Implementing USP Chapter <797>
Permanent storage and easy retrieval of Journal articles and formulations.
- Print Journal articles in color for your research and marketing needs.
- Eliminate long searches through past issues for articles and formulations.
A collection of over 70 articles from 14 years of the International Journal of Pharmaceutical Compounding focused on USP <797> issues and solutions.
This archive contains the following articles:
STANDARDS
- A Primer on USP Chapter <797>, "Pharmaceutical Compounding - Sterile Preparations," and USP Process for Drug and Practice Standards.
- Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists
- Proposed Revisions to USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations
- Misinterpretation of United States Pharmacopeia Chapter <797>
- Application of USP-NF Standards to Pharmacy Compounding
- Quality Control Analytical Methods: USP Chapter <797> Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating
- USP Chapter <797> and Preparing for JCAHO Survey
- Questions and Answers: USP Chapter <797> and JCAHO Compliance
- Sterile Product Compounding: A Comparison of ASHP and USP Guidelines
- Pharmacy Cleanroom Project Management Consideration: An Experience-Based Perspective Pharmacy Compounding Urban Legends
- PostScription: Cleanroom Standards
- Putting the Science Back into the "Art and Science" of Compounding
- Using Purified Water for Reconstitutions
- PostScription: GMPs and GCPs: A Topical Comparison
- PreScription: GMPs vs. GCPs: Manufacturing and Compounding Definitions
- Compounding Pharmacies: Before and After an Inspection
- PostScription: GMPs vs. GCPs: United States Pharmacopeia General Chapters
- Determination of Risk for Sterile Preparations
- Pharmaceutical Compounding or Pharmaceutical Manufacturing? A Regulatory Perspective
- Basics of Compounding Sterile Preparations: Nomenclature and Considerations
- PostScription: Responsibilities of a Compounding Pharmacist
TESTING
- Quality Assurance for Sterile Products
- USP Chapter <797>: Practical Solutions for Microbiology, Sterility, and Pyrogen Testing
- Sterilization and Depyrogenation Principles and Methods
- Quality Control Analytical Methods: Chemical Testing Aspects of USP 797 for Compounded Sterile Preparations
- Quality Control Analytical Methods: A Guide to Quality Control Testing for the Compounding Pharmacist
- Quality Control Analytical Methods: Particulate Matter in Injections: What is it and What are the Concerns?
- Standard Operating Procedure: Calculating the Endotoxin Load in Compounded Sterile Preparation
- Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations
- Comparison of Endotoxin Testing Methods for Pharmaceutical Products
- Evaluating and Selecting an Analytical Testing Laboratory
- Analytical Testing Facilities and Products
- Analytical Testing of Extemporaneously Compounded Preparations
- Particulate Testing for Sterile Products
- Particulates in Parenterals
- Preservation, Sterilization, and Sterility Testing of Ophthalmic Preparations
- Standard Operating Procedure: Sterility Test for Ophthalmic Solutions
- Sterile Compounding of Respiratory Inhalation Solutions
- Quality-Control Analytical Methods: The Quality of Sterility Testing
- Quality-Control Analytical Methods - Quality Control, Quality Assurance, and Quality Improvement--What is the Difference
- PreScription: Quality Improvement in Pharmaceutical Compounding
- Pharmacopeial Bacterial Endotoxins Test Chapters
- Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations
- Quality Control Analytical Methods: Strategies to Ensure a Robust Quality-control Microbiology Program
- Establishing Benchmark Rates of Microbial and Bacterial Endotoxin Contamination for Radiopharmaceuticals Compounded in Commerical Nuclear Pharmacy Settings
- Assessing the Stability of Common Radiopharmaceuticals Compounded and Utilized Outside Package Insert Guidelines
- Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
- Quality Control Analytical Methods: A Growing Codependency: Compounding Pharmacy and Safety
- Quality Control Analytical Methods: Laboratory Considerations of United States Pharmacopeia Chapter <71> Sterile Tests and Its Application to Pharmaceutical Compounding
- Quality Control Analytical Methods: The Essentials of United States Pharmacopeia Chapter <51> Antimicrobial Effectiveness Testing and Its Application in Pharmaceutical Compounding
- Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1
- Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2
- Quality Assurance and Quality Control, Part 1
- Quality Assurance and Quality Control, Part 2
- Quality Control Analytical Methods: Physical Quantitative Verification of Nonsterile Compounded Preparations: Individualized Dosage Units
- Development and Validation of an Inexpensive, Simple, and Rapid Technique for Measuring the Accuracy of Extemporaneously Compounded Pharmaceuticals
- Microbial Identification in Pharmaceutical Compounding
- Quality Control Analytical Methods: Method Validation
EQUIPMENT
- Bacterial Isolators: A New, High-tech Option for the Preparation of Sterile Admixtures
- Cleaning, Inspecting and Flow-Accuracy Testing of Ambulatory Pumps
- Consideration for Choosing a Primary Engineering Control for Compounding Sterile Products
- Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 1
