[Stability Testing related News – vol.4]

◆　New USP Chapter on Inhalation Drug Products（29-Apr-13　ECA）

In the Pharmacopeial Forum 39/1 from January/February 2013, a draft can be found of a new general chapter <5> on “Inhalation” and “Nasal Drug Products”.
Now, the general chapter has been revised in order to take into consideration the comments made on the first edition of the revised chapter.

◆　Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 – Quality Control（24-Apr-13　ECA）

On 17 January 2013, the EU Commission published the draft of the revised Chapter 6 Quality Control of the EU GMP Guide.
With regard to the new requirements on the transfer of analytical methods Chapter 6 states that A gap analysis should be performed to identify any supplementary validation needed that should be performed prior to beginning the method transfer.

◆  EMA　Annual　Report（16-Apr-13　EMA）

EMA released number of GMP inspections in 2012.
It was 368 inspections which remain on the same level as 2011 (375 inspections).

◆　Draft Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements （24-May-13　FDA）

c. Materials management
In this section, the parties should indicate who is responsible for setting specifications for raw materials; auditing, qualifying, and monitoring suppliers of those materials; and conducting required sampling and testing.
The Quality Agreement should also address how the parties are to ensure appropriate inventory management, including procedures for labeling, label printing, and reconciliation, as well as procedures for quarantine and prevention of mix-ups and cross-contamination.

◆　Implementation Deferred for General Chapters <232> Elemental Impurities?Limits and <233> Elemental Impurities?Procedures（24-May-13　USP　Convention）

The Chair of the USP Council of Experts, in consultation with the Executive Committee of the Council of Experts, has deferred proposed 5.60.30 Elemental Impurities in General Notices.
The proposed omission of General Chapter <231> Heavy Metals also has been deferred.
These deferrals will allow USP to work closely with ICH Q3D to align their activities with the implementation of General Chapters <232> and <233>.
The deferral also allows USP to work with those affected by the new elemental impurity standards. 
In this regard, USP plans to form an Advisory Group on the Implementation of General Chapters <232> and <233>.

◆　WHO publishes Draft on Revised Process Validation Guideline: Validation Life-Cycle Required（22-May-13　ECA）

Chapter 4 on Phase I (Process design) mentions that some process validation studies may be conducted on pilot-scale batches.
Chapter 5 on qualification describes the classical DQ, IQ, OQ, PQ stages in case of a traditional approach.
Phase III (continued process verification) should provide evidence that a “state of control” is maintained throughout the product life-cycle.