GMP News - Packaging


Draft USP Chapter <671> Containers - Performance Testing

A draft version of general chapter <671> Containers—Performance Testing has been recently published in the Pharmacopeial Forum - and is open for comments until end of March.



Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use"

A draft of a revised version of the European Phramacopoeia general chapter on glass containers has been published for comment. Read more about the Ph. Eur. draft general chapter 3.2.1 "Glass Containers for Pharmaceutical Use".



USP Draft Chapter <771> Ophthalmic Products - Quality Tests

In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a revised draft of general chapter <771> Ophthalmic Products-Quality Tests has been published for comment. Read more about the draft USP chapter <771> describing quality tests for opthalmic dosage forms.



EU Draft regulation on the use of BPA in varnishes and coatings

The European Commission (EC) proposed a new Commission Regulation (EU) on the use of bisphenol A (BPA) in varnishes and coatings intended to come into contact with food. The draft regulation will also amend Regulation (EU) No. 10/2011 on plastic materials and articles to come into contact with food (Plastics Regulation) and lower the specific migration limit (SML) for BPA. Read more about the Draft Commission Regulation



Rationale for the omission of the "well-closed" specification from USP general chapter <671>

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>.



Effect of primary packaging on drug stability of solid dosage forms

In the Pharmacopeial Forum 42(4) [Jun-Jul 2016] a stimuli article on the effect of primary packaging on the drug stability of solid dosage forms has been published . Read more about The Effect of Primary Packaging on the Physical Degradation of Metformin, Lisinopril, and Simvastatin Solid Doses During Patient Use When Stored at Different Temperature and Humidity Conditions.



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".



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.



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?".



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.




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.



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>.



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.



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.



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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