GMP Audits

QACAL Technology consultants include American Society for Quality (ASQ) certified quality auditors with extensive experience in EMA, GMP, FDA, MHRA, Health Canada and other international regulatory guidelines. They understand the impact that continuous compliance oversight has on maintaining a QMS and have the expertise in performing internal/external quality system, supplier/vendor qualifications, and medical device audits. Our ASQ-certified auditors have conducted audits for both contract manufacturers and owner companies in the pharmaceutical, biotechnology, medical device, and personal care products industries.

QA Audit Preparation and Response

  • Assist QA Department with preparation for an audit conducted by clientele or an inspection being conducted by a regulatory body
    • Document and Data Review
    • Conduct internal process audits to detect and correct non-compliance
    • SOP writing
  • Assist QA and operations staff in resolving Quality issues and develop action plans to correct deficiencies
    • Assist QA with Audit Responses
    • Assist with Part 11 Remediation and Compliance
    • Qualify Excel Spreadsheets:  Microsoft Excel is not Part 11 compliant. However, there are security and protective measures that can be implemented to decrease risk.
  • Conduct Vendor Qualification and Maintenance Audits

 

QACAL provide third-party vendor audit services for the pharma manufacture. It includes all types of vendors like raw material vendor, machinery supplier, Software and IT vendor, packaging material vendor or contract manufacture.

Auditing in simple terms could be defined as an inspection of a process or a system to make sure that it complies with the requirements of its intended use.

There are two types of audits that are conducted:

  1. Internal Audit (Self Inspection):
  2. External Audit: This is conducted for the suppliers or any outsourcing operations carried out by the pharmaceutical industry. The contract giver (Industry) is responsible to access the competence of the Contract acceptor (supplier or any other outsource operations department) as per the GMP guidelines.

The rationale for Conducting Internal and External Audit as per ICH Guidelines Q10:

PROCEDURE FOR CONDUCTING AN AUDIT: 

  1. Frequency of Audit: 
  2. Responsibilities: 
  • Documentation
  • Audit Preparation.
    • Conducting of Audit
    • Completing and Follow Up of Audit

Third party Auditing is an integral part of pharma operation and cannot be neglected as it helps in product realization, process performance, quality monitoring. It is must tool for continuous improvement of quality system of an industry.