- Controlled Environment Testing Association Applications Guide for the Use of Barrier Isolators in Compounding Sterile Preparations in Healthcare Facilities, Part 2
- Local Ventilation for Safe Containments in the Pharmaceutical Industry
- Sterile Compounding with Barrier-Isolation Technology
- Technology Spotlight: A USP-Grade Water System
- Using Automated Compounding Devices in the Practice of Pharmacy
- Microbial Air-Sampling Equipment, Part 1: Meeting USP Chapter <797> Standards
- Microbial Air-Sampling Equipment, Part 2 - Experiences of Compounding Pharmacists
- Tips for Cleanroom Construction and Renovation
- Aqua Pura: Water Purification Systems and United States Pharmacopeia Waters for the Compounding Pharmacy, Part 1
- Aqua Pura: Water Purification Systems and United States Pharmacopeia Waters for the Compounding Pharmacy, Part 2: USP Waters: Experts at the United States Pharmacopeia Answer Compounders' Questions
- Quality-Control Analytical Methods: Aqua Pura: Water Purification Systems and United States Pharmacopeia Waters for the Compounding Pharmacy, Part 3: Testimonials and Comparisons
- Quality Control: Analytical Methods: Calibration of Equipment and Calibration Curves
- Sterilization of Compounded Parenteral Products: Verification of Autoclaves
- A Needle-free Reconstitution and Transfer System for Compounded Sterile Intravenous Drug Solutions: In Compliance with United States Pharmacopeia Chapter <797> Standards
- Basics of Compounding: Certification of Sterile Equipment and Facilities: What Pharmacists Need to Know
- Dry-heat Depyrogenation Ovens for Pharmaceutical Compounding Facilities
- Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom
IMPLEMENTATION
- Sterile Preparations, Part 1
- Sterile Preparations, Part 2: The Responsibilities of Compounding Personnel in Implementing USP Chapter <797> Pharmaceutical Compounding
- Sterile Preparations, Part 3: Considerations for Implementing USP Chapter <797> Pharmaceutical Compounding
- Sterile Preparations, Part 4: Considerations in Selection and Use of Disinfectants and Antiseptics
- Sterile Preparations, Part 5: Verification of Accuracy, Sterility, and Sterilization of Compounded Preparations
- Sterile Preparations, Part 6: 2008 Revisions to Chapter <797>
- Sterile Preparations, Part 7: Microbial Contamination Risk Levels, 12-Hour Use, and Immediate Use
- Sterile Preparations, Part 8: Stability and Beyond-Use Dating
- Sterile Preparations, Part 9: Immediate Use Compounded Sterile Preparations
- Sterile Preparations, Part 10: First Revision: The Main Changes, Events, and Rationale
- Overview of Beyond-Use Dating for Compounded Sterile Preparations
- Sterile Preparations, Part 11: Hazardous Drugs
- Sterile Preparations, Part 12: Sterilization Methods
- Sterile Preparations, Part 13: Environmental Quality and Control
- Sterile Preparations, Part 14: Environmental Quality and Control (Continued)
- Sterile Preparations, Part 15: Personnel Training, Cleansing, and Garbing
- Sterile Preparations, Part 16: Suggested Standard Operating Procedures
- Sterile Preparations, Part 17: Elements of Quality Control
- Sterile Preparations, Part 18: Verification of Automated Compounding Devices for Parenteral Nutrition Compounding and Finished Preparation Release Checks and Tests
- Quality Control: 5 Steps to Improve Quality in the Compounding Lab
- Beyond-use Date: Establishment and Maintenance
- Depyrogenation Options for the Compounding Cleanroom
- Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date
- Basics of Compounding: Unique and Special Characteristics of Sterile Dosage Forms
- Basics of Sterile Compounding: Aseptic Processing
- Applying Quality of Design Concepts to Pharmacy Compounding
- Introduction to Quality Control in a Compounding Pharmacy
OPERATIONS
- Quality Control Analytical Methods: Quality Issues Related to Compounding with Commercial Products
- Sterile - Product Preparations: Mix or Buy?
- Improving the Management, Operations and Cost Effectiveness of Sterile-Product Compounding
- Training and Competency Consideration for Pharmacies Providing Compounded Sterile Preparations
- PostScription: Experts Everywhere
- PostScription: Sterile Product Admixture Preparation
- Purchasing Chemicals for Pharmaceutical Compounding
- Compliance by Hospitals and Healthcare Facilities with the Revised United States Pharmacopeia Chapter <797>
- Contract Sterilization and Validation Companies Offer New Options for Sterile Compounded Preparations
- Preparing Nonsterile and Sterile Hazardous Compounds in an Institutional Setting
- Compounding with Hydrates and Solvates
- PreScription: Beginning of a New United States Pharmacopeial Convention, Inc., Cycle
- PreScription: Sterile Product Outsourcing: Growing Trend in Hospitals
- Compounding with Organic Salts
- Compounding with Esters
- PreScription: Compounding with Manufactured Products
- Home Infusion: Overcoming the Barriers to Entry
- Basics of Compounding: Repackaging, Part 1
- Basics of Compounding: Repackaging, Part 2
- Decontamination Technology: The Missing Element
- Standarized Compounding: The Importance of Doing it the Same Way Every Time
- Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing
- Basics of Sterile Compounding: Contamination Control
- Root Cause Analysis, Part 2: Sterile Compounding
- Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1
- Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 2