|Item No.||Item Name/Description||Price Each||Qty|
|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.
|40.001||Mini-Booklets - GMPs|
This booklet is larger than the typical ones - making it easier to read. This booklet includes the regulations as commonly referred to as the cGMPs – Title 21 CFR, parts 210 and 211. Also included is the code regarding electronic records and electronic signatures – Title 21 CFR, Part 11. As a bonus, we are also including an electronic copy of the ICH Guideline Q7a – commonly referred to as the cGMPs for APIs. With these three guidelines, quality and compliance professionals will have the general regulations at their fingertips. As stated, the print of the code in this booklet is also larger for ease in reading.
|40.002||Quality System Regulations: 21 CFR, Part 820|
This is a handy reference booklet listing all of the regulaitons as listed by the FDA for QSR's. This is a compilation of the code found in 21 CFR, Part 820.
A mini-booklet containing the "GMP's" for API's.
|40.005||Barr Decision Court Transcript|
Transcript from the 1993 court ruling. A must have for any serious QA person.
|Please Note:||PO Orders|
To order by PO, please select "check" on the order processing page and include the PO Number in the note field. If we have any questions, we will contact you.
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