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Good Quality Control Laboratory Practice
Course Summary
The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or GQCLP. Regulatory authorities inspect laboratories to confirm that they meet the standards.
This course explains how to comply with GQCLP, and it provides advice on laboratory work in general.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Access guidelines and regulations relevant to GQCLP
• Outline the role and elements of a laboratory quality system
• Specify some basic laboratory safety practices
• Identify key types of laboratory document and summarise their contents and relationships
• Outline the management of reference standard substances and reagents
• Specify good practices for data recording and record keeping
• Describe how to handle out-of-specification conditions
• Specify some good housekeeping rules for the laboratory, and outline the role of audits and inspections
Who will benefit from this course
This module provides essential learning for all personnel of analytical laboratories, especially those working on quality control sampling and testing in a medicinal products manufacturing environment.
Module Outline
Introduction
Definitions, GQCLP principles, Guidelines, regulations and standards, Contributions to quality
Laboratory quality system
The quality system and quality manual, Quality system elements, Important SOPs, Typical sample flow
Basic laboratory safety practices
Hazardous situations, Dangerous chemicals, Material safety data sheets, Basic rules for lab safety
Laboratory documentation
The documentation system, Sampling plans, Test methods, Specifications, Analytical method validation protocols, Standard operating procedures, Change control, Calibration records, Laboratory notebooks
Reference standards and reagents
Pharmacopoeias, Reference standard substances, Management of reference standards, Management of reagents
Record keeping and data recording
Raw vs derived data, Completing laboratory notebooks, ALCOA+, Reviewing records, Summarising records, Integrity of electronic data, Types of electronic data, Record retention and storage
Managing out-of-specification events
OOS event categories, Handling an OOS event, Initial laboratory investigation, Retesting, resampling, and averaging results, Formal management investigation, Documentation and corrective action, Out-of-trend conditions
Housekeeping, inspections and audits
Safety and efficiency, Regulatory inspections, Auditing, Undergoing inspections and audits
Roles
Laboratory personnel and management
CPD Points
Undergoing evaluation for 1 CPD point which will be awarded retrospectively on course completion
Region
Level
Introductory/Intermediate
Course Study Time
Approx 1 hour
Europe, USA, Other