Conducting on-site and
Documentary GMP audits

GMP audits (Good Manufacturing Practice) are a key tool to ensure that pharmaceutical companies meet established quality standards. GMP audits evaluate manufacturing processes and quality control systems to ensure that products are safe and effective.

What are GMP audits?

Why are GMP audits necessary?

1. Compliance with legal requirements: GMP audits are a mandatory requirement of many international and national regulators such as FDA (USA), EMA (European Union) and others. Companies that fail to pass these audits can face serious legal and financial consequences, including product recalls and fines.
2. Product Quality Assurance: Audits help identify and correct potential problems in the manufacturing process, resulting in better quality products and safer products for consumers.
3. Increased consumer and partner confidence: Companies with successful GMP audits have a significant competitive advantage, as it demonstrates a high level of commitment to product quality.

GMP audit process

1. Preparatory Phase: This phase involves gathering and analyzing preliminary information about the company, its manufacturing processes and quality control systems. Key areas to be audited are identified.
2. Conducting the audit: This includes inspection of manufacturing facilities, evaluation of documentation, interviews with personnel and data analysis. Auditors verify compliance with all aspects of GMP, including cleanliness of facilities, control of raw materials, manufacturing and packaging processes, and product traceability system.
3. Final Report and Recommendations: After the audit is completed, a detailed report is prepared that includes the non-compliances identified and recommendations for corrective action. The company is given time to implement corrective actions and re-audit if necessary.

Advantages of working with professional auditors

Advantages of working with professional auditors

• Expert opinion: Professional auditors have in-depth knowledge and experience in the field of GMP, which allows them to effectively identify and analyze potential problems.
• Objectivity: External auditors provide an independent assessment that avoids bias and provides an objective picture of the status of production processes and quality systems.
• Timely identification of problems: Regular GMP audits help to detect and correct potential non-compliances in a timely manner, which reduces the risk of serious problems and improves the overall efficiency of the production process.

The services we provide:

• GMP audits of pharmaceutical manufacturers for compliance with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union approved by Decision of the Council of the Eurasian Economic Commission dated November 3, 2016, No. 77:
• Field audit of pharmaceutical manufacturers for compliance with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union approved by the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 No. 77 and license requirements in accordance with Resolution No. 686 dated July 6, 2012;
• Documentary audit, assessment of the enterprise using means of remote interaction;
• Assessment of corrective and preventive action measures (CAPA);
• Development of corrective and preventive action measures (CAPA);
• On-site or documentary audit of contract, production site for compliance with the requirements of the Rules of Good Manufacturing Practice of the Eurasian Economic Union, approved by the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 № 77 and license requirements in accordance with Resolution № 686 of July 6, 2012