Quality Agreement Guideline and Template

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7 APIC Quality Agreement Policy 3. Purpose and Scope 3.1 Purpose This document is intended to provide expert advice to the API/intermediary industry and its customers on how to implement and maintain appropriate quality agreements. It is clear that uniform standards for such agreements bring the following benefits to the industry: Reduced workload (due to reduced editing time) Faster implementation (due to reduced review times) Reduced complexity (due to reduced diversity) Compliance with this document will provide the current state of the art for quality agreements in the pharmaceutical supply chain (API/intermediate). The APIC Quality Agreement Guideline and the corresponding model are designed as a flexible model for the creation of quality agreements wherever such an agreement is desired. It defines the appropriate points that should be addressed in a quality agreement. The template is designed to have global reach and content, making it suitable for use in all regions. 3.2 Scope The Directive and the model cover agreements between the API manufacturer/intermediaries and its customers (users or distributors). It does not apply to agreements between distributors and their customers, nor to the purchase of chemical/non-GMO raw materials by the API/intermediary manufacturer: the model is not really suitable for these purposes, but parts of the model can be used to create an agreement for these areas. In addition, the model may not always be suitable for atypical APIs.

In such cases, the model may be adapted or other models may be used where appropriate (e.B. IPEC model; see footnote 1). For an APIC policy and model specific to outsourced analytical services, see The model is suitable for both generic APIs and proprietary substances, even if they are provided for use in clinical trials. The term generic API is used for all APIs that can essentially be obtained from multiple sources or manufactured and delivered to multiple customers, as opposed to APIs sold only by the originality company or its exclusive licensees. These generic APIs are patent-free; they are usually described in the monographs of the pharmacopoeia and provided on the basis of standard specifications. Proprietary substances are APIs or intermediates manufactured exclusively for a customer who typically holds intellectual property rights in the process. This activity is also known as contract manufacturing or customer synthesis. It can be managed under a contract manufacturing supply contract where the main raw materials are delivered from the customer to the supplier. The provider is widely used in this policy and the corresponding model for a company that provides the product, i.e. an API or API intermediary, to its customer. The terms contract acceptor (instead of supplier) and contractor (instead of customer) are considered synonymous in practice and can therefore be used alternately if the parties prefer; They are quite common in the field of customer-specific synthesis. Version 02 July 2017 Page 7/42 Europe`s new approach to ensuring the quality of APIs and its impact on manufacturers and producers IPA/EDQM/WHO Mumbai Conference 28 September 2012 Dr.

Florence Benoit-Guyod, EDQM Inspector, 10 APIC Quality Agreement Guideline 5. Format and structure of a quality agreement 5.1 General aspects The Annex to this APIC Directive is a ready-to-use quality agreement (see the typical structure of such an agreement in point 5.2). The Introduction and General Provisions sections deal with the scope and terms of the Agreement. The quality responsibilities section, also in some cases referred to as the division (or delimitation) of responsibilities, includes the main quality and regulatory issues and the corresponding responsibilities usually found in a quality agreement. However, the model does not mention all points of the pharmaceutical quality system, as the quality requirements sufficiently covered by reference to the applicable quality standard/GMP (as indicated in section 1 of the model) do not need to be repeated in the agreement. Quality tasks can be assigned to one or both parties as needed. In order to provide a convenient and quick overview, a tabular format has been chosen for this section. The format of the template should be flexible, with the template providing all the individual elements required for most quality agreements.

There are several ways in which both parties can benefit from using a standardized template: The template can completely replace its own agreement The template can be used as the basis for a (slightly) modified and custom draft contract Some sections of the template can be used when drafting your own agreement The template wording can be used to resolve disputes, if it is mutually understood as good industry practice. Therefore, the proposal is the ideal common starting point for all subsequent negotiations on a quality agreement (see Chapter 6 of this Guideline). If necessary or at the request of a Party, country- or product-specific requirements may be added to the standard text. The template is only available in English as English is the most widely used language in the global business and communications industry, and therefore represents the best common ground between parties of different native languages. The deadlines specified in a quality agreement can be indicated descriptively (the most common terms: immediately, immediately, without undue delay, in time, within a reasonable time) or by an exact number. Generally accepted definitions of descriptive terms can be found in the glossary of this document. Temporal differences between the regions concerned must be taken into account. Version 02 July 2017 Page 10/42 15 APIC Quality Agreement Guideline 8. Glossary Active Pharmaceutical Ingredient (API) – Any substance or mixture of substances intended for the manufacture of a drug (or: drug) that becomes an active substance of the drug in the manufacture of a drug. These substances are intended to have a pharmacological or other direct effect on the diagnosis, cure, mitigation, treatment or prevention of disease or to impair the structure or function of the human or animal body. Unfavourable trend Unfavourable tendency Values of a measure of product or process quality that is outside the normal capacity of the process or that indicates a reasonable probability that the product will not meet the specifications before the end of the shelf life or retest time assigned to it. Agreement Concluded by the parties and legally binding on them.

Atypical active ingredient A substance whose main use is not contained in a medicinal product and whose manufacturer may therefore not seek to meet the specific requirements of pharmaceutical customers who represent an insignificant volume of business. These substances are addressed in the European Medicines Agency`s `Question and Answer Document` on Good Manufacturing Practice (section `EU GMP Guide, Part II: Essential requirements for active substances used as starting materials: GMP compliance for active substances`, point 6). (State or regulatory) Authority Any court, tribunal, arbitrator, agency, legislative body, commission, officials or other instruments (a) of a government of any country, (b) of a federal, state, province or other political subdivision thereof, or (c) of a supranational body, including but not limited to the European Medicines Agency (EMA). Working day Any day of the week, with the exception of Saturday, Sunday or the day on which the party is required to act, is regularly closed for business, i.e. Monday to Friday (European working hours), except on official national or regional public holidays or the closure of the factory. CEP Certificate issued by the European Directorate for the Quality of Medicinal Products demonstrating that the product meets the requirements of the European Pharmacopoeia monograph and/or the requirements for transmissible spongiform encephalopathy (TSE). .

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