文档介绍：Roman Pharmaceuticals
Corporation
Standard Operation Procedures
&
GMP Procedures
Version #1
Est. 2006
Roman Pharmaceuticals Corporation
Standard Operation Procedure
Version #1
INDEX
SOP No TITLE
QC 099-00 Guidelines for writing a Standard Operating Procedure.
QC 100-00 Documentation Control.
QC 101-00 Training Program.
QC 102-00 Reserve samples and retention of records.
QC 103-00 Sampling of Raw Materials.
QC 104-00 Analysis and Documentation of Raw Materials.
QC 105-00 Quality Control Unit.
QC 106-00 Review of Batch Records by Quality Control.
QC 106-00A Packaging Batch Record.
QC 107-00 Handling of plaints.
QC 108-00 Auditing Contract Laboratories.
QC 109-00 Analysis and Documentation of Finished Products.
QC 110-00 Sampling of finished product.
QC 111-00 Physical Inspection of tablets/capsules.
QC 112-00 GMP training program.
QC 113-00 Documentation practices.
QC 114-00 Stability Studies.
QC 115-00 Thickness Test.
QC 116-00 Self-Audit.
QC 117-00 Microbiologist Test.
QC 118-00 Change Manufacturer Lot Number.
QC 119-00 Validation
QC 120-00 Validation of Equipment.
QC 121-00 Validation of Manufacturing Process.
QC 122-00 Validation of Supplier.
QC 123-00 Validation of Supplier’s Certificate of Analysis.
QC 124-00 Validation of Cleaning Room Procedures in