PIC/S, EU - GMP/GLP Audits

Good Manufacturing Practice (also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and quality controlled to the quality standards appropriate for their intended use and as required by the product specification. GMP defines quality measures for both production and quality control. It also defines general measures to ensure that processes used in production and testing are clearly defined, validated, reviewed and documented; and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals, including vaccines.

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GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.

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vighnsolution is fast becoming the first choice EU GMP compliance partner for manufacturers in the Asian region. our certified EU GMP pre-inspection auditor will provide a thorough assessment of the facility’s readiness prior to inviting the PIC/S, EU regulators for the audit. Flexible GXP pharmaceutical auditing solutions, helping you to improve control over quality for your complex supply chains. Our GMP auditors evaluate and monitor your suppliers, subcontractors, and service providers supporting your pharmaceutical product lifecycle.

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Our EU GMP compliance services are conducted in 5 phases: