ICH Draft on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Q12

ICH Draft on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Q12

Posted: Monday March 5th, 2018

Author: Pinky Mazumder

On November 16, 2017 the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) published a draft guidance on Q12 titled, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guidance was established to address certain technical and regulatory gaps found during consultations concerning other ICH Quality guidelines, such as Q8, Q9, Q10, and Q11.

Unlike previously established ICH Q8 and Q11 guidelines, which focus on the early stages of the product lifecycle, the Q12 guideline provides guidance on the commercial phases of the product lifecycle. As well, this guideline also facilitates the management of post-approval chemistry manufacturing control (CMC) and provides assistance on reducing regulatory burden.

Categorization of post-approval CMC

Following market approval, drug products may still undergo various CMC for which communication with the respective regulatory body is required. This is due to the high potential risk to the quality of the product associated with CMC changes, and hence require a risk-based categorisation of the type communication required with the regulatory body. Such changes of high potential risk to the quality of the product, may require approval from the regulatory body before implementation. It is possible that an inspection may also be related to such changes. On the other hand, low-risk changes may sometimes only warrant notification and would not require prior approval by the regulatory body for implementation. Such changes are to be communicated to the regulatory body as a notification or the classified submission category within the prescribed time frame. According to the ICH Q12 guideline, harmonization of the risk-based categorization of post-approval CMC changes between regulations is encouraged.

Established conditions

With the Common Technical Document (CTD) outlining all of the submission requirements for a market authorization application, there is still the lack of a harmonized approach to identify which elements of an regulatory submission are necessary for product quality and would require a regulatory submission if changed after obtaining market approval. As a result, the guidance introduces these elements as established conditions for manufacturing and control. Importantly, established conditions should not be confused for regulatory commitments such as post-approval stability commitments. Some established conditions may even be part of the manufacturing process include parameters such as critical process parameters and key process parameters. The guideline has also provided a decision tree for the identification of established conditions and their reporting categories.

Relationship between regulatory assessment and inspection

It is often found that communications between regulatory evaluators and inspectors facilitate the regulatory review of a submission. Inspectors may provide additional GMP and/or facility related information that affects the outcome of the review.

For more information on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, please refer to the ICH Q12 draft guideline.

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