Good Control Laboratory Practice (GCLP)

This training DVD, in three parts. demonstrates how Good Control Laboratory Practice contributes to Good Manufacturing Practice (GMP) and demonstrates the basic requirements of GCLP in a pharmaceutical manufacturing environment.

Part 1

GCLP and its contribution to GMP. The importance of complying with Standard Operating Procedures (SOPs) and Methods of Analysis. The consequences of non-compliance.

• Standard procedures for the handling, preparation and identification of samples, reagents, primary reference standards and working standards to ensure that they conform to established standards of quality and purity.
• Labelling, storage and traceability of laboratory reagents, reference standards and working standards.
• The calibration, validation and verification of laboratory equipment before and after use.

Part 2

The importance of record keeping and the storage of laboratory data.

• Rules which determine the preparation, format and issue of procedures and methods of analysis.
• Analytical tests and assessments. Accuracy of test results – good and bad.
• The significance of handwritten data, signatures, computerised data, security procedures and the storage of laboratory documents.

Part 3

A review of general rules for safe working in a control laboratory.

• Safe handling, storage and correct disposal of hazardous chemicals, laboratory and biological waste.
• Potential cause of accidents. Dealing with spillages and the potential hazards associated with glassware.
• Personal hygiene. Protective clothing and personal protective equipment.
• Good Housekeeping practices and general tidiness.
• COSH Regulations and reporting of potential hazards