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USER GUIDE <Finished Product Specifications Form User Guide> Published by autho

USER GUIDE <Finished Product Specifications Form User Guide> Published by authority of the Minister of Health Health Products and Food Branch User Guide Our mission is to help the people of Canada maintain and improve their health. Health Canada HPFB=s Mandate is to take an integrated approach to the management of the risks and benefits to health related to health products and food by: $ Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and, $ Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health. Health Products and Food Branch 8 Minister of Public Works and Government Services Canada 2009 Available in Canada through Health Canada - Publications Brooke Claxton Building, A.L. #0913A Tunney's Pasture Ottawa, Ontario K1A 0K9 Tel: (613) 954-5995 Fax: (613) 941-5366 Également disponible en français sous le titre : Manuel de l’utilisateur <Manuel de l’utilisateur du formulaire de spécifications relatives au produit fini> Health Canada Finished Product Specifications Form User Guide FOREWORD User Guides are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. User Guides also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. User Guides are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met. As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this guide, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guides or guidance documents. Health Canada Finished Product Specifications Form User Guide TABLE OF CONTENTS INTRODUCTION .......................................................................................................................... 1 1.1 Policy Objectives .................................................................................................... 1 1.2 Scope and Application............................................................................................ 1 GUIDANCE FOR IMPLEMENTATION ...................................................................................... 1 2.1 Completing the FPS form ....................................................................................... 1 2.2 Recognized Test Methods....................................................................................... 4 APPENDIX 1: Finished Product Specifications form.................................................................... 5 APPENDIX 2: Acceptable Tolerance limits for Quality Test Parameters ................................... 14 Health Canada Finished Product Specifications Form User Guide 1 1 INTRODUCTION 1.1 Policy Objectives This guide is intended to explain the new approach to submission of Finished Product Specifications for Product Licence Applications. 1.2 Scope and Application This guide applies to the submission of all non-compendial pre-market submissions of Natural Health Products that fall under the NHP regulations. This document should be read in conjunction with the Evidence for Quality of Finished Natural Health Products guidance document. 2 GUIDANCE FOR IMPLEMENTATION The NHPD has developed a new approach to the assessment of the evidence for quality of finished natural health products (NHPs) that will expedite the pre-market authorization process. This new quality assessment process is intended to ensure that specifications meet with acceptable standards. The following document consists of a Finished Product Specifications (FPS) template, and Tables 1, 2 and 3 which outline prescribed tolerance limits for each type of test required for NHPs. A list of NHPD recognized test methods is now also available via the Controlled Vocabulary search in the NHPD Ingredient Database. By submitting the Finished Product Specifications information in this form, the applicant is meeting the requirements of section 5(i) of the Natural Health Products Regulations. The testing requirements listed in the template, the limits in Tables 1-3 and the list of recognized test methods are consistent with the current Evidence for Quality of Finished Natural Health Products guidance document, which can be referred to for more detailed guidance. The responsibility to maintain complete quality information, including full test records, remains in place, and documentation must be provided to Health Canada on request. Auditing of documentation may occur during post-market and site-licensing evaluations. 2.1 Completing the FPS form Note: macros must be enabled in Microsoft Word in order to check the boxes on the form. If the boxes cannot be checked, from the Main Menu select ‘View’, select ‘Toolbars’, from the drop down list select ‘Control Toolbox’ and select the ‘Exit Design Mode’ icon . Brand Name The brand name must be indicated on the FPS and must match the brand name indicated on the Product Licence Application (PLA) form. Sections A & B Health Canada Finished Product Specifications Form User Guide 2 Sections A and B are intended to provide descriptive information about the product. The type of dosage form must be specified in section A, and the types of ingredients contained in the product must be identified in section B. This information is required as it serves to assist both the applicant and the NHPD Assessment Officer in determining what evidence will be required to support the quality of the product. As an example, if a NHP contains both a plant and an isolate, then the applicant is able to attest that microbial contamination limits meet those that pertain to the plant material (the less stringent of the two). As another example, if the product type does not include plants, extracts, homeopathic medicines or traditional medicines, the Assessment Officer is immediately aware that pesticides testing may not be required. Section C The list of medicinal ingredients and/or standardized constituents, their quantities, quantity tolerance limits and test method information, as well as identity testing is all indicated in section C. The quantity and potency (if applicable) of each medicinal ingredient must be included along with its tolerance limits. Three options are provided for quantification of the medicinal ingredient: quantification by input; a finished product assay by a method on the list of NHPD recognized test methods or an equivalent validated in house method; or assay by a test method recorded in section E of the form. Note that when an ingredient is not assayed at the finished product stage (i.e. addition is verified by GMP and in-process controls), a rationale is required to justify the absence of analytical testing. It should be clear whether testing of constituents (potency) for the purpose of standardization is done at the finished product or raw material stage (or both stages) and the test method used should be either from the list of NHPD recognized test methods or else specified in section E of the form. For identity testing, it must be indicated for each medicinal ingredient whether the test methods meet those set out in the List of NHPD Recognized Methods or an equivalent validated in house method, whether the tolerance limits meet the requirements laid out in Table 1, and whether testing occurs at the finished product or raw material stage. Note: If additional rows are required at any time, move your cursor to the outside right of the table (beside the last row) and press enter; a new row should appear. Alternatively, you may attach separate sheets of the same form if necessary. Section D Section D confirms that the product is tested in accordance with NHPD’s Evidence for Quality of Finished Natural Health Products guidance document and is subdivided into three sections:  D(1) relates to general parameters which apply to all NHPs;  D(2) relates to ingredient-specific testing parameters for both medicinal and non-medicinal ingredients; and  D(3) relates to performance standards for specific dosage forms. Health Canada Finished Product Specifications Form User Guide 3 The NHPD’s prescribed limits for the parameters in subsections 1, 2 and 3 are laid out in Tables 1, 2 and 3, respectively (found in Appendix 2). For each applicable test parameter, it must be indicated whether the test methods meet those set out in the List of NHPD Recognized Methods or an equivalent validated in house method, whether the tolerance limits meet the requirements laid out in Tables 1, 2, and 3, and whether testing occurs at the finished product or raw material stage. This can be done by checking the appropriate boxes under each column, i.e. check the box marked “yes” if limits meet the requirements or “no” if they do not meet the requirements and provide the limits in Section F. If the product does not contain the specific ingredient, indicate so by checking the box under ‘Product does not contain this ingredient’. If testing is not required (e.g. microbial testing in products containing >50% alcohol), indicate so by checking the box under ‘N/A’ and provide a rationale. With regards to the list of ingredient-specific parameters in section D(2), there is space at the end of the list to declare any additional specific tests uploads/s1/ fps-user-guide-eng.pdf