Biological Product Deviation Reports
Annual Summary for Fiscal Year 2005
Attachment 4: List of BPD Codes for Non-Blood
Printable version of this document
Return to Annual Summary for Fiscal Year 2005
CBER enters the fourth level detail code (e.g., A, B, C) into the database as standardized remarks to further describe some of the codes, in particular miscellaneous codes. These codes are not included on the BPD report form.
IM-**-** INCOMING MATERIAL SPECIFICATIONS
IM-10-** Miscellaneous
IM-10-01 Other
IM-12-** Container
IM-12-01 Specifications not met
IM-12-02 Defective
IM-13-** Closures
IM-13-01 Specifications not met
IM-13-02 Defective
IM-14-** Source or raw material does not meet specifications or otherwise found to be unsuitable
IM-14-01 Other
IM-14-02 Contains precipitate
IM-14-03 Contaminated with microorganism
IM-14-04 Contaminated with mold
IM-14-05 Impurities exceed specification
IM-14-06 Testing deviation
IM-14-07 Stored or shipped at incorrect temperature or lack of controlled temperature
PC-**-** PROCESS CONTROLS
PC-20-** Miscellaneous
PC-20-01 Other
PC-21-** Manufacturing or processing performed using incorrect parameters
PC-21-01 Other
PC-21-02 Incorrect temperature
PC-21-03 Filling not performed according to specifications
PC-21-04 Aseptic processing procedures not performed according to specifications
PC-22-** Process/Procedure
PC-22-01 Other
PC-22-02 Interruption of process
PC-22-03 Environmental monitoring excursions
PC-22-04 Equipment not qualified/calibrated
PC-22-05 Sanitization not performed or performed incorrectly
PC-22-06 Failed media fill
PC-23-** Process Water - specification not met
PC-23-01 Other
PC-23-02 Water for injection
PC-23-03 Purified water
PC-24-** Bulk material does not meet specifications or otherwise found to be unsuitable
PC-24-01 Other
PC-24-02 Contains precipitate
PC-24-03 Contaminated with microorganism
PC-24-04 Contaminated with mold
PC-24-05 Impurities exceed specification
PC-24-06 Stored at incorrect temperature
PC-24-07 Stored for an excessive hold time
TE-**-** TESTING
TE-30-** Miscellaneous
TE-30-01 Other
TE-31-** Safety
TE-31-01 Performed incorrectly
TE-31-02 Not performed or not documented
TE-32-** Purity
TE-32-01 Performed incorrectly
TE-32-02 Not performed or not documented
TE-33-** Potency
TE-33-01 Performed incorrectly
TE-33-02 Not performed or not documented
TE-34-** Sterility
TE-34-01 Performed incorrectly
TE-34-02 Not performed or not documented
TE-35-** Identity
TE-35-01 Performed incorrectly
TE-35-02 Not performed or not documented
TE-36-** Stability
TE-36-01 Performed incorrectly
TE-36-02 Not performed or not documented
LA-**-** LABELING
LA-40-** Miscellaneous
LA-40-01 Other
LA-41-** Package insert
LA-41-01 Incorrect
LA-41-02 Missing
LA-41-03 Not current or approved
LA-42-** Product label
LA-42-01 Incorrect
LA-42-02 Missing
LA-43-** Carton label
LA-43-01 Incorrect
LA-43-02 Missing
LA-44-** Expiration date
LA-44-01 Extended
LA-44-02 Missing
LA-45-** Lot number
LA-45-01 Incorrect
LA-45-02 Missing
LA-46-** Storage temperature
LA-46-01 Incorrect
LA-46-02 Missing
LA-47-** Administration route
LA-47-01 Incorrect
LA-47-02 Missing
LA-48-** Concentration or volume
LA-48-01 Incorrect
LA-48-02 Missing
PS-**-** PRODUCT SPECIFICATIONS
PS-50-** Miscellaneous
PS-50-01 Other
PS-51-** Product specification not met
PS-51-01 Other
PS-51-02 Contains precipitate
PS-51-03 Contaminated with microorganism
PS-51-04 Contaminated with mold
PS-51-05 Impurity levels
PS-51-06 Moisture
PS-51-07 Preservative content
PS-51-08 Potency
PS-51-09 Appearance
A - Cloudy
B - Hemolyzed
PS-51-10 Fill volume
PS-52-**Component packaged with final product did not meet specifications
PS-52-01 Other
PS-52-02 Contains precipitate
PS-52-03 Contaminated with microorganism
PS-52-04 Contaminated with mold
PS-52-05 Fill volume
PS-53-** Stability testing failed
PS-53-01 Other
PS-53-02 Potency
PS-53-03 Preservative
PS-53-04 Container closure integrity
PS-53-05 Chemical analysis/purity
PS-53-06 Moisture
PS-54-** Administration set (packaged with product) incorrect or incomplete
PS-54-01 Other
PS-54-02 Incorrect or missing label
PS-54-03 Defective
PS-54-04 Expired
QC-**-** QUALITY CONTROL and DISTRIBUTION
QC-60-** Miscellaneous
QC-60-01 Other
QC-61-** Product distributed inappropriately
QC-61-01 Other
QC-61-02 Product distributed prior to completion of required testing
QC-61-03 Product distributed prior to CBER approval of a PAS
QC-61-04 Product distributed less than 30 days after submission of CBE-30 or prior to submission of CBE-30
QC-61-05 Product distributed prior to validation of process
QC-61-06 Outdated product distributed
QC-62-** Shipping and storage
QC-62-01 Other
QC-62-02 Product shipped at incorrect temperature
QC-62-03 Product stored at incorrect temperature
QC-63-** Product identified as unacceptable, and not quarantined
QC-63-01 Other
QC-64-** Packing
QC-64-01 Other
QC-64-02 Vial missing
QC-64-03 Packaged incorrectly
MI-**-** MISCELLANEOUS
MI-70-** Miscellaneous
MI-70-01 Other