An Introduction to Good Quality Control Laboratory Practice

  • ID: 2863580
  • Training
  • Leopink
1 of 2
Within the medicinal products industry's Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control of starting materials, intermediates, bulk products, finished products, and packaging, are required to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or GQCLP, standards. Regulatory authorities may inspect laboratories for compliance with the standards.

This module introduces QC laboratory staff to the requirements that they need to meet to comply with GQCLP.

OBJECTIVES

- Access GQCLP guidelines and regulations

- Describe typical contents of a laboratory quality manual

- State some basic laboratory safety practices

- Identify key types of laboratory document and summarise their contents and relationships

- Specify good practices for record keeping and data recording

- List key features of test methods and specifications

- Identify regulations and guidelines on the management of electronic data

- Outline how to handle out-of-specification conditions

- State why laboratory housekeeping is important and identify types of audit
Note: Product cover images may vary from those shown
2 of 2
Introduction
Defines QA, GMP, QC and GQCLP, and distinguishes GQCLP from GLP. Outlines GQCLP principles and identifies major sources of guidance and regulations. Lists major components of an analytical laboratory’s operations.

Laboratory quality manual
Defines quality system and quality manual, sets out the elements of a quality system, lists uses of a manual, and identifies important standard operating procedures (SOPs).

Basic laboratory safety practices
Describes laboratory hazards, sets out the contents of Material Safety Data Sheets and lists their uses, and specifies basic rules for
lab safety.

Laboratory documentation
Identifies key types of laboratory document and summarises their contents and relationships. Describes the function and contents of method validation protocols, specifications, test methods, calibration records and SOPs. Sets out requirements for validation of test methods. Emphasises the importance of change control.

Record keeping and data recording
Emphasises the importance of record keeping and gives examples of key records. Gives guidance on completing lab notebooks and reviewing records. Specifies requirements for retention and storage of data records.

Test methods and specifications
Describes the sourcing, preparation and use of reference standard substances. Discusses management of standards and reagents. Sets out a typical test method. Outlines good practice regarding specifications.

Good automated laboratory practices
Identifies regulations and guidelines on the management of electronic data. Lists regulated data sources. Sets out requirements for electronic data storage.

Managing out-of-specification events
Defines categories of out-of-specification (OOS) event. Describes the process of investigating an OOS event: initial laboratory investigation, formal management investigation, documentation and corrective action. Discusses requirements and restrictions on retesting, resampling, and averaging results. Outlines analysis of out-of-trend conditions.

Housekeeping and lab audits
Emphasises importance of lab housekeeping and auditing.

Additional resources
Provides access to important sources of regulation and guidance.

Assessment
Multiple-choice mastery assessment.
Note: Product cover images may vary from those shown
3 of 2

Loading
LOADING...

4 of 2
Note: Product cover images may vary from those shown
Adroll
adroll