summarizingannextoichq8,productdevelopme

ICH has released the draft consensus guidelines - the annex to ICH Q8 on Pharmaceutical Development. The much awaited release is in its step 2 of ICH process and was made public in November 2007. This is the second release within ICH step 2 processes connecting ICH Q8. The Earlier draft version of Q8 published in 2004 got wide spread response in the industry circles.

The Annex to Q8 provides further clarifications of key concepts outlines in the core guidelines. Additionally, the annexure also explains the principles of quality by design (QbD). In other words, there are two fundamental concepts which emerge from Q8 as whole – (a) integrated pharmaceutical development and (b) submission of related information’s in common technical document format.

Here, what I mean to say with integrated pharmaceutical development is that the guidance discusses the process or methodology in which the elements of pharmaceutical development are undertaken during the entire lifecycle of the product.

This is a systematic approach for product development which generally differs from company to company. A company may choose different strategies, either an empirical or a systematic approach. On one way where it helps creating the knowledge wealth for the product from its inception, developmental phases to throughout its lifecycle, on the other hand, the systematic approach facilitates the organized and efficient review of applicant’s data with greater understanding of product and its manufacturing processes.

In fact, it is the knowledge gained and submitted to the authorities and not the volume of data.

The guidance emphasizes minimum elements for pharmaceutical development as:

• • Defining the target product profile as it related to quality, safety and efficacy;

  • Identifying critical quality attributes (CQAs) of drug products. The critical quality attributes hav an impact on product quality and can be studied and controlled;

  • Determining the quality attributes of the drug substance, excipients etc. and selecting the types and amount of excipients to deliever drug product of the desired quality;

  • Selecting an appropriate manufacturing process; Identifying a control strategy.

The guideline refers to the concepts and tools i.e. design space which is outlines in the parent Q8 guideline.

The design space for a proposed manufacturing process can be described in the section of the application that includes the description of the manufacturing process and process controls.

Another key aspect which is addressed in the annexure are the explanation for some of the suggested contents for the 3.2.P.2 Pharmaceutical Development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.

Pharmaceutical development information is submitted in Section P.2 of the CTD. Other information resulting from pharmaceutical development studies could be accommodated by the CTD format in a number of different ways in the registration application, for e.g.:

• • Quality Risk Management and Product and Process Development, For example, risk analyses and functional relationships linking material attributes to product CQAs can be included in P.2.1, P.2.2, and P.2.3. Risk analyses linking the design of the manufacturing process to product quality can be included in P.2.3.

  • Design Space, The product and manufacturing process development sections of the application (P.2.1, P.2.2, and P.2.3) are appropriate places to summarize and describe product and process development studies that provide the basis for the design space(s).

  • Control Strategy. The detailed information about input material controls, and process controls should still be provided in the appropriate CTD format sections (e.g., drug substance section (S), control of excipients (P.4), description of manufacturing process and process controls (P.3.3), controls of critical steps and intermediates (P.3.4).

• Drug Substance Related Information. CQAs can be appropriate in the pharmaceutical development section of the application (e.g., P.2.1).