Regulatory Compliance and Gap Analysis

Procedure: Regulatory Compliance and Gap Analysis
Country: Global Procedure
Version #: 11/27/2023
Author: Daria Kostiuchenko
Editor: Daria Kostiuchenko

ID: GP-PhR-GAP-SR
Category: Pharmaceuticals
Validity: Until MA Application
Certified by: Vlad Reznikov
Copyright: Pattern of USA Inc.

SUMMARY

Gap analysis involves assessing and identifying any shortcomings or gaps in a registration dossier compliance with local regulatory standards. These gaps could include missing documentation, incomplete testing, or lack of adherence to specific guidelines. Unlike risk assessments that concentrate on identifying potential risks and vulnerabilities, gap analysis primarily aims to identify discrepancies between the current state of compliance and the desired level mandated by regulatory requirements to address shortcomings.

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Must-Have Requirements, Recognized Standards, and Certifications:

  • Registration file with technical documentation in available format

Nice-to-have:

  • Regulatory Intelligence and Strategic Consulting see GP-PhR-RI-SR card
  • Intellectual Property Rights Protection see GP-PhR-IP-SR card

Typical Gaps and Deficiencies: Incomplete documentation, non-compliance with regulatory guidelines, missing standards

Implementation Period: Immediately

Deliverables: Compliance Enhancement, Action Plan & Gap Analysis Report

PHASE

TASK

TASK

START

DURATION

  

Fee

  

KPI

NUMBER

TITLE

OWNER

W/M/Q/Y

in weeks

3rd Party 

Service 

State

  

0

In-house Pre-Submission Activity

              

  0.1

NDA signing or validation

Executor

week 1

1

        

  0.2

Contract Closing

MAH

week 1

1

        

  0.3

Invoice is sent to MAH and paid

Executor

week 2

1

        

  0.4

SOW is approved by MAH

Executor

week 2

1

      

SOW

I

Gap Identification

              

  I.1

Input information obtaining

MAH

week 3

1

        

  I.2

Identification of the relevant regulatory requirements

Executor

week 4

2

        

  I.3

Identification of risks, deficiencies, gaps in registration file

Executor

week 4

2

        

  I.4

Identification of gaps in production, labeling, QA & reporting

Executor

week 4

2

      

Report

II

Address the concerns

              

  II.1

Assess non-compliance effects for MA

Executor

week 6

1

        

  II.2

Address Gaps for regulatory compliance to MAH

Executor

week 6

1

      

Report

III

Resolve the problem

              

  III.1

High-risk areas to mitigate risks prioritization 

Executor

week 7

1

        

  III.2

Discrepancy mitigation strategy development with CAPA

Executor

week 7

2

        

  III.3

CAPA for procedural changes by MAH

MAH

week 9

1

        

  III.4

CAPA for conducting personnel training by MAH 

MAH

week 9

1

        

  III.5

CAPA for conducting personnel training by MAH 

MAH

week 9

1

        

  III.6

Ensure alignment with local regulatory guidelines

Executor

week 10

1

        

  III.7

Registration dossier adjustment with relevant local updates

Executor

week 11

2

      

Master-file

F

Final Phase In-house Post-Authorization Activity

              

  F.1

Service Acceptance Certificate signing

MAH

week 13

1

        

  F.2

Final Invoice

Executor

week 13

1

        

  F.3

Final Payment

MAH

week 14

1

        

  F.4

Contract Termination

Executor

week 14

1

        

  F.5

Archiving and limiting access

Executor

week 15

1

      

Archiving

 

Feel free to submit a Request for Proposal (RFP) for a specific country or territory to info@patternofusa.com