QAC01

An Introduction to Good Quality Control Laboratory Practice

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.

Approved by the Royal Society of Chemistry for purposes of continuing professional development.

Approximate Course Time: 2 hours

Level: Foundation

CPD Points: 2

Audience: QC laboratory staff

Category: GMP/QA/QC

Region: USA, Europe, Other

Who will benefit from this module?

All staff engaged in the quality control of medicinal products will find the module valuable as an introduction or refresher course.

Learning 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

Module outline

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.

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