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JANUARY 2013PREPARATION OF A SITE MASTER FILE FOR A MANUFACTURER OF COSMETIC PRODUCTSPREPARATION OF A SMF FOR A MANUFACTURER OF COSMETIC PRODUCTS1JANUARY 2013WHAT IS A SITE MASTER FILE ? A Site Master.

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2.1 The Site Master File is prepared by the cosmetic and/or Household Hazardous Substance manufacturer and contains specific information about the quality assurance, the production and/or quality control of HHS manufacturing operations carried out at the named site and any closely integrated operations at adjacent and ...

Trial documents (protocol, investigator's brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.) Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)

1.1 The site master file (SMF) is prepared by the pharmaceutical manufacturer and should contain specific information about the quality management policies and activities of the site, the production and/or quality control of pharmaceutical manufacturing operations carried out at the named site and any closely ...

Prepare a Site Master File containing about 25 to 30 A4 size pages as per contents are given in Annexure. Each page of SMF shall have the following header. Document No.: Effective Date: Each page of SMF shall have the following footer. Prepared by: Approved by: Date: Date: a) Contents page. b) Approval page.

The Site Master File (SMF) or Regulatory Binder contains essential documents. The requirement to maintain a set of essential documents within a Trial Master File (TMF) comes from International Conference on Harmonisation Good Clinical Practice (ICH GCP).

The major deliverable of a clinical study is an organized collection of documents called a Trial Master File (TMF). ... Investigative sites collect Essential Documents and other documents in paper form in a regulatory binder and/or in electronic form in an investigative site file (ISF).

The reason why the TMF is so important is that it permits the study to be independently recreated from these study records. TMF is a quality process, allowing to document all of the activity that has been performed during the study.

A Site Master File (SMF) is a GMP document that describes the site, major activities, key personnel, site layout, etc. ... A Quality Manual (QM) is an ISO 9001 document that described the whole Quality Management System.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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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
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
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 workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
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