation  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 218).  To prepare your organization for FDA inspections, and to avoid FDA warning letters, attend the upcoming Audio seminar: Successful FDA Inspections - preparation, conduct, follow-up.

FDA Publishes Article on Drug CGMPs and How they Contribute to Drug Quality

The recently published article discusses the role and importance of cGMP in drug manufacturing, as well as describes what actions FDA takes when a company is not in compliance with cGMP. The article is written in a Q&A format. One interesting question was: "If a manufacturer is not following cGMPs, are drug products safe for use?

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: Laboratory Failure Investigations . To download your free copy, go to the Laboratory Compliance Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on July 31, 2009). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

New Audio Seminar Schedule

Understanding and Implementing ISO 17025
Requirements, Strategies and Tool Kits for Laboratory Accreditation
Recorded, available with all reference material at any time

Successful FDA Inspections
Preparation - Conduct - Follow Up
Recorded, available with all reference material at any time

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