GMP Workflow Basics

What does GMP stand for in workflow?

• GMP

• GFP

• GWP

• GAP

Why are GMP regulations important in workflow?

• To encourage inconsistency in products

• To decrease employee morale

• To increase production costs

• To ensure quality, safety, and consistency of products.

What is the purpose of documentation in GMP workflow?

• To increase productivity

• To waste time

• The purpose of documentation in GMP workflow is to ensure compliance, facilitate traceability, and provide a reference for audits.

• To confuse employees

How does quality control play a role in GMP workflow?

• Quality control plays a critical role in GMP workflow by ensuring that products meet the required quality standards and regulations.

• Quality control only applies to non-regulated products

• GMP workflow does not require adherence to quality standards

• Quality control is not relevant in GMP workflow

What are the training requirements for employees in GMP workflow?

• Training only on company-specific procedures

• Training on unrelated topics

• No initial training required

• Initial training on GMP regulations, company-specific procedures, and job-specific tasks, followed by ongoing training to stay updated.

Explain the auditing procedures in GMP workflow.

• Auditing procedures in GMP workflow focus solely on employee training without assessing processes.

• Auditing procedures in GMP workflow involve conducting random inspections without documentation review.

• Auditing procedures in GMP workflow do not require record-keeping for compliance evaluation.

• Auditing procedures in GMP workflow involve reviewing and evaluating processes, documentation, and records to ensure compliance with Good Manufacturing Practices standards.

What are corrective actions and why are they important in GMP workflow?

• Corrective actions are only important in GMP workflow for minor issues.

• Corrective actions in GMP workflow are primarily focused on blaming individuals rather than improving processes.

• Corrective actions are unnecessary in GMP workflow as they slow down production.

• Corrective actions are essential in GMP workflow to address and rectify deviations, ensuring product quality and compliance.

How often should audits be conducted in GMP workflow?

• At least annually

• Bi-annually

• Every 5 years

• Quarterly

What type of documents are typically included in GMP documentation?

• Financial reports, marketing materials, personal emails

• Cooking recipes, travel itineraries, shopping lists

• Weather forecasts, sports scores, celebrity gossip

• Standard Operating Procedures (SOPs), batch records, validation protocols, quality control records, and training records

What are some common quality control tools used in GMP workflow?

• Flowcharts

• Control Charts, Pareto Analysis, Fishbone Diagrams, Scatter Diagrams, Histograms, Check Sheets

• Pie Charts

• Bar Graphs