Uniform system for determining manufacturing costs

Therefore, it was decided by the Association to have a Manual prepared outlining a Uniform System for determining Manufacturing Costs, containing, as one of its major features, the Unit Method of calculating Manufacturing Overhead. The system presented herewith was designed after considerable study of the problems and requirements of pharmaceutical manufacturers. It is the result of six years work with approximately twenty pharmaceutical manufacturers, representing a good cross section of the average sized houses. The purpose of this Manual is to present a simple, uniform method of computing manufacturing costs and to act as a guide for those companies desiring to use such a method. Manufacturing Costs only are dealt with here, that is, the cost of producing products and placing them on the shelf in the finished stock room. Distribution Costs have not been studied sufficiently by the Association to produce results which can be included here. This Manual is written with the idea that it will be read and used by people who are thoroughly familiar with the processes involved in the manufacture of pharmaceuticals and by members of their organizations who have a working knowledge of accounting, even though they may not be expert cost accountants. It is prepared with the knowledge that most of the companies in the Association are average sized organizations, who really do not need an elaborate system of cost accounting. Therefore, a simple system is outlined herein requiring very little clerical labor for its maintenance. The adoption of the methods presented herein by the Association will give the membership reliable manufacturing cost data. In addition, it will make the comparison of costs at Association meetings a more valuable and helpful procedure

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June – 2 July 2021

Publisher Copyright: © 2022The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was agreed in the past consultations that the evaluation principles in the guidelines are still valid, but a review was recommended to provide more clarity and case-by-case flexibility. The opportunity was therefore taken to review the experience and identify areas where the current guidance could be more permissive without compromising its basic principles, and where additional explanation could be provided regarding the possibility of reducing the amount of data needed for regulatory approval. The meeting participants applauded the leading role taken by the WHO in providing a much-needed streamlined approach for development and evaluation of SBPs which will provide efficient and cost-effective product development and increase patient access to treatments. It was recognized that the principles as currently described in the draft WHO guidelines are based on sound science and experience gained over the last fifteen years of biosimilar approvals. However, since these guidelines when finalised will constitute the global standard for biosimilar evaluation and assist national regulatory authorities in establishing revised guidance and regulatory practice in this complex area, it was felt that further revision and clarity on certain perspectives in specific areas was necessary to dispel uncertainties arising in the current revised version. This report describes the principles in the draft guidelines, including topics discussed and consensus reached.Peer reviewe

Comment letters to the National Commission on Commission on Fraudulent Financial Reporting, 1987 (Treadway Commission) Vol. 2

https://egrove.olemiss.edu/aicpa_sop/1662/thumbnail.jp

Assurance-santé étatisée : un abécédaire en 68 points destiné aux Canadiens

Le document original contient un feuillet : Copie marquée, votre attention est particulièrement dirigée à la page 12, paragraphe 38 (cote du document : CEBR 3.37.1). Voir aussi le document CEBR 3.37.2Collection Chagnon;Page couverture : La législation qui mettrait en vigueur ce projet (esquissé par un Comité consultatif formé exclusivement de fonctionnaires) est soumise à l’étude et à la discussion du Comité parlementaire sur la sécurité sociale depuis mars 1943. Elle consiste en une loi fédérale qui contient en annexe une loi-type qui pourrait être adoptée par chacune des provinces. Bien que conservé par le Comité parlementaire qui juge utile d’en continuer I’étude au point de vue constitutionnel et financier, ce projet de loi fut récemment révisé et imprimé, accompagné d‘une note annonçant qu‘il subira sa première lecture en février 1944