|Item No.||Item Name/Description||Price Each||Qty|
These booklets are available in print or pdf format. Print format booklets are a handy 5.5" x 8.5" size and are perfect for handing out to employees for reference or training purposes. PDF versions are 8.5" x 11" and will be delivered to the email address you provide at checkout.
|20.001||Computer System Validation|
This 33-page guideline is written to provide an outline of the requirements to become compliant with 21 CFR, Part 11. The contents include: Computer validation outline, The Plan, Definitions, Audit Check Sheet, System Documentation, Validation Report, Testing Documentation, Helpful Hints, Training, Security, Change Control and Continuity Plans.
|20.002||Preparing for the Audit|
This 14-page guideline provides an outline of the preparations for an audit. The contents are as follows: Approaching the Inspection, Purpose of the Inspection, Aftermath and Response, Preparing for the Audit, The Six Rules, Preparing to be in Compliance, Handling the Audit and The Exit Interview.
|20.003||Basic Elements of an Investigation|
One of our most popular booklets - A 14-page guideline providing the "tools" necessary to conduct a successful investigation and to document your findings. Sections include: The Basic Elements, Determining What To Do, Describe What Happened, How to Prevent Recurrence, The Barr Decision, Evaluating "What does it mean?", What is the Impact on Release and CAPA. Also included is a disk with the SOP - Handling OOS Issues.
|20.004||Prevention of Cross Contamination|
Cross-contamination guide 23 pages in length detailing how to prevent such an issue. Sections include: Personnel, Visual Inspections, Premises, Rework, Equipment, Line Clearances, Production, Printed Material, Starting Materials, Material Flow and Packaging Operations.
Various aspects of pharmaceutical cleaning are presented in this 22-page guideline. The contents include: Facilities, The Regulations, Equipment, Maintenance, Component Storage, Using Your Senses, People, Facilities Cleaning Validation, Validation, Verification of Sampling, General Considerations, Limits, Example Cleaning Standard, Cleaning Agents, Clean and Dirty Hold Time Studies and Storage of Equipment.
|20.006||The Quality Audit Guideline|
A 23-page guideline offering tools to help people performing audits to get the best out of the process. Sections include: Terms and Definitions, Auditor Responsibities, Purpose of the Audit, Auditor Ethics, Audit Philosophy, FDA Systemic Inspection Approach, Types of Audits, Competence, Auditor Skills and Conduct, Communication, Auditor Problems, Listening, Tactics Chart, Independence, Observation and Objectivity.
|20.007||Annual Product Review Guideline|
The annual review of product operations is a process that can be arduous and dreaded by quality professionals. Our staff has made every effort to generate an outline of what is necessary to understand the systems necessary to properly compile an Annual Product Review. An evaluation should be made to verify all local or corporate standards are met concerning the program and outline provided in this guideline. This 13-page guideline was written to provide an outline of what is required to become compliant with 21 CFR, 211.180(e). The contents are as follows: Six Requirements APR for APIs Senior Management Approval Interpreting APR Results Seven Basic Points for Effective APRs FDA cGMP Notes on APRs Contents of an APR SOP on APR As a bonus, we are also including an electronic copy of the Annual Product Review SOP – a $60 value free.
|20.008||Corrective Action and Preventative Action|
Although each situation is unique and requires some form of intervention by knowledgeable personnel, this guideline was written to provide a “tool” for your investigation team. Following these basic instructions, the staff or individual responsible for a CAPA program will be able to fulfill most, if not all, of the requirements of a compliance auditor. Our staff has made every effort to generate an outline of what is necessary to include in a CAPA program. An evaluation should be made to verify that all local or corporate standards are met concerning the program and the outline provided in this guideline. This 26-page guideline was written to provide an outline of what is required to become compliant with a CAPA program.
