The Importance of a Pharmaceutical Audit Checklist for Drug Industry

An audit checklist for pharmaceutical manufacturers is an indispensable resource, enabling them to conduct routine safety and quality checks while improving production processes.

Check that there is an applicable provision in legislation which stipulates that those at locations where APIs or medicinal products are manufactured, imported and exported must cooperate with inspectors rather than hinder their work.

1. Documentation

Pharmaceutical companies must document each stage of drug development. Documentation guidelines serve to provide audit techniques guidance for agents and managers examining taxpayer claims of increasing research activities credit for increasing research activities claimed. They can also help prepare a company in defense of its tax credits during an IRS examination.

Regulatory inspectors dedicate much of their time examining documents and records held by businesses, with documentation being an essential element. A systematic approach to documentation also assists companies with complying with FDA cGMP regulations which mandate a formal system of controls to ensure drugs meet quality standards – this involves creating strong quality management systems, procuring high-grade raw materials, creating robust operating procedures, as well as monitoring for deviations, failures, or errors that might occur.

2. Document Control

Document control is essential to any regulated industry, but pharmaceutical firms require it even more so. With numerous government regulations and thousands of documents to manage, document control software can help streamline processes while simultaneously reducing risks and assuring regulatory compliance.

Pharmaceutical companies that utilize an efficient document management system can implement clear policies and procedures regarding all documents, including standardizing structures, approving new or amended documents for release or change, reviewing them regularly, and taking any appropriate actions when they become obsolete.

Efficient document management ensures that documents related to different drugs remain separate through consistent metadata and file naming, making for simple organization.

3. Training

Training is an integral component of pharmaceutical operations and should be seen as an investment in both staff and patients’ wellbeing. Formal internal training helps employees understand the intricate web of regulatory requirements while providing them with skills needed to audit their processes effectively.

Effective training requires early identification of knowledge gaps and offering employees opportunities to acquire new skills. CBM assessments provide learning leaders with valuable data for tailoring future training programs accordingly.

Employing the appropriate internal auditing software can ease the strain on employees, freeing up more time for patient care and other areas of business. A mobile-ready inspection platform makes auditing simpler for staff allowing them to quickly capture wins and report issues while on the move.

4. Document Management Software

Pharmaceutical manufacturers need a system of controlling quality documentation, and an effective document management system such as MasterControl Documents can assist them in doing this effectively and ensure cGMP compliance.

An efficient document management system in pharmaceuticals serves as the single source of truth for all documents, helping eliminate communication breakdowns that often occur when different departments or divisions approach managing a process differently and decreasing wasteful time spent by workers on various processes. Furthermore, faster market arrival of drug products allows faster adoption rates.

An effective pharmaceutical document management system offers robust functionality, such as version and revision control, approval workflows, archiving, electronic signatures that comply with 21 CFR Part 11, secure central repository access, electronic signature compliance for 21 CFR Part 11 regulations and more. Such systems are invaluable tools in maintaining regulatory compliance with cGMP, GLP or any other international requirements.

5. Auditing

Regulatory bodies conduct audits to ensure pharmaceutical companies comply with strict standards. They may inspect manufacturing plants, supplier facilities or third-party vendors without prior notification – typically unannounced by teams of inspectors.

As audits serve as the foundation for making recommendations and building public trust that products meet safety requirements, it is also crucial that drug manufacturers understand what will be covered during these audits in order to keep their licenses.

This portion of the audit checklist covers more general facility issues, including whether there is enough floor space available for production and adequate atmospheric controls; additionally it may address warehouse storage and distribution.