GMP News - Packaging

27.07.16

Ph. Eur. Drafts on Rubber Closures (3.2.9) and Plastic Containers for Blood (3.2.3)

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".

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13.07.16

Drafts of revised USP plastic packaging chapters <661.1> and <661.2>: removal of the biological reactivity test for oral and topical dosage forms

In a recent Pharmacopeial Forum two revised USP general chapters have been published for comment. With these drafts, the USP expert committee is removing the requirement for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms. Read more about the draft chapters of <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.

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18.05.16

EMA publishes Q&A on data required for sterilized primary packaging materials used in aseptic manufacturing processes

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?".

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11.05.16

USP publishes draft of a new general chapter <661.3> for plastic components used in manufacturing

In the Pharmacopoeial Forum (PF)  42(3) (May-June 2016) the USP General Chapters - Packaging and Distribution Expert Committee proposes a new general chapter  <661.3> Plastic Components and Systems Used in Pharmaceutical Manufacturing and a revised version of general chapter <1661> Evaluation of Plastic Packaging and Manufacturing Systems and Their Materials of construction with Respect to Their User Safety Impact. Read more about USPs Proposal on Plastic Components and Systems Used in Pharmaceutical Manufacturing.

 

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23.03.16

USP develops new General Chapter on Metal Packaging Components

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.

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07.01.16

Revised USP Chapter <670> Containers - Auxiliary Packaging Components

In the Pharmacopoeial Forum 42(1) a revised Draft of USP Chapter <670> Auxiliary Packaging Components was published for comments. Comment deadline is March 31, 2016. Read more about the revised USP Auxiliary Packaging Components Chapter <670>.

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16.12.15

EMA publishes Principles for QR Codes

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.

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25.11.15

New USP Chapter on Package Integrity become official

The USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum 40(5). The New and revised chapters will become official on August 1, 2016 (USP 39-NF34 1S)  in form of 4 general chapters. Find out more about the new USP Chapters on the Integrity of Pharmaceutical Packaging.

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04.11.15

New USP General Chapters on Extractables and Leachables: <1663>, <1664>

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)).

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22.10.15

Revised USP General Chapter <661> Containers-Plastics

The revised USP General Chapter <661> (Containers - Plastics) and new General Chapters <661.1> and <661.2>  will become official on May 1, 2016 (USP 39-NF34). Find out more about the USP General Chapters.

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07.10.15

Draft of Delegated Act regarding Safety Features published

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)".

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01.07.15

Track&Trace - IT Implementation ordered by European Pharmaceutical Associations

The "European Medicines Verification Organisation" (EMVO) has developed a model for the practical and cost effective implementation of the system for data storing and has also signed framework agreements with three partners. Find out more about the EMVO model.

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10.06.15

USP Chapter <1207>: Container Closure Integrity Testing

The USP Chapter <1207> on the integrity testing of primary containers of sterile dosage forms is currently in the second round of review. Its adoption is expected for this year. Find out more about USP Chapter <1207>.

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03.06.15

Optimized Method for determining the Water Vapour Permeability for Packaging - new USP Proposal

A USP article published in the Pharmacopoeia Forum discusses an improved method for the determination of the water vapour permeability in packaging for solid dosage forms such as tablets or capsules. Find out more about the optimization of the water vapour permeability test for packing materials.

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27.05.15

New USP Chapter on the Integrity of Pharmaceutical Packaging

The USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum. New proposals about the content have been published - now in form of 4 general chapters on the integrity of packaging materials. Find out more about the new USP Chapters on the Integrity of Pharmaceutical Packaging.

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