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SOP for Post-Market Surveillance for Transdermal Patches

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SOP for Post-Market Surveillance for Transdermal Patches

Standard Operating Procedure for Post-Market Surveillance for Transdermal Patches

1) Purpose

To establish procedures for monitoring the safety and performance of transdermal patches after market release, ensuring timely detection, reporting, and management of adverse events and product quality issues.

2) Scope

This SOP applies to the post-market surveillance team responsible for monitoring transdermal patches, including pharmacovigilance, quality assurance (QA), regulatory affairs, and medical affairs personnel.

3) Responsibilities

3.1 Pharmacovigilance: Monitor and report adverse events related to transdermal patches.
3.2 QA/QC: Assess product complaints and non-conformities to determine if corrective actions are needed.
3.3 Regulatory Affairs: Ensure compliance with regulatory reporting requirements for adverse events and product issues.
3.4 Medical Affairs: Evaluate medical inquiries and provide expertise on product safety and efficacy.
3.5 Post-Market Surveillance Manager: Oversee the overall post-market surveillance activities and ensure timely reporting and escalation of issues.

See also  SOP for Change Control in Transdermal Patches Production

4) Procedure

4.1 Adverse Event Monitoring:

4.1.1 Establish processes for receiving, documenting, and evaluating adverse event reports associated with transdermal patches.

4.1.2 Classify adverse events according to severity and expectedness.

4.2 Product Quality Monitoring:

4.2.1 Monitor and investigate product

complaints and non-conformities related to transdermal patches.

4.2.2 Conduct root cause analysis for identified quality issues and implement corrective and preventive actions (CAPA).

4.3 Reporting and Documentation:

4.3.1 Document all adverse events, product complaints, and investigations in a structured manner.

4.3.2 Prepare and submit timely reports to regulatory authorities as per regulatory requirements.

4.4 Review and Evaluation:

4.4.1 Periodically review and evaluate post-market surveillance data to identify trends or signals that may indicate potential safety or quality issues.

See also  SOP for Visual Inspection of Transdermal Patches

4.4.2 Conduct risk assessments and determine if any updates to risk management plans or product labeling are necessary.

4.5 Continuous Improvement:

4.5.1 Implement measures to improve post-market surveillance processes based on findings from reviews and evaluations.

4.5.2 Provide training to relevant personnel on post-market surveillance procedures and regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions

6) Documents, if any

Adverse Event Reports
Product Complaint Records
Regulatory Submission Documents

7) Reference, if any

ICH E2E: Pharmacovigilance Planning
EU Pharmacovigilance Legislation
FDA Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines

See also  SOP for Adhesive Consistency Testing in Transdermal Patches

8) SOP Version

Version 1.0

Transdermal Patches Tags:Adhesion Testing Protocol, Analytical Method Development SOP, Assay of Active Ingredient SOP, Contamination Prevention SOP, Documentation SOP, Equipment calibration SOP, Equipment Cleaning SOP, Final Product Inspection SOP, Formulation development SOP, Homogeneity Testing SOP, In-process Testing SOP, Microbial Testing SOP, Personnel Training SOP, Process Optimization SOP, Process Validation SOP, Quality Control Transdermal Patches, Raw Material Inspection SOP, Release Rate Testing SOP, Sample Collection SOP, Sterility Maintenance SOP, Storage Conditions Transdermal Patches, Thickness Testing Procedure, Transdermal Patch Manufacturing SOP, Transdermal Patch Stability Testing, Waste Handling SOP

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

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