cGMP Audits
Pharmaceutical Services Corporation’s cGMP audit process will ensure that your facility meets all applicable regulatory requirements. At Pharmaceutical Services Corporation, we have expertise in cGMP norms and will audit the suppliers' manufacturing facilities for compliance to cGMP, where required assistance to implement cGMP will be offered. To completely fulfill your needs, a Pharmaceutical Services Corporation Audit Coordinator can be assigned to your project to ensure full compliance with cGMPs and NIH (National Institute of Health) guidelines.
 Contract Manufacturer Audits
We conduct in-depth Manufacturer Audits to assure the manufacturer has the ability to maintain full compliance with cGMPs and fulfill your needs. We also provide services for evaluating, selecting and monitoring a contract manufacturer.
Contract Laboratory Audits
We determine and monitor the cGMP compliance throughout the period of the contract laboratory activities. Compliance to cGMP is required for all testing activities associated with the manufacturer for human use.
Supplier/Vendor Audits
We conduct inspection audits with each supplier/vendor of critical raw materials, components and supplies to assure the supplier/vendor’s compliance to cGMPs. In addition, we can assist you in developing a vendor audit program and can participate with your personnel on audits.
Quality/Product Audits
We conduct in-depth Quality/Product Audits to assess the completeness of the company’s quality system and audit trails by defining the product critical items, enabling the audit team to focus on issues that affect product quality.
Computer System Audits
We provide guidance on how computer systems should be validated to meet cGMP requirements and/or provide highly independent audits to assure your computer systems are in compliance with the FDA requirements.
General cGMP Compliance Audits
We provide cGMP Compliance Audits to you on a one time or annual basis. We conduct highly independent and impartial audits and provide reports to you with suggestions for improvement.
cGMP Audit Training
We train your personnel and help them to prepare and pass regulatory and corporate audits and inspections successfully.
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