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- Key: V: applicable to veterinary medicinal products Requirements for selection and justification of starting materials for the manufacture of chemical active substances in veterinary medicinal products For veterinary medicinal products what guidance...
- Application of this document does not introduce any new requirements but ensures harmonisation and avoids potential confusion. Removal of heavy metals tests from a specification - Substances with a Ph. Is it necessary to submit a variation when...
- The only exceptions can be made where the active substance cannot exist on its own, for example, due to insufficient stability without a stabilising agent, or in the case of herbal dry extracts if it is not possible to produce a solid extract without excipients. What is the definition of an API mix? The manufacture of an API mix is considered to be the first step of the manufacture of a finished product. In certain circumstances, i. S or part 2. A re-test period for the API mix can in such cases be accepted, if justified. In case of an API mix prepared due to workability purposes or reasons other than safety and stability, the manufacturing steps from the addition of the excipient to the API should be described in the appropriate part of CTD 3. In addition the steps following addition of the excipient must be conducted in accordance with GMP Part I and an appropriate manufacturing authorisation.
- However, additional justification on the choice and level of antioxidant needs to be provided, and a control test is required for the antioxidant in the API mix. Particular care should be given regarding API mix acceptability in cases where different sources of API are used in the same medicinal product to avoid a medicinal product with alternative compositions c Are APIs in solutions e.
- ASMFs for solutions are acceptable in certain circumstances as explained under question 1. For an existing Ph. If there is no Ph. An API mix is acceptable when there are safety or stability issues: What data should be submitted to justify the acceptability of an API mix for which there is no Ph. In all cases the choice and level of excipient should be justified. In case the originator uses no stabiliser, it is expected that the same approach as the originator is taken by any subsequent new product. Acceptable stability reasons include both chemical and physical stability. Results with a stabiliser should demonstrate a relevant stability improvement. For APIs of an explosive nature the use of an API mix may be justified, and an appropriate explanation is considered sufficient. A justification based only on workability reasons, e.
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Toxicological considerations e. Data supporting the choice and the amount of the excipient should also be provided. Information requested for the excipient s — Ref. Annex I section 3. Where should the excipient be stated? Excipients should be stated in the composition of the drug product Module 3. A for products for veterinary use ; in the SmPC — 6. For the PL for products for veterinary use: section 3 i. See also QRD templates.- The same principles apply as for ASMFs. The following information should be required as additional information in the case of a CEP: The description of the manufacturing process for preparation of the mixture should be provided by the API manufacturer to the applicant - in addition to the CEP. This information should be part of section 3. If a new CEP is presented as a variation then these above mentioned elements should also be included as part of that submission. In addition, as far as the variation submission category is concerned and whether or not a Type IA or even a variation will be possible at all, particular consideration should be given to the potential impact of the change on the currently registered specifications of both the API and the finished product conditions 1 and 2 under variation change code B.
- In this instance, as far as condition 2 is concerned, it is important to note that product specific requirements also include the qualitative, and where relevant, quantitative composition of the API mix, as indicated in the CEP, which may impact the currently registered composition of the finished product see question 1b. It is also common practice where a CEP is used that additional information can be provided in the marketing authorisation application dossier e.
- Active substance - Declaration by the qualified person on the good-manufacturing-practice status of the active substance manufacturer 1. The active substance in my product is widely used, but not normally as a pharmaceutical active substance, and I am having some difficulty in confirming compliance. What should I do to furnish the required declaration? The active substance in my product is widely used, but not normally as a pharmaceutical active substance , and I am having some difficulty in confirming compliance. It is recognised that for a small number of medicinal products the primary use of the active substance is not in a medicinal product and the producer may therefore not be aiming to meet the specific requirements of pharmaceutical customers that represent an insignificant volume of business.
- Alternative sources should normally be sought but in exceptional circumstances the manufacturing-authorisation holder should assess and document to which extent GMP is complied with and provide a risk-based justification for the acceptance of any derogation. The declaration provided by the qualified person should set out in detail the basis for declaring that the standards applied provide the same level of assurance as GMP. The European Medicines Agency will collect experience with this approach which can be used as a basis for discussion on related amendments to guidelines in the future. Active Substance - Good-manufacturing-practice compliance for sterilisation of an active substance 1. What kind of good-manufacturing-practice documentation is needed for an active substance manufacturer who performs sterilisation of an active substance? This implies that for any active-substance manufacturer who performs sterilisation and subsequent aseptic handling of the active substance , a valid manufacturing authorisation or GMP certificate from an EEA authority or from an authority of countries where mutual recognition or other Community arrangements apply has to be submitted.
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Also, the active-substance manufacturer has to submit data on the sterilisation process of the active substance including validation data to the marketing-authorisation applicant or holder for inclusion in the dossier submitted for the finished product and approval by the licensing authority or authorities. Active Substance - Starting materials of herbal origin 1. How should the quality of a starting material of herbal origin be controlled when it is used to manufacture a semi-synthetic active substance? Starting materials of herbal origin should be characterised to ascertain their suitability and a contaminant profile should be established and submitted, taking into consideration the number of chemical steps between the starting material and the semi-synthetic active substance.- In all cases, the scientific name genus, species, variety and author of the plant and plant part used should be specified. If the starting material is an extract or an isolated constituent, the extraction solvent and strength e. The quality of the starting material of herbal origin should follow the principles set out in the European Pharmacopoeia monographs on herbal drugs, herbal drug preparations, extracts and essential oils, as applicable: the potential presence of foreign matter, pesticides, microbiological contamination, total ash, heavy metals, aflatoxins, ochratoxin A, radioactive contamination, residual solvents, and other relevant impurities should be discussed. Potential contaminants that may be carried through the extraction and purification processes should be fully addressed taking into account the production of the herbal drug, and the subsequent extraction and purification processes. The specification for the starting material of herbal origin should be fully justified by the applicant and should include suitable tests for identity, assay, impurities and potential contaminants.
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Compliance with the guideline on good agricultural and collection practice GACP is not mandatory in the steps prior to the starting material of a semi-synthetic active substance , since it applies to herbal medicinal products and traditional herbal medicinal products. However, information on the geographical origin, collection or cultivation, harvesting, and post-harvest treatments possible pesticides and fumigants used and possible radioactive contamination could justify limited testing for possible contaminants. Change in the appearance of tablets during storage 1. When is a change in the appearance of an oral medicinal product during its shelf life considered acceptable?- H July A change in the appearance of an oral medicinal product during its shelf-life is considered acceptable when all of the following conditions are met: The root cause of the change is known and the change has no influence on other product characteristics e. In all other situations, a change in appearance should be assessed on a case-by-case basis. Data submission Expand section Collapse section 1. Is the submission of data regarding manufacturing process validation,analytical validation,and stability studies, produced only by the developer of the product sufficient? If the developer of product is presented as one of the product manufacturers? Does it make any difference if the developer of the product is presented as one of the product manufacturers or not?
- The new product has the same formula and manufacturing method of the developed product. Provided that the formula, manufacturing process, analytical methods and packaging materials are the same, data originating from the developer of the product is normally sufficient. As regards manufacturing process validation, the marketing authorisation holder , according to the guideline on process validation , must submit with the new application the process validation scheme and the commitment to carry out process validation and initiate stability studies along with the batch analysis for production scale batches for the new manufacturing site. This is irrespective of whether the product developer is one of the manufacturing sites of the new product or not. Who is responsible to verify the production scale validation data when this is available?
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