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Users Club - General Quality / Compliance / Inspections

Download more than 500 documents: SOPs, examples, templates, checklists, FDA waning letters, 483 inspectional observations, FDA and other official guidelines, presentations/publications from FDA personnel.

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Standard Operating Procedures

SOP
Generation and Maintenance of SOPs

S-104

 

SOP
Document Management and Control

S-105

 

SOP
Handling Deviations from Standard Operating Procedures

S-106

 

SOP
Writing and Distribution of Electronic SOPs

S-107

 

SOP
Internal Audits – Preparation, Conduct, Follow-up

S-108

 

SOP
Handling Out-of-Specification Results

S-115

The FDA requires that an investigation be conducted whenever an Out-of-Specification (OOS) result is observed. This SOP defines the requirements for dealing with OOS results. Even if a batch is rejected based on an OOS result, the investigation is necessary to determine if the result is associated with other batches of the same drug product or other products. This SOP deals with results that fall outside the specifications or acceptance criteria established in new drug applications, official compendia, or by the manufacturer and suspect within test results. The SOP applies to OOS as a result of analytical errors, process errors and manufacturing errors.

 

SOP
Handling Out-of-trend Results
S-116

 

SOP
Out-of-Specification Data Trending

S-117

 

SOP
Investigating Manufacturing Incidents

S-118

 

SOP
Going from GLP to GMP

S-120-01

 

SOP
GLP Facilities and Environmental Control

S-121

 

SOP
Training for GLP Compliance

S-123

 

SOP
Training for GMP Compliance

S-124

 

SOP
Training for GxP, 21 CFR Part 11 and Computer Validation

S-125

Defines responsibilities and how to specify training needs, training techniques and how to document results.

 

SOP
Building a GMP System for International Environments

S-126

 

SOP
Risk Assessment for Systems Used in GxP Environments

S-134

FDA’s 21st CGMP initiative suggests risk-based inspections. Companies are expected to document risks that the system has on product quality, product safety and public health. Information is used, for example, to define the extent of validation, to define the scope of 21 CFR Part 11 and to implement controls such as electronic audit trail, electronic copies and archiving of records. This procedure establishes a method for identifying, evaluating and prioritizing the risks associated with the use of systems in applicable GxP applications, specifically but not only where such systems are subject to regulation under 21 CFR Part 11.

 

SOP
International GMP Inspections: Preparation, Conduct, Follow up

S-142

 

SOP
Requirements, Responsibilities and Tasks of the Qualified Person

S-145

 

SOP
Recording of GLP Raw Data

S-149

 

SOP
Historical SOP File for GLP Regulations

S-150

 

SSOP
Archiving of GMP Data and Other Documents

S-162

 

SOP
Archiving and Retrieval of GCP Data and Other Documents Retention

S-164

 

SOP
Elemental Impurity Control According to ICH Q3D

S-416

 

Case Studies
How to Respond to 483s and Warning Letters Related to OOS and Failure Investigations
E-417

Templates / examples / checklists / case studies

Checklist
Drug CGMP Quality Systems

E-110

Well-functioning and well-documented quality systems are important for complying with Current Good Manufacturing Practice regulations and for meeting business goals. Use this checklist to define gaps between a quality system as required by the FDA and your actual system. use this information to close the gap.

 

Checklist
Pharmaceutical Quality Systems in Testing Laboratories

E-120

 

Checklist
ISO 17025
E-178

 

Checklist
Laboratory audit

E-184

Use this checklist to audit your laboratory. It is also most useful to learn what 3rd party auditors and regulatory inspectors will look at.

