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1.020GOOD DOCUMENTATION PRACTICESAuthorized by: Brenda Pavlic, CPhT1.0PURPOSE 1.1This SOP will outline the Quality requirements for all documenting practices. Documents (e.g. compounding records,.

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How to write good documentation Fit for context. Clearly written and to the point. Visual where possible. Skimmable. Up to date. Discoverable & Tracked.

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of documents. The importance of documentation: As per GMP documentation control "If it is not written down, then it did not happen".

Basic requirements of GDP: Always record the entries at the time of activity simultaneously. Always record date with the signature in GMP records. Always use an indelible ballpoint pen to record data in GMP records. Always enter the data directly into the GMP records in the English language.

Good documentation practice (GDocP), also known as good record-keeping practice or GRK, is a set of internationally accepted guidelines that ensure the reliability, integrity, and veracity of data collected during the research, development, manufacturing, and testing of drugs and medical devices.

Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.

Good Documentation Practice Standards It requires that documentation must be created and retained to provide a traceable, historical record of all activities as well as be readily accessible for product investigations, periodic product reviews, or any internal or external (e.g., FDA, EMA) audits.

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

The GDPs are an internationally accepted practice by which research and manufacturing data is documented and preserved.

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© Copyright 1997-2025
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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
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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