Chosen: Part 2


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The information should include extension protocol limiting the maximum time period for extrapolation. In the case of any significant negative trend for stability data observed during long-term and accelerated testing, the sponsor should commit to notify any shelf-life extension as a substantial amendment. No, tabulated batch results are sufficient.

Data for representative batches should be included in the batch analysis table of the investigational medicinal product dossier. Results for batches controlled according to previous, wider specifications are acceptable if the results comply with the specification for the planned clinical trial.

The results should cover the relevant strengths, but the batches do not need to be the same that will be used in the clinical trial. Data from representative batches should be provided. This implies that data should be provided for each proposed site. However, where one legal entity has multiple sites in the same country , then batch data from one site only would be sufficient.

These functional aspects should include usability, dose delivery performance, the controls for quality of the container and rationale for choice and optimisation of the design, including size and shape of the container closure system. It is known that the size and shape of the container can affect ease of handling and dispensing of drops by patients, especially those with impaired dexterity such as the elderly.

Usability, i. It is recommended that a formal usability study is undertaken, in accordance with a valid protocol to systematically observe and evaluate the usability of the eye drop medicinal product , particularly for novel containers and containers that are required to be used in a specific non-intuitive way. The usability study may be integrated into clinical or therapeutic equivalence studies.


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In the absence of such study data, evidence of usability should be supported by published or other data, if available, and risk assessment. Dose delivery performance should be qualified by evaluation of accuracy and reproducibility of dose delivery from the dropper in various orientations such as inverted or inclined. The force required to dispense a drop should be correlated with physical capabilities of the target patient population.

In addition to the general information to be provided on quality of containers Ph Eur monograph 3. Plastic containers manufactured by blow-fill-seal process are particularly prone to surface defects and the specification should include tests for:. Appropriate acceptance criteria and standards for control of excessive burrs, sharp edges container opening characteristics should be established and outlined in the dossier, including photographs as necessary. The sample size should be adequate and justified. The product information texts SmPC, Patient Information Leaflet, Labels should include appropriate instructions based on the development data and studies undertaken.

Samples of the drug product should be provided to the Competent Authorities, on request, to enable independent assessment and reporting on the quality of the container. The European Pharmacopeia Ph. Active substances for pharmaceutical use have to comply with the Ph.

Pharmacopoeial active substances should also comply with their specific monograph. Ideally, compendial grade excipients should be used in new veterinary medicinal products. Premixes for medicated feeding stuffs should comply with the requirements of the European Pharmacopeia Ph. It is expected that these products comply with the requirements for non-aqueous preparations for oral use. In cases where an oral powder and a premix for medicated feedingstuffs have the identical composition, it would be expected that the same microbiological limits would be applied to both pharmaceutical forms.

In this case the stricter limits are applicable normally those for oral powders requested in chapter 5. In principle, a veterinary medicinal product can only be authorised if it fully dissolves and remains in solution without further aid in drinking water of the usual pH range which is usually a pH range between 5. If a pH adjustment of the drinking water is necessary this should be done with excipients acid, base or buffer included as part of the authorised veterinary medicinal product. Exclusions are only acceptable if justified e.

The use of unlicensed acids or alkalis for the pH adjustment of the drinking water before or after adding the veterinary medicinal product in order to achieve the necessary solubility is not acceptable unless justified. Such an example would be considered to be two different pharmaceutical forms and also in this specific problem case, routes of administration and therefore to need two different marketing authorisation sub numbers, as well as two different summaries of product characteristics. In the European Union, different marketing authorisations sub numbers are necessary for different pharmaceutical forms.

See the guideline on the categorisation of new applications versus variation applications. Another reason is that using multidose containers for both intramammary and parenteral use may result in an increased risk of microbial contamination of the product in its multidose container. Rubber stoppers bungs used for vial closures for multidose veterinary injectables are often punctured many times during use. Therefore suitable criteria regarding fragmentation and self-sealing are required. Should the general chapter on rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders 3.

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Chosen: Part Two

Which criteria for the maximum number of rubber fragments are deemed acceptable for a test design which is a multiple of the number of punctures described by Ph. Should a worst-case scenario be used? If suitable justification is provided, the requirement maximum of five fragments contained in this chapter does not necessarily need to be applied.

