Overview:

The GMP Fast Track Freshers Training Programme is a useful training course for individuals either new to a healthcare manufacturing company or moving departments, to learn and understand more about Good Manufacturing Practice (GMP) and its application.

The first day of the programme is the Introducing GMP Training (1 Day) Course, building an understanding of GMP and its application.

The second day progresses to investigate electronic records and signature requirements for America and the EU. Important consideration is given in the use of best practice SOPs, and corresponding training and evaluation. An overview of the validation process and how it is implemented is described and explained.

The course enables learners to investigate the regulatory drive for implementing risk management (review of Q9 Guidance), including the FMEA risk assessment method and the importance of change control including related issues. Learners also apply their learning by reviewing real case studies where GMP non-compliance could occur, determining potential solutions to such situations.

Content:

• What is GMP?

  • The history behind GMP

  • Why is there a need for GMP?

  • Quality assurance links to GLP, GCP, GDP, and GAMP®

• GMP and its link with Quality Assurance and Quality Control

  • The importance of the quality unit

  • Change control and its impact

  • The new focus of applying risk assessment

• What are the relevant regulations?

  • The Orange Guide and European Directives

  • Change control and its impact

  • The Code of Federal Regulations

• Who the regulatory agencies are, how they audit and enforce the regulations, including legal requirements

  • MHRA

  • FDA

  • Types of audit including the FDA systems approach

  • Internal audits

  • Current hot topics in the regulatory world

• Investigate the 4 Ps: People; Procedures and documentation; Production areas and equipment; Products and components

• People - Adequacy, experience, training and the role of the Qualified / Responsible Person

  • Organisational structure and adequacy

  • The importance of training, experience and qualification as viewed by the regulators

  • Personal hygiene requirements

• Procedures and documentation - from the completion of SOPs to in-process controls

  • Document control

  • Sufficient and efficient use of SOPs

  • Packaging instructions, batch manufacturing records, in-process controls and associated documents

  • Warehouse and logistics; status labelling, and FIFO

  • Associated errors with documentation

• Production areas and equipment - premises, layouts and considerations

  • The importance of cleanliness; clean rooms, sterile operations and gowning operations (including links to micro-biological and cross contamination)

  • An overview of basic microbiology and GMP

  • Layout of facilities and equipment

  • Packaging and manufacturing equipment; design, validation, line clearance, components and materials, label control and reconciliation

• Products and components

  • Incoming, handling, storage, packaging, labelling and non-conforming products

  • Threat of mix-up and contamination

  • Importance of change control and purchasing

  • Printing on packaging

  • Product security attention through on-line controls

  • Process validation and change control; life cycle concepts

• Understand good documentation practices

  • Basic terms and definitions relating to manufacturing and packaging operations

  • Types of documents; records and instructions

  • Legal requirements; retention period and completion

  • Lifecycle of an SOP

  • Regulatory requirements

  • How to complete a document correctly

  • Electronic records and signatures and 21 CFR Part 11

• The importance of Standard Operating Procedures (SOPs)

  • Managing SOPs effectively

  • Everyday use of SOPs

  • What makes a good SOP?

  • Training requirements and best practices

• Explore errors in documentation using examples and case studies

  • Common everyday occurrences which affect businesses and customers

  • SOP problems

  • Common highlighted FDA warning examples

• Investigate why healthcare manufacturing companies have to carry out validation

  • History of validation and links to GMP

  • What is validation and its purpose?

• Understand the key stages of the validation model, terminology, and processes for new and other projects

  • What is GAMP®?

  • The principles of validation

  • European and USA regulations and validation, including 21 CFR Part 11 and Annex 11 and 14 (EU GMP Guidance)

  • What can go wrong in companies?

• Investigate why Change Control is a vital ingredient of GMP for pharmaceutical and medical device manufacturers

  • Consider the consequences of non–compliance to GMP for patients through inadequate application of the Change Control process

• Identify why Risk Management has become important in the regulatory world of healthcare manufacturing

  • Interpret the ICH Q9 guidance document, including common Risk Management terms used and how it can relate to being used in companies

  • Consider utilising a Failure Modes Effects Analysis (FMEA) method for applying Risk Management approach for change control activities

• Solve problems for GMP improvements

  • Investigate several problem solving techniques to apply to a real scenario

• Apply previous course learning to identify potential GMP violations and their consequences

• Use case studies of possible real events in manufacturing plants

  • Team activities, analysing problems and identifying solutions

  • Review of recorded real events; FDA warning letters and latest topics

• Use interactive case studies to analyse scenarios

  • Reflect that people are the biggest threat to GMP

  • Examine real reported incidents

  • Determine behaviours that improve GMP

  • Apply the FMEA risk assessment method to a potential new project

• Relate to real work activities

  • Plan for workplace improvements

  • Action plan for applying learning