Yearly Biologic Product Report (YBPR) Template
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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
- Address
- Responsibility / Product type
1.2. Drug product
1.2.1. Drug product unit
- Facility
- Address
- Responsibility / Product type
1.2.2. Drug product kit (if applicable)
- Facility
- Address
- Responsibility / Product type
Section 2: Production Information on Drug Substance and Drug Product Lots
2.1 Drug product lots sold on Canadian market
- Drug Identification Number (DIN)
- Dosage form
- Strength
- Number of lots sold
2.2 Lot disposition
2.2.1 Drug substance
- Facility name / Product type
- Current reporting period
- Aborted
- Completed
- Quarantined
- Rejected
- Released
- Previous reporting period
- Aborted
- Completed
- Quarantined
- Rejected
- Released
Details on aborted, quarantined, and rejected lots:
2.2.2. Drug product
- Facility name / Product type
- Current reporting period
- Aborted
- Completed
- Quarantined
- Rejected
- Released
- Previous reporting period
- Aborted
- 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]
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
- Date investigation initiated
- Root cause
- Resolution and corrective and preventative action (CAPA)
- Product disposition
(b) [Facility name - product type]
- Description of event
- Date investigation initiated
- Root cause
- Resolution and corrective and preventative action (CAPA)
- Product disposition
2.5.2. Drug product
(a) [Facility name - product type]
- Description of event
- Date investigation initiated
- Root cause
- Resolution and corrective and preventative action (CAPA)
- Product disposition
(b) [Facility name - product type]
- Description of event
- Date investigation initiated
- Root cause
- Resolution and corrective and preventative action (CAPA)
- Product disposition
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
- Percentage of invalid tests
- Explanation/cause and any corrective/preventive actions
- Previous reporting period
- Total number of tests performed
- Percentage of invalid tests
(b) [Facility name - product type]
- Test name
- Current reporting period
- Total number of tests performed
- Percentage of invalid tests
- Explanation/cause and any corrective/preventive actions
- Previous reporting period
- Total number of tests performed
- Percentage of invalid tests
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
- Number of OOS
- Number of confirmed OOS
- Details
- Previous reporting period
- Total number of tests performed
- Number of OOS
- Number of confirmed OOS
(b) [Facility name - product type]
- Test name
- Current reporting period
- Total number of tests performed
- Number of OOS
- Number of confirmed OOS
- Details
- Previous reporting period
- 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
- Rationale
- Change level
- Regulatory status
(b) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
4.1.2 Drug product
(a) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
(b) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
4.2 Raw material suppliers and non-compendial specifications
4.2.1 Drug substance
(a) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
(b) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
4.2.2 Drug product
(a) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
(b) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
4.3 Analytical methods
(a) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
(b) [Facility name - product type]
- Brief description
- Rationale
- Change level
- Regulatory status
Section 5: Test Results
5.1 In-process test results
5.1.1 Drug substance
(a) [Facility name - product type]
- Process step
- In-process control
- Acceptance criteria / Action limits
- Range of results (n)
- Observed shifts or trends
(b) [Facility name - product type]
- Process step
- In-process control
- Acceptance criteria / Action limits
- Range of results (n)
- Observed shifts or trends
5.1.2 Drug product
(a) [Facility name - product type]
- Process step
- In-process control
- Acceptance criteria / Action limits
- Range of results (n)
- Observed shifts or trends
(b) [Facility name - product type]
- Process step
- In-process control
- Acceptance criteria / Action limits
- Range of results (n)
- Observed shifts or trends
5.2 Lot release test results
5.2.1 Drug substance
(a) [Facility name - product type]
- Lot release test
- Acceptance criteria
- Range of results (n)
- Observed shifts or trends
(b) [Facility name - product type]
- Lot release test
- Acceptance criteria
- Range of results (n)
- Observed shifts or trends
5.2.2 Drug product
(a) [Facility name - product type]
- Lot release test
- Acceptance criteria
- Range of results (n)
- Observed shifts or trends
(b) [Facility name - product type]
- Lot release test
- Acceptance criteria
- Range of results (n)
- Observed shifts or trends
Section 6: Stability Studies
6.1 Stability lots
6.1.1 Drug substance
(a) [Facility name - product type]
- Lot number
- Batch size
- Enrolment date
- Storage condition
- Completed (and proposed) test intervals
- Study type / purpose
(b) [Facility name - product type]
- Lot number
- Batch size
- Enrolment date
- Storage condition
- Completed (and proposed) test intervals
- Study type / purpose
6.1.2 Drug product
(a) [Facility name - product type]
- Lot number
- Batch size
- Enrolment date
- Storage condition
- Completed (and proposed) test intervals
- Study type / purpose
(b) [Facility name - product type]
- Lot number
- Batch size
- Enrolment date
- Storage condition
- Completed (and proposed) test intervals
- Study type / purpose
6.2 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]
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)
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