FDA Releases Draft Guidance on Setting Limits for Mutagenic Impurities

Just about two months after the release of the equivalent ICH M7 guidance FDA adapted this document as official FDA Draft Guidance entitled "M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk". The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The guidance can be viewed and downloaded from the FDA website. To learn everything about regulatory requirements and analysis of genotoxic/mutagenic/carcinogenic impurities in drug substances and drug products including requirements of ICH M7 attend the Labcompliance audio seminar: "FDA/EMA Compliance for Genotoxic Impurities" and receive 10+ best practice guides for easy implementation

FDA Releases Final Guidance for Computer System Validation

The title of the new guidance is "Blood Establishment Computer System Validation in the User’s Facility". The guidance seems to very specific for Blood Establishment Systems, however the recommendations are fully applicable for all Commercial Off-the-Shelf Computer Systems. It is the only such guide available for FDA regulated industry and readers can learn what FDA's expectations are for validating computer systems at the users site. The guidance can be viewed and downloaded from the FDA website.

Revised EU GMP Guide Requires formal Transfer of Analytical Methods

The requirements are documented in the revised Chapter 4 Quality Control of the EU GMP guide.  Section 6.37 reads: Prior to transferring a test method, the transferring site should verify that the test method(s) comply with those as described in the Marketing Authorization or the relevant technical dossier. The original validation of the test method(s) should be reviewed to ensure compliance with current ICH requirements. A gap analysis should be performed and documented to identify any supplementary validation that should be performed, prior to commencing the technical transfer process. Sections 6.38 and 6.39 describe the requirements and contents of a transfer protocol. Recommended procedures are similar to the final release of USP <1224>. To read and download revised draft, click here. To learn more about requirements and examples for analytical method transfer attend the Labcompliance seminar and received a tool kit such as checklist, SOP and example transfer protocol.

Detailed Comparison between EU & Indian GMP Requirements for APIs

According to a new EU directive as of Jan 2, 2013, all APIs imported  to the EU must have been manufactured in compliance with standards at least equivalent to the GMPs of the EU (ICH Q7). The new directive requires either a written confirmation from the national competent authority of the exporting country that the APIs manufactured there are compliant with GMP at least equivalent to EU standards, or the exporting country is on an approved list of non-EU countries that have been assessed by the EU or inspected by an EU member State to ensure they meet EU manufacturing standards. Because India is a major exporting country of APIs a comparison between EU and Indian  GMP standards is of utmost importance. Such a comparison has been developed and published on 141 pages by "Drug Regulations", an organization that provides free online resource to Pharmaceutical Professionals.

ICH Releases M7 Guidance for Mutagenic Impurities

On February 6, 2013, ICH has published Step 2 of the guidance: "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk". The guide is built on requirements and approaches of already existing guides from FDA, EMA and industry task forces and has the potential to consolidate all of them into one global guidance.. To learn everything about regulatory requirements and analysis of genotoxic/mutagenic/carcinogenic impurities in drug substances and drug products including requirements of ICH M7 attend the Labcompliance audio seminar: "FDA/EMA Compliance for Genotoxic Impurities" and receive 10+ best practice guides for easy implementation  

FDA Warning: Paper print-outs of e-records incomplete, missing e-audit trail, no back-up of raw data

The warning letter was received by a pharmaceutical manufacturer. Primary deviations included: no back-up of raw data, printed copies of e-records do not include all raw data and metadata, e.g., no instrument control parameters, no security control of electronic data, SOP does not include provisions for audit trail reviews. The company had responded to all related 483 observations, but most responses have been inadequate for a variety of reasons. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-273. Non members can preview excerpts. Attend the Labcompliance audio seminar to learn everything about FDA requirements to ensure integrity, security and availability of regulated electronic records.

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 Best Practice Document "SOP: Disaster Recovery of Computer Systems". To download your free copy, go to the Computer System Validation Package.. Scroll down and click on the corresponding ICON on the left (offer expires on May 10, 2013). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

2-day In-Person Seminars with Dr. Ludwig Huber

• Istanbul, Turkey
  Validation and Part 11/Annex 11 Compliance of Computer Systems
  June 05/06, 2013
  Elite World Hotels
                       
• San Diego, USA
  GMP Compliance for Quality Control and Contract Laboratories
  August 26/27, 2013,
   
• Boston, USA
  Analytical Instrument Qualification and System Validation
  August 29/30, 2013, Boston, USA