GMP

Term from Biotechnology industry explained for recruiters

GMP (Good Manufacturing Practice) is a system of rules that ensures products like medicines, food, and medical devices are consistently produced with high quality and safety standards. Think of it as a strict rulebook that companies must follow when making products that will be used by people. When you see GMP on a resume, it means the person has experience working in environments that follow these strict quality rules. Similar terms you might see are "cGMP" (current Good Manufacturing Practice) or "FDA GMP" - they all refer to the same concept of following strict quality guidelines in manufacturing.

Examples in Resumes

Led team of 5 technicians in GMP manufacturing facility

Maintained GMP compliance for vaccine production process

Developed standard operating procedures following GMP guidelines

Conducted quality audits in cGMP environment

Typical job title: "GMP Specialists"

Also try searching for:

Quality Assurance Specialist Manufacturing Specialist GMP Compliance Officer Quality Control Manager Production Supervisor Validation Engineer GMP Trainer

Example Interview Questions

Senior Level Questions

Q: How would you handle a major GMP compliance issue in production?

Expected Answer: Should demonstrate leadership in crisis management, knowledge of corrective action procedures, ability to communicate with regulatory authorities, and experience in implementing systematic solutions to prevent future issues.

Q: Describe your experience in developing GMP training programs.

Expected Answer: Should show experience in creating comprehensive training systems, maintaining training records, evaluating effectiveness, and ensuring ongoing compliance through regular updates and assessments.

Mid Level Questions

Q: What documentation is required in a GMP environment?

Expected Answer: Should explain the importance of Standard Operating Procedures (SOPs), batch records, deviation reports, and change control documents, with examples of how to maintain them properly.

Q: How do you ensure cleaning procedures meet GMP standards?

Expected Answer: Should discuss cleaning validation, documentation requirements, proper cleaning agent selection, and monitoring procedures to maintain cleanliness in production areas.

Junior Level Questions

Q: What are the basic principles of GMP?

Expected Answer: Should mention key elements like proper documentation, following procedures, maintaining clean facilities, proper training, and quality control checks.

Q: Why is documentation important in GMP?

Expected Answer: Should explain that documentation provides proof of actions taken, ensures consistency, allows for traceability, and is required for regulatory compliance.

Experience Level Indicators

Junior (0-2 years)

  • Basic understanding of GMP principles
  • Following Standard Operating Procedures
  • Basic documentation practices
  • Understanding of personal hygiene requirements

Mid (2-5 years)

  • Writing and reviewing SOPs
  • Conducting internal audits
  • Investigation of deviations
  • Training other staff on GMP procedures

Senior (5+ years)

  • Managing quality systems
  • Interacting with regulatory inspectors
  • Leading compliance initiatives
  • Developing quality improvement programs

Red Flags to Watch For

  • No understanding of basic documentation requirements
  • Lack of attention to detail
  • No knowledge of contamination prevention
  • Unable to explain importance of following procedures
  • No experience in regulated environments

Related Terms