An Auditor's Toolkit: GMP Requirements

17 checklists, SOPs, and forms (80+ pages) related to Quality Systems including:

➢ 1. Failure Investigations Checklist

To View an EXCERPT from this checklist - click here

➢ 2. Part 11 Compliance Assessment Checklist

➢ 3. Change Control Audit Checklist

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➢ 4. FDA Preapproval Inspection Requirements Checklist

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➢ 5. Batch Record Review SOP

➢ 6. Batch Record Review Checklist

➢ 7. Quality Disposition Form

➢ 8. Supplier Assessment Plan Design Considerations Checklist

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➢9. Good Documentation Practice Guide

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➢10. Software Supplier Auditing Checklist

➢11. CAPA Auditing Checklist

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➢12. Aseptic Gowning Qualification/Requalification Program

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➢13. Process Validation Audit Checklist

➢14. Conducting Effective Drug GMP Audits: Basic Principles (Reference Article)

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➢15. and 16. A Guide to Effective Drug GMP Auditing Practice

➢17. Conducting Effective Drug GMP Audits SOP

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1. Failure Investigations Checklist

➢To View an EXCERPT from this checklist - click here

This three-page checklist contains 39 items related to conducting effective failure investigations, including:

➢Basic elements of an effective failure investigation program

➢Investigation containment

➢Conducting the investigation

➢Investigation conclusions, rationale and close-out

➢CAPA and effectiveness

2. Part 11 Compliance Assessment Checklist

This nine-page checklist contains 39 items related to effectively conducting effective Part 11 assessments, including:

➢Validation & system documentation

➢Training & SOP

➢Record and integrity protection

➢Record output

➢Sequence and device control

➢Application security & user authority

➢Code/password controls

➢Records-Audit trails, retention, retrieval & deletion

➢Open controls

➢E-signature data & components

➢E-signature controlled session

3. Change Control Audit Checklist

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This five-page checklist contains 57 items related to effectively auditing change control program, including:

➢Basic elements of a change control program

➢Scope of change control program

➢Assessment of potential changes

➢Review, approval and documentation of changes

➢Verification of changes

4. FDA Preapproval Inspection Requirements Checklist

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This seven-page checklist contains 119 items which covers FDA targets of interest related to preapproval inspections. Areas reviewed for the subject product include:

➢Data development

➢Raw materials

➢Manufacturing process

➢Finished product results

➢Stability results

➢Laboratory procedures (data integrity)

➢Equipment qualification

➢Cleaning procedures and validation

➢Overall cGMP status-quality system

➢Facilities

➢Equipment

➢Materials

➢Production

➢Laboratory control

➢Packaging and labeling

5. Batch Record Review SOP

This six-page SOP contains 37 items related to conducting an effective batch record review.

6. Batch Record Review Checklist

This three-page checklist contains 44 items related to conducting an effective batch record review, including:

➢Master batch records

➢All executed batch records

➢Executed blister packaging records

➢Executed bottle packaging records

➢Executed label printing and labeling records

7. Quality Disposition Form

8. Supplier Assessment Plan Design Considerations Checklist

To View Complimentary Excerpt - click here

This three-page checklist contains 81 items related to developing a plan to assessing your suppliers, including:

➢QA/QC

➢SOPs

➢Personnel qualifications/CVs

➢Training programs

➢Computer systems

➢Disaster recovery/business continuity plan

➢General security and confidentiality

➢Material receipt and control

➢Environmental monitoring

➢Pest control program

➢HVAC system review

➢Water system

➢Temperature & RH control & monitoring/cold storage

➢Laboratory review

➢Equipment

9. Good Documentation Practice Guide

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This three-page guide provides an overview of good documentation practices which may be used within the operational areas of FDA-regulated industries. The expectations in this guide are intended to be used in the generation, review, approval and execution of controlled documentation, including procedures, protocols, records and reports. This guide contains 36 items related to implementing good documentation practice.

10. Software Supplier Auditing Checklist

This four-page checklist contains 25+ items related to creating your own software supplier audit tool.

11. CAPA Auditing Checklist

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➢Basic Requirements

➢Datastream analysis for potential quality concerns

➢Responding to specific nonconformities, events or exceptions

➢Actions to correct and prevent recurrences

➢Verification of CAPA Actions (effectiveness checks)

➢Documentation of CAPA actions and Activities

12. Aseptic Gowning Qualification/Requalification Program

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This checklist provides 65 questions dvided up into the following six (6) categories below, including:

➢cGMP and regulatory expectations

➢Training module for aseptic gowning qualification

➢Initial qualification training

➢Skill check assessment

➢Acceptance criteria for initial qualification

➢Operator requalification

13. Process Validation Audit Checklist

57 Audit Checkboxes that include:

➢Basic Elements of a Process Validation Program
➢Validation Master Plan
➢Process Validation Documentation
➢Process Qualification Requirements
➢Impact of Changes to Process Validation
➢Revalidation

14. Conducting Effective Drug GMP Audits: Basic Principles (Reference Article)

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This article reviews the following subject matter below, including:

➢Different types of audits

➢External audits

➢Internal audits

➢Benefits of an audit plan

-Focus

-Key areas

-Roadmap

➢Preparing to conduct an audit

-Code of Federal Regulations Title 21

-FDA Guidelines

-Warning Letters

-Standard tests and practices

➢Forming audit teams

➢Auditing techniques

-Observe

-Compare

-Ask

-Report

➢Audit meetings and reports

-Daily meetings

-Closeout meetings

-Audit report

➢Benefits of audits

15. and 16. A Guide to Effective Drug GMP Auditing Practice (PDF PowerPoint Training Presentation and Trainer Instructional Notes)

30 slide PDF PowerPoint training presentation. This PDF readymade presentation provides "core" subject matter content, and allows you to customize specific information within your presentation. Trainer instructional notes, which contain discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.

*Please note that these trainer instructional notes are comprehensive in nature.

Subject matter content reviewed in this presentation includes:

➢Defining an audit

➢Why conduct internal assessments?

➢Internal vs. external audits

➢Written audit procedures

➢Which areas FDA review for company internal audit programs

➢Confidentiality

➢35 investigational approaches used by FDA to evaluate GMP product quality

-Verification of quality and compliance systems

-Questions to ask

➢Conducting internal audits from a "top down" Quality System

➢Inspection Technique (QSIT) model approach

➢FDA's quality system sub-systems

➢Regulatory authority sources for conducting audits

➢Auditor qualifications

-Auditing checklists

-Pitfalls to avoid

➢A well-designed audit checklist for a GMP inspection-examples

➢Soft skills for the internal auditor

➢Elements to consider during the execution of an internal audit

➢Audit report issuance-key elements

➢Communicating audit findings

-Examples

➢Internal audit closure

➢Common problems with closing out audits

17. Conducting Effective Drug GMP Audits SOP

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This 11 page procedure provides process and documentation requirements for the effective, organized and structured conduct of internal audits. The procedure section of this SOP contains 30+ proposed actions and responsibilities related to the subject matter content below, including:

➢Audit scheduling

➢Execution of the internal assessment

➢Audit frequency and continued audit scheduling

➢Internal audit close out

➢Actions for continuation of internal audits

*The SOP also includes a two (2) page Audit Report Template

 An Auditor's Toolkit: GMP Requirements is only $159.00