Pages: PREVIOUS 1 2 3 5 NEXT


Item No.   Item Name/DescriptionPrice EachQty 
10.085SOP - Sampling and In-process Checks During Liquid Filling
A basic outline of a procedure ready for your customization. Add your company name, SOP number and any specifics necessary for your particular operation and the procedure is ready for implementation.
10.086SOP - Sampling Purified Water
A basic outline of a procedure ready for your customization. Add your company name, SOP number and any specifics necessary for your particular operation and the procedure is ready for implementation.
10.087SOP - Computer Source Code Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.088SOP - Computer System Business Continuity Plan - Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.089SOP - Computer System Documentation Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.090SOP - Computer System e-Record Standard
Customizable standard for your use. Don't re-invent the wheel - use this standard as the outline.
10.091SOP - Computer System e-Signature Standard
Customizable standard for your use. Don't re-invent the wheel - use this standard as the outline.
10.092SOP - Computer System Periodic Review Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.093SOP - Computer System Security Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.094SOP - Computer System Testing Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.095SOP - Computer System Validation Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.096SOP - Computer System Validation Planning and Execution Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.097SOP - Software Supplier Evaluation Policy
Customizable policy for your use. Don't re-invent the wheel - use this policy as the standard.
10.098SOP - Personnel Responsibilities and Documentation Policy
Policy covering the GMP requirements for personnel and the documentation required to prove training has been done. Don't re-invent the wheel - use this policy as the guideline.
10.099SOP - Control over penicillin production policy
Policy regarding the control parameters to be evaluated and implemented for facilities which operate and produce penicillin products.
10.100SOP - GMP Training Program
A 17 page SOP on developing and maintaining a GMP Training Program. Great template to develop you own program or change an existing one.
20.000Booklets
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.
20.001Computer 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.
20.002Preparing 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.
20.003Basic 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.
20.004Prevention 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.
20.005Pharmaceutical Cleaning
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.
20.006The 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.
20.007Annual 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.
20.008Corrective 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.


 Pages: PREVIOUS 1 2 3 5 NEXT

secure shopping


Security Policy       Privacy Policy       Site Map      
Copyright © 2017 Compliance Insight, Inc. All rights reserved.
Powered by EZWebCatalog