Users Club - General Quality / Compliance / Inspections

Download more than 350 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 Templates and examples Reference papers - private authors FDA regulations and official FDA Guidelines Other regulations, official guidelines and advice from industry task forces Presentations, publications, interviews with FDA personnel	Computer validation Equipment qualification Network Qualification/Internet Electronic Records/Part11 Method validation/reference standards Warning letters/483/Establishment Inspection Reports FDA regulations/predicate rules

Standard Operating Procedures

SOP
Generation and Maintenance of Standard Operating Procedures.

S-104

We all know that SOPs are required for day-to-day operation. However, they only make sense if they are used by all personal. This SOP is most useful to develop and document SOPs for highest acceptance by inspectors AND users.
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SOP
Document Management and Control

S-105

SOP
Handling Deviations from Standard Operating Procedures

S-106

SOP
Conducting Management Reviews

S-111

SOP
Handling Out-of-Trend Situations

S-116

SOP
GLP Facilities and Environmental Control

S-121

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

Healthcare products marketed to a specific country or sponsored by a specific organization should comply with GMP regulations of that country or with the guidelines of the organizations, no matter where the products have been developed and manufactured. This procedure should help to effectively build a GMP system that complies with all major national and international regulations and guidelines.

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
Recording of GLP Raw Data

S-149

SOP
Archiving of GMP Data and Other Documents

S-162

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
Initial and On-going Training

E-117

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.

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
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.

Reference Paper
Developing an Effective 21 CFR Part 11 Training Program Supporting Regulatory Compliance

P-213

Defines responsibilities and how to specify training needs, training techniques and how to document. Complementary to the SOP in G-009

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

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 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
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).