◆  New USP Chapter on Moisture Barrier of Plastic Packaging Systems (06-Jun-18 ECA)

The United States Pharmacopeia, USP, published a draft of a new general chapter in Pharmacopeial Forum (PF) 44(3) [May- June 2018]: <1671> The Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems. This chapter is applicable to pharmaceutical manufacturers, packagers, and repackagers.

According to USP, the proposed new general chapter <1671> has been developed to support general chapter Containers—Performance Testing <671> which has been revised and published for comment in the same issue of PF.

The new chapter <1671> is intended to

  • describe the methodology of proving the moisture barrier equivalency of two similar packaging systems based on the moisture vapor transmission rate (MVTR) measurements described in general chapter <671>;
  • define the upper limit of the MVTR for an oral dosage form drug product (tablet, see below);
  • compare the desiccant-based and water-based MVTR methods; and
  • explain how to leverage MVTR data to complement, and possibly reduce, stability studies when a new packaging system or a new drug product packaging configuration is introduced.

The scope of this chapter is restricted to

  • solid oral dosage form (SODF) drug products;
  • MVTR based on Methods 1, 2, and 3 (desiccant-based) described in general chapter <671>;
  • MVTR based on Method 4 (water based) described in <671>, and
  • repackaging of SODFs.

A maximum demonstrated moisture permeability of ≤ 0.8 per day per tablet (MVTR/Unit) was established. The maximum demonstrated level of MVTR may be used in order to introduce new packaging presentations without the need of specific drug product stability testing prior to implementation. MVTR is one of many factors in assessing packaging system change including introducing new packaging configuration (e.g., HDPE bottle with a new count). These factors are, amongst others, the composition of the container–closure system, product requirements, and stability. However, MVTR may be useful in a product development setting, to decide on the packaging components before packaging exhibit batches, or in a pharmacy setting where product is being repackaged.

In addition, the USP Packaging and Distribution Expert Committee is proposing the following revisions to <671>, which are meant to update the current chapter. The key changes being proposed are:

  • Add USP Desiccant, Small RS; USP Desiccant, Medium RS; and USP Desiccant, Large RS to aid stakeholders in the execution of the chapter,
  • Add a new water-filled method as an alternative approach to the desiccant-filled method in the Moisture Vapor Transmission for Plastic Packaging Systems section,
  • Introduce a new informational chapter <1671> (see above), that is meant to support the current chapter revision.

 

◆  Air technology for laboratories: new VDI guidance published (13-Jun-18 ECA)

The new VDI guidance 2051 "Air-conditioning - Laboratories" has been published as a white print in April 2018. It covers protection objectives for persons, environment and products in different types of laboratories, such as biological, chemical or radionuclide labs.

For the use of laboratories, risk assessments are to be prepared and protection objectives to be defined. That should include the handling of dangerous substances, the protection of individuals and the removal of heat loads. This in turn influences the design of air duct systems, including fume hoods. However, further issues need to be considered or may influence the achieving of protection objectives, such as pressure level concept, spatial separation of laboratories from rooms with different uses, the tightness of rooms and the description of actions taken in case of disturbances. VDI 2051 covers these issues and is addressed to, inter alia, architects, planners, authorities and service providers.

The VDI 2051 guideline is available at the Beuth Verlag in English and German.

 

◆  The Return of FDA's Quality Metrics Programme (04-Jul-18 ECA)

In 2015 the US Food and Drug Administration (FDA) had started an initiative in order to use so-called quality metrics for the planning of their risk-based inspections. The FDA wishes that, after it has come into force, manufacturers will convey defined quality scores to the FDA via an electronic portal. The FDA plans to use these to calculate specific statistics which are supposed to allow for risk-based management and planning by the FDA. The Quality Metrics Initiative then started with a voluntary phase and a revised draft guidance was published in November 2016. However, after this it became somewhat quite. Since the initiative started, industry provided a lot of feedback - fearing additional efforts and expenses.

Now the FDA announced two updated programmes: the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program.

In the introduction FDA is also focussing on the benefits for industry, saying that with implementing a quality measurement program, "companies improve their overall quality systems" and finally product quality.

What is the current status of FDA's Quality Metrics Program?

After the publication of the 2016 draft guidance, FDA was actively promoting the program. The authority was "giving presentations, participating on panels, responding to questions, and actively listening to stakeholders". Now, also with consideration of the various feedback, FDA has initiated these two new programs mentioned above.

Regarding the portal for data collection, FDA remains "interested in performing external testing though do not yet have an estimated time for this activity".

The Quality Metrics Feedback Program

This program introduces in fact two new voluntary phases; one for Type C formal meeting requests and pre-abbreviated new drug application (pre-ANDA) meeting requests and one to gain feedback from those establishments for which Type C formal meetings or pre-ANDA meetings do not apply.

In these meetings, companies can describe in detail their currently used (internal) quality metrics actions including "routine assessment and management oversight of quality culture"!

The Site Visit Program

This program goes even further, and FDA will come to the facilities. The purpose is "to provide experiential and firsthand learning opportunities to FDA staff involved in the development of the FDA Quality Metrics Program and to provide stakeholders with an opportunity to explain the advantages and challenges associated with implementing and managing a robust Quality Metrics Program".

On site, five to ten FDA representatives will then observe "how quality metrics data are gathered, collected, and reported to management".