GMP audit. Aston Clinton

• Alpla. Aston Clinton

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

Personnel and Hygiene

• Are all employees wearing proper Personal Protective Equipment (PPE)?

  Yes

  No

  N/A

• Are hygiene facilities (e.g., handwashing stations) easily accessible and functional

  Yes

  No

  N/A

• Are employees trained and aware of GMP protocols and entry requirements?

  Yes

  No

  N/A

• Are there any signs of non-compliance in the factory?

  Yes

  No

  N/A

• Is the health status of employees regularly monitored (e.g., absence of illness)?

  Yes

  No

  N/A

Facility and Environment

• Is the facility clean, well-organized, and free of waste buildup?

  Yes

  No

  N/A

• Are pest control measures in place and effective?

  Yes

  No

  N/A

• Are ventilation, lighting, and temperature controls functioning properly?

  Yes

  No

  N/A

• Are cleaning schedules and records available and up to date?

  Yes

  No

  N/A

• Are there any cracks, leaks, or maintenance issues in the infrastructure?

  Yes

  No

  N/A

Equipment and Maintenance

• Are machines and equipment clean, well-maintained, and properly calibrated?

  Yes

  No

  N/A

• Are cleaning and maintenance logs for equipment complete and accessible?

  Yes

  No

  N/A

• Is there any visible contamination or damage to the equipment?

  Yes

  No

  N/A

• Are tools and utensils stored in designated areas?

  Yes

  No

  N/A

Raw Materials and Storage

• Are raw materials stored in a clean, dry, and appropriate environment?

  Yes

  No

  N/A

• Are materials properly labeled with dates (e.g., expiry and batch numbers)?

  Yes

  No

  N/A

• Is there a system in place for FIFO (First In, First Out) or FEFO (First Expired, First Out)?

  Yes

  No

  N/A

• Are storage areas free from pests, contamination, and temperature/humidity issues?

  Yes

  No

  N/A

Production and Processing

• Are standard operating procedures (SOPs) followed and available for the operators?

  Yes

  No

  N/A

• Are records and documentation properly filled out and accurate?

  Yes

  No

  N/A

• Is there any evidence of cross-contamination in the production process?

  Yes

  No

  N/A

• Are work surfaces and tools kept clean and ready for use?

  Yes

  No

  N/A

Quality Control

• Are there clear and defined quality standards for products?

  Yes

  No

  N/A

• Are the Quality Technicians aware of the quality standards

  Yes

  No

  N/A

• Are samples of raw materials inspected, and finished products tested and documented?

  Yes

  No

  N/A

• Are there systems in place for managing non-conforming products?

  Yes

  No

  N/A

• Are lab testing areas clean, organized, and properly equipped?

  Yes

  No

  N/A

Documentation and Record-Keeping

• Are GMP policies, procedures, and records readily available and up to date?

  Yes

  No

  N/A

• Are training records for employees complete and accessible?

  Yes

  No

  N/A

• Are deviations, corrective actions, and preventive actions documented?

  Yes

  No

  N/A

• Is there a traceability system in place for materials and finished products?

  Yes

  No

  N/A

Waste Management

• Is waste segregated, stored, and disposed of properly?

  Yes

  No

  N/A

• Are waste containers clearly labeled and regularly emptied?

  Yes

  No

  N/A

• Is there any evidence of improper disposal or accumulation of waste?

  Yes

  No

  N/A

Compliance and Continuous Improvemnt

• Are internal audits conducted regularly, and are findings acted upon?

  Yes

  No

  N/A

• Are corrective actions from previous audits fully implemented?

  Yes

  No

  N/A

• Are GMP requirements aligned with local regulatory standards?

  Yes

  No

  N/A

• Is management actively involved in promoting GMP practices?

  Yes

  No

  N/A