Auditing Methods
We are a European GMP auditing service based in Hangzhou, China.
We begin our audits by meeting key factory personnel to outline the audit's purpose and scope, understand quality management practices, and review the organization of the company. We identify the warehouses, production areas, utilities, in-process controls, and quality control facilities within audit scope. If containment is a concern, it is given special attention.
The warehouse and tank area tour covers the receipt, sampling, status management, stock rotation, and storage conditions of the materials. Materials must come from qualified suppliers and the samples must be representative. The batches must be eleased through a robust process, and stored appropriately.
The purpose of the workshop tour is to inspect the maintenance and cleanliness of the production equipment. Hygiene is paramount. Regular maintenance schedules must be implemented. In multi-product workshops, we distinguish between dedicated and shared equipment, filters, and tools. We verify the absence of residue traps and other difficult-to-clean places. The production line must be designed for ease of cleaning. Equipment should be calibrated according to a regular schedule. In-process controls must be reliable, performed on samples collected in a manner that prevents contamination. The production records should be completed contemporaneously. When handling genotoxic substances, emphasis is placed on the steps where they are introduced and purged. In fermentation processes, we consider the purity of the broths. Microbiological cleanliness is also addressed, as we check for stagnant water and other potential hazards. Closed systems are preferred but must be regularly drained and dried. Recovery management (solvents, materials, products) must be conducted under clean and validated conditions. Refining and primary packaging operations should be safeguarded against contamination risks. Additionally, we see labelling control as a critical aspect of Good Manufacturing Practice.
We include additional expectations not covered in ICH Q7 or the European GMP Guide Part II, such as worker health protection and batch homogeneity, which would give you assurance that the samples you will draw will be representative of the entire batch.
Our audits of intermediates
Our audits of intermediates, regulatory starting materials, and excipients are conducted according to the same principles, but only to the extent applicable to the purpose of such materials. We aim to achieve an appropriate balance. If the audit scope concerns primary packaging materials, medical devices, etc., the principles are the same, though other suitable standards are applied.For sterile products, we place additional emphasis on the design of facilities, equipment, and production processes. Aseptic process simulation (media fill) is a critical area of focus. We also review environmental controls, time controls, the qualification of sterilizing filters, and the validation of sterilization and aseptic processes. We examine the sampling schemes and release procedures.
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Conducted with order and method.
Our audit of QC facilities verifies that the activites of the laboratory are conducted with order and method. The tests should be performed with a suitable level of precision on calibrated instruments. We expect that analytical records be completed while the operations are ongoing. Electronic data should be stored safely and reviewed regularly if critical. We always review the suitability and, where appropriate, the validation of the analytical methods.
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The quality management system
The last part of our audit concerns the quality management system, whether it was documented in standard procedures that are reviewed, approved and copy-controlled. We review the annual reports of product quality, including the investigation of any deviations, OOS results, and customer complaints. Investigations should be scientifically sound and address root causes to prevent recurrence. We check how major changes are controlled and notified. We review the batch records, validation reports, and risk evaluation reports. The supplier audit reports and other key qualification documents are examined, especially for purchased intermediates.
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The qualifications and training programs
Finally, the qualifications and training programs of the personnel receives our due attention, including the programs for new hires, the annual training plan, and other aspects that demonstrate the competence of individuals responsible for key functions related to the quality and safety of the product. The audit concludes with a meeting where both positive and negative observations are explained.
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Following the audit
Following the audit, a plan of corrective and preventative actions is requested to address the observations noted. Evaluation and comments are provided until the audit is fully closed out. This service is offered at no cost.
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If the audit report is sufficiently positive
If the audit report is sufficiently positive, without critical or numerous major observations, our report will recommend issuing a QP declaration of GMP compliance immediately, without waiting for the final closure of the audit.
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Our audits of intermediates
Our audits of intermediates, regulatory starting materials, and excipients are conducted according to the same principles, but only to the extent applicable to the purpose of such materials. We aim to achieve an appropriate balance. If the audit scope concerns primary packaging materials, medical devices, etc., the principles are the same, though other suitable standards are applied.
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For sterile products
For sterile products, we place additional emphasis on the design of facilities, equipment, and production processes. Aseptic process simulation (media fill) is a critical area of focus. We also review environmental controls, time controls, the qualification of sterilizing filters, and the validation of sterilization and aseptic processes. We examine the sampling schemes and release procedures.
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