 

Case Studies
How to Respond to 483s and Warning Letters Related to OOS and Failure Investigations
E-417

 

Case Studies
How to Respond to GLP Related 483's and Warning Letters
E-428

 

Case Studies
How to Avoid and Respond to Training Related 483s and Warning Letters

E-430-01

 

Checklist
Using Computer Systems in ISO 17025 Environments
E-610

 

Checklist
Elemental Impurity Control according to ICH Q3D
E-611-01

 

Case Studies
 Assessment of Potential Genotoxic Impurities

E-620

 

Form
Training records

K-1023

 

Form
Vertical Audit

K-1112

 

Form
Project Plan for ISO 17025
K-1545

 

Form
Documenting Corrective Actions

K-3511

 

Form
Documenting Preventive Actions

K-3512

 

Form
Risk Categories Based on Compliance Impact

K-4033

 

Form
Risk Categories Based on Business Impact

K-4034

 

Master Plan/Template/Examples
Building a GLP Laboratory

M-135

 

Primer
FDA Inspection Survival Guide

M-222

 

Primer
Risk Management in the (Bio)Pharmaceutical and Device Industry

M-241

 

Reference papers and presentations, private authors

 

Reference Paper
How to avoid FDA Warning Letters

A-121

During inspections the FDA verifies that companies procedures and processes are in compliance with FDA GxP regulations such as Good Laboratory Practices, Good Clinical Practices and Good Manufacturing Practices. If the FDA inspections identify deviations from the regulations, they will issue inspectional observations using a special form with number 483. These reports are usually called 483’sor 483 inspectional observations. Depending on the severity of deviation the companies may get a warning letter later on. Such warning letter can have a significant impact on a company's business and reputation. This articles gives recommendations on how to avoid warning letters.

 

Reference Paper
How to set Up A CAPA Program From Scratch

A-124.

 

Reference Paper
In Search of Standard Definitions for Validation, Qualification, Verification and Calibration.

A-154

Published in BioPharm.
An agreement on the terminology is of utmost importance for a common understanding of validation, calibration and qualification. It frequently happens at validation symposia that different speakers used different terms for the same thing and the same terms for different things. This article elaborates on terms most frequently used in the area of validation, calibration and qualification in analytical laboratories. Whenever available, official terms are used together with a reference to the source.

 

Presentation:
Writing Effective SOPs for Regulatory Compliance

P-132

Ludwig Huber.

 

Presentation:
Six steps to Successful FDA GMP Inspections

P-133

Ludwig Huber.

 

Presentation:
Towards an ASEAN Sectoral MRA on GMP Inspection

P-160

Sia Chong Hock, Chairman of the ASEAN MRA taskforce on GMP Inspection for Medical Products gave a presentation at the ISPE conference in Singapore on June 1, 2009 about the history, status and further plans for harmonizing GMP inspections.

FDA regulations and official FDA Guidelines

 

For enforcement of laws Federal Agencies such as the FDA promulgate rules or regulations. These are published as the Code of Federal Regulation (CFR) in the Federal Register. FDA regulations are coded as 21 CFR Part xxx and inform the public and industry how the laws are implemented. The most well-known FDA regulations are the GLP and GMP regulations. GMP stands for Good Manufacturing Practice, but there are many more. Sometimes these regulations are also called “predicate rules”. A table with a list of the most well-known FDA regulations can be downloaded from the 'regulations' website of the users club section.

In many cases regulations are not detailed enough for inspectors and for the industry. In this case the FDA develops guidance documents. They provide assistance to the regulated industry by clarifying requirements imposed by Congress or issued in regulations by the FDA and by explaining how industry may comply with these statutory and regulatory requirements. They also provide specific review and enforcement approaches to help ensure that the FDA's employees implement the agency's mandate in an effective, fair and consistent manner. FDA Guidance documents related to selected topics can be be found on users club websites that are related to selected topics

 

FDA Guidance
Inspection of medical device manufacturers

 F-334

 

FDA Guidance
Guide to Inspections of Foreign Pharmaceutical Manufacturers

F-338

 

FDA Guidance
Guide to Inspections of Bulk Pharmaceutical Chemicals

F-340

 

