revison
dkf.j
05Qualitydocumentation.pptxQuality Documentation
Documentation Overview
The Quality Manual
Types of Quality Documentation
Quality Documentation
Four Attributes of GMP Documentation
Types of Documents
SOP: Standard Operating Procedure
Examples of SOP Categories
Typical SOPs
Components of an SOP
Control of SOPs
Control of SOPs
Raw Material Specifications
Raw Materials
Raw Materials Example
Product Specifications
Master/Batch Production and Control Records
Master/Batch Production Records
EBR
Laboratory Records
Equipment Cleaning and Use Logs
Equipment Log Example
Distribution Records
Complaint Files
Document Format
Why All The Documentation
Everything you always wanted to know about good documentation but were afraid someone might tell you
Everything you always wanted to know about good documentation but were afraid someone might tell you
Good Documentation Practices
Everything you always wanted to know about good documentation but were afraid someone might tell you
ENTRIES
ELECTRONIC RECORDS
ELECTRONIC RECORDS (con’t)
ELECTRONIC RECORDS (con’t)