|20.010||Change Control Guideline|
One of the most basic controls in pharmaceutical operations is the change control process. Going beyond just basic documentation, the true change control system will provide for evaluation, approval and regulatory filing of all changes – equipment, processes, facility, etc. This 17-page guideline was written to provide an outline of what is required to become compliant with change control. The contents are as follows: FDA Expectations and Check Points Four Reporting Categories Audit your System Changes in Limbo Procedures reflecting Practice Emergencies Global Company Changes Implementing Changes Streamline the Process What is in a Change Control SOP? As a bonus, we are also including an electronic copy of the Change Control SOP – a $60 value free.
|20.011||Documentation Systems Guideline|
This encompassing booklet reviews many of the documentation systems required to operate in a compliant state in the current GMP environment. Some of the sections of this 41-page guide include: Part Numbers/Item Numbers Complaint Files The Batch Record Laboratory Logbooks Forms SOPs Contractors Cleaning Logs Change Control Validation Training Environmental Controls Maintenance Inspections Calibration Investigations Documentation Storage
|20.013||Calibration Master Plan|
As with any operation in life, planning is a critical aspect of the successful outcome. This guideline was written to offer suggestions as to the planning phase or establishing a calibration master plan or to be used to evaluate a currently existing plan. Following these guidelines, the department responsible for implementing a calibration and control plan will achieve success. As an added section to the guide, we have also included guidelines regarding Preventative Maintenance – a sometimes-intertwining field with calibration work. This 17-page guideline was written to provide a training and compliance “tool” for your team. Our staff has made every effort to generate an outline of necessary to understand the system for calibrations. The contents are as follows: · Purpose of a Plan · Control of Contractors · QA Responsibilities · Records · Metrology Responsibilities · Scheduling System · Definitions · Labeling · Calibration Intervals · Procedures · Measurement Traceability · Calibration Quality · Calibration Equipment Adequacy · Equipment Maintenance
|20.014||Packaging, Labeling, Receiving and Warehousing Guideline|
The reviews of four key areas of pharmaceutical operations have been combined in this manual providing a comprehensive compliance overview of these critical operations. Some of the key highlights of this booklet are as follows: Packaging Definitions Label Control Packaging Qualifications Master Label Books Material Compatibility Tests Receiving and Warehousing Overview Packaging Specification Development Evaluating Receipts Packaging Process Control Quarantine Labeling Certification Labeling Suppliers Receiving
|20.015||Quality Agreements and Third Party Manufacturers|
All products that are produced at a Third Party Manufacturer (TPM) must be in compliance with Quality Policies & Standards, cGMPs, and all other applicable regulatory requirements. It is also required that there be as part of all new and renegotiated contractual business agreements with TPMs, a specific section of the business contract that clearly defines the quality related requirements, and roles and responsibilities of the parties entering the contract. This 14-page guideline was written to provide an outline of what is required to become compliant with GMPs as they relate to TPMs. The contents are as follows: Introduction TPM Selection and Approval TPM Business Agreements Ongoing QA Responsibilities and Support Change Control Standard Quality Agreement SOP – Electronic Version As a bonus, we are also including an electronic copy of the Quality Agreement and TPM SOP – a $125 value free.
