GMP Compliance Adviser Update No. 3/2019
GMP in Practice
Chapter 1 Quality Management Systems
1.K.5 Serialisation of Folding Cartons in the Pharmaceutical Industry
Medicinal products must be safe – one key requirement in this regard is to ensure that patients are protected from counterfeit medicinal products in the legal supply chain. Particular importance is placed on the serialisation of the packaging: The clear labelling of each individual sales package is one possible approach to prevent counterfeit medicines from entering the legal supply chain. To this end, EFPIA has developed an initiative providing for a 2D matrix code. However, the uniform introduction of this code in Europe or even worldwide is opposed by the fact that many countries have already developed their own concepts. The revised chapter provides an overview on regulatory expectations, the EFPIA initiative and serialisation schemes already implemented. (Roland Kleissendorf)
13.A.11 GMP aspects when handling print data
Print data play an important role in drug safety. This is reflected in the fact that the majority of all product recalls are attributable to errors in printed packaging materials. When you consider the logistical and financial costs associated with a product recall, it quickly becomes clear that handling print data requires clear definitions and defined processes. The generation and control of print data requires technical knowledge and an understanding of GMP. If the preparation is outsourced to an external repro house, these must be selected and audited according to defined criteria. (André Deister, Ilka Henkel)
13.A.12 GMP aspects in the design of packaging materials
The design of packaging also has an influence on drug safety that should not be underestimated. Since the design development of packaging materials tends to take place in an environment far removed from GMP, it is important to pay early attention to quality assurance elements for both the design and the technical implementation. It is recommended to create a technical guideline for the development of the Design Manual. (André Deister, Ilka Henkel)
GMP Regulations
Chapter C EU Directives and Guidelines
C.8.2.1 Safety features for medicinal products for human use
Question and Answers – Version 14
The Q&A document on safety features should be seen as a supplement to the Anti-Counterfeiting Directive 2011/62/EU and the Delegated Regulation (EU) 2016/161, which entered into force on 9 February 2019. The comprehensive document contains a total of 110 questions and answers, which are assigned to 12 different topics. It sets out frequently asked questions and answers regarding the implementation of the rules on the safety features for medicinal products for human use. The focus lies on providing information on the technical aspects and should help to facilitate its implementation.
Chapter E ICH-Guidelines
E.3.D ICH Q3D (R1): Guideline for Elemental Impurities
In March 2019, the ICH published the final revision of the Guideline for Elemental Impurities Q3D (R1). The reason for this revision is an adjustment of the PDE value for cadmium by inhalation.
Cadmium is now listed with a new inhalation PDE value of 3.4 μg/day. The original value published in 2014 was 1.7 μg/day. This did not agree with the oral and parenteral PDE calculations, as a modifying factor was not taken into account. Following a public consultation in May 2018, the value was revised and is now corrected.