Packaging line clean and clearance operations where a product or strength change occurs as a part of a line change-over, can be a challenging process.

People working to clean and clear previous product from the line, before the next product commences, often make mistakes. It happens easily through interruptions, human error, work breaks etc. 

The GMP Packaging Line Clearance (2 Day) course is a bespoke interactive training programme designed by ITS in conjunction with a customer’s line supervisors/managers, to address an organisation’s specific operational needs and requirements.   The purpose is to create a line clearance audit where operators (and potentially others, e.g. setters) involved on the line, have to carry out a line audit and identify items that should not be present, such as components, residue rogue product, documentation and tooling.

The second part of the day uses video and discussion to investigate where GMP issues were identified and missed by the operators and their respective teams.   Consequential implications are reviewed and real life regulatory audit and non-compliance issues are examined.

The main purpose of this course is to heighten individual GMP awareness during change-over, subsequent line clean and clearance in the company’s real environment.

Day 1 On-line audit

• Carry out a line clearance GMP audit, on a packaging line, to identify non-compliance issues remaining from last production run such as
• product residue
• primary packaging; blisters, tubes, bottles, sachets, vials etc
• secondary packaging; printed and non-printed components including verification systems
• on-line printing requirements
• labels
• tertiary packaging; shrink-wrap, Trespaphan, PVC, etc
• batch documentation, packaging instructions, batch records etc

Day 2 Classroom training for Leaders/Supervisors and their teams

• Review and discuss individual audits and assess actual GMP potential violations, including video
• Investigate packaging line clearance compliance issues including
• Microbiological contamination, cross contamination and foreign material contamination
• Review audit findings, common problems and assess other risks
• utilising findings from day, video and common identified problems e.g. mix-ups, bad practice, personal hygiene and documentation errors
• Consider and review use of own SOPs, work instructions and checklists during line clearance
• Complete an assessment questionnaire to check course understanding and plan for improvements

Please contact ITS for more details on suitable learner numbers, the audit and training approach, and course cost.

We will offer advice on setting up of lines with non-compliance issues and the best individuals to benefit from the audit and training. Due to the bespoke nature of this course an individual quotation will be raised for each customer.

This training course can only be carried out onsite.

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›