|20.016||Quality Systems Guideline|
The FDA’s new directives build upon complete and implemented Quality Systems. Quality Systems assure overall compliance with GMPs. This 21-page guideline was written to provide an outline of what is required to become compliant with Quality Systems. The contents are as follows: What is a Quality System? FDA Systemic Inspection Approach QSIT Outline Quality Systems and the Future of the FDA A Goal of the FDA – Prevent Recurrence Implementing a Quality System Quality Audits Personnel Balance of Quality System Elements A Partial Compliance and Quality System List
This extensive 31-page guideline offers a variety of stability points to evaluate by QA personnel. This guideline is a must if you have any involvement with stability programs in a pharmaceutical environment. Sections include: · Definitions · Why test for stability? · Various guidelines available · Stress Testing · Photostability · Selection of Batches · Sample collection and ID · Bracketing · Matrixing · Test Attributes · When to test · Storage conditions · Evaluation of data · Expiration dating · Protocols · Sending samples to an outside lab · Implementing an effective program · Handling a stability failure
|20.018||The Barr Decision|
In February of 1993, one of the most influential court decisions to impact daily pharmaceutical operations was made. Our staff has made every effort to generate an outline of what is necessary to understand the outcome of this decision and the impact on quality systems. As an added overview, we have included an overview of “Conducting an Investigation”. This section of the guideline will give the reader a summary of what is required to be in an investigation as outlined by the Barr Decision and GMP. A bonus for purchasing the booklet is a diskette containing the 47 page final decision. This 17-page guideline was written to provide a training and compliance “tool” for your team. Our staff has made every effort to generate an outline of necessary to understand the Barr Decision. The contents are as follows: · Background · Court Rulings – An Overview · Error Type Review · Retesting · Resampling · Averaging · Remixing · Blend Testing · Validation Criteria · Investigation Overview
|20.019||The Batch Record|
The batch record, a documented account of manufacturing operations, is often a misunderstood or misused system. This booklet will review the regulations for batch records, evaluate the life cycle of batch record development, examine supporting documentation, compare European and US batch record philosophy, and provide a few practical guidelines for batch records. The primary goal of this extensive 24-page booklet is to provide the reader with knowledge of how to compile and create a master batch record. The reader’s goal should be the ability to create a completed batch record that appropriately details operation activities. The batch record should be sufficiently clear and detailed that any third party reviewer could examine the document and have minimal questions. The reader should also be to obtain a product “history” that includes development and scale-up for use as a trouble-shooting tool.
|20.020||Pharmaceutical Training Guideline|
This 15-page booklet offers practical approaches for training in FDA regulated industries. Various aspects of conducting and evaluating training are provided. Topics are as follows: · Quality Disciplines · A Successful Training Program · Who Plans the Training? · What are your training needs? · How do you provide training? · Training for different levels · The basics of training · Evaluation of training · Evaluating effectiveness · The budget · Why programs fail · New employee training program outline
This extensive 48-page booklet offers readers detailed guidance regarding a variety of validation topics. This is a must-have tool for any validation or compliance officer dealing with any aspect of validation within a pharmaceutical operation. Topics include: · GMP Validation Standard · Process Validation · Analytical Validation · Cleaning Validation · Computer Validation · Equipment/Facility/Utility Validation · Validation Document Storage · Validation Master Planning
|20.024||Product Acceptance Sampling Guideline|
This 17 page guideline offers detailed insight into establishing and/or evaluating a sampling plan. This is a must have read for inspectors or those who look to understand the complex issues surrounding sampling plans.
|20.027||Filtration Guideline - Process and HEPA|
This 17-page guideline covers that basics regarding two very important fields of knowledge - Process filtration and HEPA filtration. The aspects of filtering a process stream are covered along with validation and FDA concerns. For HEPA filtration, there is a review of how it is done and a comparison with the various room classifications.
|20.036||Drug Master Files|
A 20-page booklet detailing the process for filing a DMF. Sections include: Definitions, Types, What to Submit, General Information and Suggestions, Format, Assembly, Delivery, Authorization to Refer, Holder Obligations, Re-Organization and Closure of a DMF.
|20.039||Export Requirements and Certifications|
A 34-page review of the requirements for export and certification of pharmaceutical products. Includes examples and reference.
|20.040||Visual Inspection - A Guideline for Cleaning Validation|
This guide will help an operator perform a visual cleaning verification of equipment prior to use, and provide insight for the cleaning crew to confirm successful cleaning operations. To be useful, this guideline should be applied to operations after validation has been performed or as part of a validation strategy. Sampling of equipment surfaces for confirmation of successful cleaning operations is not part of this guideline.
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