THE NEW PHARMA PACKAGE: FAR REACHING CONSEQUENCES FOR THE GMP ENVIRONMENT

   

GMP/GDP – On Demand Online Training

You can book the desired online training from our extensive database at any time. Click below for more information.

   

Stay informed with the GMP Newsletters from ECA

The ECA offers various free of charge GMP newsletters  for which you can subscribe to according to your needs.

A long discussion will soon come to an end. It is expected that a amendment to the Directive 2001/83/EC will probably be finalised in June 2010.

Many colleagues in industry might have heard already that the Directive will establish measures against counterfeit medicine. But what are the consequences for the GMP environment. This will be described in the following article:

On 11 December 2008, the European Commission published a press release as well as three legislative proposals intended to improve the supply of safe, innovative and accessible medicinal products in Europe. The most important one for the GMP environment is Part 3 which deals with combating counterfeit medicines as well as illegal distribution of medicinal products. But what does this mean? The new amendment of Directive 2001/83/EC will include:

  • Creating a legal basis for the Commission to be able to require specific safety features on the packaging of prescription-only medicinal products
  • Mandatory site inspections of supplying wholesalers, records of inspected wholesalers in a Community database and harmonised procedures for official inspectors
  • Stricter requirements on the import of active ingredients, among others the requirement to pharmaceutical manufacturers to inspect all producers of the active ingredients used

The proposals by the European Commission to prevent the counterfeiting of medicinal products are amendments or supplements to Directive 2001/83/EC, mainly concerning Articles 46 and 54. Even though the wording of the requirements is still quite vague, the implementation into legally binding regulations will have far-reaching consequences for the pharmaceutical industry.

Extractables & Leachables - Live Online Training

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training

Control of the GMP compliance of APIs and Excipients

Article 46 is amended to include the requirements on the use and distribution of active pharmaceutical ingredients (APIs). Among other things, the text lays down that only such APIs can be used that have been produced in compliance with the rules of Good Manufacturing Practice. The task of monitoring the fulfillment of these requirements by the manufacturers of the used APIs lies with the marketing authorisation holder. In addition, the Article defines that APIs used as starting materials for the manufacture of medicinal products can only be imported if they have been produced in compliance either with the EU GMP rules or with comparable regulations, and this fact is confirmed in writing by the exporting country. The latter requirement can be omitted if the exporting country is listed and classified as sufficiently safe by the EU with regard to its domestic GMP rules, frequency of inspection and information exchange.

There is still a final discussion about how far excipients will be covered in the Directive. But it seems that excipients will definitely be covered in the final text. As rational for this approach it was stated that both excipients and active pharmaceutical ingredients should be subject to relevant good manufacturing practices developed at the European level taking into account their own specificities. The European Commission is called to develop specific GMP for APIs and specific GMPs for excipients taking into account the very characteristics of those two different categories of ingredients and specially the fact that excipients have no therapeutic activity

New Packaging Requirements: Track and Trace

Article 54 deals with the introduction of features meant to prevent counterfeiting through identification, authentication and traceability of prescription medicinal products. These features are intended to enable pharmacists to verify authenticity, to identify each package and to determine whether unauthorised opening of the packaging has been attempted. This Article is still under discussion. In total 56 amendments to the draft guidelines have now been voted on, whereby a large number of the amendments relate to the topic of the introduction of safety features (2D-Data Matrix Code). Recently there have been intense discussions on what safety features are to be prescribed and for what medicines. An amendment from Greece in which this specification was to be extended - from one just for medicines available on prescription - to also include non-prescription medicines, was requested, but rejected. However if the amendment is undertaken, the European Commission will be obliged to submit field reports every two years on the application of the guidelines, in particular experiences with safety features. This should evaluate, whether an expansion of the coding obligation is required and should please manufacturers of OTC products, since according to information from the Federal Trade Association of Pharmaceutical Manufacturers (BAH), investment costs up to 120,000€ per production line will be necessary to carry out the technical specifications.

FDA also finalised a Guideline on Identification for Medicinal Products

The new Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardised Numerical Identification for Prescription Drug Packages, defines the SNI, i.e. the standardized numerical identifier, which is meant to facilitate tracking & tracing solutions on the packaging of prescription medicinal products in the future. Here, the manufacturer is supposed to assign the SNI to his smallest packaging unit. In case this unit is further broken down, e.g. by a trader, the latter has to assign new SNIs that can be traced back to the original SNI. How this should be done exactly is a question unanswered by the document. Standards for track & trace systems for product authentication are not mentioned either.

The text sets out that the SNI is to consist of the sNDC (serialised National Drug Code), a combination of the already existing NDC and a unique serial number. In this context, the greatest change between the former draft and the final guidance can be found. While the draft document determined that the serial number should be 8 digits long, the final version defines a length of up to 20 digits. The reason for this lies in objections by the industry stating that, with an additional randomisation of the serial numbers, 8 digits would not provide enough possibilities.

The SNI shall be applied to the packaging in a way that can be read both by machines and by human beings. The method for this is not laid down in the guidance. From the FDA's point of view, batch numbers and expiration dates should not be coded in the SNI. According to the CFR requirements, these data are already present on the labelling, but can be entered in data bases linked to the serial number in question.

European Compliance Academy (ECA) established as Foundation

Since its foundation in 1999 the European Compliance Academy (ECA) has been lead as a membership association. Today, the organisation counts close to 4.000 members from almost 60 countries and is the leading European advanced training and information services provider with regard to pharmaceutical quality assurance and GMP compliance.

With the beginning of 2010 the organisation was transferred to the "ECA Foundation" - with the purpose to exchange "information between representatives of the industry, the medicines authorities and the universities in the field of pharmaceutical quality assurance, especially with regard to the area of Good Manufacturing Practice (GMP)." It is lead by a foundation board with 10 members representing European regulatory authorities as well as the pharmaceutical and biopharmaceutical industry.

The new foundation is comprised of a non-profit educational organisation and two non-profit interest groups. The ECA Academy is providing GMP Conferences as forums for exchanging information between industry, authorities and academia as well as education courses and advanced trainings as part of the "ECA GMP Certification Programme". Moreover, the European Qualified Person (QP) Association represents the interests of individual Qualified Persons (QPs) in Europe and supports a harmonised approach for all EU Member States. The second interest group, the "Rapid Microbiological Methods Group" supports the idea of the use of rapid microbiological methods and a harmonised approach in the EU and the USA. A third interest group on "Good Quality Supply Chain Practices" is planned to be established in 2010.

GMP Pre-sterilized Packaging Material - Live Online Training

Recommendation

Thursday, 14 November 2024 9 .00 - 17.15 h

GMP Pre-sterilized Packaging Material - Live Online Training

"This is an important step", commented Daniel Scheidegger, ECA Chairman and Vice President Operations and Managing Director of Genzyme Pharmaceuticals, Liestal, Switzerland the newly established foundation. "It provides the ECA with an up do date legal background for the further development of its services."

To find out more about the ECA Foundation please also visit www.gmp-compliance.org.

Author:
Dr Gerhard Becker, Dr Robert Eicher
CONCEPT HEIDELBERG

Go back

To-Top
To-Bottom