Session 12_Documents and Good Documentation Practices.pdf - Documentation Good Documentation Practices DOCUMENTS The document is information(meaningful

Session 12_Documents and Good Documentation Practices.pdf -...

This preview shows page 1 - 7 out of 19 pages.

Documentation & Good Documentation Practices
Image of page 1
DOCUMENTS The document is information (meaningful data) and its supporting medium, which could be in paper form, CD, computer files, or microfilm. Good Documentation Practices, in brief, enable communications of intent and consistency of actions (ISO-9000: 2000).
Image of page 2
DOCUMENTS Organizations develop ( establish ), and keep documents that describe (1) how the Quality Management System is applied to a specific product, (2) establish documents on product requirements (specifications), (3) establish documents to provide information about how the facility perform activities and processes (procedures), and (4) establish documents to provide objective evidence performed or results achieved (records), then the organization management can claim that they fulfill the Good Documentation Practices requirements.
Image of page 3
Purpose of Documents The purpose of Good Documentation (as set out in the WHO Good Manufacturing Practices guidelines for Pharmaceutical products) are: To define the specifications and procedures for all materials and methods of manufacture and control To ensure that all personnel concerned with manufacturing know what to do and when to do it.
Image of page 4
..Purpose of Documents To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale. To ensure the existence of documented evidence, traceability, and to provide records and an audit trail that will permit investigation. And to ensure the availability of the data needed for validation, review, and statistical analysis.
Image of page 5
DOCUMENTS TYPES (CATEGORIES) The following are the types of documents, which organization should establish and keep: Guidelines
Image of page 6
Image of page 7

You've reached the end of your free preview.

Want to read all 19 pages?

  • Fall '17

What students are saying

  • Left Quote Icon

    As a current student on this bumpy collegiate pathway, I stumbled upon Course Hero, where I can find study resources for nearly all my courses, get online help from tutors 24/7, and even share my old projects, papers, and lecture notes with other students.

    Student Picture

    Kiran Temple University Fox School of Business ‘17, Course Hero Intern

  • Left Quote Icon

    I cannot even describe how much Course Hero helped me this summer. It’s truly become something I can always rely on and help me. In the end, I was not only able to survive summer classes, but I was able to thrive thanks to Course Hero.

    Student Picture

    Dana University of Pennsylvania ‘17, Course Hero Intern

  • Left Quote Icon

    The ability to access any university’s resources through Course Hero proved invaluable in my case. I was behind on Tulane coursework and actually used UCLA’s materials to help me move forward and get everything together on time.

    Student Picture

    Jill Tulane University ‘16, Course Hero Intern

Stuck? We have tutors online 24/7 who can help you get unstuck.
A+ icon
Ask Expert Tutors You can ask You can ask You can ask (will expire )
Answers in as fast as 15 minutes
A+ icon
Ask Expert Tutors