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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