Quality and Compliance
Tackling the gap to compliance is an urgent activity. However, establishing a quality culture is essential for enabling quality assurance. At No deviation, we have helped manufacturing achieve, retain, and regain cGMP compliance for diverse regulatory agencies including FDA (US), EMA (Europe), HSA (Singapore), NMPA (China), SAHPRA (South Africa) and other PIC/S member countries.
Gap to compliance:
Our team of SMEs can help you resolve non-compliance arising from an internal or external audit, an FDA form 483 or equivalent. We will provide specific short-term actions and long-term solutions to avoid the recurrence of the problem.
Whether it is an issue related to data integrity or quality system, No deviation has the capability to drill down to the root cause of the problem and help you put in place effective corrective and preventive action (CAPA) programs including development, execution, monitoring, and project management.
- We have successfully delivered a 6-month HVAC remediation project that has helped avoid an AIDS drug shortage in Africa.
- We have helped customers regain their GMP licenses by addressing all deficiencies and supporting the regulatory inspection.
- We have addressed the risk of product cross-contamination for a Class 3 medical devices plant.
No deviation’s experts have worked for most of the major pharmaceutical MNCs and can help your organisation set up the documentation and training necessary for an effective Pharmaceutical Quality System (PQS) including preparing and reviewing your standard operating procedures and identifying actionable quality metrics. This will help your company deliver the product quality on time.
If you are looking to improve your company output, why not start by looking at your quality culture? We can help you assess your organisation’s quality maturity and develop the necessary enabler to help your team deliver higher performance.
Audit and assessment:
We can help to evaluate if existing facilities are fit for purpose by conducting a rigorous technical due diligence audit.
Looking to buy new equipment or to assess material suppliers? We have SMEs around the globe ready to help you address all critical aspects of the product lifecycle and work as your partner to mitigate your risk.
Please fill up the details below to download the brochure
Suspension of a site’s GMP certification imposes substantial stress and impact on business, as well as the potential shortage of market supply. This case study
Pharmaceutical quality is quintessential. Any departures from pharmaceutical quality are called deviations and can occur at any point during a process or product lifecycle. Deviations