When designing facilities there are numerous aspects to consider. These include, not only the regulatory and normative requirements but also the, functionality and cost effectiveness as well as the principles of hygienic design. As part of this process, it is standard practice to differentiate between product contact and non-product contact components. This affects, for example, the choice of materials and the required surface finish.
Important design characteristics for hygienic design are explained using the example of different types of connections, feeding and dosing systems, and clean room installations. The design principles of hygienic design can also be applied when designing lifting equipment, roller conveyors, scaffolding and racks.
The application of hygienic design in production plants for the manufacture of active ingredients and pharmaceuticals is shown by means of examples. Hygienic design is of particular importance in aseptic production and when handling highly active substances.
It is important that hygienic design is taken into consideration as early as possible during the planning phase and that the required design criteria are outlined in the user requirements specification.
(Ruven Brandes, Richard Denk)
Active Pharmaceutical Ingredients (APIs) differ from starting materials, excipients and raw materials in that they have a medicinal, pharmacological or other effect on the function of the body. In addition, there are clear regulatory requirements for the manufacture, testing and trade of APIs which, in contrast to the other substances mentioned, are regularly supervised by the authorities.
There are many parallels between the GMP-compliant manufacture of APIs and the production of medicinal products, as the comparison of EU GMP Guide Part I for medicinal products and EU GMP Guide Part II for APIs shows. There are however also a number of important differences to be considered if manufacturers of APIs are to stay within the official requirements, thus ensuring GMP compliance.
(Rainer Gnibl, PhD)
At the European level, the EMA and EDQM have a number of important tasks in relation to the supervision of medicinal products:
The European Medicines Agency (EMA) is responsible for marketing authorisations in the centralised procedure, pharmacovigilance and coordination of the Member States’ duties of supervision.
The European Directorate for the Quality of Medicines (EDQM) is responsible for the elaboration of the European Pharmacopoeia, issues CEP certificates and coordinates the network of Official Medicines Control Laboratories (OMCLs). The EDQM can request inspections from the EU Commission.
The legal basis for the supervision of medicinal products for human use, investigational medicinal products and veterinary medicinal products comprises numerous directives and regulations. Compliance with the regulations is verified by mean of official inspections. Community procedures for inspections and information exchange play an important role in this. They are designed to facilitate cooperation and the ex-change of information between the competent authorities of the EU Member States and to support the harmonisation of inspection procedures.
International cooperation in the area of medicinal product monitoring is facilitated by mutual recognition agreements. After a successful equivalence assessment of the GMP and inspection systems of two contracting parties, inspections can be mutually recognised. The work of the PIC/S makes an important contribution to the harmonisation of inspection procedures and training content for inspectors.
(Michael Hiob, PhD)
On April 2, 2020, the address of the Division of Regulatory Programs in Subpart A – General Provision, §820.1 Scope under (e) Exemptions or variances was updated:
“For guidance on how to proceed for a request for a variance, contact Division of Regulatory Programs 2, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1438, Silver Spring, MD 20993-0002.”
No further amendments were made.
The additions made concern Paragraph §600.3 Definitions:
No amendments in content were made to the CFRs 601, 606 and 680. They are
current as of 1 April 2020.