GMP News - Packaging

In Pharmacopeial Forum 42(4) [Jun-Jul 2016] a stimuli article on the rationale for the proposed omission of the "well-closed" specification from the general chapter <671> Containers-Performance Testing has been published. Read more about the Rationale for the Omission of the Packaging and Storage Statement from USP-NF Monographs and the Omission of the "Well-Closed" Specification from Containers-Performance Testing <671>.

In Pharmeuropa 28.3 revisions of two Ph. Eur. general chapters on containers (3.2.9 and 3.2.3)  have been published for comment. Deadline for comment is September 30, 2016. Read more about the drafts for 3.2.9 "Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders" and 3.2.3 "Sterile plastic containers for human blood and blood components".

The European Medicines Agency, EMA, recently published questions and answers on what data is required for sterilisation processes of primary packaging materials subsequently used in an aseptic manufacturing process. Read more about "What data is required for sterilisation processes of primary packaging materials subsequently used in an aseptic manufacturing process?".

The USP is currently developing a new general chapter on metal packagings. The proposed title of the new general chapter <662> is  "Metal Packaging Components and their Materials of Construction". Find out more about the developing process of the proposed general chapter on metal packaging components.

According to a current publication of EMA, QR codes can be put in the future on package leaflets and outter packaging. Now, this also applies to centrally authorised medicinal products. Find out more about the EMA Principles for QR Codes.

Two new USP General Chapters on extractables and leachables have become official on August 1, 2015 (USP 38-NF33, first supplement): <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems and  <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. References to these new chapters have now been integrated in the drafts of General Chapters on Ophthalmic Products <771> and Injections <1> (PF 41(5)).

The European Union has published the draft of the delegated act. It defines standards with regard to the technological and organisational requirements for the safety features required in the future. Find out more about the draft of the "Commission delegated Regulation (EU)".