A GMP Audit can be a hectic and stressful occasion. Let us help take some of the weight away from the core teams as they prepare for the audit.
Our consultants will ensure that all personnel are aware of the requirements for conducting in-house, client and regulatory audits. At HPS, we have worked with multiple regulatory agencies including, FDA, EMA, Japan, Singapore (HSA), Turkey and Brazil.
HPS consultants, who are spread across the globe from Singapore to United Stated of America, have extensive experience in handling a variety of audits such as General, Data Integrity, Pre-Approval Inspections (PAI’s), GMP Manufacturing Certification, and Drug Product Market Distribution.
Our consultants have served in different roles and responsibilities including, Front Room, Back Room, Leading Laboratory Walkthroughs and Responding to Observations.
Audit Preparation Packages Include:
- Frequent Gemba walkthroughs for laboratories, manufacturing facilities and other departments.
- Preliminary in-house inspections alongside department personnel and leadership teams.
- Performing Mock Audits with cross-functional teams.
- Reviewing employee training records, safety protocols and risk assessments.
- Review cleanliness and proper hygiene throughout facility and ensuring effective Environmental Monitoring programs.
- Ensuring all Data Integrity and Security are in place for all processes including audit trail review.
- Assist quick response times to auditor documentation requests such as training records, validation packages, SOP’s and quality records.
To best prepare for an audit, HPS will assist in the list above and to use other tools and platforms as necessary with due diligence in following all regulatory standards and guidelines in any step or process.
Contact us to discuss how to ensure that your company is proactive in meeting all compliance and integrity expectations.
📩 info@hiproscientific.com
📱 +65 8163 3185 (Call or WhatsApp)