FDA Guidance
Drug manufacturing inspections - FDA Compliance Program Guidance Manual

F-341

 

FDA Guidance
Guide to Inspections of Quality Systems

F-351

 

FDA Guidance
Process Validation: General Principles and Practices (2008)

F-554

 

FDA Guidance

Process Validation: General Principles and Practices (2011)

F-559

Other regulations, official guidelines and recommendations from industry task forces

 

EU Annex
Europe Annex 15 to the EU Guide to Good Manufacturing Practice Qualification and Validation

H-214

July 2001, The document is based on the PIC/S recommendations and has been drafted in consultation with Member States Inspectors within the expert group on Inspections and Control of Medicinal Products.

FDA Presentation
FDA CBER's Recent Initiatives, Policies, and Inspections

G-205

In 62 detailed slides James S. Cohen from the US FDA discusses and presents the status and further FDA plans, for example: development of an FDA Agency wide integrated risk based quality system standard, seven steps to speed drug product availability, transfer of therapeutic products from CBER to CDER, international collaborations, science based policies and standards and experience with risk based system inspection

 

FDA Presentation
Process Validation

G-207

The presentation gives an overview on current thinking of process validation. The presentation relates to FDA's 21 Century GMP Initiative. The importance of validation master plans is emphasized.

 

FDA Presentation
Pharmaceutical Ingredient Supply Chain, 2009

G-208

Joseph Famulare, Deputy Director, Office of Compliance, Center for Drug Evaluation & Research

 

FDA Presentation
Pharmaceutical GMP’s for the 21st Century” , FDA’s New Initiative on Drug Product Quality

G-210

Janet Woodcock, FDA's director for the Center for Drug Evaluation and Research

 

FDA Presentation
Pharmaceutical GMP’s for the 21st Century” , FDA’s New Initiative on Drug Product Quality

G-211

Update by Janet Woodcock, FDA's director for the Center for Drug Evaluation and Research

 

FDA Presentation
FDA Update on the Drug Quality Reporting System

G-212

Since the early 1970s, the FDA has operated the Drug Quality Reporting System (DQRS), which encourages health care professionals to report observed or suspected defects or quality problems with marketed drug products. Juliaette Johnson of the FDA has developed a slide presentation with update of the system. The presentation also includes contact information for reporting, a chart with primary defects reported and links to a website with all forms.

 

FDA Presentation
Inspections and Risk: A Regulatory Perspective

G-219

Mark A. Elengold, Deputy Director, Operations, Center for Biologics Evaluation and Research, PDA International Congress.

 

FDA Presentation
Update from David Horowitz, US FDA, on FDA's 21 st Century GMP Initiative

G-221

David Horowitz, Director, Office of Compliance, FDA CDER, gave an update on current status, future plans and upcoming announcements on FDA's drug GMP initiative at the joint FDA/PDA joint regulatory conference. Horowitz gave specific examples for topics such as "Encouraging best manufacturing practices", "Risk-based approaches", "Enhanced coordination", "Consistency",and "Predictability and international collaboration". He also gavec an overview of FDA's Steering Committee and 15 active working groups. They plan to publish new White Papers and at least five new new Guidance Documents (some final, some draft).

 

FDA Presentation
FDA Presentation: Nicholas Buhay, CGMP in the USA, 54 Slides, Beijing 2005 (G-223)

G-222

Introduction to CGMP: Current Good Manufacturing Practices

 

FDA Presentation
Nicholas Buhay, Counterfeit Drugs, 48 Slides, Beijing 2005

G-223

 

FDA Presentation
Robert Horan, FDA cGMP Inspections, Beijing 2005

G-224

 

FDA Presentation
Robert Horan, FDA API Inspections, Beijing 2005

G-225

 

FDA Presentation
The FDA Process for Approving Generic Drugs, Beijing 2005

G-226

 

