How we do it
Factory floor inspection
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 tour of the warehouses and tank area 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 like foreign matters, dust, and pest. Additionally, we see labelling control as a critical aspect of Good Manufacturing Practice.
Additional expectations not covered in ICH Q7 or the European GMP Guide Part II are included, 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.
Beyond APIs
Audits of intermediates, regulatory starting materials, and excipients are conducted according to the same principles, but only to the extent applicable to the intended uses 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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Aseptic processing
For sterile products, we place additional emphasis on the design of facilities, equipment, and production processes. Aseptic process simulation (media fill) is a critical topic. Environmental controls, time controls, the qualification of sterilizing filters, the validation of sterilization and aseptic processes are other crucial areas. The sampling schemes or the release procedures are not neglected.
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QC Data Integrity
Our audit of quality control aims at verifying that the activities of the laboratory are conducted with order, method, and reliability.
Tests should be performed with a suitable level of precision on calibrated instruments. Analytical records should be filled-in while the operations are ongoing. Electronic data should be stored safely and routinely reviewed if critical. We always review the suitability and, where appropriate, the validation of the analytical methods.
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Documentary review
The final stage of an audit concerns the quality management system. Was it documented in standard procedures that are reviewed, approved, and copy-controlled? Is product quality regularly reviewed? Is the investigation process for deviations, OOS results, and customer complaints scientifically sound, identifying and addressing root causes to prevent recurrence?
Major changes are reviewed to ensure they were controlled and notified. Batch records, validation reports, risk evaluation reports, supplier audit reports, and other key documents are included.
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Personnel competence
The qualifications and training programs of the personnel receives the auditor's due attention, including the training of new hires, the annual training plan, and other aspects demonstrating the competence of individuals responsible for key functions related to the quality and safety of the product.
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Wrapping up
The audit concludes with a meeting where both positive and negative observations are explained. If the audit is successful, without critical or numerous major observations, the report will recommend issuing a QP declaration of GMP compliance without delay, without having to wait for the final closure of the audit.
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Following up
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 eventually closed out. This service is offered at no additional cost.
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At all stages in these processes, your recommendations, questions, and feed-back are always welcome.
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