YEARLY BIOLOGIC PRODUCT REPORT (YBPR)
Proprietary/brand and non-proprietary name
Sponsor
Reporting period
Number of volumes submitted
Contact information for this YBPR
Section 1: FACILITIES INFORMATION
1.1.
Drug substance
Facility
1.2.
Address
Responsibility / Product type
Address
Responsibility / Product type
Address
Responsibility / Product type
Drug product
1.2.1. Drug product unit
Facility
1.2.2. Drug product kit (if applicable)
Facility
Section 2: PRODUCTION INFORMATION ON DRUG SUBSTANCE AND DRUG PRODUCT LOTS
2.1
Drug product lots sold on Canadian market
Drug Identification Number
(DIN)
2.2
Lot disposition
Dosage form
Strength
Number of lots sold
[Product name – Report year]
[Sponsor]
2.2.1 Drug substance
Facility name /
Product type
Current reporting period
Aborted
Previous reporting period
Completed
Quarantined
Rejected
Aborted
Released
Completed
Quarantined
Rejected
Released
Details on aborted, quarantined, and rejected lots:
2.2.2. Drug product
Facility name /
Product type
Current reporting period
Aborted
Previous reporting period
Completed
Quarantined
Rejected
Aborted
Released
Completed
Quarantined
Rejected
Released
Details on aborted, quarantined, and rejected lots:
2.3
Reprocessed lots
2.3.1 Drug substance
(a)
[Facility name-product type]
(b)
[Facility name-product type]
2.3.2. Drug product
(a)
[Facility name-product type]
(b)
[Facility name-product type]
2.4
Reworked lots
2.4.1 Drug substance
(a)
[Facility name-product type]
(b)
[Facility name-product type]
YBPR Template (2014.2)
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[Product name – Report year]
[Sponsor]
2.4.2. Drug product
(a)
[Facility name-product type]
(b)
[Facility name-product type]
2.5.
Critical deviations and non-conformances
2.5.1 Drug substance
(a)
[Facility name-product type]
Description of event
(b)
Date
investigation
initiated
Root cause
Resolution and corrective
and preventative action
(CAPA)
Product disposition
Root cause
Resolution and corrective
and preventative action
(CAPA)
Product disposition
Root cause
Resolution and corrective
and preventative action
(CAPA)
Product disposition
Root cause
Resolution and corrective
and preventative action
(CAPA)
Product disposition
[Facility name-product type]
Description of event
Date
investigation
initiated
2.5.2. Drug product
(a)
[Facility name-product type]
Description of event
(b)
Date
investigation
initiated
[Facility name-product type]
Description of event
YBPR Template (2014.2)
Date
investigation
initiated
Page 3 of 10
[Product name – Report year]
[Sponsor]
Section 3: INFORMATION ON ANALYTICAL METHOD PERFORMANCE
3.1
Invalid lot release and stability tests
(a)
[Facility name-product type]
Test name
Current reporting period
Total number
of tests
performed
(b)
Percentage of
invalid tests
Previous reporting period
Explanation/cause and any
corrective/preventive actions
Percentage of
invalid tests
[Facility name-product type]
Test name
Current reporting period
Total number
of tests
performed
Percentage of
invalid tests
Previous reporting period
Explanation/cause and any
corrective/preventive actions
3.2
Retesting due to out-of-specification (OOS) test results
(a)
[Facility name-product type]
Test name
Current reporting period
Total number
of tests
performed
(b)
Total number of
tests performed
Number of
OOS
Number of
confirmed
OOS
Total number of
tests performed
Percentage of
invalid tests
Previous reporting period
Details
Total number
of tests
performed
Number of
OOS
Number of
confirmed
OOS
[Facility name-product type]
Test name
Current reporting period
Total number
of tests
performed
YBPR Template (2014.2)
Number of
OOS
Number of
confirmed
OOS
Previous reporting period
Details
Total number
of tests
performed
Number of
OOS
Number of
confirmed
OOS
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[Product name – Report year]
Test name
[Sponsor]
Current reporting period
Total number
of tests
performed
Number of
OOS
Number of
confirmed
OOS
Previous reporting period
Details
Total number
of tests
performed
Number of
OOS
Number of
confirmed
OOS
Section 4: SUMMARY OF CHANGES
4.1