The pack concerned should be proven to meet the requirements of the Ph. Note that the maximum number of fragments expected remains exactly as in the Ph. For example, if the closure has been shown capable of withstanding X punctures with fragmentation and self-sealing characteristics which meet the relevant Ph.

That is, with no additional increase in fragments for the increased number of punctures. Some examples of advice if necessary in combination which could be included in the SmPC section 4.


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It is not possible to have a product in both powdered and granulated forms under the same marketing authorisation. The two different pharmaceutical forms require different SPCs, labelling , etc, and have different marketing authorisation numbers. Note: If authorised via the centralised system the two different pharmaceutical forms would be authorised under the same marketing authorisation , but with different MA sub-numbers and different SPCs, labelling , etc.

The Agency may give a scientific opinion, in the context of cooperation with the World Health Organization, for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article The Committee for Medicinal Products for Human Use may, after consulting the World Health Organization, draw up a scientific opinion in accordance with Articles 6 to 9.

The provisions of Article 10 shall not apply. For these applications, it is of great importance to apply standards that ensure the same adequate product quality as for products to be marketed in the European Union EU. In this context, stability data need to be submitted by the applicant that demonstrate stability of the medicinal product throughout its intended shelf-life under the climatic conditions prevalent in the target countries, i.

Merely applying the same requirements as for the use in the EU, i. Therefore, in order to safeguard product quality throughout its entire intended shelf-life, stability studies under the conditions defined for climatic zones IVb need to be performed, i. In cases where these data demonstrate stability over the required period of time, no special storage conditions need to be labelled.

As an alternative, storage conditions need to be labelled, including humidity, e. However, it has to be noted that due to the technical equipment and logistics available in some of the climatic zone-IV countries as well as the education and compliance of patients in the respective area, exposure of medicinal products to higher temperatures and humidity cannot be ruled out. This needs to be taken into account when defining shelf-life and storage conditions. For products to be stored at 'normal conditions', i.

Please note that for aqueous products in semipermeable containers to be marketed in climatic zone III, i. As an alternative, the calculation factors described in section 2. As foreseen by the note for guidance on declaration of storage conditions, when a product needs to be stored refrigerated, the wording 'store in a refrigerator' should be used in the labelling , and a reference to the temperature range, e.

According to the same note for guidance , when the need for refrigerated transport cool chain , in addition to refrigerated storage, is envisaged, the following statement should be used: 'store and transport refrigerated'. In summary, the expiry date should be calculated from the date of release or in case the period between the date of production and the date of release exceeds 30 days, from the date of production.

The product expires at the end of the specified month. In the worst case, this method of calculation results in an extension of the expiry date of two months:.

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Table 1: Example of the calculation of the expiry date of a tablet with a shelf life of 24 months. It is expected that a shelf life for the intermediate product is detailed in the dossier and stability data to support this are also presented in the dossier. Particularly for products with a shelf-life of less than twelve months, this is not considered acceptable. See table 1 for recalculated expiry dates. Later the mistake was identified by QWP and in March the present corrected version was published.

Endotoxin testing is not requested at the end of shelf life, taking into account the fact that it is not considered a stability-indicating parameter. The shelf-life specification should be completed with a footnote stating that endotoxins are not tested during stability studies.

Sterility testing should be performed at least at the end of shelf life but it can be replaced by testing of the container closure integrity. Depending on the nature of the container, intermittent integrity testing might be envisaged, independent of whether the sterility testing is replaced or not.

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In principle, each product will be assessed on its own merits and differences may exist. Although the CHMP position paper relates only to medicinal products for human use, the same principles can be applied if necessary to veterinary medicinal products when there is a known or demonstrated potential for medication errors. However, when the difference in storage temperature potentially leads to detrimental medication errors in daily practice, such a difference cannot be accepted.

Yes, as long as the selected design is explained and justified. However, veterinary companies may elect to follow this guideline. Where the guideline is followed, all aspects of the guideline should be followed. Finished product stability guidance does not address storage of bulk product during the manufacturing process.

The objective is to increase the transparency of the supporting data required and not to introduce any new regulatory requirements. The data required will depend on the type of product and the activities performed i. The described framework is intended to cover all pharmaceutical bulk products. However, it is understood that the requirements for some specific types of products e. The question most frequently arises in relation to solid oral dosage forms particularly tablet cores before coating or packaging but could be applicable at any stage in the manufacturing process of any pharmaceutical product where bulk is held in storage prior to further processing e.

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