The use of alternate methods, especially for USP methods, some of which are rather old, has long been a question that both the industry and the FDA have contemplated. Alternate methods can be easier to use and, in some instances, more accurate and reliable. But how can you demonstrate that an alternate method is indeed equivalent to an existing method?
It is paramount that a Quality Control laboratory has a calibration and preventative maintenance program for the laboratory instrumentation so that there is assurance that the instrumentation continues to be “fit for purpose” and that there is confidence in the accuracy and reliability of all analytical instruments. There should be a controlled, comprehensive list of the instrumentation within the laboratory,
It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action. However, what can get overlooked during the investigation process is the importance of trending. This is a key component of root cause confirmation, assessing the appropriateness and effectivity of corrective action and determining whether there are any underlying cause/s for noted repeat incidents.
During 2017, the USP issued a Stimuli article for a proposed new chapter, titled “The Analytical Procedure Lifecyle <1220>”, which incorporates the concept of Quality By Design (QbD) and the principles of ICH Q8-R2, Q9, and Q10 for the development and management of analytical test procedures.
There are three lifecycle phases:
- Procedure Design and Development
- Procedure Performance Qualification
- Continuous Procedure Performance Verification
A cornerstone of the design and development phase is the establishment of the Analytical Target Profile (ATP).
The ISPE has issued a GAMP: Records and Data Integrity guide which provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate and available throughout their lifecycle. A critical component of the data lifecycle is Data Review.
Data review should be based upon a thorough process which is defined within the procedure.
The USP is planning to revise their USP<1058> Analytical Instrument Qualification Chapter, August 01, 2017. The planned principal changes to USP<1058> are as follows:
- The revised USP chapter introduces the concept of a user-driven risk assessment to establish the level of integrated instrument qualification to demonstrate “fitness for purpose” of the instrument.
The MHRA has presented their 2016 inspectorate deficiency trend data for 2016. MHRA publishes the assessment with the hope that industry will perform their own assessment against the deficiency findings, as part of self-inspection and continuous improvement. A complete version of the MHRA presentation can be found here.
In comparison to 2015,
The recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance document (here) states that the FDA considers that the owner’s (those who engage the services of the contract facilities) Quality Unit responsibility includes approving or rejecting the contract facility’s product or service (be it for testing,
It is critical during the inspection process that FDA inspectors can determine the veracity of the data that is presented to them. The draft Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” dated August 10, 2016, provides inspectors detailed instructions on how to verify the integrity of the data during inspection by ensuring the data is “…complete,
The FDA recently issued a draft Guidance document; entitled “Control of Elemental Impurities in Drug Products”. This document provides guidance in light of the issuance of ICH Q3D Elemental Impurities and USP<232> Elemental Impurities – Limits and USP<233> Elemental Impurities – Procedures. USP <232>.
Last week, the FDA released a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here) which replaces the 2000 Draft Guidance document “Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods Validation”.