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Good Manufacturing Practice

Biovigates’s Good Manufacturing Practice (GMP) experts can work to evaluate systems at your pharmaceutical, biotechnology, medical device organization or at your vendor sites to determine if the systems in place are sufficient to meet your manufacturing needs and the current regulatory standards.

We’re able to conduct audits on your behalf, using your established audit program

 Our GMP experts have experience auditing systems against applicable regulatory and industry standards. Our experts work with you to apply the correct standards based on your needs, the activities or services provided, and the stage of your project. During our evaluations, we can identify areas for improvement or potential compliance risks. We assess a wide range of systems—most notably those used in quality, production, packaging and labeling, materials, laboratories, distribution, and equipment and facilities.

Services Include:

PREPARING YOU FOR INSPECTION

Our GMP expertise means we’re perfectly placed to prepare you for inspections. Offering a wealth of services, we can train employees on inspection interview techniques, conduct GAP analysis on your systems, processes, or facilities, and facilitate full mock inspections and more.

Biovigate can partner with your organization to conduct facility walkthroughs to support process improvements throughout the company. Through support services such as inspection training, gap analysis, or risk assessments, our team can strengthen the compliance of your systems.

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Find business needs

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Solutions tailored to your needs

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Align tactic with objective

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Results deliver measurable

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Frequently asked question

Biovigate adheres to GMP by implementing rigorous quality control systems, conducting regular audits, and continuous staff training. Our facilities are equipped with state-of-the-art technology, and we maintain detailed documentation to ensure traceability and accountability at every production stage.

Biovigate follows GMP guidelines as set by international regulatory bodies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), and WHO (World Health Organization). These guidelines encompass aspects like hygiene, documentation, process validation, and quality control.

GMP audits at Biovigate are conducted regularly by both internal and external auditors. Internal audits are carried out quarterly to ensure ongoing compliance, while external audits by regulatory bodies occur annually or as required.

Any deviations or non-conformities are promptly investigated through our CAPA (Corrective and Preventive Action) system. We identify the root cause, implement corrective actions, and monitor the effectiveness of these actions to prevent recurrence.

We stay informed through continuous professional development, participation in industry conferences, and active engagement with regulatory bodies. Our quality assurance team regularly reviews and updates our practices to align with the latest GMP standards.