Documentation in
Pharmaceutical Industry
REGULATORY AFFAIRS (M. Pharm., Sem 1)
MPH 104T – Unit I – Part 1
Dr. Bapi Gorain
Department of Pharmaceutical Sciences and Technology
BIT, Mesra
Learning outcomes
• Documentation
• Master Formula Record
• Batch Formula Record
• Distribution records
Documentation
Documentation
• Document or report is written, typed, printed or electronic matter that
provides information or evidences.
• Objective of documentation
Documentation
• Importance of documentation
Documentation
• Preparation, issue and use of documents:
• It should be set to correct use and be easy to check
• Several important components should be indicated in the document
• Issued documents should not be hand written
• All corrections should be signed and dated
• Documents should have sufficient space for entry of required information
• Instructions should be clear, precise, unambiguous and in plain English
• Documents should be kept up-to-date
• Should be authourised to responsible QA authority wherever necessary
Documentation
• Retention of documents and records:
• All original data should be retained 1 year after the expiry date of the batch
• Products with no expiry, should be kept for six years from the date of
manufacturing
• Records can be retained on microfilms or microfiche
• Paper or film records should be stored in a restricted access area
• Electronic records should be retained by computer storage system
Documentation
• Storage and retrieval of document:
• Disposal of document
Documentation
• Electronic data use and maintenance:
• These electronic data also required to maintain record
• Access to the documents should be restricted by password
• Any changes should be recorded and detected
• Protected by backup transfer
• Should be available on demand
Master Production and Control Record
Master formula record
• MPCR term has been borrowed from USFDA CFR 211.186
• Other names:
• Master formula record
• Master formula and packaging instructions (WHO)
• Manufacturing formula and manufacturing instruction (TGA)
• Master manufacturing instructions and master packaging instructions (MCC)
Master formula record
Master formula record: Sample
Batch Production and Control Record
Batch formula record
• BPCR term has been borrowed from USFDA CFR 211.188
• Other names:
• Batch processing record/ Batch manufacturing record (BMR)/ Batch packaging record
(India)
• Batch processing record/ Batch packaging record (WHO, MHRA, TGA)
• Batch record (manufacturing)/ Batch record (packaging) (MCC)
Batch formula record
Distribution records
Distribution Records
Distribution Records
