Important steps in preparing for an EU GMP inspection

EU-GMP Inspection – A comprehensive assessment of a pharmaceutical manufacturing site’s  activities, quality control and operational procedures and facilities to ensure regulatory compliance.  

Purpose of  EU-GMP inspection

– Ensure compliance with regulations: The purpose of the inspection is to ensure that production facilities are in compliance with strict safety and quality regulations in order to protect the health of consumers. 

– Comprehensive assessment: This process involves checking all aspects of pharmaceutical manufacturing to ensure that no step in the process could pose a risk to product’s quality. 

To pass the EU-GMP inspection, you need to prepare: 

1/ Detailed inspection schedule:  

• Opening meeting: The opening meeting was to introduce the EU-GMP inspection team, the objectives of the inspection and the implementation plan, including the content, timing and methodology of the inspection. 

• Practical EU GMP inspection: The inspection team will conduct direct inspections at the production facility, usually following the route of warehouse area -> plant -> packaging; Technical area -> Analytical -> documents. The inspection team often divides into small groups during the inspection process. There is a wrap-up meeting every day. 

• Closing meeting: At the final inspection team meeting, attended by all inspection members, the inspector will announce the deficiencies and their classification, discuss the findings and set a deadline for the CAPA. 

2/ Prepare the facility systems  

To prepare well for an EU-GMP inspection, you need to ensure that:

• All production facility areas need to be cleaned and kept tidy.
• The environment is clean, tidy, and complies with hygiene standards, thereby minimizing the risk of errors during production and storage.

Some of the areas where errors are easily detected include: 

• Sampling area at warehouse: Ensure the sampling area is clean and follow sampling procedures to avoid contamination and cross-contamination. 

• Weighing area at production: Area to be cleaned.

• Tableting and granulating area: Pay attention to dust during production

• Storage area: Products and ingredients must be properly stored and clearly labeled to avoid confusion. 

• Warehouse: Insects need to be checked and controlled to prevent them from damaging raw materials and products. Especially small insects which are difficult to control.

• Chemical storage area: Make sure chemicals are stored properly, and that they are within their expiration date. 

• Machinery and equipment: Ensure all machinery and equipment are kept clean, functional, maintained and calibrated on time. 

• Pay attention to waste paper: Keep working areas be free of paper waste and other waste to maintain a clean and safe work environment. The types of raw data that are torn off also need to be noted according to GDP (Good Documentation Practices) regulations. 

3/ Documents and procedures: 

• Review the entire logbook to avoid GDP errors and at the right frequency: This includes keeping clear, accurate and unambiguous records and carrying out the required record-keeping at an appropriate frequency. 

• Review training records and job descriptions: Ensure that all staff are fully trained and training records are up to date. Job descriptions (JDs) should be clear and relevant to the actual duties of each employee. 

• Operating instructions and logbooks are available in relevant areas: Ensure that operating instructions and logbooks are available in relevant production and quality control areas so that employees can access and comply with instructions promptly. 

• Important documents are always available for EU-GMP inspection team to review when needed, important documents such as:

            – Site Master File

            – Validation Master Plan

            – Quality Manual

            – Registration Dossier

            – Layout.

=> These documents should be reviewed quickly before being submitted to the EU-GMP inspector. 

• CAPA Gap assessment, CAPA mock audit: Ensure that CAPA has been fully implemented, evidence is documented, and that the error is not repeated or will not be detected in a future inspection. 

• Batch files and reports stored in the records room need to be neatly arranged and convenient to retrieve when needed. 

• Prepare documents in advance at the EU-GMP inspection reception room to ensure the ability to provide documents quickly and accurately when requested by the inspection team. This saves time and makes a good impression on the inspection team. 

4/ For computer systems and software  

• Sample measurement data file must be placed in the correct location, the trash has no file: Make sure that all sample data is stored in the correct location and that no important data is left in the trash to avoid loss or confusion. 

• Note: Do not leave too many accounts on the window, need to sign-out when not in use: Ensure system security by limiting the number of active accounts and ensuring unused accounts are signed out to prevent unauthorized access. 

• Full data assurance, audit trail and backup: To ensure data integrity. 

5/ Detailed staff assignment  

It is important to assign specific personnel to each task, ensuring that each personnel knows their duties clearly.

Optimize work efficiency and best prepare for EU-GMP inspection. 

• Meeting opener: The task is to introduce the inspection team, state the objectives of the meeting and the inspection, and provide an overall plan for the inspection. The opening person will be the company’s leadership representative, quality director, department head. 

• Meeting Endor: Summarize the initial findings and comments from the EU-GMP inspection team, outline next steps, and thank the inspection team. 

• The person directly responding to the inspection: As a manager and employee responsible for related work. Need to understand clearly the details of work and processes in the area you are responsible for, ready to provide detailed information when being asked.

• Document provider (runner): Assist the inspector, quickly retrieve necessary documents or materials from other areas. 

• Interpreters if needed, or English-speaking staff will cross-support other departments in responding to inspections. 

• The remaining staff work normally, ensuring that production and management activities are not interrupted. Employees should not pay too much attention to the inspection to maintain focus and work efficiency. 

=> It is necessary to fully train employees and ensure that all employees understand and comply with production and quality control procedures. 

=> Helps reduce risks and enhance preparation for EU-GMP inspection.

6/ EU-GMP pre- inspection

• TConduct internal audits: Detect and correct potential issues before the EU-GMP inspection team arrives. Internal audit help check the facility’s readiness and ensure that all standards are being followed. 

• The consultant should conduct a mock audit to best prepare the manufacturing facility for the EU-GMP inspection. 

7/ Arrange production schedule  

• The production schedule ensures that production is not significantly interrupted while still allowing for inspection. Production schedules need to be adjusted to match the EU-GMP inspection schedule, ensuring all areas are ready.

8/ Other

• Focus on EU-GMP inspected products: Ensure that the products and manufacturing processes involved in the inspection comply with EU-GMP standards.  

• Long-standing issues need to be addressed, or adequate responses prepared to avoid criticism or discovery during an inspection. 

• Uniform for EU-GMP inspector: Ensure that the audit team is appropriately attired when entering cleanroom areas, ensuring hygiene and compliance with safety standards. Clothing must be clean, neat and tidy. 
• EU-GMP Inspector Response: Ensure that all questions and requests from the inspection team are answered in a direct, concise, accurate, transparent and timely manner. 

Thorough and detailed preparation prior to an EU-GMP inspection inspection is of utmost importance. From staffing, preparing documentation, conducting internal inspection, to preparing the inspection team uniforms and ensuring that all questions are answered professionally, all contribute to the success of an EU-GMP inspection.

Thanks to these preparations, the manufacturing facility will not only meet the requirements of the EU-GMP inspection, but also maintain high quality standards in pharmaceutical production.