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  • Annex B: Site Master File Cosmetics/hhs

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ANNEX B: Site Master File Cosmetics/HHSEXPLANATORY NOTES FOR INDUSTRY ON THE PREPARATION OF A SITE INFORMATION FILETABLE OF CONTENTS Page 1.Document History .

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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.

  1. Press the ‘Get Form’ button to access the form and open it in the editor.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.

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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.

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

1.3 A Site Master File should contain adequate information but, as far as possible, not exceed 25-30 pages plus appendices. Simple plans outline drawings or schematic layouts are preferred instead of narratives. The Site Master File, including appendices, should be readable when printed on A4 paper sheets.

A Site Master File (SMF) is a document prepared by a manufacturer that provides specific, factual information about the production and control of manufacturing operations at a named site, as well as any closely integrated operations nearby buildings.

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.

Study Site Master File (ISF): The file held by the site Principal Investigator containing the essential documents that demonstrate that the trial has been conducted in ance with regulatory requirements and ICH GCP, enabling both the conduct of a clinical trial and the quality of the data produced to be evaluated.

1.3 A Site Master File should contain adequate information but, as far as possible, not exceed 25-30 pages plus appendices. Simple plans outline drawings or schematic layouts are preferred instead of narratives. The Site Master File, including appendices, should be readable when printed on A4 paper sheets.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232