The below article was written for this blog by QA Manager, Zahra Khokher and our Associate Director of PV, Ejaz Butt.

SOP Writing, Gap Analysis & Inspection Readines

Background

In the pharmaceutical industry, it is very important that a MAH has documented procedures in place in accordance with the regulatory requirements. This is a critical requirement in pharmacovigilance (PV) where patient safety is at risk if compliant procedures are not in place. From adverse event case management and PV training to signal detection and the implementation of risk management plans, the scope of PV SOPs is very broad and requires collaboration across multiple functions to develop and maintain SOPs.

How Zigzag can support you

Zigzag can help you develop your SOPs and can also review your existing SOPs to identify any gaps in the quality management system. If your SOPs are well-written, this will improve your day-day processes and ultimately contribute towards achieving regulatory compliance. For newer SOP topics, your company may benefit from customised SOP training. Zigzag specialise in providing SOP training whether it is face-face or WebEx training, we can accommodate your requirements.

Zigzag can also help you to become inspection ready by providing the above services and also carrying out mock inspections.

Quality Assurance (QA) Services

Zigzag specialise in providing the following QA services for PV:

• Conducting Audits

• Corrective And Preventative Actions (CAPA) Management

• Preparing Risk Assessment Tools and Audit Schedule / Universe

We can support you with auditing the many parties that may form part of your global PV system included but not limited to:

• Affiliates / Local Operating Companies

• Distributors

• Marketing Partners

• PV Service Providers / Vendors

For system-based PV audits, we have experience in conducting audits of:

• Aggregate Safety Reporting

• Safety Oversight in Clinical Trials

• Market Research Programmes

• Patient Support Programmes

• PV System Master Files

• Risk Evaluation and Mitigation Strategy (REMS) Programmes

If you are looking to outsource PV services to a new provider, we can also assist with qualification audits of the provider to give you the assurance that the provider can meet your company’s needs in accordance with regulatory requirements.

Contact us for more information at info@zigzagassociates.com or find out more on our website.

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