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                Get Annex B: Site Master File Cosmetics/hhs
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How to fill out the ANNEX B: Site Master File Cosmetics/HHS online
The ANNEX B: Site Master File Cosmetics/HHS is a crucial document designed for manufacturers of cosmetics and Household Hazardous Substances (HHS). This guide will provide step-by-step instructions to assist users in completing the form accurately and efficiently online.
Follow the steps to fill out the ANNEX B: Site Master File Cosmetics/HHS online.
- Press the ‘Get Form’ button to access the form and open it in the editor.
 - Begin with Section C.1, providing general information about your firm. Include the firm’s name, address, and details relevant to understanding your manufacturing operations, ensuring the information does not exceed 250 words.
 - In Section C.1.2, indicate the licensed activities of cosmetics and/or HHS products according to the National Regulatory Authority (NRA), including any necessary conditions or restrictions stated.
 - For Section C.1.4, list the exact name and address of the site, including the contact telephone and fax numbers, as well as a 24-hour contact number.
 - Section C.1.5 requires you to describe the actual products manufactured on the site and any toxic or hazardous substances handled. Note if household or traditional/herbal products are also produced.
 - Proceed to Section C.1.6 to provide a short description of the site, covering the location, size, building types, and surrounding environment, keeping it within 250 words.
 - In Section C.1.7, report the number of employees engaged in various roles related to quality assurance, production, and distribution, including part-time employees expressed in full-time equivalent terms.
 - Section C.1.8 asks for details about any outside scientific or technical assistance utilized in your operations, including company names, contact numbers, and a brief outline of the services provided.
 - When filling out Section C.1.9, describe the quality management system your firm utilizes, including quality policies, audit programs, and standards such as ISO 9001, within 750 words.
 - Continue through the form sections (C.2 to C.9), providing detailed descriptions and necessary information as outlined in each requirement. Use concise bullet points or numbered lists for clarity where applicable.
 - Once all sections are completed, save your changes. You will have the option to download, print, or share the form as needed.
 
Complete the ANNEX B: Site Master File Cosmetics/HHS online today to ensure compliance and streamline your documentation process.
The Site Master File is a requirement in just about every set of pharmaceutical regulations except the US FDA for GMP operations and would be a fundamental expectation to receive a GMP certificate. You should most certainly have one in place prior to your certification inspection and be prepared to provide it.
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