FDA Presentation
FDA Presentation: Nicholas Buhay, Solid Oral Dosage Forms, Beijing 2005

G-227

 

FDA Presentation
Anita Richardson, Associate Director for Policy, Office of Compliance & Biologics Quality: Writing An Effective 483 Response

G-229

 

FDA Presentation
Electronic Source Documentation in Clinical Investigations

G-240  

 

FDA Presentation
The Facts About Source Documents

G-241

 

FDA Presentation
The Role of the Investigator in Clinical Research Clinical Studies

G-242

 

FDA Presentation
An FDA Audit: What the Investigator and Sponsor Need to Know

G-243

 

FDA Presentation
Overview of the U.S. FDA Pharmaceutical Quality Regulatory System and Recent Surveillance, Guidance, Enforcement Activities

G-244

Fred Blumenschein at the 2nd European GMP Conference, Organized by the European Compliance Academy and the Unversity of Heidelberg.

 

FDA Presentation
Lifecycle Approach to Process Validation

G-245

Grace McNally, US FDA CDER, Athens, 2007
Explains the process and details of four lifecycle steps

 

FDA Presentation
Can Less Really Be More?
Source Documentation in Clinical Trials

G-246

 

FDA Presentation
Regulatory Expectations for Process Validation

G-247

Chris Joneckis, PhD, CBER
Starting from the 1987 guide Dr. Joneckis explains the evaluation of process validation that ends with the lifecycle approach as recommended in the 2008 draft guide.

 

FDA Presentation
Process Validation: A Product Reviewer’s Perspective

G-248

Barry Cherney, Ph.D. Deputy Director at CDER gave "A Product Reviewer's Perspective" with examples for 483's and recommendations such as: Process validation is an activity that should continue throughout the entire life cycle of the product.

 

FDA Presentation
FDA's Foreign Inspection Program

G-249

FDA’s Foreign Inspection Program
Susan Laska, Deputy Director Division Foreign Field Investigations
The presentation demonstrates the significant increase in foreign inspections between 2003 and 2011.
 

 

FDA Presentation
Current International Compliance Issues, Changing to a Culture of Quality

G-250

Presented at the ISPE Conference 2012 in Singapore by Carmelo Rosa, M.S.,Psy.D., Office of Compliance, FDA/CDER
Director Division of International Drug Quality, Office of Manufacturing and Product Quality.

 

FDA Presentation
Implementing Quality by Design (2007)

G-251

 

FDA Presentation
Update on Implementing Quality by Design (2009)

G-252

 

FDA Presentation
2012 Update on FDA Inspections and Product Recalls

G-253

The update has been presented by Ilisa B.G. Bernstein and Connie T. Jung, RPh, PhD, from CDER's Office of Compliance at the APhA Annual Meeting in New Orleans, LA, on March 11. The objective of the presentation was to describe FDA activities during the last year and to state how changes in FDA regulations and actions will affect the conference participant’s. The 50-page slide presentation includes includes statistics on new drug approvals and on applications of generic drugs. Quite interesting was the information on drug product recalls from 2007 to 2012 . It shows an increasing trend with a big jump in the first quarter of FY 2012

 

FDA Presentation
The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions

G-269

 

FDA Presentation
Surveillance and Enforcement for Biological Products

G-270

 

FDA Presentation
FDA Compliance Update: Quality Systems

G-277

Mary Malarkey, Director, FDA Office of Compliance and Biologics Quality, Joint PDA/FDA Meeting, 2008
With Citation Hitlist for Biological Products, intermediates, substances

 

FDA Presentation
CGMP Deficiencies Cited During International Inspection

G-278

Douglas A. Campbell inserted 5 slides about international inspection trends in his presentation about “Regulatory Trends in Aseptic Processing”. Data are from 2009 and 2010 . Besides a summary overview, detailed breakdowns are presented for Europe, China and India. Laboratory control deviations rank highest in the overview as well as in Europe and China.