Quality Control Methods in Chemical Laboratories

Course details

Benefits of attending

At the end of the course you will... understand why an efficient laboratory is typically a complaint laboratory recognize the concept of being ""in control""

Who should attend

This course is designed for all staff involved with pharmaceutical quality control laboratories – chemical, physical and microbiological. This course will be of particular interest and applicability to QC lab managers, QA managers and QA auditors, Analytical Development lab managers and anyone involved with the healthcare manufacturing and research industries.

Course Overview

The Quality Control (QC) Laboratory is the nerve center of the pharmaceutical company – if analyses are incorrect, product is erroneously released for sale, and people die! This course is designed to assure that the testing performed in your laboratories is beyond reproach , and that the results generated are trustworthy, believable, robust.. The process of acquiring sound scientifically based data requires analytical methods that have been properly validated and tests being performed by qualified, trained, personnel using equipment that has been properly qualified.

As science and technology become more exact, more quantifiable, and more precise, the ability to perform competent analysis becomes daily more of a challenge. This course is designed to ensure and assure that healthcare manufacturer’s laboratories operate in a GMP compliant manner. Efficient Laboratories are compliant laboratories – compliant laboratories are efficient and scientifically trust worthy laboratory. This course does not delve into the science behind laboratory testing, but rather into the ensuring that the laboratory meets its regulatory compliance requirements, and that the product of testing performed is reliable and dependable

Course Outline

• Laboratory Management
• Managing for laboratory efficiency
• Standard analytical times
• Staffing requirements for laboratoy efficiency
• Laboratory space requirements
• Electronic Records (21CFR11)
• Spreadsheet validation
• Laboratory deviations, incidents and being ""in control""

Laboratory Analyst Training

• The 13 core laboratory SOPs
• The SOPs that all analysts must know before taking their hands out of their pockets
• Laboratory mathematics
• Laboratory manipulations
• Laboratory records
• Systematic errors
• Pharmacopoeas
• USP – mandatory elements, voluntary elements
• ICH Guidelines
• FDA and their role in laboratory testing
• GMP/GLP requirements of laboratories and analysts
• Handling Out-Of-Specification Situations
• Handling Out-Of-Trend Situations
• FDA Warning Letters – tools for training

Method Development

• Method development planning
• Assay simplicity
• Assay robustness
• Assay economics
• Analytical method life-cycle

Method validation

• Accuracy, precision, linearity
• Range, specificity, robustness
• ICH Guideline Requirements

Method Transfer

• Method transfer from analytical development to method user
• Objective assessments of successful method transfer
• Lab-lab method transfer; analyst-analyst method transfer

Reference Standards

• Primary standards
• Characterization of standards
• Working (secondary) standards
• Compendial standards
• Reagents and buffers – formulations and expiration dating
• Instrument Calibration And Qualification
• Instrument Calibration Fundamentals
• Calibration of pH meters, balances, incubators, refrigerators,
• IQ/OQ of laboratory water systems, stability chambers, GCs/HPLCs, spectrophotometers
• Instrument Qualification explained