Dating of multi use containers Chat gratis con maduras en el mobile
It should be noted that the definition of active substance given in part II of the European Union (EU) good-manufacturing-practice (GMP) guide (active substances) states that an active substance is a substance or a ‘mixture of substances’, but this definition takes into account cases when active substances are not single chemically defined substances (e.g.herbal extracts) and it is not meant to allow a mixture of chemically defined active substances to be considered as a single active substance.Should the materials always comply with the specifications in the European Pharmacopoiea and if not, which quality standards are considered to be acceptable? general notices 1.3, it is not obligatory that only materials complying with a given specification in a chapter of the Ph. For solid oral dosage forms and solid active substances, it has been agreed by the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party that plastic materials compliant with the relevant European Union (EU) food legislation relating to plastic materials and articles intended to come into contact with foodstuffs are considered acceptable.
Acceptance of such different tablet appearances in the specification of a single strengthproduct would formally also allow the company to dispense these two appearances in the same container/blister, which may even cause greater confusion.
An in-use shelf life should only be set if necessary, i.e.
when significant changes as defined in ICH Q1A (R2), or veterinary VICH GL3 as relevant, are observed. Storage without the protection of the immediate container is considered as a worst case scenario, and can in some instances be used to assess the need for an in-use shelf life.
However, it may be that the choice of a packaging material for a given product has to take into account factors other than the method of sterilisation.
In such cases these other factors need to be clearly documented, explained and scientifically justified in the marketing authorisation dossier.”Aseptic processing cannot be considered as a simple replacement for terminal sterilisation. Eur.) general text 5.1.1: methods of preparation of sterile products states that, “wherever possible, a process in which the product is sterilised in its final container (terminal sterilisation) is chosen,” and that, “if terminal sterilisation is not possible, filtration through a bacteria-retentive filter or aseptic processing is used; wherever possible, appropriate additional treatment of the product (for example, heating of the product) in its final container is applied.” Such a combination of aseptic processing with non-standard lower temperature heat treatments, either before aseptic filling, or after aseptic filling, should be pursued where possible in line with the recommendations of the Ph. The guideline therefore does not prevent the use of heat-labile packaging materials for sterile products, but there must be justified reasons for having such packaging for sterile products, and these must be supported by the overall benefit:risk balance of the product.