40 %
60 %
Information about Documentaion

Published on September 25, 2013

Author: celestialsensation



Documentaion in GMP

Presented by: Vinitha Nair M.Sc Bio-analytical Sciences Part 2


Why Documentation is necessary? Documentation is a key area for companies in the pharmaceutical industry. This practice is to ensure safe and effective pharmaceutical products.

Why is it done? To ensure that the personnel authorized to release a batch for sale or reject it, have all the information that is necessary to take decision. To ensure that all personnel connected with manufacturer and control know what to do and when to do. To define the specification for all materials, methods of manufacture and control. To provide information during investigation, if a batch is suspected to have defect(s). To make available data needed for validation , review and statistical analysis.

Points To Be Noted!!! 1 • Documents should specify the title, nature and purpose. 2 • They should be laid out in an orderly fashion and should be easy to check. 3 • Reproduced documents should be clear and legible. 4 • Documents should be regularly reviewed and kept up to date. 5 • Any alteration made in the entry of a document should be signed and dated.

Important documents as per GMP Policies SOP Specifications MFR BMR Manuals Master plans/ files Validation protocols Labels Records

Important Documents  Standard Operating Procedure (SOP): A document that describes a routine procedure of general use which is not specific to one product.  Master Production and Control Record (MPCR): A document that describes the procedure for the preparation of a specific product.  Batch Production and Control Record (BPCR): An exact copy of the approved MPCR issued for each production batch to record the data for that particular batch.

Attributes of a good document Accurate Clear Complete Consistent IndelibleLegible Timely Direct Authentic Authorized

Certifying agencies ICH • www.ich. org WHO • www.who.i nt US FDA • www.fda.g ov EU/EMEA • www.eme a.europa.e u

Bottom Line “If it is not documented . . .it did not happen!” or, it’s a rumor!” In FDA-speak

References • • • • • • • › ... › Guidance Documents

Add a comment

Related presentations

Related pages

Documentation - Wikipedia, the free encyclopedia

Documentation is a set of documents provided on paper, or online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white ...
Read more Wörterbuch :: documentation :: Deutsch-Englisch ...

Englisch-Deutsch-Übersetzung für documentation im Online-Wörterbuch (Deutschwörterbuch).
Read more

PHP: Documentation

Documentation for PHP 4 has been removed from the manual, but there is archived version still available. For more informations, please read Documentation ...
Read more

MATLAB Documentation - MathWorks Deutschland

Select Your Country. Choose your country to get translated content where available and see local events and offers. Based on your location, we recommend ...
Read more

Documentation | Definition of Documentation by Merriam-Webster

You cannot visit the country unless you have the proper documentation. Keep your receipts as documentation of your purchases. Can you provide documentation ...
Read more


Full Documentation; Service Packs; Release Notes; System Requirements; VERSION 9. CONNECT TO COMMVAULT. Sign up to receive Commvault's event/webinar ...
Read more

Documentation | Azure

Get the tools, documentation, and sample code you need to build and manage powerful applications using Microsoft Azure. Documentation, tutorials and more.
Read more - Documentation Guides & Manuals

This site hosts documentation for openSUSE and SLES/SLED related products as well as projects. The user manuals and technical documentation that is ...
Read more

jQuery API Documentation

search Search jQuery API Documentation. jQuery API. jQuery is a fast, small, and feature-rich JavaScript library.
Read more

Willkommen | SM-DOCU

SM-DOCU ist eine übersichtliche und strukturierte IT-Dokumentation für den Mittelstand. Von Praktikern für Praktiker, um die "lästige" Pflicht der ...
Read more