"Development of analytical methods to accurately and precisely determine residual active pharmaceutical ingredients and cleaning agents on pharmaceutical surfaces"

American Pharmaceutical Review

Volumn 5, Issue 2, 2002, Pages 35-40

  Shifflet, Michael J ^a   Shapiro, Mark ^a  

^a Pfizer's Global Manufacturing   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHEMICAL AGENT; DRUG; ORGANIC SOLVENT;

ACCURACY; ANALYTIC METHOD; ARTICLE; ATOMIC ABSORPTION SPECTROMETRY; CHEMICAL PROCEDURES; CLEANING; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG MANUFACTURE; EQUIPMENT; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PROCESS TECHNOLOGY; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; SAMPLING; STANDARDIZATION; VALIDATION PROCESS;

EID: 0036061651     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. "Guide to Inspections of Validation of Cleaning Processes Division of Field Investigations"
2. "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations"
3. "Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Products"
4. "Cleaning Validation in a Pharmaceutical Research Facility"
5. "Validation of a Cation-Exchange Method to Test for Residual Amounts of a Cleaning and Sanitizing Solution on Pharmaceutical Process Equipment"
6. "Validating a Reversed-Phase HPLC Method to Determine Residual Nonoxynol-9 on Pharmaceutical Process Equipment Using a Nonporous Silica Column"