Pharmaceutical Validation Services
Vendor audit and Qualification
P.V.S. performs vendor audits and qualifications covering Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs), which provide support to the pharmaceutical and biotechnology industries.
Site Audit and Regulatory Inspection Qualification
Our expert can perform a Pharmaceutical and Biotechnology facility regulatory audit (Mock Audit) and qualification according to FDA, Canadian and EU GMP requirements:
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Facility design compliance
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Documentation and procedures systems
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Quality system
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Process validation (production and utilities)
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Manufacturing lines validation and qualification
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Training policy and records
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Quality control laboratories methods, procedures and equipment
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Gap analysis
Stability study
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Shelf life stability study
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Stability studies under accelerated conditions
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On-going stability program
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Development of stability indicating method
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Stress study and by-products determination
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Statistical data and trend analysis
Gap and CAPA Analysis
Gap Analysis
The main objective of using the Gap Analysis in the biopharmaceutical and pharmaceutical industries is to identify the gap between the regulatory requirements governing the company operations and the current status of the company operations.
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CAPA Analysis
The FDA and regulators world-wide require manufacturers of pharmaceutical, biological and medical devices not only to have a Corrective and Protective Actions (CAPA) procedure in use.
PRODUCT STUDY AND REGULATION
Our team shares its expertise in the matters of product study and regulations.
Services include:
