Published on September 25, 2013
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 • www.ncbi.nlm.nih.gov • www.slideshare.net • www.smccd.net • ec.europa.eu • www.gmp-compliance.org • onlinelibrary.wiley.com • www.hc-sc.gc.ca › ... › Guidance Documents
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 ...
Englisch-Deutsch-Übersetzung für documentation im Online-Wörterbuch dict.cc (Deutschwörterbuch).
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