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  • 1.020 Good Documentation Practices

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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 fill out the 1.020 GOOD DOCUMENTATION PRACTICES online

Filling out the 1.020 GOOD DOCUMENTATION PRACTICES form is essential for maintaining quality standards in documentation practices. This guide will provide you with clear, step-by-step instructions to ensure that you complete the form accurately and efficiently.

Follow the steps to successfully complete the form.

  1. Click the ‘Get Form’ button to access the form and open it in your preferred online document management tool.
  2. Begin by entering the authorized name in the designated field. In this case, it is Brenda Pavlic, CPhT.
  3. In the purpose section, summarize the quality requirements for documentation practices addressing how documents provide traceability and materials' acceptability.
  4. Complete the frequency section by ensuring you detail how often the documentation is conducted, aiming for consistency.
  5. Under the responsibility section, list all personnel involved in the documentation process such as pharmacists, technicians, and customer service representatives.
  6. In the procedure section, acknowledge the importance of making all documentation permanent, legible, and accurate. This includes using blue or black indelible ink for entries.
  7. Ensure all entries are recorded at the time tasks are performed with sufficient detail to reconstruct activities at a later date.
  8. Include signatures and dates on entries, following the common format of Month-Day-Year.
  9. Use 'N/A' for any unused spaces and include units of measurement appropriately, ensuring numeric values adhere to the specified formats.
  10. In the event of errors, follow the procedure for corrections by drawing a line through the incorrect entry and entering the correct information above or below it.
  11. After completing the form, review it for accuracy, ensuring compliance with all requirements outlined in the guidelines.
  12. Save your changes, and choose to download, print, or share the completed form as necessary.

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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
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
Help Portal
Legal Resources
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