[Stability Testing related News – vol.2]

◆European Medicines Agency revises guidance related to post-authorisation procedures and in relation to applications for marketing authorisation of generic / hybrid medicinal products. (26-Feb-13 EMA)

One Q&A example is for Type IB Variations:
1. What changes are considered Type IB Variations?
Commission Regulation (EC) No 1234/2008 (‘the Variations Regulation’) defines a minor variation of Type IB as a variation which is neither a Type IA variation nor a Type II variation nor an Extension. Such minor variations must be notified to the National Competent Authority/European Medicines Agency (‘the Agency’) by the Marketing Authorisation Holder (MAH) before implementation, but do not require a formal approval. However, the MAH must wait a period of 30 days to ensure that the application is deemed acceptable by the National Competent Authority/the Agency before implementing the change (“Tell, Wait and Do” procedure).

◆Final GDP Guideline published by EU Commission(12-Mar-13 ECA)

The long awaited EU GDP Guideline was published in the Official Journal of the European Union by EU Commission on 7 March 2013.
This document will replace the current GDP Guideline published in 1994 (94/C 63/03).
The new GDP Guideline will apply not only to the wholesalers and manufacturers of pharmaceuticals, it also incorporates the specific requirements for the Brokers dealing with pharmaceutical products.
The draft guideline received a high number of comments and questions on the requirements stated for the role of the Responsible Person (RP) and the required qualification; apart from minor changes this section has remained almost unchanged!
“The wholesale distributor must designate a person as Responsible Person.
The Responsible Person should have appropriate competence and experience as well as knowledge of and training in GDP.
Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness and the security of any intermediate storage facilities. “
The old industry standard for storage at a hub up to the maximum of 72 hours is not included, there is no time limit, and it is not clear how the companies are expected to ensure that the temperature requirements and cleanliness levels are maintained.

◆China Publishes New Good Distribution Practices(6-Mar-13 ECA)

The Chinese Ministry of Heath (MOH) published on 22 January 2013 new requirements on Good Distribution – respectively on Good Supply Practices for Pharmaceutical Products.
The new regulations apply not only to distributors but also to pharmaceutical manufacturers.
They will go into effect as of 1st June 2013.
In conformity with the new requirements wholesalers have to establish a comprehensivie quality management system including qualified personnel.
India had just recently published a Draft GDP Guide.

◆Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation(13-Mar-13 FDA)

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.
Example Guidelines and Criteria-4. The split tablet, when stored in pharmacy dispensing containers (no seal/no desiccant), should demonstrate adequate stability for a period of 90 days at 25o C, plus or minus 2o C/60 percent Relative Humidity (RH), plus or minus 5 percent RH.

◆ICH publishes New Draft Guideline on Genotoxic Impurities(6-Mar-13 ECA)

The ICH has published a draft guideline for comment on the determination and the control of DNA reactive (mutagenic) impurities in medicinal products.
The guideline is entitled: “M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”.
The draft of the “M7” Guideline was published for comment on 7 February 2013 on the ICH website as a “Step 2 Document”.

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