Manufacturing process and controls
4.1.1 Drug substance
(a)
[Facility name-product type]
Brief description
(b)
Rationale
Change level
Regulatory status
Change level
Regulatory status
Change level
Regulatory status
Change level
Regulatory status
[Facility name-product type]
Brief description
Rationale
4.1.2 Drug product
(a)
[Facility name-product type]
Brief description
(b)
[Facility name-product type]
Brief description
4.2
Rationale
Rationale
Raw material suppliers and non-compendial specifications
4.2.1 Drug substance
YBPR Template (2014.2)
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[Product name – Report year]
(a)
[Facility name-product type]
Brief description
(b)
[Sponsor]
Rationale
Change level
Regulatory status
Change level
Regulatory status
Change level
Regulatory status
Change level
Regulatory status
Change level
Regulatory status
Change level
Regulatory status
[Facility name-product type]
Brief description
Rationale
4.2.2 Drug product
(a)
[Facility name-product type]
Brief description
(b)
Rationale
[Facility name-product type]
Brief description
Rationale
4.3
Analytical methods
(a)
[Facility name-product type]
Brief description
(b)
Rationale
[Facility name-product type]
Brief description
YBPR Template (2014.2)
Rationale
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[Product name – Report year]
[Sponsor]
Section 5: TEST RESULTS
5.1
In-process test results
5.1.1 Drug substance
(a)
[Facility name-product type]
Process step
(b)
In-process control
Acceptance criteria /
Action limits
Range of results (n)
Observed shifts or trends
Acceptance criteria /
Action limits
Range of results (n)
Observed shifts or trends
Acceptance criteria /
Action limits
Range of results (n)
Observed shifts or trends
Acceptance criteria /
Action limits
Range of results (n)
Observed shifts or trends
[Facility name-product type]
Process step
In-process control
5.1.2 Drug product
(a)
[Facility name-product type]
Process step
(b)
[Facility name-product type]
Process step
5.2
In-process control
In-process control
Lot release test results
5.2.1 Drug substance
(a)
[Facility name-product type]
YBPR Template (2014.2)
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[Product name – Report year]
[Sponsor]
Lot release test
(b)
Acceptance criteria
Range of results (n)
Observed shifts or trends
Acceptance criteria
Range of results (n)
Observed shifts or trends
Acceptance criteria
Range of results (n)
Observed shifts or trends
Acceptance criteria
Range of results (n)
Observed shifts or trends
[Facility name-product type]
Lot release test
5.2.2 Drug product
(a)
[Facility name-product type]
Lot release test
(b)
[Facility name-product type]
Lot release test
Section 6: STABILITY STUDIES
6.1
Stability lots
6.1.1 Drug substance
(a)
[Facility name-product type]
Lot number
(b)
Batch size
Enrolment
date
Storage
condition
Completed (and proposed) test
intervals
Study type /
purpose
[Facility name-product type]
YBPR Template (2014.2)
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[Product name – Report year]
Lot number
Batch size
[Sponsor]
Enrolment
date
Storage
condition
Completed (and proposed) test
intervals
Study type /
purpose
Storage
condition
Completed (and proposed) test
intervals
Study type /
purpose
Storage
condition
Completed (and proposed) test
intervals
Study type /
purpose
6.1.2 Drug product
(a)
[Facility name-product type]
Lot number
(b)
Enrolment
date
[Facility name-product type]
Lot number
6.2
Dosage form &
strength
Dosage form &
strength
Enrolment
date
Stability test results
6.2.1 Drug substance
(a)
[Facility name-product type]
(b)
[Facility name-product type]
6.2.2 Drug product
(a)
[Facility name-product type]
(b)
[Facility name-product type]
YBPR Template (2014.2)
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[Product name – Report year]
[Sponsor]
Section 7: ANALYSIS OF ADVERSE DRUG REACTION REPORTS ATTRIBUTABLE TO PRODUCT QUALITY
Section 8: PRODUCT RECALL AND CORRECTIVE ACTIONS
Section 9: CERTIFIED PRODUCT INFORMATION DOCUMENT (CPID)
YBPR Template (2014.2)
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